precision biosciences presentation

Aura Biosciences to Host a Urologic Oncology Investor Event to Present Early Non-Muscle Invasive Bladder Cancer (NMIBC) Data from its Ongoing Phase 1 Trial on Thursday, October 17, 2024

BOSTON, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function, today announced that it will host a virtual urologic oncology investor event on Thursday, October 17, 2024, at 4:30 PM ET. Aura also announced that Dr. Sabine Brookman-May is joining Aura as its Senior Vice President, Clinical Development Urologic Oncology in October 2024.

Virtual investor event on Thursday, October 17, 2024, to present early NMIBC data from ongoing Phase 1 trial

The event will feature key opinion leaders (KOLs) Max Kates, MD (Brady Urological Institute at Johns Hopkins), Joe Jacob, MD, MCR (SUNY Upstate), Neal Shore, MD, FACS (Carolina Urologic Research Center) and Gary Steinberg, MD, FACS (Rush University). The KOLs will discuss the early NMIBC data from Aura’s ongoing Phase 1 trial as well as the high unmet medical need and current treatment landscape in NMIBC. To register for the virtual event, click here.

The ongoing Phase 1 multi-center, open-label clinical trial is designed as a window of opportunity study to assess the safety and feasibility of local administration of a novel virus-like drug conjugate (bel-sar (AU-011)) as a monotherapy prior to standard of care. The study is designed to evaluate different approaches to optimize the feasibility of local administration and includes histopathological evaluation after a single dose to assess bel-sar’s biological activity and dual mechanism of action including the characterization of the immune response.

A live question and answer session will follow the formal presentation.

The live webcast of the event will be available on the “Investors & Media” page under the “Events & Presentations” section of Aura’s website at https://ir.aurabiosciences.com/events-and-presentations, where a replay of the webcast will be archived for 90 days following the presentation date.

Dr. Sabine Brookman-May to join Aura as its Senior Vice President, Clinical Development Urologic Oncology

“We are excited to expand our leadership team with the appointment of Dr. Sabine Brookman-May who brings years of experience leading bladder cancer development globally with a multidisciplinary approach to clinical research,” said Elisabet de los Pinos, Ph.D, Chief Executive Officer of Aura. “Dr. Brookman-May’s appointment comes at an important time for Aura’s bladder cancer program, as we develop the strategic clinical development plan for bel-sar in bladder cancer and more broadly in oncology.”

“I look forward to joining Aura and believe that virus-like drug conjugates are one of the most exciting novel class of drugs that are currently being developed in NMIBC with the potential to transform the treatment paradigm for patients with bladder cancer,” said Dr. Brookman-May. “I believe Aura has a unique opportunity with bel-sar’s highly differentiated dual mechanism of action to potentially become a new standard of care for patients living with this disease. I look forward to leading Aura’s urologic oncology therapeutic area.”

Dr. Brookman-May brings over 20 years of multidisciplinary experience in urology, spanning clinical care, academia, industry and entrepreneurial innovation. Dr. Brookman-May has served as Vice President, Global R&D, Bladder Cancer Development Head at Janssen Research and Development with responsibility for strategic and clinical oversight of its portfolio of bladder cancer programs. Prior to this position, Dr. Brookman-May also served in several research and clinical positions at Janssen of increasing complexity and responsibility since 2012. In addition, Dr. Brookman-May holds an academic appointment as a professor in the Department of Urology at Ludwig-Maximilians University Munich. She is a board-certified urologist with certificates in both medical tumor treatment and sports medicine, and has published more than 200 peer-reviewed papers in the field of urologic oncology.

