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AIGEN Sciences signs an AI-based ‘transcription factor inhibitor’ development contract with Incurix

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."

Thyas Co. Ltd., a Kyoto University spin-off, Closes JPY 2.1B Series B Financing
from Eight Roads Ventures/F-Prime to Develop Novel iPSC-derived Immune
Cell Platform

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.

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."

Oxilio OXL001 formulation optimisation and clinical trial preparation contract with Quotient Sciences

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]).

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."

Applied Pharmaceutical Science receives FDA Fast Track Designation for APS03118 for the treatment of metastatic NSCLC previously-treated with a selective RET inhibitor

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.

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.

Silence Therapeutics Appoints Craig Tooman President and Chief Executive Officer

On February 21, 2022 Silence Therapeutics plc, Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid ("siRNA") therapeutics for the treatment of diseases with significant unmet medical need, reported that Craig Tooman, previously Chief Financial Officer ("CFO"), has been appointed President, Chief Executive Officer ("CEO") and Board member of Silence, and Mark Rothera has stepped down as President, CEO and Board member, effective immediately (Press release, Silence Therapeutics, FEB 21, 2022, View Source [SID1234608362]). Rhonda Hellums, previously Vice President, Finance, has been appointed CFO.

"On behalf of the Board, I would like to thank Mark for his contributions over the last 18 months and we wish him well," said Iain Ross, Chairman at Silence. "Craig is a seasoned leader who understands all aspects of our corporate strategy and the immediate need to maximize our potential going forward. With Craig as CEO and Dr. Giles Campion leading our exceptional research and development efforts, I am confident that Silence is now well-positioned to capitalize appropriately on the positive data we recently reported with SLN360 and ensure long-term shareholder value."

Craig Tooman, President and CEO, commented, "I am extremely pleased to have the opportunity to lead Silence and have come to appreciate the strong stewardship of Iain Ross as Chairman of the Board. I look forward to working with Giles, the executive team, and full Board, to take Silence through its next exciting stage of growth."

Craig Tooman joined Silence in January 2021, and brings more than 30 years of operational, financial and merger and acquisition ("M&A") experience. Most recently, he was Chief Operating Officer and CFO at Vyome Therapeutics, and prior to this was CEO of Aratana Therapeutics where he successfully negotiated a merger with Elanco. Before Aratana, Mr. Tooman was the CEO of Avanzar Medical Inc., a private oncology company, and CFO of Enzon Pharmaceuticals until its acquisition by Sigma Tau. Prior to that he led the $1.1 billion M&A initiative and integration of ILEX Oncology and Genzyme Corporation. He also held key positions at Pharmacia and Upjohn. Mr. Tooman currently serves on the Supervisory Board and Audit Committee of CureVac, which accomplished a successful initial public offering on Nasdaq in August of 2020. He holds a BA in Economics from Kalamazoo College and an MBA from the University of Chicago.

Rhonda Hellums has over 25 years of corporate finance, accounting, strategic planning, M&A, treasury management, investor and public relations. Prior to joining Silence in April 2021, she held management positions at several large healthcare companies, including KCI (now 3M+KCI) and Genzyme Corporation. She previously served as CFO of Deer Oaks Mental Health and prior to that, CFO of Aratana Therapeutics, a publicly traded pet therapeutics company. Ms. Hellums received her BBA degree in Accounting and Information Systems and MBA from the University of Texas at San Antonio.