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.

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").

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.

On July 5, 2022 ArriVent Biopharma, Inc., dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported that the first patient has been enrolled in its Phase 1b trial of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) or HER2 mutations, including exon 20 insertion mutations (Press release, ArriVent Biopharma, JUL 5, 2022, https://arrivent.com/press-release/arrivent-biopharma-announces-first-patient-enrolled-in-global-phase-1b-trial-of-furmonertinib-in-advanced-or-metastatic-non-small-cell-lung-cancer-with-egfr-or-her2-mutations/?utm_source=rss&utm_medium=rss&utm_campaign=arrivent-biopharma-announces-first-patient-enrolled-in-global-phase-1b-trial-of-furmonertinib-in-advanced-or-metastatic-non-small-cell-lung-cancer-with-egfr-or-her2-mutations [SID1234616468]). Furmonertinib, an oral, irreversible, pan-EGFR mutant selective inhibitor—which has been shown to be highly brain penetrant—was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) in this indication.

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"This is an important milestone for ArriVent as it represents the initiation of our Company’s first clinical trial and the first global study for furmonertinib—a promising therapy for patients with NSCLC," said Stuart Lutzker, M.D., Ph.D., President of R&D at ArriVent. "Furmonertinib was initially developed and approved in China for EGFR T790M mutant NSCLC, and more recently was approved in China as a first-line treatment for classical EGFR mutant NSCLC by our partners Allist Pharmaceuticals, who continue to advance its development in other indications including EGFR exon 20 insertion mutant NSCLC."

Continued Dr. Lutzker: "In parallel to the important clinical research ongoing by our partners in China, we look forward to further developing furmonertinib globally in a broad spectrum of EGFR and HER2 mutant NSCLC patients, including those with brain metastases, which occurs in 50-60% of patients during the course of their disease. With this FDA designation, we will be able to expedite the development and regulatory review process of furmonertinib, and if successful, deliver this EGFR inhibitor as a meaningful treatment option for the thousands of patients impacted by this serious and life-threatening disease."

The FDA’s Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

About Furmonertinib

Furmonertinib is an oral, small molecule, highly brain-penetrant, pan-EGFR mutant inhibitor that targets both classical (exon 19 deletion and L858R) and atypical EGFR mutations, including exon 20 insertion mutations as well as HER2 exon 20 insertion mutations. Furmonertinib is approved in China as an anticancer therapy for EGFR T790M NSCLC patients, and more recently, as a first-line treatment for classical EGFR mutant NSCLC patients. Furmonertinib is being developed in China by Allist Pharmaceuticals and in the rest of the world by ArriVent Biopharma.

About EGFR mutant NSCLC

Globally, lung cancer is the leading cause of cancer-related deaths among men and women. Non-small cell lung cancer (NSCLC) is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the epidermal growth factor receptor (EGFR) is a common and early event in the development of NSCLC and is present in approximately 32% of NSCLC patients. The most common EGFR activating mutations are exon 19 deletions and a point mutation in exon 21 (L858R), which together are termed classical EGFR mutations and account for approximately 67% of all the EGFR mutations. 31% of EGFR activating mutations are termed atypical EGFR mutations of which exon 20 insertion mutations constitute 9% of EGFR activating mutations overall.

About the Phase 1b Clinical Trial

The furmonertinib Phase 1b, open-label, multi-center, dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations, including Exon 20 insertion mutations. Patients will be enrolled into two stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion). For more information about the trial, please visit clinicaltrials.gov (NCT05364073).

On July 5, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in a pre-recorded fireside chat at the William Blair Biotech Focus Conference 2022, which will be available to view on-demand beginning Monday, July 11, 2022 (Press release, Exelixis, JUL 5, 2022, View Source [SID1234616484]).

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for at least 30 days.