About Max Kates, MD

Max Kates, MD is an Associate Professor of Urology and Oncology in the Brady Urological Institute at Johns Hopkins. He directs the Division of Urologic Oncology for the Brady Urological Institute and is a clinical director of the bladder cancer multidisciplinary clinic. Dr. Kates completed his undergraduate degree at Wesleyan University in Connecticut before pursuing his medical degree at Mount Sinai School of Medicine in New York. He then went on to train at Johns Hopkins for his urologic residency and Society of Urologic Oncology (SUO) fellowship. Dr. Kates has expertise in all areas of urologic oncology, with a particular clinical emphasis on prostate and bladder cancer and research interest in novel treatments for cancers of the urinary tract. Dr. Kates has authored more than 135 journal articles in the fields of bladder, prostate, and kidney cancer. He currently has a provisional patent for a novel intravesical chemotherapy developed with nano-engineer collaborators. Additionally, Dr. Kates has made important discoveries into the mechanism of action of intravesical BCG, the most common treatment for bladder cancer and is the principal investigator on multiple trials.

About Joe Jacob, MD, MCR

Joe Jacob, MD, MCR received his medical degree from Ohio State University College of Medicine and completed urology residency and urologic oncology fellowship at Indiana University. In addition, he holds a Master’s in Clinical Research from Indiana University. He is currently an associate professor at SUNY Upstate, where he is both Director of Urologic Oncology and of the bladder cancer program. His published research includes work in genomic profiling of genitourinary tumors as well as assessments of immuno-oncologic biomarkers. Dr. Jacob has conducted numerous clinical trials both as a principal investigator (PI) and is an active global PI. He is currently a member of the Bladder Clinical Trials Committee for the Society of Urologic Oncology.

About Neal Shore, MD, FACS

Neal Shore, MD, FACS graduated from Duke University and Duke University Medical School. He completed his general surgery/urology residency at New York Hospital-Cornell Medical Center/Memorial Sloan Ketering Cancer Center. He serves as the Medical Director for the Carolina Urologic Research Center. Dr. Shore has conducted more than 400 clinical trials, focusing mainly on genitourinary oncology, and has authored more than 350 peer-reviewed publications and numerous book chapters. He serves on the Society for Immunotherapy of Cancer (SITC) Guidelines Committee for Bladder Cancer, as well as the boards of the Bladder Cancer Advocacy Network, the APCCC Scientific Steering Committee, Maple Tree Cancer Alliance, Alessa Therapeutics, Photocure, and the Duke Global Health Institute. He is the Chair of both the Prostate Cancer Academy and the Bladder/Kidney Cancer Academy, and the co-chair of the annual AUA International Prostate Forum. He has served/serves on the editorial boards of Reviews in Urology, Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, JUOP and World Journal of Urology. He is the Editor of Reviews in Urology and serves as an Editor of Everyday Urology-Oncology. He is a Fellow of the American College of Surgeons.

About Gary Steinberg, MD, FACS

Gary Steinberg, MD, FACS received his medical degree from the University of Chicago Pritzker School of Medicine and completed urology residency and urologic oncology fellowship at The Brady Urological Institute- Johns Hopkins University. He is a professor in the Department of Urology at Rush University in Chicago. Dr. Steinberg is a national authority in the surgical treatment of bladder cancer and continent urinary tract reconstruction and is a recognized expert in translational bladder cancer research as well as innovative clinical trials. A prolific researcher, Dr. Steinberg has made significant contributions to our understanding of both non-muscle invasive and invasive bladder cancer and serves as the principal investigator on numerous clinical trials, working to identify new novel therapies as well as molecular biomarkers to detect the disease. Dr. Steinberg has authored or coauthored more than 200 articles as well as nearly two dozen chapters for medical textbooks. Currently, he serves on the editorial board of multiple urologic oncology journals and is the immediate past chairperson of the scientific advisory board of the Bladder Cancer Advocacy Network.

