On September 14, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the inventor of its ovarian cancer CAR-T technology, Dr. José Conejo-Garcia, Chair of the Immunology Department at Moffitt Cancer Center, will be presenting at the Antibody Society and Ovarian Cancer Research Alliance’s Emerging Immunotherapeutics for Ovarian Cancer Symposium on September 23, 2021 (Press release, Anixa Biosciences, SEP 14, 2021, View Source [SID1234587671]). Dr. Conejo-Garcia will discuss a number of treatment approaches to ovarian cancer including the Chimeric Antigen Receptor-T cell (CAR-T) Technology approach he invented that is in development with Anixa, known as Follicle Stimulated Hormone Receptor (FSHR)-mediated CAR-T technology ("the technology"). The therapy based on this technology was recently authorized by the U.S. Food and Drug Administration (FDA) for Phase 1 clinical testing.

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During the presentation, titled, "Tumor-derived antibodies for multi-faceted immunotherapeutic targeting of human ovarian cancer," Dr. Conejo-Garcia will discuss the technology, which is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T.

"I am particularly motivated to discuss our novel FSHR-mediated CAR-T technology at this event as part of the goal to spread awareness around current and emerging antibody and immune therapies for the treatment of ovarian cancer," commented Dr. Conejo-Garcia. "Moffitt has been in collaboration with Anixa to prioritize and advance this program into human clinical trials. We will look forward to verifying results of this therapeutic approach in solid tumors. Importantly, if this therapeutic approach is successful this could enable a significant shift in the overall treatment paradigm."

Dr. José Conejo-Garcia and his research team developed the FSHR-mediated CAR-T technology when he was at the Wistar Institute where he contributed to report for the first time on the role of T-cell responses in the outcome of ovarian cancer patients. Anixa has an exclusive, world-wide license to this technology.

More information about the event can be found at: View Source

On September 14, 2021 Emergent BioSolutions Inc. (NYSE:EBS) and Providence Therapeutics reported they have entered into a five-year contract development and manufacturing (CDMO) services agreement spanning Emergent’s integrated capabilities, including development services, bulk drug substance formulation and drug product manufacturing, to support Providence’s COVID-19 messenger RNA (mRNA) vaccine development (Press release, Emergent BioSolutions, SEP 14, 2021, View Source [SID1234587669]). In 2022, Emergent will manufacture tens of millions of doses of PTX-COVID19-B drug product, as well as batches of PTX-COVID19-B formulated bulk drug substance with the potential to yield hundreds of millions more doses, for global populations in need of pandemic relief.

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Under the terms of the five-year agreement, Emergent will provide current Good Manufacturing Practice (cGMP) manufacturing services for two presentations of the PTX-COVID19-B vaccine product, both the formulated bulk drug substance and finished drug product (fill/finish), at Emergent’s facility in Winnipeg, MB, Canada. Additional process and analytical development services will occur from Emergent’s Center of Excellence for Development Services in Gaithersburg, Maryland. The baseline agreement signed between Emergent and Providence Therapeutics is valued at approximately $90 million, covering manufacturing services, studies to support global supply chain activities, as well as facility and equipment investments.

"Emergent’s commitment to fight the COVID-19 pandemic is anchored in our partnerships with innovators who share the same mission to address public health threats around the world," said Adam R. Havey, executive vice president and chief operating officer at Emergent BioSolutions. "This collaboration is a testament to Emergent’s long heritage and experience in Canada. We are proud that Providence has chosen our Winnipeg team and site to manufacture its Canadian mRNA technology in Western Canada, one of the few facilities in the country manufacturing large quantities of mRNA COVID-19 vaccine doses today."

As commented by Brad Sorenson, Providence CEO, "Providence is very pleased to have the resources necessary to ramp up commercial manufacturing of its COVID vaccine here in Canada. We look forward to working side-by-side with Emergent to deliver tens of millions, and potentially hundreds of millions of doses of our world-class vaccine to developing countries across the globe. It has always been Providence’s mission to produce the highest quality medicines at affordable prices, and with Emergent’s help we are closer to achieving this goal."

To date, Emergent has partnered with numerous pharmaceutical and biotech innovators, as well as the U.S. government and non-government organizations in providing critical contract manufacturing services (drug substance manufacturing, drug product manufacturing and development services) in response to the COVID-19 pandemic.

On September 14, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported its participation at this upcoming investor conference (Press release, Nkarta, SEP 14, 2021, View Source [SID1234587668]):

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Cantor Virtual Global Healthcare Conference
Tuesday, September 28, 2021
4:00 p.m. ET – fireside chat presentation

A simultaneous webcast of the presentation will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately four weeks.

On September 14, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported that George Farmer, Ph.D., Chief Financial Officer, will present at the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on September 21, 2021 at 4:35 PM EDT (Press release, PureTech Health, SEP 14, 2021, View Source [SID1234587667]). A webcast of the presentation will be available at View Source

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On September 14, 2021 ISA reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product ISA101b, for the treatment of recurrent and metastatic oropharyngeal cancer (OPC) that is positive for Human Papilloma Virus type 16 (HPV16) (Press release, ISA Pharmaceuticals, SEP 14, 2021, View Source [SID1234587666]).

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The Fast Track process is designed to facilitate the development of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and frequent communication with the FDA throughout the entire drug development and review process and marketing application.

Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals commented: "Recurrent and metastatic HPV16 positive OPC is a form of head-and-neck cancer with a high unmet medical need. The Fast Track designation for ISA101b underlines the potential benefit of this immunotherapy for patients suffering from this disease." Last week ISA Pharmaceuticals announced that the first patient has been dosed in a new phase 2 study in this indication.

ISA101b induces strong and specific immune responses to HPV16 virus proteins, and (re-)establishes a powerful T-cell immune response against virus infected and/or cancerous cells and tissues. It is using ISA’s proprietary Synthetic Long Peptide (SLP) technology. ISA101b is studied in HPV16 positive cancers in combination with Libtayo (cemiplimab) in three phase 2 clinical trials under a strategic collaboration with Regeneron. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.

HPV16 is a major cause of head-and-neck cancer. Head-and-neck cancer can be a severe and life-threatening disease. More often than not it is diagnosed in middle aged adults. Once these cancers progress to advanced stages median survival times are short.

About Fast Track designation
Fast Track is a process designed to facilitate the development, and expedite the review of, drugs to treat serious conditions that address an unmet medical need, by providing a therapy where none exists or providing a therapy which may be potentially better and shows some advantage over available therapy. Fast Track designation includes opportunities for more frequent meetings with the FDA to discuss trial design, development plans, data needed to support drug approval, submission of a New Drug Application (NDA) on a rolling basis, and eligibility for accelerated approval and priority review, if relevant criteria are met.
Visit the FDA’s website for more information.