Aurigene Discovery Technologies Limited Announces Drug Discovery, Development and Commercialization Partnership with EQRx

On July 5, 2022 Aurigene’s small molecule drug discovery platform reported The collaboration combines EQRx’s pioneering business model to accelerate the development of drug candidates in the areas of oncology and immune-inflammatory diseases and improve global access to innovative medicines (Press release, Aurigene Discovery, JUL 5, 2022, View Source [SID1234616480]).

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Under the terms of the collaboration agreement, Aurigene and EQRx will collaborate on drug discovery, pre-clinical and clinical development and commercialization. Aurigene will lead drug discovery and pre-clinical development efforts, and EQRx will assume responsibility for clinical development, manufacturing, regulatory and commercialization efforts. The parties would share both funding for the discovery and development of the programs and financials resulting from the commercialization of any eventual drug candidates.

"This agreement with EQRx further validates Aurigene’s proven expertise in discovery and preclinical development of novel therapeutics and moves Aurigene forward into building a global oncology franchise participating in the end-to-end value chain," said Murali Ramachandra, Ph.D., Chief Executive Officer of Aurigene. "We are excited to collaborate with EQRx and contribute to developing and delivering innovative medicines to patients at more affordable prices."

"We are pleased to partner with Aurigene to expand our future pipeline and accelerate the discovery of next-generation therapeutics," said Carlos Garcia-Echeverria, PhD, chief of Rx creation at EQRx. "Our combined efforts will focus on some of the most high-impact therapeutic targets across oncology and immune-inflammatory diseases. Given our mission, we believe these future programs hold the potential to create important treatments for patients and drive meaningful savings for healthcare systems around the world."

Urovant Sciences and Pierre Fabre Médicament Enter into Exclusive License Agreement to Commercialize Vibegron for the Treatment of Overactive Bladder in the European Economic Area, UK, and Switzerland

On July 5, 2022 Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., and Pierre Fabre Médicament reported they have entered into an exclusive license agreement for Pierre Fabre to register and commercialize vibegron for the treatment of Overactive Bladder (OAB) in the European Economic Area, UK, and Switzerland, with some option territories, which notably include French-speaking countries of Sub-Saharan Africa, Turkey, and certain Eastern European countries (Press release, Pierre Fabre, JUL 5, 2022, View Source [SID1234616481]). Urovant will retain full rights in the United States and other select markets.

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"We are thrilled to partner with Pierre Fabre, a leader in the international biopharmaceutical space," said Jim Robinson, Chief Executive Officer of Urovant Sciences. "Their experience in the global OAB and Benign Prostatic Hyperplasia (BPH) market make them uniquely suited to deliver vibegron to more patients who need it across Europe and surrounding areas."

Under the terms of the agreement, Urovant Sciences will receive payments up to USD $75 million, based on upfront, regulatory, and sales milestone payments. Additionally, Urovant will receive royalties based on sales performance.

Urovant Sciences and Pierre Fabre will share responsibility for vibegron clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.

"We are delighted to enter into this partnership with Urovant, which will bring effective treatment and improved quality of life to all patients suffering from Overactive Bladder (OAB) in Europe. This partnership confirms Pierre Fabre’s extensive expertise in urology and in women’s health for five decades and the group’s ambitions to offer therapeutic solutions to chronic diseases that are very disabling in everyday life," said Eric Ducournau, group CEO at Pierre Fabre.

About Overactive Bladder

Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1

While 33 million US adults experience the bothersome symptoms of OAB, approximately 546 million people ≥ 20 years are affected by OAB worldwide. 1,2

Alpha Tau Hosting Key Opinion Leader Meeting on Alpha DaRT Clinical Trials

On July 5, 2022 Alpha Tau Medical Ltd. (Nasdaq: DRTS) ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that it will host a hybrid in-person/virtual key opinion leader (KOL) meeting at Convene (North Hub Room), located at 530 5th Ave. New York, NY on Monday, July 18, 2022 beginning at 10:30 am Eastern Time (Press release, Alpha Tau Medical, JUL 5, 2022, View Source [SID1234616466]). For those attending in-person, breakfast will begin at 10:30 am Eastern Time. For those attending virtually, the presentations and webcast will begin at 11:00 am Eastern Time.

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The meeting will feature presentations from KOLs Michael J. Zelefsky, MD, Memorial Sloan Kettering Cancer Center, Mark D’Andrea, MD, University Cancer Centers, and Robert Den, MD, Alpha Tau’s Chief Medical Officer, who will discuss Alpha Tau’s therapy (the Alpha DaRT radiation technology) and the Company’s clinical trial outlook. For those attending the event in person, a selection of the Company’s proprietary applicators will also be available for demonstration.

