Fruquintinib

Jan. 08, 2025 -- Mirror Biologics, Inc., specializing in development and manufacturing of immunotherapy products where the active ingredient is living, non-genetically altered, allogeneic (“off-the-shelf”) immune cells, announces that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany. The parties will collaborate to conduct a Phase II clinical trial to evaluate the combination of an experimental immunotherapy drug, AlloStim® from Mirror, and an immune checkpoint inhibitor (ICI), avelumab (BAVENCIO®) from Merck KGaA, Darmstadt, Germany, in fourth-line metastatic colorectal cancer: NCT06557278. Colorectal cancer (CRC) is the third most common cancer and the second most common cause of cancer deaths worldwide. In 2023, approximately 153,020 individuals were diagnosed with CRC and 52,550 died from the disease in the United States. There were more than 1.9 million new CRC cases and 0.9 million deaths reported worldwide in 2020. CRC incidence is increasing, and it is estimated that the number of CRC patients worldwide could reach 2.5 million by 2035. There is a high unmet medical need to provide additional treatment options that could potentially extend life with quality for advanced metastatic CRC patients. ICI drugs have revolutionized the treatment and prognosis for several solid tumor types. The tumor types most susceptible to ICI are tumors characterized as immunologically ‘hot,’ meaning those that have high numbers of infiltrating anti-tumor immune cells. However, most solid tumors and almost all CRC tumors are immunologically ‘cold,’ having no infiltrating immune cells, making them refractory to ICI immunotherapy. This collaboration intends to use experimental AlloStim® to attempt to convert ICI-unresponsive CRC tumors into ICI-responsive tumors. If successful, this could provide a new treatment option for these patients. The combination of experimental AlloStim® and ICI has previously resulted in a rare objective tumor response in a patient with metastatic CRC, which has provided the rationale for further exploration of this combination in this indication: see: Objective response after immune checkpoint inhibitors in a chemotherapy-refractory pMMR/MSS metastatic rectal cancer patient primed with experimental AlloStim® immunotherapy. Dr. Michael Har-Noy, Founder and Chief Medical Officer of Mirror Biologics stated: “We are pleased to enter into this clinical collaboration with Merck KGaA, Darmstadt, Germany, evaluating the potential of investigational AlloStim® in combination with avelumab in patients who are suffering from advanced metastatic colorectal cancer. These patients have limited treatment options and are refractory to immunotherapy. The investigation of combination therapies may uncover additional possibilities for these patients. We look forward to working with Merck KGaA, Darmstadt, Germany to explore how we can bring the potential of immunotherapy to more patients.” Under the terms of the agreement, Mirror Biologics will be the sponsor of the clinical study, and Merck KGaA, Darmstadt, Germany will supply avelumab for the study. The Phase II open-label study is expected to accrue up to 50 patients with metastatic CRC who are both chemotherapy- and immunotherapy-refractory and who have failed at least one third-line, non-chemotherapy treatment (e.g., regorafenib, TAS-102 with or without bevacizumab or fruquintinib). The clinical study will be conducted at approximately 10 sites in the USA. Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking PD-L1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma. Avelumab has also been granted approval as monotherapy for the treatment of adults and pediatric patients (12 years and older) with metastatic Merkel cell carcinoma and for patients with locally advanced or metastatic urothelial carcinoma. Mirror Biologics, Inc. is a private Delaware corporation with headquarters, blood donor center, drug depo storage, distribution, clinical research, as well as immunological and bioengineering development operations in Tampa, Florida. Mirror also has GMP manufacturing operations in Jerusalem, Israel and additional clinical operations in Thailand and Malaysia. The lead product candidate, AlloStim® is an "off-the-shelf" non-genetically manipulated, living, immune cell immunotherapy protected by over 200 issued patents worldwide and derived from precursors purified from the blood of healthy donors. AlloStim® is a platform drug, that is broadly applicable to cancer and infectious disease indications. AlloStim® is being evaluated in a Phase IIb open-label clinical study in third-line metastatic colorectal cancer at 4 sites in USA, and in a Phase II/III randomized, controlled clinical study in advanced/metastatic liver cancer at 5 sites in Thailand and 3 sites in Malaysia. In addition, AlloStim® is being evaluated in a Phase I/II clinical trial in 40 healthy adults over 65yo in the USA as a means to reverse immunosenescence and restore broad universal respiratory viral protection in seniors against both known viruses (such as influenza A and B, RSV and coronavirus) and currently unknown viral pathogens, including emerging viruses with pandemic potential. The content above comes from the network. if any infringement, please contact us to modify.

The move is part of HUTCHMED’s strategy to concentrate on its core business of developing new therapies for immunological diseases and cancers. Credit: THICHA SATAPITANON/Shutterstock. HUTCHMED (China) has agreed to sell a 45% equity interest in the non-core, non-consolidated joint venture (JV) Shanghai Hutchison Pharmaceuticals (SHPL) for $608m to GP Health Service Capital and Shanghai Pharmaceuticals Holding. The move is part of HUTCHMED’s strategy to concentrate on its core business of developing new therapies for immunological diseases and cancers, particularly its antibody-drug conjugate platform. SHPL was established in 2001 with Shanghai Pharma. SHPL’s consolidated net income attributable to HUTCHMED was $47.4m in 2023. The proceeds from the sale will be invested in advancing HUTCHMED’s core business strategy, which includes a focus on antibody-targeted therapy conjugates (ATTCs). The ATTCs, which combine antibodies with targeted therapeutics, will enter clinical trials in the second half of 2025. GP Health Service Capital will gain a 35% equity interest from HUTCHMED for $473m, while Shanghai Pharma will increase its stake by 10% for $135m, resulting in a 60% ownership post-transaction. HUTCHMED will retain a 5% equity interest in SHPL. A three-year transition period will follow, during which HUTCHMED will propose the general manager for SHPL and guarantee a minimum net profit growth of 5% annually to GP Health Service Capital, with compensation capped at $95m. HUTCHMED anticipates a gain of $477m before taxation from the disposal. The transactions are subject to regulatory approvals and shareholder consent, with an Extraordinary General Meeting (EGM) to be convened for approval. The completion of the sale is expected by the end of the first quarter of 2025. HUTCHMED CEO and chief scientific officer Dr Weiguo Su stated: “We continue to invest in our prolific in-house research and development platform, including our new ATTC programmes that we believe have significant potential impact on the treatment of cancers. This divestment brings us additional resources and further focus. “Our continual approach to engineering our own innovative, highly selective drug candidates has delivered several medicines with enhanced selectivity and limited off-target activity, allowing sustained target inhibition and flexibility for use as part of combination therapies.” In January 2023, Takeda entered into an exclusive licence agreement with HUTCHMED (China) and its subsidiary Hutchmed for the development and marketing of fruquintinib.