On February 22, 2022 Apollo Therapeutics, a biopharmaceutical company focused on translational biology and asset-centric drug development, and King’s College London, reported the formation of a new strategic collaboration (Press release, Apollo Therapeutics, FEB 22, 2022, View Source [SID1234608363]).

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The collaboration will leverage the distinct strengths of each organization with a focus on developing novel therapeutics for patients across multiple disease areas. King’s has one of the leading scientific discovery portfolios worldwide and will contribute biological research breakthroughs with the potential to create high-impact medicines. In addition, the university’s associated hospitals and clinician scientists are ideally positioned to provide support to programs during clinical development. Apollo’s translational scientists and drug development architects will progress these research programs under Apollo’s asset-centric portfolio model to rapidly and efficiently bring those with the greatest promise through clinical investigation and ultimately to patients.

"Translating our biomedical research into effective therapies that improve health is a key priority for King’s researchers. I am delighted that this new partnership with Apollo will provide new routes for us to achieve this goal," said Professor Reza Razavi, Vice President (Research) at King’s College London. "Apollo has an excellent track record in partnering with academics to progress their discoveries into therapies. King’s researchers are looking forward to working with Apollo to progress promising therapeutic programs into their drug discovery pipeline and on to clinical impact."

"When looking at research output, King’s College London is one of the largest and most successful centers for biomedical research and education in the UK and indeed globally. With its broad clinical presence, we have also found King’s has exceptional insight in selecting and advancing research that can translate effectively into therapeutic programs," said Dr. Richard Mason, chief executive officer of Apollo. "We are proud to initiate this partnership with our newest collaborator as we look to grow both our portfolio of programs and our relationships with the world’s leading scientists and biomedical institutions. This collaboration continues to build on recent the progress we have made in advancing our internal pipeline, building our team and establishing our US operations in Cambridge, Mass."

King’s College London joins Apollo alongside other top global research partners, Imperial College London, University College London, and the University of Cambridge.

On February 21, 2022 AIGEN Sciences, an artificial intelligence-based new drug development biotech, reported that it signed a joint research agreement with Incurix to develop new anticancer drugs based on artificial intelligence (AI) (Press release, AIGEN Sciences, FEB 21, 2022, View Source [SID1234643551]).

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This contract applies artificial intelligence technology based on transcriptome profiles based on Eisen Science’s protein structure to develop new anticancer drugs based on transcription factor inhibitors, which are attracting attention as major anticancer targets but are known to be difficult to develop. The goal is joint development.

Eisen Science plans to derive new substances that can regulate transcription factors based on its artificial intelligence platform. Afterwards, Incurix will be responsible for verification of effective substances and lead substances and follow-up development of final candidate substances by utilizing the new substances derived from Eisen Science using the transcription factor direct inhibitor new drug development technology platform. The terms of the contract will be kept confidential as agreed between the two companies, and the profits secured through commercialization, such as third-party technology transfer, will be shared in a certain ratio according to the stage of candidate material development at the time of profit generation.

Accordingly, AIGEN Science uses its platform ‘AIGEN Discovery’ to initially select about 10,000 ‘focused library’ compounds that show the effect of regulating transcription factors at the cellular level from a library of 3 billion compounds. Next, we plan to use the protein structure of the transcription factor to discover effective substances that bind with high affinity, and then proceed with optimization using ‘AIGEN Optimizer’ to discover leading substances.

Kang Jae-woo, CEO of Eisen Science, said, "Through joint development with Incurix, which specializes in developing anticancer drugs that directly inhibit transcription factors, we will successfully lead the development of new drugs for transcription factor targets (difficult-to-target) that were difficult to access through traditional methods. "As Eisen Science’s artificial intelligence platform is a model based on transcriptome data, synergy is expected with Incurix, which has expertise in developing transcription factor inhibitors, and we have high expectations for future joint development."

On February 21, 2022 Thyas Co. Ltd., a Kyoto-based biotechnology company developing induced pluripotent stem cell (iPSC)-derived immune cell therapies for cancer and infectious diseases, reported the closing of JPY 2.1B Series B financing (Press release, Thyas , FEB 21, 2022, View Source [SID1234629215]). The financing was co-led by Eight Roads Ventures Japan and F-Prime Capital Partners, the world’s leading healthcare investor group, with follow-on participation by D3 LLC, a Japanese investor specialized in the bio-healthcare field.

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Thyas, a Kyoto University spin-off, is pioneering producing iPS cell-derived T cells for the treatment of cancers and infectious diseases. In recent years, autologous CAR-T therapies have demonstrated remarkable efficacy. However, many challenges still remain for the production of sufficient numbers for clinical and commercial operations since quantity and quality of patient-derived T cells vary. Thyas’ technology, originated by Dr. Shin Kaneko, a professor at the Center for iPS Cell Research and Application (CiRA), Kyoto University, Japan, makes it possible to manufacture a large number of iPSC-derived immune cells with potent cytotoxicity and large proliferative capacity, which demonstrate significant efficacy and persistency in vivo. The therapeutic benefits are expected to be treating patients with no/few or exhausted immune cells, breaking through an immunosuppressive microenvironment with large numbers of immune cells, and completely removing cancer cells. Thyas is one of a few companies in the world that successfully established robust differentiation technologies to generate potent CD8ab expressing killer T cells, which have strong avidity to target tumor cells and enhanced migratory activities into tumor cites.

Proceeds from the financing will support the continuing development of iPSC-derived killer T cells, iPSCderived CAR-NK cells recently-added to its portfolio of product candidates, and other exploratory-stage iPSC-derived immune cells. Thyas also initiates development of the next generation products from hypoimmunogenic iPSC. The financing and other supports from F-Prime and Eight Roads will also enable Thyas to expand its team to support the company’s future growth, including establishment of operations in the U.S.A, where Thyas seeks candidates of executives, Sr./Jr. scientists, medical experts, and other experts in the field. Meanwhile, the Kyoto site continues to expand its R&D capacities. F-Prime and Eight Roads will give Thyas strategic advices for the company’s growth and proactive support for syndicating next financing rounds.

"We are gratified to share with this exceptional investor group our vision that we bring the novel cell therapies to patients to cure solid cancers," said Yasumichi Hitoshi, President and Chief Executive Officer of Thyas. "With help from F-Prime and Eight Roads, we can leverage the most advanced iPSC-to-immune cell differentiation technologies stemmed from our geographical advantages, i.e. Kyoto University, the Mecca of iPS Cell research, and combine them with the world’s topmost biotech infrastructure and a talent pool in the U.S.A. We are going to be a genuine international company."

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.