Kumquat Biosciences, Inc.

Takeda’s stem cell platforms aim to improve treatment options for both solid tumours and blood cancers. Credit: PeopleImages.com – Yuri A via Shutterstock. Takeda and Alloy Therapeutics have announced a new partnership to accelerate the development of advanced cancer therapies using innovative stem cell technology. The companies will focus on Takeda’s proprietary induced pluripotent stem cell (iPSC)-derived chimeric antigen receptor (CAR)-T and CAR-NK platforms, known as iCAR-T and iCAR-NK. These platforms aim to improve treatment options for both solid tumours and blood cancers. iPSCs are special cells that can be reprogrammed to act similarly to stem cells, capable of turning into almost any cell type in the body. Takeda’s iCAR-T and iCAR-NK platforms use iPSCs to create immune cells engineered to target and destroy cancer. Unlike traditional CAR-T therapies – which are custom-made for each patient using their own cells – iCAR-T and iCAR-NK therapies are designed to be “off-the-shelf”. This means they can be produced in advance and used for multiple patients, making treatment faster, more accessible, and less expensive to manufacture. Through this partnership, Alloy gains co-exclusive rights to develop and commercialise iCAR-T and iCAR-NK therapies for cancer treatment. Alloy will also share the technology with its biotech and pharmaceutical partners to expand its use in developing therapies for various types of cancer, including difficult-to-treat solid tumours. Alloy is establishing a Japanese subsidiary to focus on cell therapy development to support these efforts. This deal isn’t the first pact that Alloy has made with big pharma. In May 2024, Alloy licensed its ATX-Gx and ATX-CLC murine platforms to Eli Lilly, providing tools for fully human antibody discovery. These platforms aim to simplify and accelerate therapeutic development. The partnership also integrates Alloy’s technology with Lilly’s Catalyze360 programme, which supports biotech startups by offering drug discovery tools, lab space, and R&D expertise. The iCAR-T platform was originally developed through a collaboration between Takeda and Kyoto University’s Center for iPS Research and Application (CiRA). The first CAR-T cell therapy created via the collaboration entered process development toward clinical testing in 2018, according to a company announcement that year. It hasn’t always been a smooth journey for Takeda in the oncology sector. Earlier this year, the Japanese pharma axed three early-stage CAR-T cell therapy prospects from its R&D pipeline. However, Takeda’s R&D president Andrew Plump said that the company “remains committed to oncology and will continue to develop therapies across haematologic and solid tumours”, in a February 2024 quarterly results call with investors. Takeda demonstrated this commitment by signing a deal exceeding $1.2bn with US-based Kumquat Biosciences in April 2024 to develop an unnamed immuno-oncology small molecule inhibitor. Several other biotechs have dipped their toes into the iPSC space. In September 2024, GC Therapeutics (GCTx) raised a $65m Series A funding round to deliver its off-the-shelf iPSC-based medicines. In August 2023, New York-based BlueRock Therapeutics signed a collaboration and option agreement with bit.bio to discover and manufacture iPSC-derived regulatory T cell-based therapies. bit.bio has its own opti-ox precision cell programming technology, which is used for controlling the expression of transcription factor combinations within cell therapies. Free Whitepaper Optimise your cell therapy process: a guide to cell thawing Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer. This guide addresses how cell thawing has historically developed into the new techniques used today, along with the physical and biological implications of key metrics and components such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

CMS' estimated Leqembi costs, Takeda's immuno-oncology deal with Kumquat Biosciences, and Fujifilm Diosynth Biotechnologies' layoff round made our news this week. Medicare's spending projection on the Alzheimer's drug Leqembi is way higher than Eisai's own estimates. Takeda signed an immuno-oncology deal potentially worth more than $1.2 billion. Fujifilm Diosynth Biotechnologies is restructuring its small-scale business unit. And more. 1. Report: Spending on Leqembi could hit $3.5B next year, CMS says The Centers for Medicare & Medicaid Services estimated that Eisai and Biogen’s Leqembi would cost Medicare about $3.5 billion next year, according to a document summarizing a February stakeholder call that was first obtained by Stat. The number was much higher than Eisai's own projection of about $2 billion in revenue for 2026. 2. Takeda inks sweet $1.2B-plus deal with Kumquat for immuno-oncology program Takeda has signed a deal for an immuno-oncology small-molecule inhibitor from Kumquat Biosciences. Kumquat can give Takeda global development and commercialization rights after phase 1. The pact includes $130 million in near-term payments, more than $1.2 billion in future milestones, plus tiered sales-based royalties. 3. CDMO Fujifilm Diosynth's restructuring plan may leave up to 240 staffers out of work Fujifilm Diosynth Biotechnologies is laying off up to 240 workers as part of a restructuring of its small-scale business unit. The Japanese CDMO cited “the short-term impacts of reduced venture capital investment into early-stage research projects,” especially in the cell and gene therapy space, as the reason. The company’s sites in Texas, North Carolina, Massachusetts and England may be affected. 4. Shinobi strikes deal with electronics powerhouse Panasonic to create new cell therapy manufacturing platform Shinobi Therapeutics has signed a collaboration pact with Panasonic and Kyoto University to develop a new manufacturing platform to crank out induced pluripotent stem cell-based T-cell therapies more efficiently at lower costs. Panasonic is responsible for creating the closed-system manufacturing device, and Shinobi will contribute its iPSC knowledge. The first prototype is expected next April. 5. 89bio lines up China CDMO to build API plant for commercial production of MASH candidate San Francisco-based 89bio has struck a deal asking China’s BiBo Biopharma Engineering to help it build a plant that will produce the bulk active ingredient for the U.S. biotech’s metabolic dysfunction-associated steatohepatitis (MASH) candidate pegozafermin. 89bio will pay the Chinese CDMO $135 million in several tranches. BiBo has two facilities in China that produce more than 20 commercial products. 6. Eisai on your hi-fi: Leqembi maker supports creation of Alzheimer's podcast miniseries Eisai is funding a podcast miniseries called “Rethinking Alzheimer’s Disease.” The unbranded program was created by Mission Based Media and is focused on the steps between a patient developing symptoms and getting diagnosed, as well the future of Alzheimer’s diagnosis and therapy. Other News of Note: 7. FDA slams 3 Indian drugmakers in flurry of recent Form 483s 8. Ferring taps CDMO SK pharmteco to boost long-term supply of gene therapy Adstiladrin 9. SCG teams with A*STAR on iPSC manufacturing technology for cell therapies (release)

Takeda has entered into a partnership with California-based Kumquat Biosciences to develop and market a novel immuno-oncology small molecule inhibitor as a mono- and/or combination-therapy. Under the terms of the partnership, Takeda will lead the later stages of development and commercialization and Kumquat will be responsible for initial research and phase 1 clinical trials. Takeda has obtained exclusive global rights to the drug, with Kumquat receiving up to $130 million in near-term payments and potentially more than $1.2 billion in milestone payments and royalties on future sales. Kumquat CEO Yi Liu expressed excitement about the collaboration's potential to speed up the drug's clinical development and extend its reach to help more cancer patients. Back in 2021 , Kumquat inked a potential $2 billionmulti-year collaboration with Eli Lilly focused on the discovery, development and commercializationof potential novel small molecules that stimulate tumor-specific immune responses. Founded in 2019, Kumquat has secured over $100 million in funding from investors including OrbiMed, Sequoia Capital China, EcoR1, Lilly Asia Ventures and Roche Venture Fund.