On February 21, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Medigene AG (FSE: MDG1, Prime Standard, "Medigene"), a clinical-stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that they have entered a multi-target research collaboration to develop T cell receptor (TCR) based immunotherapies against cancer (Press release, BioNTech, FEB 21, 2022, View Source [SID1234608351]). The initial term of the collaboration is three years.

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Medigene will contribute its proprietary TCR discovery platform for the development of TCRs against multiple solid tumor targets nominated by BioNTech. Medigene’s automated, high throughput TCR discovery platform is designed to bypass central tolerance to yield high affinity TCRs. T cell therapy has become a disruptive medical innovation in the treatment of patients with cancer. Engineered TCR-modified T cells (TCR-T cells) are reprogrammed to express a TCR that can recognize specific antigens only present on tumor cells, thereby enabling a precise and potent immune response to attack a patient’s tumor.

"This collaboration with Medigene expands our cell therapy portfolio and TCR discovery capabilities, and further strengthens our ability to be a leader in the rapidly emerging field of engineered cell therapies," said Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "We look forward to working closely with Medigene to develop new treatments which address solid tumors with high unmet medical need."

Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: "Medigene is at the forefront of the development of TCR-T therapies for oncology. The sale and licensing deal with BioNTech is an important validation from a global leading biotech company of our proprietary technologies to discover and characterize highly specific TCRs and empower resulting TCR-T cells to fight solid tumors. This partnership provides Medigene with meaningful financial resources to fuel our next generation development programs targeting potentially novel tumor-specific "dark matter" antigens, further tools to enhance T-cell-based immunotherapies, as well as additional potential strategic deals with future milestone payments and royalties."

BioNTech will acquire Medigene’s next generation preclinical TCR program, which combines TCR-4 of Medigene’s MDG10XX program targeting PRAME with Medigene’s proprietary PD1-41BB switch receptor technology. BioNTech will also obtain the exclusive option to acquire additional existing TCRs in Medigene’s discovery pipeline and will receive licenses to the company’s PD1-41BB switch receptor and precision pairing library. This has the potential to augment TCR cell therapy efficacy and can be applied to all BioNTech cell therapy programs.

Under the terms of the agreement, Medigene will receive EUR 26 million upfront, as well as research funding for the period of the collaboration. BioNTech will be responsible for global development and hold exclusive worldwide commercialization rights on all TCR therapies resulting from this research collaboration. Medigene will be eligible to receive development, regulatory and commercial milestone payments up to a triple digit million EUR amount per program in addition to tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration and royalties on products utilizing at least one of the licensed technologies.

On February 21, 2022 Oxilio Ltd is a privately held pharmaceutical development company reported that focused on repurposing known drugs for the treatment of cancer through a programme of corporate alliances coupled with rapid proof of concept clinical development (Press release, Quotient Sciences, FEB 21, 2022, View Source [SID1234621608]).

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Oxilio signed an exclusive global licensing agreement with TRx Biosciences on 20th October 2021 for the use of their platform technology to support the development of Oxilio’s formulation, OXL001. Oxilio has since progressed the product and now signed a significant service contract with Quotient Sciences, a drug development and manufacturing accelerator, to support the formulation development and preparation of clinical trials for OXL001.

Mark Egerton, CEO of Quotient Sciences said, "By leveraging our integrated development and clinical testing platform, Translational Pharmaceutics, Oxilio and TRx Biosciences will have the flexibility to adjust formulations based on emerging clinical data within their study, enabling us to improve their likelihood of success, reduce their development time and ultimately get new medicines to patients faster. We look forward to working with both companies as we prepare to take OXL001 into the clinic later this year."

Commenting, Oxilio Director Dr Simon Yaxley said: "Quotient has significant capabilities for scientific innovation and adaptation which will further complement Oxilio’s already substantial scientific capacity. We look forward to taking Oxilio’s highly promising formulation OXL001 into the clinic later this year which, if successful, offers tremendous near-term potential benefit for cancer patients."