About Aura Biosciences

Aura Biosciences is a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function. Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with primary choroidal melanoma, and other ocular oncology indications as well as in early-stage clinical development in bladder cancer. We are evaluating the safety and efficacy of bel-sar as a potential vision-sparing therapy in an ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with early-stage choroidal melanoma. Bel-sar is also being evaluated in additional solid cancers, including bladder cancer. Our mission is to develop vision and organ-sparing therapies to improve patient outcomes in cancer. Aura is headquartered in Boston, MA. For more information, visit aurabiosciences.com. Visit us @AuraBiosciences and on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward-looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of bel-sar for the treatment of cancers including bladder cancer; statements regarding the Company’s expectations for the Phase 1 trial of bel-sar for bladder cancer; statements regarding the timing of the Company’s plans to present data with respect to its Phase 1 clinical trial of bel-sar for the treatment of bladder cancer; statements regarding the Company’s expectations for an improved quality of life of patients after treatment with bel-sar and changes to the treatment paradigm for patients; statements regarding the Company’s beliefs and expectations for the high unmet medical need for an effective local treatment in urologic oncology; statements regarding the Company’s expectations for the estimated patient populations and related market opportunities for bel-sar; and statements regarding the timing of the announcement of early NMIBC data from Aura’s ongoing Phase 1 trial of bel-sar.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s preclinical and clinical trials may not be predictive of future results in connection with future clinical trials; the risk that interim data from ongoing clinical trials may not be predictive of final data from completed clinical trials; the risk that governmental authorities may disagree with Aura’s clinical trial designs, even where Aura has obtained agreement with governmental authorities on the design of such trials, such as the Phase 3 special protocol assessment agreement with the U.S. Food and Drug Administration; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; Aura’s ongoing and planned preclinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

Investor and Media Contact:

Alex Dasalla Head of Investor Relations and Corporate Communications [email protected]

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Aura Biosciences to Host a Urologic Oncology Investor Event to Present Early Non-Muscle Invasive Bladder Cancer (NMIBC) Data from its Ongoing Phase 1 Trial on Thursday, October 17, 2024

Sabine Doris Brookman-May, MD, PhD to join Aura as Senior Vice President, Clinical Development Urologic Oncology

BOSTON, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function, today announced that it will host a virtual urologic oncology investor event on Thursday, October 17, 2024, at 4:30 PM ET. Aura also announced that Dr. Sabine Brookman-May is joining Aura as its Senior Vice President, Clinical Development Urologic Oncology in October 2024.

Virtual investor event on Thursday, October 17, 2024, to present early NMIBC data from ongoing Phase 1 trial

The event will feature key opinion leaders (KOLs) Max Kates, MD (Brady Urological Institute at Johns Hopkins), Joe Jacob, MD, MCR (SUNY Upstate), Neal Shore, MD, FACS (Carolina Urologic Research Center) and Gary Steinberg, MD, FACS (Rush University). The KOLs will discuss the early NMIBC data from Aura’s ongoing Phase 1 trial as well as the high unmet medical need and current treatment landscape in NMIBC. To register for the virtual event, click here.

The ongoing Phase 1 multi-center, open-label clinical trial is designed as a window of opportunity study to assess the safety and feasibility of local administration of a novel virus-like drug conjugate (bel-sar (AU-011)) as a monotherapy prior to standard of care. The study is designed to evaluate different approaches to optimize the feasibility of local administration and includes histopathological evaluation after a single dose to assess bel-sar’s biological activity and dual mechanism of action including the characterization of the immune response.

A live question and answer session will follow the formal presentation.

The live webcast of the event will be available on the “Investors & Media” page under the “Events & Presentations” section of Aura’s website at https://ir.aurabiosciences.com/events-and-presentations , where a replay of the webcast will be archived for 90 days following the presentation date.

Dr. Sabine Brookman-May to join Aura as its Senior Vice President, Clinical Development Urologic Oncology

“We are excited to expand our leadership team with the appointment of Dr. Sabine Brookman-May who brings years of experience leading bladder cancer development globally with a multidisciplinary approach to clinical research,” said Elisabet de los Pinos, Ph.D, Chief Executive Officer of Aura. “Dr. Brookman-May’s appointment comes at an important time for Aura’s bladder cancer program, as we develop the strategic clinical development plan for bel-sar in bladder cancer and more broadly in oncology.”

