Marengo Therapeutics, Inc.

Marengo's precision, Vβ chain targeted T cell activator technology reinvigorates anti-tumor immune responses in refractory tumor models Invikafusp alfa is being evaluated as a single-agent in an ongoing Phase 1/2 clinical trial (STARt-001) to treat PD(L)1 resistant "cold" cancers First disclosure of preliminary Phase 1 clinical results from the STARt-001 study CAMBRIDGE, Mass., Oct. 30, 2024 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches to precision T cell activation, today announced first-in-human clinical data for its lead selective T cell activator, invikafusp alfa (STAR0602), will be presented in a late-breaking oral presentation at the Society for Immunotherapy of Cancer's (SITC) 39th Annual Meeting taking place November 8-10th, 2024 in Houston, Texas. Presentation details: Title: A Phase 1/2 study of Invikafusp alfa (STAR0602), a first-in-class TCR β chain-targeted bispecific antibody, as monotherapy in patients with antigen-rich solid tumors resistant to anti-PD(L)1 Conference: 39th SITC Annual Meeting Abstract Number: LBA-1470 Session Title: Late-Breaking Abstract Session 2 Session Date and Time: Saturday, November 9, 2024, 11:45 AM - 12:15 PM Presenter: James L. Gulley, M.D., Ph.D. (National Cancer Institute, Bethesda, Maryland, USA) About Marengo Therapeutics Marengo Therapeutics, Inc. is a clinical-stage biotechnology company advancing innovative T cell-targeting therapies to revolutionize cancer treatment. The company's proprietary Selective T Cell Activation Repertoire (STAR™) platform is designed to selectively engage distinct T cell subsets by targeting the Vβ chain of the T cell receptor (TCR), empowering the immune system to combat cancer. To learn more, visit marengotx.com. About the STAR™ Platform Marengo's STAR™ platform is a multi-specific antibody-fusion technology derived from a proprietary library of antibodies targeting germline-encoded variable Vβ regions of the TCR. These antibodies are fused with T cell co-stimulatory moieties to promote durable anti-tumor immune responses. About Invikafusp alfa (STAR0602) Invikafusp alfa (STAR0602) is the lead candidate from Marengo's STAR™ platform. It is designed to selectively activate a common Vβ T cell subset found in all cancers by combining a non-clonal mode of TCR activation with a T cell co-stimulatory signal in a single molecule. This innovative approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing anti-tumor immunity and enabling durable tumor clearance. Extensive preclinical studies demonstrate STAR0602's potent anti-tumor activity in both mouse and human ex vivo models via a novel mechanism of action. About the STARt-001 Clinical Study STARt-001 is a Phase 1/2 clinical trial evaluating the safety, tolerability, and preliminary efficacy of invikafusp alfa as a monotherapy in biomarker-selected patients with advanced antigen-rich solid tumors, including PD-1 refractory and rare tumor types. The trial consists of two parts: Phase 1 dose escalation and Phase 2 dose expansion. For more information, visit clinicaltrials.gov (Identifier: NCT05592626). Patients interested in participating in this study at the National Cancer Institute (NCI) can contact NCI's toll-free number: 1-800-4-CANCER (1-800-422-6237) (TTY: 1-800-332-8615), visit the website at , or email [email protected]. Marengo Contacts: Media: Peg Rusconi | [email protected] Investors: Svetlana Makhni | [email protected] SOURCE Marengo Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Invikafusp alfa has recently demonstrated single agent clinical activity across different PD-1 resistant cancers in the ongoing START-001 Phase1/2 clinical study The collaboration plans to evaluate the combination of Marengo's first-in-class TCR Vβ selective dual T cell agonist, STAR0602 (Invikafusp alfa), with Trodelvy (sacituzumab govitecan-hziy) Gilead's Trop-2 directed ADC in a new multi-center Phase I/II clinical study (START-002) Marengo will sponsor the clinical trial and Gilead will provide Trodelvy CAMBRIDGE, Mass., Sept. 13, 2024 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotech company pioneering a new way to activate T cells targeting the Vβ chain of the T cell receptor to select the optimal T cell subsets against cancer, today announced that it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc. to study the combination of STAR0602 (Invikafusp alfa) with Trodelvy® (sacituzumab govitecan-hziy), a Trop-2-directed antibody-drug conjugate (ADC), as a potential treatment for adult patients with metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and metastatic triple-negative breast cancer (TNBC). The planned combination trial, sponsored by Marengo, is expected to commence soon. This study will evaluate the safety, tolerability, and preliminary efficacy of STAR0602 (Invikafusp alfa) in combination with Trodelvy in patients with metastatic TNBC or metastatic HR+/HER2- breast cancer, aiming to explore a novel therapeutic strategy that could offer new treatment options for patients. "We are excited about the clinical potential of combining our novel selective dual T cell activator with Gilead's antibody-drug conjugate, Trodelvy," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "This innovative approach leverages the strengths of two unique modalities to target and potentially eradicate cancer cells more effectively. With the possibility to deliver target cytotoxic agents directly to tumors, which release more tumor antigens for selectively activated and expanded Vβ6/10 T cells to recognize and build long-term immune memory, we believe this combination may have the potential to improve cancer patient outcomes." Under the clinical study collaboration and supply agreement, Gilead will provide Trodelvy to Marengo, who will conduct and sponsor the combination study. Marengo and Gilead will retain all development and commercial rights to their respective compounds, including as monotherapy or as combination therapies. The combination of invikafusp alfa and sacituzumab govitecan-hziy is investigational and not approved by any health authority globally. The safety and efficacy of this combination has not been established. About Marengo Therapeutics Marengo Therapeutics, Inc, a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and other diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, Marengo's proprietary Selective T Cell Activation Repertoire (STAR) platform leverages an extensive biological understanding of T cell function and receptor signaling to create a world in which everyone's immune system can defeat cancer. To learn more, visit marengotx.com. About STAR™ Platform Marengo's STAR™ Platform is a multi-specific antibody-fusion platform derived from Marengo's proprietary library of antibodies targeting germline-encoded variable (V)β regions of the TCR fused to different T cell co-stimulatory moieties. Combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule, promotes a distinct mechanism of action that promotes durable anti-tumor Vβ T cell responses. About STAR0602 STAR0602 is Marengo's lead program, the first T cell activator generated from Marengo's STAR platform; a library of antibodies targeting non-clonal variable (V)β regions of the TCR fused to different co-stimulatory moieties. STAR0602 selectively targets a common Vβ T cell subset present in all cancers and, by combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule, promotes expansion of a new population of clonally enriched, effector memory Vβ T cells that turbo-charge tumor immune responses and promote durable clearance of tumors. STAR0602 has undergone extensive preclinical testing, which demonstrates potent anti-tumor activity in both mouse and human ex vivo tumor models attributed to a distinct mechanism of action from existing cancer immunotherapies. About the START-001 Clinical Study START-001 is a Phase 1/2 clinical trial evaluating the safety, tolerability, and preliminary clinical activity of STAR0602 as a single agent in biomarker selected patients with advanced antigen-rich solid tumors including PD-1 refractory and rare tumors. This open-label, multi-center trial consists 2 of two parts: Phase 1 dose escalation and Phase 2 dose expansion. For more information, please visit clinicaltrials.gov (trial identifier: NCT05592626). For patients interested in enrolling in this study at NCI, please contact NCI's toll-free number 1800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the website and/or email [email protected] . SOURCE Marengo Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Cancer is a big part of Ipsen’s growth strategy, evident in a series of business deals struck by the company in recent years to expand its oncology portfolio and drug pipeline. An Ipsen worker who allegedly profited from stock transactions based on non-public knowledge of his employer’s $247 million buyout of a cancer drug developer has now been charged with insider trading. The Securities and Exchange Commission on Tuesday filed a complaint against Ipsen employee Dishant Gupta. Gupta has agreed to plead guilty, according to a separate court filing. The monetary penalty has yet to be decided. The U.S. Attorney’s Office for the District of Massachusetts has also filed criminal charges against Gupta for his alleged conduct. Paris-based Ipsen maintains U.S. operations in Cambridge, Massachusetts. In early 2022, Ipsen started talking with Epizyme about acquiring that Cambridge-based company’s drug, Tazverik, according to the SEC complaint. Tazverik won FDA approval in 2020 for the treatment of follicular lymphoma. Negotiations between Ipsen and Epizyme progressed from a potential acquisition of the cancer drug to a buyout of the entire biotech company. The Epizyme acquisition was announced on June 27, 2022. presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB Gupta lives in New Jersey and often worked from home, the SEC said in the complaint. He is director of data strategy and operations, a role that involves the marketing and strategic pricing of products. Through this position, Gupta allegedly learned about the market potential and marketing strategy for a drug that appeared to be Tazverik. In the months leading up to the acquisition announcement, the SEC said Gupta ran numerous internet searches using the phrases “Epizyme buyout” and “Epizyme takeover.” Nine days before the deal was announced, Gupta searched the phrase “Ipsen acquired Epizyme,” according to the complaint. While the companies negotiated the transaction, Gupta allegedly accumulated Epizyme shares. From April to June of 2022, the complaint notes that Gupta purchased Epizyme stock on 27 different days. “While Gupta built a position in Epizyme throughout this period, he was most aggressive in the weeks leading up to the announcement,” the SEC said in the complaint. “Specifically, between June 16, 2022, and June 24, 2022, Gupta purchased approximately 200,000 shares, spending nearly $160,000.” The acquisition announcement came in the early morning hours of June 27, timed to happen ahead of the stock market open in Europe. By 9:30 am Eastern time, Gupta had sold all of his Epizyme shares for a profit of $260,078.27, the SEC said. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum The SEC complaint, filed in the U.S. District Court for the District of Massachusetts, is case number 24-cv-12316. According to a court filing, Gupta has entered a written agreement to plead guilty to one count of securities fraud. He must give up the money he gained illegally and also pay a civil fine. Per terms of the plea, Gupta is barred from serving as am executive or director of any publicly traded company. The terms of this settlement are still subject to court approval. Oncology products are the biggest driver of revenue for Ipsen, accounting for more than €2.3 billion of the company’s €3.1 billion in 2023 sales. Besides the deal that brought the company Tazverik, Ipsen had acquired the approved Merrimack Pharmaceuticals pancreatic cancer drug, Onivyde. the company has also struck deals for programs still in development. In July, Ipsen reached an agreement for global rights to a Phase 1-ready antibody drug conjugate (ADC) from Foreseen Biotechnology. That deal followed the April acquisition of global rights to an ADC from Sutro Biopharma. Ipsen’s oncology interest extends to other types of drugs. In 2022, months after the Epizyme acquisition, Ipsen began a partnership with Marengo Therapeutics focused on the R&D of T cell receptor therapies for cancer.