The Alpha DaRT technology is based on inserting directly into the tumor small amounts of radioactive radium-224 affixed to metal sources which are designed to decay and release radioactive atoms that diffuse inside the tumor, emitting short-range alpha radiation that aims to damage and kill cancer cells within a short period of time.

During the KOL presentations, Alpha Tau’s recent clinical trials, upcoming U.S. pivotal trial in recurrent cutaneous Squamous Cell Carcinoma (SCC), other upcoming clinical trials, and the Company’s pre-clinical work on potential immunological effects of the Alpha DaRT technology will be discussed.

A Q&A session will follow the formal presentations. To register for the event or webcast, please click here. If you would like to attend in person, please indicate this selection when registering and you will receive an email confirming your attendance closer to the event with specific location details.

Michael J. Zelefsky, MD is an internationally renowned radiation oncologist who is Professor of Radiation Oncology at Memorial Sloan Kettering Cancer Center and the Weil Cornell Medical Center. He serves as the Chief of the Brachytherapy Service at MSKCC which represents one of the most active sites for performing brachytherapy in the world, involved in highly innovative and sophisticated oncology procedures incorporating the delivery of radiation-based implants directly into tumors. Dr Zelefsky is the incumbent Greenberg Chair of Prostate Cancer Research at MSKCC and serves as the Co-Leader of the Genitourinary Disease Management team for the hospital as well as the Director of GU Radiation Oncology. He has published over 400 papers in Oncology as well as Book Chapters and Reviews. He also serves as the Editor in Chief of the Journal Brachytherapy.

Mark D’Andrea, MD is a board-certified Radiation Oncologist providing services in Houston, Brenham, and Huntsville. Primarily affiliated with University Cancer Centers, Dr. D’Andrea has been named one of Houston’s Top Doctors from 2016 through 2021. He has received the Patient’s Choice award, Most Compassionate Doctor, and Peer Reviewed Physician, among several other distinctions over the years. Dr. D’Andrea has over 30 years of expertise in breast cancer, prostate cancer, lung cancer, head and neck cancer, gastrointestinal cancer, and gynecologic cancer treatments. Dr. D’Andrea has been published in over 30 clinical medical research publications.

Robert Den, MD has served as Alpha Tau’s Chief Medical Officer since 2019. Dr. Den specializes in radiation oncology and conducts innovative research across a broad variety of malignancies. From 2011 to 2015 and from 2015 to the present, Dr. Den has served as an assistant professor and an associate professor, respectively, at Jefferson University, where he has also served as a clinical practitioner since 2007. Dr. Den holds a B.S. in Chemistry from Yale University and an M.D. from Harvard Medical School.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Boehringer Ingelheim, Evotec and bioMérieux launch Aurobac, a joint venture to fight Antimicrobial Resistance

On July 5, 2022 Boehringer Ingelheim, a leading research-driven biopharmaceutical company, the life science company Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and bioMérieux, a world leader in in vitro diagnostics, reported that they have formed a joint venture to create the next generation of antimicrobials along with actionable diagnostics to fight Antimicrobial Resistance (AMR) (Press release, Boehringer Ingelheim, JUL 5, 2022, View Source [SID1234616482]).

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The resulting company, Aurobac Therapeutics SAS, will combine the best capabilities of the three founding companies towards developing a new precision medicine approach, from diagnosis to cure. The aspiration is to succeed in the fight against AMR, which is a major public health threat. Having routine surgery such as caesarean sections or hip replacements may become life threatening, and complications from common diseases such as diabetes and injuries or cuts will become harder to manage because of growing resistance to antibiotics in patients.

"The rise of antibiotic-resistant infections – also called antimicrobial resistance, or AMR – is indeed a looming global crisis," said Michel Pairet, Head of Boehringer Ingelheim’s Innovation Unit and Member of the Board of Managing Directors. "Antibiotic resistance kills about 1.27 million people globally every year1 and it has been estimated that by 2050, as many as 10 million worldwide deaths could result from AMR2, making it potentially deadlier than cancer."

Werner Lanthaler, CEO of Evotec added: "The grim prospect of a post-antibiotic era has many causes but only one solution: The development of new, targeted, and effective antimicrobial therapies. We are excited to launch Aurobac together with our partners at Boehringer Ingelheim and bioMérieux, to combine our complementary strengths. By leveraging Evotec’s multimodality approach to infectious diseases, we are confident that Aurobac will be able to generate much-needed progress to tackle the global challenge of AMR."

"bioMérieux has a strong expertise in antimicrobial resistance. We supply the most comprehensive integrated diagnostic solutions to support an appropriate use of antibiotics (antimicrobial stewardship)," said Alexandre Mérieux, bioMérieux Chairman and CEO. "Our role within the joint venture is to develop and commercialize diagnostic tests, including Companion Diagnostics, which deliver rapid, reliable and actionable results. This participation in Aurobac is perfectly aligned with bioMérieux’ full commitment to sustain antibiotic efficacy for future generations."