“I look forward to joining Aura and believe that virus-like drug conjugates are one of the most exciting novel class of drugs that are currently being developed in NMIBC with the potential to transform the treatment paradigm for patients with bladder cancer,” said Dr. Brookman-May. “I believe Aura has a unique opportunity with bel-sar’s highly differentiated dual mechanism of action to potentially become a new standard of care for patients living with this disease. I look forward to leading Aura’s urologic oncology therapeutic area.”

Dr. Brookman-May brings over 20 years of multidisciplinary experience in urology, spanning clinical care, academia, industry and entrepreneurial innovation. Dr. Brookman-May has served as Vice President, Global R&D, Bladder Cancer Development Head at Janssen Research and Development with responsibility for strategic and clinical oversight of its portfolio of bladder cancer programs. Prior to this position, Dr. Brookman-May also served in several research and clinical positions at Janssen of increasing complexity and responsibility since 2012. In addition, Dr. Brookman-May holds an academic appointment as a professor in the Department of Urology at Ludwig-Maximilians University Munich. She is a board-certified urologist with certificates in both medical tumor treatment and sports medicine, and has published more than 200 peer-reviewed papers in the field of urologic oncology.

About Max Kates, MD

Max Kates, MD is an Associate Professor of Urology and Oncology in the Brady Urological Institute at Johns Hopkins. He directs the Division of Urologic Oncology for the Brady Urological Institute and is a clinical director of the bladder cancer multidisciplinary clinic. Dr. Kates completed his undergraduate degree at Wesleyan University in Connecticut before pursuing his medical degree at Mount Sinai School of Medicine in New York. He then went on to train at Johns Hopkins for his urologic residency and Society of Urologic Oncology (SUO) fellowship. Dr. Kates has expertise in all areas of urologic oncology, with a particular clinical emphasis on prostate and bladder cancer and research interest in novel treatments for cancers of the urinary tract. Dr. Kates has authored more than 135 journal articles in the fields of bladder, prostate, and kidney cancer. He currently has a provisional patent for a novel intravesical chemotherapy developed with nano-engineer collaborators. Additionally, Dr. Kates has made important discoveries into the mechanism of action of intravesical BCG, the most common treatment for bladder cancer and is the principal investigator on multiple trials.

About Joe Jacob, MD, MCR

Joe Jacob, MD, MCR received his medical degree from Ohio State University College of Medicine and completed urology residency and urologic oncology fellowship at Indiana University. In addition, he holds a Master’s in Clinical Research from Indiana University. He is currently an associate professor at SUNY Upstate, where he is both Director of Urologic Oncology and of the bladder cancer program. His published research includes work in genomic profiling of genitourinary tumors as well as assessments of immuno-oncologic biomarkers. Dr. Jacob has conducted numerous clinical trials both as a principal investigator (PI) and is an active global PI. He is currently a member of the Bladder Clinical Trials Committee for the Society of Urologic Oncology.

About Neal Shore, MD, FACS

Neal Shore, MD, FACS graduated from Duke University and Duke University Medical School. He completed his general surgery/urology residency at New York Hospital-Cornell Medical Center/Memorial Sloan Ketering Cancer Center. He serves as the Medical Director for the Carolina Urologic Research Center. Dr. Shore has conducted more than 400 clinical trials, focusing mainly on genitourinary oncology, and has authored more than 350 peer-reviewed publications and numerous book chapters. He serves on the Society for Immunotherapy of Cancer (SITC) Guidelines Committee for Bladder Cancer, as well as the boards of the Bladder Cancer Advocacy Network, the APCCC Scientific Steering Committee, Maple Tree Cancer Alliance, Alessa Therapeutics, Photocure, and the Duke Global Health Institute. He is the Chair of both the Prostate Cancer Academy and the Bladder/Kidney Cancer Academy, and the co-chair of the annual AUA International Prostate Forum. He has served/serves on the editorial boards of Reviews in Urology, Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, JUOP and World Journal of Urology. He is the Editor of Reviews in Urology and serves as an Editor of Everyday Urology-Oncology. He is a Fellow of the American College of Surgeons.

