On July 5, 2022 IVERIC bio, Inc. (Nasdaq: ISEE) and DelSiTech Ltd, reported an exclusive global license agreement providing Iveric Bio with the right to develop and commercialize new formulations of Zimura (avacincaptad pegol) using DelSiTech’s silica-based sustained release technology (Press release, Ophthotech, JUL 5, 2022, View Source [SID1234616472]). As part of Iveric Bio’s lifecycle expansion plan for Zimura, the Company is committed to developing sustained release technologies for the treatment of age-related macular degeneration (AMD). These technologies potentially could address patients being treated for geographic atrophy (GA) and intermediate AMD.

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"We are thrilled to collaborate with the DelSiTech team on investigating additional sustained release formulations for Zimura with their drug delivery expertise and advanced technology and look forward to evaluating a sustained release formulation in GA and potentially earlier stages of AMD," stated Pravin U. Dugel, MD, President of Iveric Bio. "Previously reported post-hoc analyses from GATHER1 suggest that Zimura may have the potential to impact AMD in early stages before atrophy occurs in patients. We believe Zimura, which is a chemically synthesized RNA aptamer, is amenable to injectable sustained release formulations."

"As a leading developer of long-acting controlled release formulations for small molecules and biological entities, we are excited about collaborating with Iveric Bio on bringing innovative solutions to patients living with AMD," stated Lasse Leino, PhD, Chief Executive Officer of DelSiTech. "We are inspired by the opportunity to leverage our drug delivery technology to potentially help AMD patients early and improve their treatment experience."

"This agreement underscores our commitment to invest in lifecycle initiatives for Zimura," said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We are excited about the possibilities to expand Zimura into earlier stages of AMD and potentially allow for a next-generation treatment to help patients with GA."

"We are proud to bring our competencies into this promising alliance and contribute to Iveric Bio’s mission to address unmet needs for patients," said Dr. Frederic Dargelas, Head of Business Development and Alliance Management for DelSiTech.
Under the terms of the license agreement, Iveric Bio will pay DelSiTech an upfront payment of €1,250,000, as well as development and commercial milestones and royalties on net sales of licensed products.

In addition to working with DelSiTech, Iveric Bio plans to explore the potential for Zimura in earlier stages of AMD by initiating a clinical trial studying the current formulation of Zimura in patients with intermediate AMD in the fourth quarter of 2022. The development strategy in this indication is subject to global regulatory feedback from the U.S. Food and Drug Administration (FDA) and other regulatory authorities, which Iveric Bio plans to obtain before initiating this trial.

About Zimura GATHER1 and GATHER2 Clinical Trials
Iveric Bio previously announced that GATHER1, the Company’s first Phase 3 clinical trial for Zimura (avacincaptad pegol) for GA, met its pre-specified primary efficacy endpoint with statistical significance. The most frequently reported ocular adverse events in this trial were related to the injection procedure. The Company expects topline data for GATHER2, the Company’s second Phase 3 clinical trial for Zimura for GA, to be available in the third quarter of 2022, approximately one year after the enrollment of the last patient in the trial plus the time needed for database lock and analysis. If 12-month results from GATHER2 are positive, the Company plans to submit applications with the FDA and the European Medicines Agency (EMA) for marketing approval of Zimura for GA. There are no FDA or EMA approved treatments available for patients with GA.

About Zimura
Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b. By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex (MAC) and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for GA and earlier stages of AMD.

On July 5, 2022 BioVaxys Technology Corp. (CSE: BIOV, FRA: 5LB,OTCQB: BVAXF) ("BioVaxys" or the "Company") reported that is proposing to settle an aggregate of approximately $497,000 in debt through the issuance of common shares to be issued at a deemed price of $0.10 per common share (Press release, BioVaxys Technology, JUL 5, 2022, View Source [SID1234616471]). Completion of the debt settlement remains subject to the finalization of definitive documentation and the approval of the Canadian Securities Exchange.

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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).