On June 15, 2022 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported that the Company has acquired a minority stake in Israel-based Squalus Medical, the inventor and developer of the StingRay Laser System (the "StingRay System"), a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast and lung cancers (Press release, Innovation Pharmaceuticals, JUN 15, 2022, View Source [SID1234616001]).

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The StingRay System combines new fiber optic technology with an advanced laser console and computerized intelligent control that allows an excellent match between the structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The console integrates advanced imaging modalities, and guides the physician, making sure the treatment is adjusted to the specific patient needs with real time energy control.

The StingRay System is supported by Squalus’ proprietary technologies that deliver remarkable properties for controlling laser energy. These include:

· DiLITT — Directional Laser Interstitial Thermal Therapy. DiLITT provides the ability to treat distorted or irregular shapes through accurate control of the angular energy distribution.

· ExLITT — Extended LITT. ExLITT offers the ability to easily treat large volumes through radial control of the energy.

· APM — Advanced Planning Module. These are the software tools that control the laser and do the matching between the lesion shape and energy using smart AI based algorithms.

"What Squalus is doing is truly revolutionary with the potential to help millions of patients around the world that are precluded from procedures to provide them relief from epilepsy and cancer because of the origin of their disease," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "M&A activity in recent years has demonstrated a robust market for new, safe, and effective laser-based technologies and we believe that the Squalus technology has the potential to attract the attention of leaders in the medical space. Squalus will pursue the FDA 510(k) pathway for marketing clearance in the U.S. and the corresponding process for a CE Mark in Europe. This was an ideal investment for us to build value and diversify our portfolio. We consider the market to be substantial and the timeline shorter than pharmaceuticals. We intend to remain active in analyzing other potential value-add opportunities that can strengthen our company."

"We are thrilled with the investment from Innovation Pharmaceuticals as we are at a major inflection point with completing development of the StingRay system and beginning the process towards commercialization," said Gil Shapira, co-founder of Squalus Medical. "The medical community is facing significant challenges with treatment of resistant epilepsy and various cancers, creating an immediate need for an advanced and highly controlled energy tool like the StingRay system to improve patient outcomes and enable new treatment modalities in key verticals. Our goal is to provide this solution in the coming years via the U.S. Food and Drug Administration 510(k) pathway and the European Union’s CE Mark, processes I am very familiar with."

Epilepsy is the most prevalent serious neurologic condition in the world, affecting about 70 million people. Unfortunately, 30%-40% of those patients are afflicted with drug resistant epilepsy, meaning they receive no relief from medication.1

Squalus Medical was founded by Moshe Eshkol and Gil Shapira both highly experienced specialists in surgical lasers and medical devices. Squalus and the development of the StingRay system are also supported by a grant from the BIRD Foundation (View Source), a bi-national organization supporting Israel-US collaboration. Gil Shapira brings 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology (MIT).

1 The epidemiology of drug‐resistant epilepsy: A systematic review and meta‐analysis, Kalilani et al., Epilepsia 2018;59:2179–2193

On June 15, 2022 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the appointment of Faye Feller, M.D., to Executive Vice President and Chief Medical Officer, effective July 9, 2022 (Press release, Geron, JUN 15, 2022, View Source [SID1234616000]). Dr. Feller will succeed Dr. Aleksandra Rizo, Geronʻs current Chief Medical Officer, who will transition to a consultant role to the Company, as Senior Medical and Regulatory Advisor. Outside of Geron, Dr. Rizo has accepted a leadership position with a privately held discovery and preclinical-stage platform biotechnology company.

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Dr. Feller has been instrumental in the design, execution and management of the imetelstat development program for the past seven years, starting when she served as a medical leader in Janssen’s hematology program. She has continued her work on imetelstat since 2019, as Geronʻs Vice President of Clinical Development reporting to Dr. Rizo.

"Faye has been a cornerstone in the history of imetelstat’s clinical development. Since coming to Geron, she has played a strategic role in designing and driving execution of our Phase 3 clinical trials. In addition, she serves as the primary medical point of contact between Geron and our clinical investigators, leads the preparation of data for assessment by the data monitoring committees, and is preparing for the top-line readout of our IMerge Phase 3 trial in lower risk myelodysplastic syndromes, which is expected in early January 2023," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "With her background as clinical lead for multiple clinical trials while at Janssen, and as an attending hematologist at Memorial Sloan Kettering Cancer Center, Faye is highly qualified to assume her new role as our Chief Medical Officer."

When Dr. Feller becomes Chief Medical Officer, Dr. Rizo will transition to the consultant role, where she will continue to be involved in key imetelstat development and regulatory activities. These include assessment of data for top-line results from the ongoing IMerge Phase 3 trial in lower risk myelodysplastic syndromes (MDS) and, assuming supportive top-line results, through the planned FDA New Drug Application submission and acceptance process for imetelstat in lower risk MDS.

