Indapta Therapeutics, Inc.

HOUSTON & SEATTLE--( BUSINESS WIRE )--Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation cell therapies for the treatment of cancer and autoimmune diseases, announced today it has closed a $22.5 million round of new financing to accelerate the clinical development of its differentiated allogeneic Natural Killer (NK) cell therapy. Current investors RA Capital Management, LP, Leaps by Bayer, the impact investment arm of Bayer AG, Vertex Ventures HC, Pontifax, and the Myeloma Investment Fund, the venture philanthropy subsidiary of the Multiple Myeloma Research Foundation, completed the round. "This funding will enable us to generate significant additional data in our ongoing trial of IDP-023 in cancer as well as initial data from our first trial in autoimmune disease," said Mark Frohlich, Indapta’s CEO. "Preliminary results of IDP-023 in cancer are encouraging and we look forward to initiating our Phase 1 trial for multiple sclerosis in Q1 2025. This financing, together with our recently announced collaboration with Sanofi, highlights the promise of our differentiated platform.” Advancing Clinical Trials of Lead Product IDP-023 Indapta has completed enrollment in the safety run-in portion of the Phase 1 clinical trial of IDP-023 in Non-Hodgkin’s Lymphoma (NHL) and Multiple Myeloma (MM), in which patients received up to three doses of IDP-023 without and with interleukin (IL)-2. As presented at the Society for Immunotherapy of Cancer meeting , the mean maximum decrease in serum M-protein or light chain was 73% in responding myeloma patients with relapsed/refractory disease, with three patients achieving a reduction of 84% or greater. Enrollment of cohorts receiving IDP-023 in combination with monoclonal antibodies targeting CD20 or CD38 is underway. In August, Indapta announced FDA clearance of its IND of IDP-023 in combination with ocrelizumab in progressive MS . The company’s approach is highly differentiated from other cellular approaches to autoimmune diseases, with at least three different mechanisms that can address the biology of the disease: 1) by combining with a B cell targeting antibody like ocrelizumab, IDP-023 can deplete B cells more effectively than antibody alone; 2) g-NK cells are capable of targeting autoreactive T and B cells that are known to upregulate HLA-E; and 3) given their inherent anti-viral activity, g-NK cells can potentially address the EBV viral reservoir that contributes to the disease pathogenesis. About Indapta Therapeutics Indapta is a privately-held company focused on developing and bringing to market a diverse pipeline of cell therapies to treat the still unmet medical needs of patients with blood and solid-tumor cancers as well as autoimmune diseases. The company’s proprietary robust platform of naturally-occurring g-NK cells is specifically designed to create best-in-class, highly potent, more accessible, and scalable cell therapies. For more information, please visit www.indapta.com .