About Gary Steinberg, MD, FACS

Gary Steinberg, MD, FACS received his medical degree from the University of Chicago Pritzker School of Medicine and completed urology residency and urologic oncology fellowship at The Brady Urological Institute- Johns Hopkins University. He is a professor in the Department of Urology at Rush University in Chicago. Dr. Steinberg is a national authority in the surgical treatment of bladder cancer and continent urinary tract reconstruction and is a recognized expert in translational bladder cancer research as well as innovative clinical trials. A prolific researcher, Dr. Steinberg has made significant contributions to our understanding of both non-muscle invasive and invasive bladder cancer and serves as the principal investigator on numerous clinical trials, working to identify new novel therapies as well as molecular biomarkers to detect the disease. Dr. Steinberg has authored or coauthored more than 200 articles as well as nearly two dozen chapters for medical textbooks. Currently, he serves on the editorial board of multiple urologic oncology journals and is the immediate past chairperson of the scientific advisory board of the Bladder Cancer Advocacy Network.

About Aura Biosciences

Aura Biosciences is a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function. Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with primary choroidal melanoma, and other ocular oncology indications as well as in early-stage clinical development in bladder cancer. We are evaluating the safety and efficacy of bel-sar as a potential vision-sparing therapy in an ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with early-stage choroidal melanoma. Bel-sar is also being evaluated in additional solid cancers, including bladder cancer. Our mission is to develop vision and organ-sparing therapies to improve patient outcomes in cancer. Aura is headquartered in Boston, MA. For more information, visit aurabiosciences.com. Visit us @AuraBiosciences and on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward-looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of bel-sar for the treatment of cancers including bladder cancer; statements regarding the Company’s expectations for the Phase 1 trial of bel-sar for bladder cancer; statements regarding the timing of the Company’s plans to present data with respect to its Phase 1 clinical trial of bel-sar for the treatment of bladder cancer; statements regarding the Company’s expectations for an improved quality of life of patients after treatment with bel-sar and changes to the treatment paradigm for patients; statements regarding the Company’s beliefs and expectations for the high unmet medical need for an effective local treatment in urologic oncology; statements regarding the Company’s expectations for the estimated patient populations and related market opportunities for bel-sar; and statements regarding the timing of the announcement of early NMIBC data from Aura’s ongoing Phase 1 trial of bel-sar.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s preclinical and clinical trials may not be predictive of future results in connection with future clinical trials; the risk that interim data from ongoing clinical trials may not be predictive of final data from completed clinical trials; the risk that governmental authorities may disagree with Aura’s clinical trial designs, even where Aura has obtained agreement with governmental authorities on the design of such trials, such as the Phase 3 special protocol assessment agreement with the U.S. Food and Drug Administration; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; Aura’s ongoing and planned preclinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

Investor and Media Contact:

Alex Dasalla Head of Investor Relations and Corporate Communications [email protected]

Anixa Biosciences Announces Presentation on its Ovarian Cancer CAR-T Therapy at the Rivkin Center-AACR 15th Biennial Ovarian Cancer Research Symposium

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Sep 03, 2024, 08:30 ET

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SAN JOSE, Calif. , Sept. 3, 2024 /PRNewswire/ -- Anixa Biosciences, Inc.  ("Anixa" or the "Company") (NASDAQ: ANIX ), a biotechnology company focused on the treatment and prevention of cancer, today announced that the inventor of its ovarian cancer CAR-T technology, Jose R. Conejo-Garcia , M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine, will be speaking at the Rivkin Center and American Association for Cancer Research (AACR) 15th Biennial Ovarian Cancer Research Symposium. Dr. Conejo-Garcia will be giving the opening keynote address on Friday, September 20, 2024 .