"Aleksandra has made tremendous contributions to the development of imetelstat," Dr. Scarlett continued. "Her leadership in building and mentoring a deep and experienced development organization is evident with the internal promotion of Faye as Chief Medical Officer. We appreciate the continuity in involvement Aleksandra will provide as Faye assumes her new responsibilities."

"It has been a privilege to work with Chip and the Geron team to advance this innovative first-in-class telomerase inhibitor, imetelstat, into the late stages of clinical development. I remain confident in the potential of imetelstat to be a transformative treatment for patients with hematologic malignancies, and as such, I am fully committed to continuing to contribute to the imetelstat journey through the potential New Drug Application submission and acceptance process. In particular, I am eager to see the Phase 3 top-line results from the lower risk MDS trial expected in early January 2023," Dr. Rizo said. "I am also completely confident that imetelstat will be in excellent hands with Faye and the rest our team at Geron, many of whom I have worked with side-by-side on imetelstat over the past seven years, and for whom I have the greatest respect."

Prior to joining Geron, Dr. Feller was Senior Director at Janssen Research and Development, LLC (Janssen) and both a Compound Lead and Study Responsible Physician for multiple clinical trials of early and late-stage development assets at Janssen, including the IMbark Phase 2 clinical trial of imetelstat. Prior to Janssen, Dr. Feller was an attending physician in the leukemia department of Memorial Sloan Kettering Cancer Center in New York. She received a B.A. from New York University and an M.D. from Mount Sinai School of Medicine. She completed her residency in internal medicine at Mount Sinai Hospital and her fellowship in medical oncology at Memorial Sloan Kettering Cancer Center.

On June 15, 2022 Bristol Myers Squibb (NYSE: BMY) reported that its Board of Directors has declared a quarterly dividend of fifty-four cents ($0.54) per share on the $.10 par value common stock of the company (Press release, Bristol-Myers Squibb, JUN 15, 2022, View Source [SID1234615998]). The dividend is payable on August 1, 2022 to stockholders of record at the close of business on July 1, 2022.

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In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable September 1, 2022, to stockholders of record at the close of business on August 9, 2022.

On June 15, 2022 BioVaxys Technology Corp. (CSE: BIOV; FRA: 5LB; OTCQB: BVAXF) ("BioVaxys" or "Company"), reported that its clinical study collaborator Hospices Civils de Lyon in France ("HCL") has surgically excised the first ovarian cancer tumors from cancer patients to be used by BioVaxys for process development and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production of the Company’s ovarian cancer vaccine (Press release, BioVaxys Technology, JUN 15, 2022, View Source [SID1234615997]).

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BioVaxys recently entered collaborations with HCL and Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients. Tumor samples from both hospitals are being used by BioVaxys’ Lyon-based manufacturing partner, BioElpida ("BioElpida"), to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU.

Donors of ovarian cancer tumors are required to sign a patient consent form, with the tumor extraction, storage, and shipping logistics following a strict protocol developed by Biovaxys, and subjected to institutional and regulatory approval.

BVX-0918 produced from the surgically removed tumor cells from HCL will be screened using the identity assays derived from the OVCAR-3 cell line recently completed by BioElpida. The identity assay will be performed on every batch of autologous ovarian cancer vaccine, and is mandatory for regulatory bodies in the EU and United States.

BioVaxys President and Chief Operating Officer Kenneth Kovan stated that "The production of BVX-0918 is a process that built on the prior successful execution of sequential steps, such as the bioproduction technology transfer to BioElpida, development of validation procedures needed to support GMP manufacturing, sterility testing for transport, hapten fixation, cryopreservation methods, antibody generation, bioburden screening, endotoxin assays, and most recently, the development of the identity assays from the OVCAR-3 cell line. With the surgically excised tumors we can now begin the final stages of the vaccine production protocol and GMP validation."

BioVaxys’ vaccine platform is based on the established immunological concept that modifying surface proteins—whether they are viral or tumor—with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys’ cancer vaccines are created by extracting a patient’s own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors.

A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results.

On June 15, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara’s VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM) (Press release, Kintara Therapeutics, JUN 15, 2022, View Source [SID1234615995]).

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Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Some of the significant benefits of FTD include:

Enhanced access to the FDA, including opportunities for more frequent meetings and written consultation throughout the remaining development of VAL-083.
Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval.
FTD also allows for ‘rolling review’, whereby Kintara may submit completed sections of the VAL-083 NDA as they become available, rather than at the end of development.
"We believe Fast Track Designation is indicative of VAL-083’s potential to improve outcomes for patients with GBM, the most aggressive form of brain cancer," stated Robert E. Hoffman, President and CEO of Kintara. "We look forward to announcing top-line data from the international registrational phase 2/3 GBM AGILE Study around the end of calendar year 2023. Fast Track Designation allows us to work closely with the FDA and may expedite our commercial launch of VAL-083, if approved."