On Feb. 21, 2022, Applied Pharmaceutical Science, Inc. reported that APS03118, a next-generation selective RET inhibitor, has recently been granted Fast Track Designation by U.S. Food and Drug Administration (FDA) for the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC) previously-treated with a selective RET inhibitor (Press release, Applied Pharmaceutical Science, FEB 21, 2022, View Source [SID1234613100]). The Fast Track Designation is based on preclinical data of APS03118, which will be presented as an electronic poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2022. Investigational New Drug (IND) application of APS03118 was approved by FDA in January 2022, the global clinical trials are in initiation.

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RET aberrances contain fusions and mutations, which can lead to over-activation of RET signaling pathways and uncontrolled cell growth. Because RET oncogene is present in lung cancer, thyroid cancer, rectal cancer, breast cancer, pancreatic cancer and other solid tumors, and it has become an important target of "unlimited cancer" therapy. Cancers with RET alterations primarily rely on abnormal activation of this kinase to promote their proliferation and growth, therefore RET positive cancers are sensitive to RET inhibitors.

NSCLC patients with RET gene alterations are not rarely seen in clinic, particularly in younger, non‐smoking patients with adenocarcinoma histology, with an incidence of 7%-17%. In addition, the brain metastases often occur in lung cancer patients which is highly related with RET fusion, and the cumulative incidence is more than 60% within 24 months. Although first-generation selective RET inhibitors have achieved great success in the therapy of RET positive of NSCLC, patients inevitably acquire resistance.

APS03118 is a next-generation RET inhibitor with innovative chemical structure, and this breakthrough progresses expected to accelerate its registration process and bring new hope to RET aberrance patients. The FDA Fast Track Designation is based on preclinical data:APS03118 showed significant nanomolar level potent antitumor activity in inhibition to various RET fusion and mutations including RET gatekeeper V804M/L/E and solvent frontier G810R/S/C mutations which lead to resistance to selective RET inhibitors. In a brain tumor model, APS03118 completely eliminated brain tumors and all animals survived after dosing, demonstrating the therapeutic advantages of APS03118 for patients with brain metastases.

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. A drug that receives Fast Track Designation is eligible for some or all of the following: More frequent meetings with FDA to discuss the drug’s development plan; Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and the opportunities of Rolling Review.APS03118 is granted Fast Track Designation for the treatment of metastatic NSCLC previously-treated with a selective RET inhibitor, which will help to strengthen the communication with FDA, and accelerate the progress of clinical trials and reach the market expeditiously.

Applied Pharmaceutical Science, Inc. is a biopharmaceutical high-tech company specialized on innovative cancer precision therapy, focusing on small molecule precision cancer therapy. Dr. Jun Zhong, R&D vice president of APS, stated, APS03118 granted the Fast Track Designation of FDA, which is another breakthrough of APS in precision cancer therapy. Meanwhile, RET alterations is related to multiple malignant tumors, and we expect to extend APS03118 to other cancer therapies and reach the global market.

On February 21, 2022 MannKind Corporation (Nasdaq: MNKD) reported that it will release its 2021 fourth quarter and full year financial results, and its management will host a conference call to discuss the financial results and corporate updates at 5:00 p.m. (Eastern Time) on Thursday, February 24, 2022 (Press release, Mannkind, FEB 21, 2022, View Source [SID1234608352]).

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Presenting from the Company will be its Chief Executive Officer Michael Castagna and Chief Financial Officer Steven Binder.

Those interested in listening to the conference call live via the internet may do so by visiting the Investors page of the Company’s website at mannkindcorp.com under Events & Presentations.

On February 21, 2022 Mission Therapeutics ("Mission"), a drug discovery and development company focused on protein homeostasis by selectively inhibiting deubiquitylating enzymes (DUBs), reported that its CEO, Anker Lundemose, will attend and present at the next event in the BMO Biopharma Spotlight Series: Protein – Degraders and Other Next Gen Technologies, on Thursday, 24 February 2022 (Press release, Mission Therapeutics, FEB 21, 2022, View Source [SID1234608353]).

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The virtual event will focus on the therapeutic area of protein degraders and other emerging technologies, with an agenda consisting of fireside chats, expert presentations, and topical panels.

Dr Lundemose will be available for one-to-one meetings as well as presenting as part of the Private Company Spotlights panel and Q&A at 11.20 ET.

This will be the sixth event in the BMO Biopharma Spotlight series of webinars, which explore different therapeutic areas and enable KOLs, public companies, and key players in the private sector to discuss their scientific research and technological approaches.