MGMT

Merck & Co – known as MSD outside the US and Canada – has acquired Yale University oncology spinout Modifi Biosciences in a deal worth $1.3bn. The agreement gives Merck access to preclinical compounds designed to exploit DNA repair defects in difficult-to-treat cancers, including glioblastomas. Modifi, formed in 2021, has developed a new class of small molecules that target cancer cells lacking expression of a key DNA repair protein called MGMT. Approximately half of all glioblastomas and up to 80% of gliomas lack MGMT, which Modifi says makes these cancers a “natural first target” for its approach. Emerging research has also indicated that this MGMT deficiency is seen in many other tumour types. Merck has acquired all outstanding shares of Modifi for $30m upfront, with Modifi shareholders eligible to receive potential milestone payments totalling up to $1.3bn. David Weinstock, vice president, discovery oncology, Merck Research Laboratories, said: “DNA repair defects are a frequent hallmark of tumour cells and a major cause of resistance to cancer therapy. The… Modifi Biosciences team has developed an innovative approach that we believe has potential for treating some of the most refractory cancer types.” Also commenting on the deal, Modifi’s co-founder, Ranjit Bindra, said: “In founding Modifi Biosciences, we sought to radically change the oncology treatment paradigm for cancer patients with glioblastoma and other tumours. “We are honoured to have Merck recognise the potential of our science, and as an oncology company, [it is] perfectly positioned to advance our innovations through clinical trials and commercialisation.” Merck has made a number of acquisitions this year. In July, it completed its previously announced acquisition of EyeBio in a deal worth $3bn, giving it access to a late-stage candidate for diabetic macular oedema and neovascular age-related macular degeneration, as well as a preclinical pipeline targeting retinal diseases. The company also announced in April that it had acquired University at Buffalo laboratory spinout Abceutics in a deal worth $208m to improve antibody-drug conjugates safety, and acquired immuno-oncology company Harpoon Therapeutics and its pipeline of T-cell engagers for approximately $680m in March.

Modifi Biosciences, a spin out of Yale University founded in 2021, has been snapped up by Merck for $30 million paid upfront, and up to $1.3 billion in potential milestone payments. Modifi focuses on the development of small molecule drugs that target cancer cells with impaired DNA repair. “In founding Modifi Biosciences, we sought to radically change the oncology treatment paradigm for cancer patients with glioblastoma and other tumors,” said Ranjit Bindra, co-founder of Modifi Biosciences, professor of therapeutic radiology at Yale School of Medicine, and Scientific Director of the Yale Brain Tumor Center. “We are honored to have Merck recognize the potential of our science, and as an oncology company, they are perfectly positioned to advance our innovations through clinical trials and commercialization.” Modifi Biosciences has developed a new class of small molecule drugs that specifically target cancer cells that lack the expression of O6-methylguanine methyltransferase (MGMT), a protein that plays a key role in DNA repair. Mutations that affect DNA repair are common in cancer cells that can be exploited against them to treat drug-resistant forms of cancer. “DNA repair defects are a frequent hallmark of tumor cells and a major cause of resistance to cancer therapy,” said Dr. David Weinstock, vice president, discovery oncology, Merck Research Laboratories. “The talented Modifi Biosciences team has developed an innovative approach that we believe has potential for treating some of the most refractory cancer types.” googletag.cmd.push(function () { googletag.display('text-ad1'); }); Research published by Modifi’s scientific founders in 2022 showed that this approach had promising results in mouse models of drug-resistant glioma, a type of cancer that affects the brain and spinal cord. Since then, the company has been conducting preclinical trials in models of glioma and glioblastoma; It is estimated that up to 80% of gliomas and approximately half of all glioblastomas lack the MGMT protein, making these types of cancer the ideal first target for Modifi’s new drug class. “We designed our small molecules to have the ability to uniquely overcome clinical resistance mechanisms that have been known for decades but until now have been non-actionable. Additionally, we created the molecules in a manner which allows them to be rapidly progressed from bench-to-bedside,” said Seth Herzon, co-founder of Modifi Biosciences and Professor of Chemistry at Yale.

MILAN and NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Genenta Science (NASDAQ: GNTA), a pioneer in immuno-oncology and in cell-based therapeutics, is pleased to announce that Pierluigi Paracchi, CEO, will attend as a speaker to the Italy-U.S. meeting “Cross-Border Investments and Strategies in the Biotechnology Sector: A Transatlantic Perspective” scheduled at 2.00 PM on October 25th, 2024 at the U.S. Senate - Washington, D.C. The event is organized by the U.S. National Security Commission on Emerging Biotechnology (NSCEB) and the Italian Embassy in the U.S. The upcoming mission to Washington, D.C. is part of the strategic plan of the Italian Working Group on the Internationalization of the Biotech Sector (NWTIB) established by the Deputy Prime Minister and Minister of Foreign Affairs Antonio Tajani. Pierluigi Paracchi, as a moderator of the NWTIB, will present the recently released Interim Report (full report in English HERE). Keynote Speakers:Michelle Rozo, Vice Chair of the National Security Commission on Emerging Biotechnology (NSCEB)Mariangela Zappia, Ambassador of Italy to the U.S.Megan Frisk, Ph.D., Director Division of lnternational Affairs at the Advanced Research Projects Agency for Health (ARPA-H)Mauro Battocchi, Director General for the Promotion of ltaly at the ltalian Ministry of Foreign Affairs Pierluigi Paracchi, CEO and Co-founder of Genenta Science (Nasdaq: GNTA) Patrick Soon-Shiong, M.D., Chairman of Chan Soon-Shiong Family Foundation, Executive Chairman of ImmunityBio, Executive Chairman of California Times Andrea llly, Chair at lllycaffè From the CEO's Desk: Pierluigi Paracchi stated: “With the pandemic, biotechnologies have been elevated to strategic technologies by leading global nations. Italy, with its rich scientific heritage, must ensure that these innovations are rapidly and concretely applied, while preserving them as national assets. At the same time, the internationalization of the sector, collaboration with partner countries, and the attraction of foreign investments are crucial for ensuring competitive growth. Government investment agencies should focus on strategic operations of a competitive scale, aligning with the international standards of countries already leading the sector.” About Genenta and TemferonGenenta (www.genenta.com) is a clinical-stage biotechnology company engaged in the development of a proprietary hematopoietic stem cell therapy for the treatment of a variety of solid tumor cancers. Temferon™ is based on ex-vivo gene transfer into autologous Tie2+ hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). Temferon is currently under investigation in a clinical trial for newly diagnosed Glioblastoma Multiforme patients with an unmethylated MGMT gene promoter (uMGMT-GBM) and expects to commence a Phase 1 clinical trial for metastatic Renal Cell Carcinoma (mRCC). Temferon is designed to reach solid tumors, induce a durable immune response not restricted to pre-selected tumor antigens nor type, and avoid systemic toxicity, which are some of the main unresolved challenges in immuno-oncology. Forward-Looking StatementsStatements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion and timing of its ongoing clinical trial for newly diagnosed GBM patients with uMGMT-GBM, its expected clinical trial for metastatic RCC or any related studies, as well as Genenta’s ability to fund its research and development plans. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Genenta's Annual Report on Form 20-F for the year ended December 31, 2023 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of the date of this announcement, and Genenta undertakes no duty to update such information except as required under applicable law. Genenta MediaTiziana Pollio, Mobile: +39 348 23 15 143Email: tiziana.pollio@genenta.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0eb35962-e4cc-415b-8ed7-30daa2c62281