During the keynote address, Dr. Conejo-Garcia will discuss Anixa's chimeric antigen receptor-T cell (CAR-T) technology, which is an autologous cell therapy comprised of engineered T cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor-T cell) therapy, a new type of CAR-T. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute. Dr. Conejo-Garcia will also discuss the ongoing Phase 1 clinical trial of this technology.

"I am pleased to discuss this novel FSHR-mediated CAR-T technology at the Ovarian Cancer Research Symposium and to share ideas and advance the field of ovarian cancer research," stated Dr. Conejo-Garcia. "Anixa and its development partner, Moffitt Cancer Center, have been working together to advance this ovarian cancer therapy and we are excited about the clinical results to date—with the treatment appearing to be safe and well-tolerated, and some patients exhibiting tumor necrosis. If this therapeutic approach is successful, this could enable a major shift in the overall treatment paradigm for ovarian cancer."

More information about the event may be found at: https://rivkin.org/symposia/ocrs/ .

About Anixa Biosciences, Inc. Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com  or follow Anixa on Twitter , LinkedIn , Facebook and YouTube .

Forward-Looking Statements Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

Contact: Mike Catelani President, COO & CFO [email protected] 408-708-9808

SOURCE Anixa Biosciences, Inc.

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Anixa Biosciences to Present at the H.C. Wainwright 26th Annual Global Investment Conference

Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today...

Anixa Biosciences Announces Presentation on its Ovarian Cancer CAR-T Clinical Trial at the International Gynecologic Cancer Society 2024 Annual Meeting

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Aura Biosciences, Inc.

Us05153u1079, biotechnology & medical research.

• Aura Biosciences to Host a Urologic Oncology Investor Event to Present Early Non-Muscle Invasive Bladder Cancer (NMIBC) Data from its Ongoing Phase 1 Trial on Thursday, October 17, 2024

Sabine Brookman-May is joining Aura as its Senior Vice President, Clinical Development Urologic Oncology in October 2024 .

Virtual investor event on Thursday, October 17, 2024 , to present early NMIBC data from ongoing Phase 1 trial

Gary Steinberg , MD, FACS ( Rush University ). The KOLs will discuss the early NMIBC data from Aura’s ongoing Phase 1 trial as well as the high unmet medical need and current treatment landscape in NMIBC. To register for the virtual event, click here.

The ongoing Phase 1 multi-center, open-label clinical trial is designed as a window of opportunity study to assess the safety and feasibility of local administration of a novel virus-like drug conjugate (bel-sar (AU-011)) as a monotherapy prior to standard of care. The study is designed to evaluate different approaches to optimize the feasibility of local administration and includes histopathological evaluation after a single dose to assess bel-sar’s biological activity and dual mechanism of action including the characterization of the immune response.

A live question and answer session will follow the formal presentation.

The live webcast of the event will be available on the “Investors & Media” page under the “Events & Presentations” section of Aura’s website at  https://ir.aurabiosciences.com/events-and-presentations, where a replay of the webcast will be archived for 90 days following the presentation date.

Sabine Brookman-May to join Aura as its Senior Vice President, Clinical Development Urologic Oncology

Elisabet de los Pinos, Ph.D, Chief Executive Officer of Aura. “Dr. Brookman-May’s appointment comes at an important time for Aura’s bladder cancer program, as we develop the strategic clinical development plan for bel-sar in bladder cancer and more broadly in oncology.”

“I look forward to joining Aura and believe that virus-like drug conjugates are one of the most exciting novel class of drugs that are currently being developed in NMIBC with the potential to transform the treatment paradigm for patients with bladder cancer,” said Dr. Brookman-May. “I believe Aura has a unique opportunity with bel-sar’s highly differentiated dual mechanism of action to potentially become a new standard of care for patients living with this disease. I look forward to leading Aura’s urologic oncology therapeutic area.”

