Shasqi Appoints Steve Abella, M.D., as Chief Medical Officer and Scott Wieland, Ph.D., MBA, as SVP of Clinical Development

On May 24, 2022 Shasqi, a clinical-stage biotechnology company developing click chemistry-activated oncology therapeutics, reported the additions of Steve Abella, M.D., as Chief Medical Officer and Scott Wieland, Ph.D., MBA, as Senior Vice President of Clinical Development (Press release, Shasqi, MAY 24, 2022, View Source [SID1234615000]).

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"To maximize the potential of our novel, click chemistry-based platform and continue expanding our portfolio of programs, clinical experience and leadership are critical," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "As we reach the end of dose escalation of SQ3370, we will initiate Phase 2 studies in advanced sarcomas and other solid tumors. In addition, we are rapidly advancing our second program toward the clinic, which activates high doses of monomethyl auristatin E, a commonly used antibody-drug conjugate payload, at the tumor. Now is the perfect time to add the deep expertise in clinical strategy and execution that both Steve and Scott bring to the team. We look forward to their contributions and working with them."

"Shasqi has made tremendous progress advancing SQ3370 into and through the clinic and building a robust pipeline of click chemistry-activated therapeutics to harness potent payloads and target them precisely to the tumor," said Dr. Abella. "I’m excited to join the company’s mission and help expand the reach of their platform."

"A click chemistry-based approach has enormous potential to dramatically improve the efficacy of powerful therapies that can be localized at the tumor site using a variety of delivery methods such as direct injection or biomarker targeting," said Dr. Wieland. "I look forward to seeing where we can take this technology and what the next iterations of Shasqi’s approach can achieve in improving the cancer therapeutic landscape and the lives of patients."

Dr. Steve Abella

Dr. Abella has been working in oncology clinical research for nearly 35 years, including more than 12 years in the pharmaceutical industry. Before joining Shasqi, he served as Chief Medical Officer at Vida Development Sciences. Prior to Vida, Steve served as Chief Medical Officer at BioClin Therapeutics. Prior to that, he served as Senior Director at Gilead Sciences where he led the non-Hodgkin’s lymphoma and leukemia drug development efforts and served as a core member of the oncology senior leadership team. Prior to Gilead, he served as Executive Director at Amgen, predominately responsible for the white cell franchise (Neulasta/Nepogen) and led global development efforts across clinical research and medical affairs. Before he joined the biopharmaceutical industry, he spent 15 years in academic oncology, serving as a Professor of Pediatric, Oncology, and Medicine at the Barbara Ann Karmanos Cancer Institute where he focused on stem cell transplantation and oncology clinical trials. Steve completed his fellowship and residency training at Wayne State University School of Medicine after graduating with a degree in medicine from the Universidad Central del Este. He attended the University of Pennsylvania for undergraduate studies.

Dr. Scott Wieland

Dr. Wieland is a biopharmaceutical veteran with over 30 years of experience in the biopharmaceutical industry. Over the course of his career, Scott has served in a variety of roles and responsibilities, most recently as Executive Vice President of Development at Nanobiotix, a nanomedicine company based in Paris, France. Scott started his career leading the Behavioral Pharmacology lab at CoCensys, then moved into a variety of positions across several small biopharmaceutical companies. Scott has been responsible for drug discovery, safety pharmacology, toxicology, bioanalytical development, manufacturing, formulation, clinical supply and distribution, regulatory affairs, and all aspects of clinical trials and development during his career. Scott received a bachelor’s degree in Physiological Psychology from UC Santa Barbara, CA. He received his master’s and Ph.D. in Psychology/Biopsychology with a minor in Neuropharmacology from the University of Arizona, Tucson, AZ, and an MBA in Management from Webster University, St. Louis, MO.

About CAPACTM and SQ3370

SQ3370 is the first click chemistry-based treatment to be tested in humans. It utilizes Shasqi’s proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the tumor site. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing therapeutics across various modalities with a limited therapeutic window.

Genexine to Present at H.C. Wainwright Global Investment Conference

On May 24, 2022 Genexine (KOSDAQ: 095700), a publicly traded, clinical stage biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported that Neil Warma, CEO of Genexine will be presenting virtually at the H.C. Wainwright Global Investment Conference being held on May 23-26, 2022 (Press release, Genexine, MAY 24, 2022, View Source [SID1234614999]).

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The presentation will provide an overview of Genexine’s pipeline, business operations and corporate achievements, as well as discuss upcoming milestones with the Company’s lead assets, including GX-I7 (a first-in-class long-acting recombinant interleukin 7, in development for TNBC and GBM) and GX-188 (a first-in-class DNA vaccine, in development for cervical and head and neck cancers).