Plus, news about Akamis Bio, Tenaya Therapeutics, Reviva, Actuate Therapeutics, CG Oncology and Candel Therapeutics: Affimed shares early lung cancer data: In a Phase 1/2a trial, its bispecific innate cell engager, called AFM24, plus Roche’s Tecentriq reached a 21% overall response rate in 33 people with pretreated EGFR wild-type non-small cell lung cancer. The ORR was 24% in 17 EGFR-mutant patients. Affimed said it has selected the 720 mg dose for further development. Affimed’s shares $AFMD were down about 22% on Tuesday morning after it announced the data. — Ayisha Sharma Indapta Therapeutics gets $22.5M: The Houston and Seattle biotech raised the new round to fund clinical development of its allogeneic natural killer cell therapy. The biotech emerged with a $50 million Series A in February 2022. — Kyle LaHucik Oncolytic virus biotech has new funding and a deal in China: Akamis Bio announced that it raised new funding plus inked an out-licensing deal with Xuanzhu Biopharma for its lead candidate for up to $60 million. That figure includes private funding, the upfront for the outlicensing deal and biobucks, though CEO Howard Davis declined to disclose how much each portion is. Akamis, which rebranded from PsiOxus in 2023, is developing a gene therapy called NG-350A that is designed to target tumor cells and drive expression of CD40 agonist antibodies. The hope is that by engaging these key immune proteins, the therapy can trigger the immune system to attack the cancer. The company plans to use the funds to study the therapy in a Phase 1b rectal cancer trial. — Lei Lei Wu Tenaya’s shares slide: The company reported early results for an AAV therapy for three patients with a genetic heart condition called MYBPC3-associated hypertrophic cardiomyopathy. It pointed to biomarkers that suggested the therapy was having an initial effect, though it said “longer-term data are needed to characterize TN-201’s activity.” Tenaya said longer follow-up data as well as results from a higher dose cohort are expected next year. The company’s shares $TNYA fell 47% on Tuesday morning. — Lei Lei Wu Reviva’s long-term results for its schizophrenia drug: The Cupertino, CA-based biotech said brilaroxazine administered once daily showed sustained efficacy over one year in the open-label extension portion of a Phase 3 trial. There were no side effects with an incidence of more than 5%, but there was a 35% treatment discontinuation rate. Its stock $RVPH fell about 44% in trading on Tuesday morning. — Ayisha Sharma Actuate’s pancreatic cancer asset boosts survival: The drugmaker’s elraglusib in combination with gemcitabine and nab-paclitaxel (GnP) almost doubled the one-year survival rate versus GnP alone in a Phase 2 trial, good for a p-value of 0.002. Actuate said that 38% of treated patients were still alive at the cutoff date in November, compared with 19% of the control cohort. The company’s share price $ACTU was up 14% at market open on Tuesday. — Ayisha Sharma CG Oncology raised $238 million in its public offering, up from the $204 million it planned to bring in. — Jaimy Lee Candel ended up raising $92 million in its public offering. — Jaimy Lee

HOUSTON & SEATTLE--( BUSINESS WIRE )--Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and autoimmune diseases, today announced a collaboration with Sanofi to explore the combination of its allogeneic g-NK cell therapy, IDP-023, with Sanofi’s CD38-targeting monoclonal antibody, Sarclisa (isatuximab). Indapta has amended its ongoing phase 1 study of IDP-023, to add a cohort of IDP-023 in combination with Sarclisa for patients with relapsed/refractory multiple myeloma. Up to three dose levels of IDP-023 will be explored in the combination. Under the agreement, Indapta will sponsor the clinical trial, Sanofi will supply Sarclisa, and the Parties will co-fund the trial. As presented at the Society for Immunotherapy of Cancer Meeting, IDP-023 administered with or without interleukin-2 achieved a mean maximum reduction in serum M-protein or light chain of 73% in eight relapsed/refractory myeloma patients. This appears to be superior to prior trials of natural killer cells in myeloma. “With its deep experience in multiple myeloma and pipeline of products in hematologic malignancies and immunologic disorders, Sanofi is an excellent partner to help Indapta develop our differentiated natural killer cell product,” said Robert Sikorski, Indapta’s Chief Medical Officer. “We look forward to a close collaborative relationship and leveraging Sanofi’s expertise in the design of potential subsequent studies.” Indapta’s Proprietary g-NK Cell Therapy Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as “g minus” NK cells, or “g-NK” cells. g-NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability. IDP-023 has several differentiated mechanisms of killing target cells without the need for genetic engineering, including highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells. Indapta’s g-NK can release dramatically more immune activating cytokines and cell-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, https://doi-org.libproxy1.nus.edu.sg/10.1182/bloodadvances.2020002440 ). g-NK cells in combination with a B cell targeting antibody can also deplete normal B cells from healthy donors or patients with autoimmune disease. About Indapta Therapeutics Indapta is a privately held company focused on developing and bringing to market a diverse pipeline of cell therapies to treat the still unmet medical needs of patients with blood and solid-tumor cancers as well as autoimmune diseases. The company’s proprietary robust platform of naturally occurring g-NK cells is specifically designed to create best-in-class, highly potent, more accessible, and scalable cell therapies. For more information, please visit www.indapta.com .