Dr. Brookman-May brings over 20 years of multidisciplinary experience in urology, spanning clinical care, academia, industry and entrepreneurial innovation. Dr. Brookman-May has served as Vice President, Global R&D, Bladder Cancer Development Head at Janssen Research and Development with responsibility for strategic and clinical oversight of its portfolio of bladder cancer programs. Prior to this position, Dr. Brookman-May also served in several research and clinical positions at Janssen of increasing complexity and responsibility since 2012. In addition, Dr. Brookman-May holds an academic appointment as a professor in the Department of Urology at Ludwig-Maximilians University Munich. She is a board-certified urologist with certificates in both medical tumor treatment and sports medicine, and has published more than 200 peer-reviewed papers in the field of urologic oncology.

Max Kates , MD

Dr. Kates has made important discoveries into the mechanism of action of intravesical BCG, the most common treatment for bladder cancer and is the principal investigator on multiple trials.

Joe Jacob , MD, MCR

Dr. Jacob has conducted numerous clinical trials both as a principal investigator (PI) and is an active global PI. He is currently a member of the Bladder Clinical Trials Committee for the Society of Urologic Oncology .

Neal Shore , MD, FACS

Dr. Shore has conducted more than 400 clinical trials, focusing mainly on genitourinary oncology, and has authored more than 350 peer-reviewed publications and numerous book chapters. He serves on the Society for Immunotherapy of Cancer (SITC) Guidelines Committee for Bladder Cancer, as well as the boards of the Bladder Cancer Advocacy Network, the APCCC Scientific Steering Committee, Maple Tree Cancer Alliance , Alessa Therapeutics, Photocure, and the Duke Global Health Institute . He is the Chair of both the Prostate Cancer Academy and the Bladder/Kidney Cancer Academy , and the co-chair of the annual AUA International Prostate Forum . He has served/serves on the editorial boards of Reviews in Urology, Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, JUOP and World Journal of Urology . He is the Editor of Reviews in Urology and serves as an Editor of Everyday Urology-Oncology. He is a Fellow of the American College of Surgeons .

Gary Steinberg , MD, FACS

Dr. Steinberg has authored or coauthored more than 200 articles as well as nearly two dozen chapters for medical textbooks. Currently, he serves on the editorial board of multiple urologic oncology journals and is the immediate past chairperson of the scientific advisory board of the Bladder Cancer Advocacy Network.

About Aura Biosciences

Aura Biosciences is a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function. Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with primary choroidal melanoma, and other ocular oncology indications as well as in early-stage clinical development in bladder cancer. We are evaluating the safety and efficacy of bel-sar as a potential vision-sparing therapy in an ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with early-stage choroidal melanoma. Bel-sar is also being evaluated in additional solid cancers, including bladder cancer. Our mission is to develop vision and organ-sparing therapies to improve patient outcomes in cancer. Aura is headquartered in Boston, MA. For more information, visit aurabiosciences.com. Visit us @AuraBiosciences and on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward-looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of bel-sar for the treatment of cancers including bladder cancer; statements regarding the Company’s expectations for the Phase 1 trial of bel-sar for bladder cancer; statements regarding the timing of the Company’s plans to present data with respect to its Phase 1 clinical trial of bel-sar for the treatment of bladder cancer; statements regarding the Company’s expectations for an improved quality of life of patients after treatment with bel-sar and changes to the treatment paradigm for patients; statements regarding the Company’s beliefs and expectations for the high unmet medical need for an effective local treatment in urologic oncology; statements regarding the Company’s expectations for the estimated patient populations and related market opportunities for bel-sar; and statements regarding the timing of the announcement of early NMIBC data from Aura’s ongoing Phase 1 trial of bel-sar.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s preclinical and clinical trials may not be predictive of future results in connection with future clinical trials; the risk that interim data from ongoing clinical trials may not be predictive of final data from completed clinical trials; the risk that governmental authorities may disagree with Aura’s clinical trial designs, even where Aura has obtained agreement with governmental authorities on the design of such trials, such as the Phase 3 special protocol assessment agreement with the U.S. Food and Drug Administration ; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; Aura’s ongoing and planned preclinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC , which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