Details of the presentation are as follows:

Event: H.C. Wainwright Global Investment Conference
Date & Time: On-demand, beginning 7.00 a.m. ET, Tuesday May 24, 2022
Webcast Link: Genexine_Wainwright_investor_conf.

A replay of the presentation will be available for 90 days at the link above or by visiting www.genexine.com. Registered investors will be able to schedule a one-on-one meeting via the conference portal.

Genexine Appoints Industry Veteran Neil Warma as Chief Executive Officer to Accelerate Global Growth, Product Commercialization and Innovation

On May 24, 2022 Genexine (KOSDAQ: 095700) a publicly traded, clinical stage biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported the appointment of Neil Warma as its President and Chief Executive Officer (Press release, Genexine, MAY 24, 2022, View Source [SID1234614998]). Mr. Warma who has over 25 years of experience as a global entrepreneur, company builder and successful CEO will lead Genexine onto the world stage with a focus on advancing Genexine’s key products to market, expanding its pipeline and focusing on global drug development.

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Mr. Warma has been a successful healthcare entrepreneur for over 25 years having led and managed numerous biotechnology and pharmaceutical companies across the globe. From 2019-2022, Mr. Warma was the General Manager of I-Mab Biopharma U.S., (Nasdaq:IMAB) with offices in Shanghai, Beijing, Hangzhou, Guangzhou, Lishui and Hong Kong in China, and Maryland and San Diego, in the U.S., where he was a member of the executive team responsible for the Company’s expansion onto the global stage and for establishing I-Mab’s state-of-the-art research facilities in San Diego, California. From 2008-2017, Mr. Warma was President, CEO and Director of Opexa Therapeutics, Inc. (Nasdaq:OPXA), a publicly traded biopharmaceutical company developing novel cellular therapies for the treatment of autoimmune diseases, where he orchestrated global deals with Novartis and Merck Serono. From 2004-2007, he was President, CEO and Director of Viron Therapeutics, a private biotechnology company developing novel protein-based therapeutics for cardiovascular disease and transplantation. In 2000, Mr. Warma co-founded and later sold MedExact, a health-technology company dedicated to providing an interface between physicians and pharmaceutical companies. From 1992-2000, Mr. Warma held several key senior management roles at Novartis Pharmaceuticals at its corporate headquarters in Basel, Switzerland, in Pharma Policy and Global Marketing. Mr. Warma obtained an honors Bachelor of Science degree specializing in neuroscience from the University of Toronto and an International MBA from the Schulich School of Business at York University in Toronto. Mr. Warma currently serves on the Board of ProMIS Neurosciences (TSX:PMN) and the Biotechnology Innovation Organization (BIO). Mr. Warma has also been a member of the Board of Directors of Genexine since March 2021 and will continue to serve on the Board as an Executive Director.

"I am deeply honored to have been selected as Genexine’s new CEO by the Board of Directors," said Mr. Warma. "The Company has built a strong scientific foundation based on novel science and differentiated technology over several years. My focus will be to commercialize existing late stage products and further expand Genexine’s pipeline of life-saving products with a focus on first and best-in-class products. We will not only leverage our strength and position as a leading Korean biopharmaceutical company but will also expand our reach into the U.S. and Europe to increase our shareholder base and access new technology and top talent. Genexine has an exciting pipeline and with its global partners is conducting over 20 clinical trials, several in Phase 3 registrational trials. We expect to file several important BLAs in the next 1-3 years and commercialize our first products shortly thereafter."

"My goal is to introduce the biotech world to the top-class technology we have developed in Korea such that we can leverage our clinical data in the US and EU to reduce our development costs and speed the delivery of our products to the patient. We will also look to secure partnerships with global multinational pharmaceutical partners to share costs and leverage their substantial expertise. We are excited to be reporting some near term milestones coming up over the next several months with the planned announcement of Phase 1b/2 clinical data in our potential blockbuster product, GX-I7, the long-acting recombinant Interleukin-7 protein and Phase 2 data in our first-in-class DNA cancer vaccine being studied in cervical and head and neck cancers. These near term milestones should demonstrate our ability to execute and advance our products towards the market and, ultimately, to the patient," added Mr. Warma.

PanTher Therapeutics Secures Patent for Anticancer Drug-Eluting Stent

On May 24, 2022 PanTher Therapeutics (PanTher), a clinical-stage oncology company developing next-generation targeted therapies for solid tumors, reported that a methods-of-use patent for a deployable anticancer drug-eluting stent, exclusively licensed to PanTher, has been issued by the United States Patent and Trademark Office (USPTO) (Press release, PanTher Therapeutics, MAY 24, 2022, View Source [SID1234614997]). The patent increases the potential applicability of PanTher’s proprietary Sagittari treatment platform, which focuses on direct, localized, and sustained delivery of proven and novel therapeutic agents to attack cancer at the source.

