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BioVaxys Cancer Vaccine Manufacturing Partner Bio Elpida Reaches Bioproduction Milestone

On September 17, 2021 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys") reported that cancer vaccine manufacturing partner Bio Elpida in Lyon, France, has reached major milestones in the development of the bioproduction process for BVX-0918A, BioVaxys’ ovarian cancer vaccine and is beginning the next phase of manufacturing process development (Press release, BioVaxys Technology, SEP 17, 2021, View Source [SID1234590267]).

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Bio Elpida has completed the technology process transfer with BioVaxys and started the development phase using a Quality by Design ("QbD") approach which includes establishing the control methods and manufacturing process development. In parallel, as Bio Elpida further prepares for GMP manufacturing of BVX-0918A, the preparation of the new manufacturing facility is ongoing and on schedule. The next step is the vaccine process validation using donated tumor samples obtained following surgical excision from ovarian cancer patients.

Bio Elpida President Gilles Devillers says that "This major step is essentially a ‘dry-run’ for manufacturing the vaccine and preparation for GMP production. Although there is significant know-how required to produce a GLP process that has been contributed by both BioVaxys and Bio Elpida, production of GMP-grade vaccine is about validation, proving sterility, quality control, etc., which must all be extremely well documented for regulatory authorities."

BVX-0918A is headed for a planned Phase I clinical trial in Spain early next year with BioVaxys’ EU commercial partner Procare Health Iberia.

BioVaxys President and Chief Operating Officer Ken Kovan stated, "Today’s news represents a significant manufacturing milestone for BioVaxys and follows on the back of the news earlier this week that our CDMO partner WuXi Biologics has completed the synthesis of recombinant SARS-CoV-2 s-protein for our BVX-0320 and CoviDTH programs, further demonstrating the outstanding strength of our bioproduction partners while serving as a testimony to the operational and executional capacity of BioVaxys."

Celsion and Hainan Poly Pharm Sign Agreement to Manufacture Celsion’s DNA-based Vaccine

On September 17, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, and Hainan Poly Pharm Co. Ltd. (Shenzhen Stock Exchange 300630.SZ), a generics manufacturer dedicated to providing therapeutic-value products and services to patients and customers around the world, reported an amendment to their existing contract manufacturing agreement to include development work for Celsion’s investigational DNA-based COVID-19 vaccine (Press release, Celsion, SEP 17, 2021, View Source [SID1234590266]). Under the terms of the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for use, will also manufacture commercial batches for Celsion’s vaccine based on its TheraPlas technology. TheraPlas underlies Celsion’s GEN-1 product and its PLACCINE vaccine technology platform.

Poly Pharm is experienced with chemistry, manufacturing and controls (CMC), process development and good manufacturing processes (cGMP), including process optimization and manufacturing services to help customers advance new drug development projects. Its sites and pharmaceutical compounds have been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), China’s National Medical Products Administration (NMPA) and the World Health Organization (WHO).

Madame Fang, chief executive officer of Hainan Poly Pharm said, "Poly Pharm is a fully-integrated specialty pharmaceutical company with rich CDMO experience. Poly Pharm and Celsion have a successful cooperation on GEN-1 and have been successfully manufacturing clinical batches of GEN-1 to support Celsion’s OVATION 2 Study in advanced ovarian cancer. The GEN-1 collaboration and the DNA-based COVID-19 vaccine program demonstrate our expertise in highly cost-effective manufacturing of nucleic acid based finished drugs. We are glad that a DNA-based vaccine can be our second cooperative project. Celsion’s DNA vaccine technology platform is a promising platform as it may address global vaccine storage and distribution needs. We are pleased that Celsion has recognized Poly Pharm’s skills and dependability, especially with difficult-to-manufacture products, and we are looking forward to helping address the global COVID-19 pandemic."

Commenting on the agreement, Michael Tardugno, chairman, president and chief executive officer of Celsion said, "This is the second plasmid DNA-based investigational new drug project with Hainan Poly Pharm. Our first collaboration is GEN-1, which incorporates a DNA plasmid encoding IL-12 into a unique nanoparticle delivery system. GEN-1 immunotherapy is being evaluated in the Phase I/II OVATION 2 Study in combination with chemotherapy for patients with newly diagnosed advanced ovarian cancer. We have enjoyed a productive working relationship with Poly Pharm delivering quality product efficiently and are delighted to expand our contract manufacturing agreement with them."

About the PLACCINE platform

PLACCINE is Celsion’s proprietary plasmid and DNA delivery technology and the subject of a provisional patent application that covers a broad range of next-generation DNA vaccines. An adaptation of the Company’s TheraPlas technology, PLACCINE is a DNA vaccine technology platform characterized by a single plasmid DNA with multiple coding regions. The plasmid vector is designed to express multiple pathogen antigens along with a potent immune modifier. It is delivered via a synthetic delivery system and has the potential to be easily modified to create vaccines against a multitude of infectious diseases, addressing:

Viral Mutations: PLACCINE may offer broad-spectrum and mutational resistance (variants) by targeting multiple antigens on a single plasmid vector.
Enhanced Efficacy: The potent immune modifiers such as cytokines and chemokines may improve humoral and cellular responses to viral antigens and can be incorporated in the plasmid.
Durable Efficacy: PLACCINE delivers a DNA plasmid-based antigen that can result in durable antigen exposure and a robust vaccine response to viral antigens.
Storage & Distribution: PLACCINE allows for stability that is compatible with manageable vaccine storage and distribution.
Dosing & Administration: PLACCINE is a synthetic delivery system that should require a simple injection that does not require viruses or special equipment to deliver its payload.