Aurobac will work to shift the strategy related to antibiotic treatment regimens which at the moment leans heavily on empirical approaches using broad-spectrum and unfocused medicines. The goal is to turn this into a precision approach, using new highly effective and targeted modalities, combined with rapid and actionable diagnostics to quickly identify pathogens and their resistance patterns, and supported by new economic models.

Funded by Boehringer Ingelheim as lead investor with 30 million EUR and by Evotec and bioMérieux with 5 million EUR each, the 40 million EUR joint venture, which has its headquarters in Lyon (France), combines the world leading expertise of Evotec, one of the most active research companies in infectious diseases, with bioMérieux’s market-leading expertise in infectious disease diagnostics and with Boehringer Ingelheim’s broad drug discovery and significant clinical development capabilities.

Three partners committed to combat AMR

Boehringer Ingelheim’s participation in Aurobac is part of a wider so-called pandemic preparedness initiative, which includes a 50 million EUR investment in the AMR action fund by Boehringer Ingelheim. Boehringer Ingelheim Venture Fund has committed to invest up to 12 million EUR in AMR infection companies.

bioMérieux has over 55 years of diagnostics expertise with more than 75 percent of its research and development budget focused on antimicrobial resistance. Moreover, 80 percent of its turnover is related to the fight against AMR through a complete diagnostic solution facilitating antibiotic therapy decision-making, including antibiotic initiation, optimization, and discontinuation.

Evotec has built a world-leading platform to tackle infectious diseases. With a more than 200-strong anti-infective discovery team, the company has proven experience on multiple agent classes. On top of the company’s own pre-competitive pandemic preparedness and rapid response technology platform ("PRROTECT"), Evotec leverages its infectious disease capabilities with many industry, academic and non-profit partners and is active in a variety of networks such as the AMR Accelerator that is part of the EU’s Innovative Medicines Initiative ("IMI").

Aravive Appoints Dr. Robert B. Geller as Chief Medical Officer

On July 5, 2022 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported the appointment of Dr. Robert B. Geller as Chief Medical Officer (Press release, Aravive, JUL 5, 2022, View Source [SID1234616467]). Dr. Geller is a medical oncologist with over 30 years of drug development experience leading all aspects of clinical and medical affairs, including commercialization preparedness and launch of novel therapeutics. Dr. Geller will play a critical role in progressing Aravive’s portfolio of programs in ovarian, renal and pancreatic cancers.

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"Dr. Geller is a great addition to the management team as we near completion of the global registrational Phase 3 trial in platinum-resistant ovarian cancer, accelerate the ccRCC development program, and prepare to file our first BLA end of 2023," stated Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "Dr. Geller’s wealth of experience in clinical development and medical affairs, including direct involvement with the FDA across the entirety of drug development, submission and approval, rounds out our internal capabilities and helps to maximize the probability of success of batiraxcept."

"I feel very fortunate and proud that I am able to join Aravive at this critical juncture, as the company nears key value inflection points," stated Dr. Robert B. Geller, Chief Medical Officer of Aravive. "As a medical oncologist, I have devoted my career to caring for patients, and developing and commercializing new therapies for cancer patients. Based upon the clinical data to date on batiraxcept, I am convinced that batiraxcept has the potential to meet the high unmet medical needs of patients with advanced cancers, and potentially become a best-in-class medicine across a range of tumors, including ovarian, renal and pancreatic cancer, which require new treatment approaches."

Dr. Geller started his academic career as the Director of the Stem Cell Transplant program at the University of Chicago and as the Director of the Leukemia Service and Director of the Unrelated Transplant Program, Emory University. He then transitioned to community practice where he focused on the development of clinical pathways for patients with hematologic malignancies and solid tumors, and the expansion of community-based clinical research programs. After over two decades in clinical practice, he then transitioned to the biopharmaceutical industry, where he held positions in medical affairs and clinical development at Alexion, Heron Therapeutics, and most recently as Senior Vice President (Medical Affairs) at Coherus Biosciences where he was involved in the clinical development and successful commercialization of both their biosimilar franchise and their immune-oncology pipeline. Dr. Geller has authored over 200 publications and abstracts and has served as reviewer for numerous medical journals. Dr. Geller earned Bachelor and Master of Science degrees in Physics at MIT and Medical Doctor degree from Harvard Medical School. Dr. Geller completed a medical residency at the Hospital of the University of Pennsylvania and Medical Oncology Fellowship at the Johns Hopkins Oncology Center. Dr Geller is a Diplomat in Internal Medicine and Medical Oncology with the American Board of Internal Medicine.