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The newly awarded patent covers methods of treating a tumor using a drug-eluting stent that incorporates a degradable polymer film containing a chemotherapeutic drug. The drug is released from the film when the stent is deployed into a biliary or pancreatic duct or tissue site of the pancreas, biliary system, gallbladder, liver, small bowel, or colon.

"The patent validates the novelty and breadth of the Sagittari platform and increases our potential market, while enhancing the value of our intellectual property portfolio," said Laura Indolfi, PhD, chief executive officer of PanTher Therapeutics. "It also supports our investigational strategy of applying our technology to multiple solid tumor types, which facilitates the selection of our follow-on assets."

The Sagittari️ platform is an optimized system for precisely transporting therapeutics to the tumor site, leveraging interventional oncology to design superior localized cancer treatments. PanTher’s lead candidate, PTM-101, the first product to emerge from the Sagittari platform, is currently in Phase 1 of clinical development for the treatment of localized non-metastatic pancreatic cancers.

PanTher also announced the appointment of Dan Wildman as a strategic advisor to the company. A seasoned executive with more than 35 years of experience in the MedTech industry, Mr. Wildman is president and chief executive officer of the strategic consulting company Wildman Ventures, LLC. He previously led the Digital Surgery Strategy initiative at Johnson & Johnson and served as worldwide president of Depuy Synthes Spine and Ethicon Biosurgery. While at Ethicon Biosurgery, Mr. Wildman led the development and commercialization of a novel combination product based on a biomaterial and biologic formulation. As strategic advisor to PanTher, Mr. Wildman will apply this expertise and his decades of experience to advancing the clinical development program for PTM-101 and selecting and prioritizing other Sagittari platform product candidates.

"I am excited to join PanTher at such a pivotal moment in the company’s trajectory, with its first asset in the clinic and a newly issued patent that positions the company very competitively in a crowded space," commented Mr. Wildman. "I look forward to contributing to the growth and expansion of the company and helping realize the tremendous market potential of its pipeline."

Calidi Biotherapeutics Granted U.S. Patent for Proprietary Therapeutic Delivery Platform, Strengthening Company’s Intellectual Property Position in Immunotherapy

On May 24, 2022 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company pioneering the development of stem cell-based delivery of oncolytic viruses, reported that it has been granted a new patent (No. US 11,285,194, Combination immunotherapy approach for treatment of cancer) by the U.S. Patent and Trademark Office (USPTO) related to its proprietary SuperNova (SNV) technology platform (Press release, Calidi Biotherapeutics, MAY 24, 2022, View Source [SID1234614996]). The enhanced oncolytic virotherapy delivery platform was designed to provide and improve therapeutic treatments for multiple cancer indications. Calidi’s product candidates are in the early stages of development and have not yet been approved by the U.S. Food and Drug Administration (FDA).

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The SNV platform is composed of allogeneic, adipose-derived mesenchymal stem cells (AD-MSC) loaded with an oncolytic agent, such as the vaccinia virus, and is anticipated to be used in combination with various immunotherapy agents, including blocking antibodies. The SNV platform is designed to shield oncolytic viral payloads from the immune system, thereby efficiently delivering immuno-oncology therapy directly to tumor sites.

"Calidi’s Supernova platform has been developed through years of research in stem cell delivery and potentiation of oncolytic viruses and has the potential to revolutionize the treatment of solid tumors," said Allan J. Camaisa, CEO and Chairman of Calidi. "The addition of this patent further strengthens our intellectual property position and solidifies the opportunity to use our platform technology in advancing therapeutic discovery and development through the FDA approval process."

The Calidi approach aims to induce a durable anti-tumor immune response. In pre-clinical studies, Calidi’s SNV platform-based product candidates have been shown to shield the oncolytic viruses from destruction by the patient’s immune system, supporting efficient viral replication within the stem cells prior to delivery to tumor sites. Once there, the viral payload selectively destroys tumor cells and stimulates the patient’s immune system to attack the tumor.

"Our outstanding team of doctors and scientists have invested years of intensive research and groundbreaking work to develop Calidi’s SNV platform technology," said Boris Minev, M.D., President, Medical and Scientific Affairs at Calidi, and a patent inventor. "This patent represents the culmination of their impressive expertise, dedication, and passion, and will help the company continue to advance its novel discovery programs."