Investor and Media Contact:

Alex Dasalla Head of Investor Relations and Corporate Communications [email protected]

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Precision biosciences receives $13 million in proceeds from imugene convertible note maturity as part of the august 2023 azer-cel deal, -- payment includes $9.75 million cash and $3.25 million in imugene limited ordinary shares-- --the addition of this cash further reinforces precision&closecurlyquote;s expected cash runway into the second half of 2026--.

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, gene insertion, and gene excision, today announced maturity of a $13 million convertible note from its previously announced strategic transaction with Imugene Limited (ASX: IMU) for azercabtagene zapreleucel (azer-cel) in oncology. The proceeds to Precision BioSciences include $9.75 million in cash and $3.25 million in Imugene ordinary shares.

“We are pleased that Imugene continues to advance azer-cel toward a pivotal trial in LBCL for patients with significant unmet need,” said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences. “This marks one year since our strategic decision to focus our in-house programs exclusively on in vivo gene editing and further bolsters our balance sheet, enabling us to generate Phase 1 clinical data across multiple in vivo gene editing programs starting in the first half of 2025. In the near term, we are focused on progressing our pipeline towards the clinic and remain on track to file applications with multiple global regulatory bodies for PBGENE-HBV for chronic hepatitis B later this year.”

In August 2023, Precision announced a strategic transaction with Imugene. Under the agreement, Imugene assumed global rights to azer-cel for cancer, the ongoing clinical execution for azer-cel in large B-cell lymphoma (LBCL) patients who have relapsed following autologous CAR T treatment as well as Precision BioSciences’ CAR T capability, including manufacturing. In exchange, Precision received upfront economics valued at $21 million (all figures in USD) consisting of $8 million in cash and a $13 million convertible note. The convertible note matured on August 30, 2024 and resulted in payment to Precision of $9.75 million in cash and $3.25 million in Imugene stock. Precision is also eligible for additional payments based on azer-cel clinical milestones as well as milestones for other future nominated cancer research programs.

As of June 30, 2024, Precision had approximately $123.6 million in cash and cash equivalents, prior to receipt of the payment from Imugene. Existing cash and cash equivalents, upfront and potential near-term cash from CAR T transactions, along with expected operational receipts, continued fiscal and operating discipline, availability of Precision’s at-the-market (ATM) facility, and marketable securities are expected to extend Precision’s cash runway into the second half of 2026.

About Precision BioSciences, Inc.

Precision BioSciences, Inc. is an advanced gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com .

The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into gene to cause expression/add function), elimination (removing a genome e.g. viral DNA or mutant mitochondrial DNA), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV).

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the clinical development and expected safety, efficacy and benefit of our and our partners’ and licensees’ product candidates and gene editing approaches including editing efficiency, and the suitability of ARCUS nucleases for gene insertion, gene elimination and gene excision and differentiation from other gene editing approaches; the expected timing of regulatory processes (including filings and studies for PBGENE-HBV and PBGENE-PMM); expectations about our and our partners’ operational initiatives, strategies, and further development of our programs; expectations and updates around our partnerships and collaborations and our ability to enter into new collaborations, license agreements or other arrangements; our expected cash runway and available credit; the sufficiency of our cash runway extending into the second half of 2026; expectations about achievement of key milestones and receipt of any milestone, royalty, or other payments; expectations regarding our liquidity and capital resources; and anticipated timing of clinical data . In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “target,” “will,” “would,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ or other licensees’ ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ or other licensees’ development of product candidates; our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators’ and other licensees’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our or our licensees’ ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ or other licensees’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration and other license agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges; and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com .

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240903924891/en/

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