Oncology biotech Immix Biopharma files for a $25 million IPO

On September 17, 2021 Immix Biopharma, a Phase 1b/2a biotech developing tissue-specific therapies for solid tumors, reported that it filed on Friday with the SEC to raise up to $25 million in an initial public offering (Press release, Immix Biopharma, SEP 17, 2021, View Source [SID1234587965]).

Immix is developing a novel class of Tissue-Specific Therapeutics ("TSTx") in oncology and inflammation. Its lead asset, IMX-110, is a negatively-charged TSTx that simultaneously disables resistance pathways with a poly-kinase inhibitor and induces tumor cell death with an apoptosis inducer. IMX-110 is currently in Phase 1b/2a trials for solid tumors in the US and Australia.

The Los Angeles, CA-based company was founded in 2012 and plans to list on the Nasdaq under the symbol IMMX. Immix Biopharma filed confidentially on July 20, 2021. ThinkEquity is the sole bookrunner on the deal. No pricing terms were disclosed.

Oasmia signs agreement with FarmaMondo to commercialize Paclical® in Russia & CIS

On September 17, 2021 Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, reported that it has signed a license agreement with the Swiss-based FarmaMondo Group for the commercialization of Paclical (Apealea) in Russia and the Commonwealth of Independent States (Press release, Oasmia, SEP 17, 2021, View Source [SID1234587943]).

Paclical is the first water-soluble cancer drug with paclitaxel to receive a market authorization and is used for the treatment of for epithelial ovarian cancer, fallopian tube cancer and peritoneal cancer.

Under the terms of the agreement, the marketing authorizations which Oasmia holds in Russia and Kazakhstan will be transferred to FarmaMondo. FarmaMondo will also be responsible for all future development and commercialization activities in Russia and the Commonwealth of Independent States, which includes Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, and Uzbekistan. Oasmia will supply FarmaMondo with Paclical and will receive product supply revenues.

The signing of this agreement heralds the completion of the out-licensing of Apealea globally and Oasmia anticipates starting to receive royalties from these partnerships during 2022.

François Martelet, M.D., CEO of Oasmia, commented: "FarmaMondo is an excellent commercial partner for Paclical with a rapidly growing portfolio of high quality products in Russia and the CIS. It is focused on providing market access and specialty distribution services, through its unique and established infrastructure and geographical footprint. This agreement will enable us to focus our resources on significant value-enhancing corporate activities including pipeline development and M&A."

Yaron Spigel, President of the Board and Group CEO at FarmaMondo added: "We are looking forward to commercialising and selling Paclical in Russia and the CIS. Cremophor-EL is highly toxic, requires long infusion times, and can cause serious hypersensitive allergic reactions, requiring premedication with steroids and antihistamines. As a non-Cremophor based formulation of paclitaxel we believe that Paclical could offer a valuable alternative for many advanced ovarian cancer patients."

Huadong Medicine and PulseCath Announce Strategic Collaboration to Develop and Commercialize the iVAC mechanical circulatory product in Greater China

On September 17, 2021 PulseCath B.V., a leader in the expanding field of percutaneous ventricular assist devices for high-risk PCI, and Huadong Medicine Co., Ltd., reported that the companies have entered into an exclusive collaboration to develop and commercialize the iVAC technology in mainland China, Hong Kong, Macau and Taiwan (Greater China) and selected other Asian Pacific countries (Press release, Huadong Medicine, SEP 17, 2021, View Source [SID1234587915]).

The collaboration agreement between PulseCath and Huadong provides Huadong Medicine with a license to distribute iVAC technology in mainland China, Hong Kong, Macau and Taiwan (Greater China) and selected other Asian Pacific countries as well as for local manufacturing and development. PulseCath will retain all rights in the rest of the world.

"With extensive regional experience, the right development and regulatory capabilities, and access to a deep local network of hospitals and clinics across Greater China, Huadong Medicine is an ideal partner for us," said Oren Malchin, PulseCath’s Vice President for Marketing and Sales. "This collaboration reflects iVAC pulsatile technology’s potential to deliver meaningful value to high-risk PCI patients as well as our ability to translate our work in cardiac assist devices into long-term relationships that create sustainable value for PulseCath and our partners. We look forward to working closely with Huadong Medicine to develop and commercialize the iVAC technology in Greater China as we continue to advance the iVAC product family, develop new products, conduct further clinical studies and support our application for FDA approval, which we expect for 2022 in the United States.

Under the terms of the agreement, PulseCath will receive a significant investment in the company’s share capital and is eligible to receive a further investment as a result of potential development and regulatory milestones. In addition, PulseCath will receive a payment for regulatory activities and production in China dedicated to Greater China and selected other Asian Pacific countries. PulseCath is also eligible to royalties on iVAC’s commercial sales by Huadong Medicine in their commercial region.

Huadong Medicine will be responsible for the development as well as regulatory submissions and commercialization of iVAC in Greater China and selected other Asian Pacific countries. Huadong Medicine will also have the opportunity to participate in global clinical studies of PulseCath conducted by PulseCath. PulseCath will continue to be responsible for the development and commercialization of iVAC in Europe, the United States, and other geographies.