On July 5, 2022 Bio-Techne Corporation (NASDAQ:TECH), reported it has completed the acquisition of Namocell, Inc (Press release, Bio-Techne, JUL 5, 2022, View Source [SID1234616470]). The Namocell acquisition adds easy-to-use single cell sorting and dispensing platforms that are gentle to cells and preserve cell viability and integrity. Namocell’s instruments and consumables are critical technologies in various workflows in both biotherapeutics and diagnostics, including cell and gene therapy development and commercialization, cell engineering, cell line development, single cell genomics, antibody discovery, synthetic biology, and rare cell isolation.

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On July 5, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers reported positive interim results from Part A of the ongoing RINGSIDE Pivotal Phase 2/3 clinical trial evaluating AL102 in desmoid tumors. AL102 is a potent, selective, oral gamma-secretase inhibitor (GSI) (Press release, Ayala Pharmaceuticals, JUL 5, 2022, View Source [SID1234616469]).

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"We are very excited with the interim data from Part A of the RINGSIDE study, although early, demonstrating initial substantial anti-tumor activity for AL102 as a single agent as measured by MRI scans," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "We are also encouraged with the safety data showing that AL102 appears to be well tolerated. We look forward to presenting a more advanced and comprehensive data set at a medical meeting later in the year. The results from Part A will be used to determine the dose of AL102 to be evaluated in Part B of RINGSIDE, the randomized portion of the study, which Ayala is on track to initiate in the third quarter of 2022."

Interim Results as of the Cut-Off Date of May 1, 2022

Patient enrollment in Part A of RINGSIDE was completed in February 2022. Patients were dosed in AL102 monotherapy cohorts of 1.2 mg (daily), 2mg (2 days on, 5 days off), or 4mg (2 days on, 5 days off).
The activity of AL102 is being evaluated by change in tumor volume (central MRI readings) and response (per RECIST 1.1) determined by the investigator.
MRI scans showed decreases in tumor size in most of the 13 patients who had reached the 16-week time point.
One patient has reached a unconfirmed partial response at week 16 per RECIST.
AL102 was well tolerated at all dose levels with no dose-limiting toxicities and no Grade 4/5 adverse events were observed.
The most common treatment-related adverse events were Grade 1-2, including diarrhea, fatigue, skin rash, and nausea.
Gary Gordon, M.D., Ph.D., Chief Medical Officer of Ayala commented: "RINGSIDE is the first study to investigate AL102 exclusively in desmoid tumor patients and it has been designed to evaluate a range of different doses and dose schedules. Successful management of this disease will likely require chronic treatment and one of the key goals of our development program is to understand the optimal balance between efficacy, safety, and patient acceptability. We are encouraged by the early but very promising efficacy data and emerging favorable side effect profile for AL102 reported in these interim results."

About the RINGSIDE study
The RINGSIDE pivotal Phase 2/3 study is a randomized multi-center trial. Part A of the study is evaluating the efficacy, safety, tolerability, and tumor volume by MRI after 16 weeks of AL102 in adult and adolescent patients with desmoid tumors. It enrolled 42 patients and is evaluating 3 doses of AL102. Patients who participated in Part A will be eligible to enroll into an open-label extension study at the selected dose, and long-term efficacy and safety will be monitored. Part B of the study will be double-blind, placebo-controlled, and will start immediately after dose selection from part A, enrolling up to 156 patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint will be progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR) and patient-reported Quality of Life (QOL) measures.
For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).

About Desmoid Tumors
Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

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 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 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.