Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation differentiated immunotherapies for the treatment of cancer and autoimmune diseases, today announced that complete Phase 1 data for IDP-023, the Company’s allogeneic g-NK cell therapy, in combination with isatuximab in patients with relapsed/refractory multiple myeloma (RRMM) will be featured in an oral presentation at the Society for Immunotherapy of Cancer (SITC) 41st Annual Meeting, taking place November 4–8, 2026, in Phoenix, Arizona.

“We are highly encouraged to have achieved clinical proof-of-concept in these very advanced patients,” said Dr. Mark Frohlich, CEO of Indapta. “The patients in this cohort had exhausted most available options: all were refractory to daratumumab, two-thirds had received prior CAR-T therapy, and two-thirds had received a T-cell engager. These data support our preclinical hypothesis that IDP-023 can rescue patients with resistance to CD38-directed therapy. After recent feedback from the FDA, we are planning an expansion cohort in our current trial followed by a randomized registration-enabling trial in highly refractory patients with multiple myeloma.”

Oral Presentation Details

Title: IDP-023 Allogeneic g-NK Cells Combined with Isatuximab in Relapsed/Refractory Multiple Myeloma: Complete Safety, Efficacy, and Tumor Microenvironment Remodeling from a Phase 1/2 First-in-Human Study

Session: Clinical Oral Abstract Session

Date and Time: Friday, November 6, 2026, 12:00 PM – 12:15 PM, MST

Presenter: Mark W. Frohlich, MD, Indapta Therapeutics

Location: Phoenix Convention Center, Phoenix, Arizona, Halls BC

Poster Presentation Details

Abstract Number: 1185

Date and Time: Friday, November 6, 2026, 12:15–1:45 PM and 5:30–7 PM MST

Location: Phoenix Convention Center, Phoenix, Arizona, Poster Hall

The presentation summarizes safety and efficacy results from the Phase 1 portion of the ongoing Phase 1/2 trial (NCT06119685), focusing on 12 patients treated with IDP-023 in combination with isatuximab, an anti-CD38 monoclonal antibody approved for the treatment of multiple myeloma, together with translational analyses of the bone marrow tumor microenvironment. Patients received three doses of IDP-023 per cycle (10-20 billion cells per dose) with interleukin-2 (IL-2). Select patients received additional cycles. Patients were heavily pretreated, with a median of 6.5 prior lines of therapy (range 2–17); all were refractory to daratumumab, 92% were triple-class refractory, 58% were penta-refractory, 83% had received prior BCMA-directed therapy, 67% had received prior CAR-T therapy, and 67% had received a prior T-cell engager. All patients with available cytogenetics had high-risk disease (80% ultra-high risk), and 25% had extramedullary disease.

Key highlights from the oral presentation include:

  • The overall response rate (ORR; partial response or better) was 45% (5 of 11 response-evaluable patients) per 2026 International Myeloma Working Group (IMWG) criteria, and median progression-free survival (mPFS) was 6.3 months (95% CI, 2.0–not reached), compared with a 0% ORR and 1.6-month mPFS reported for isatuximab monotherapy in daratumumab-refractory patients (Mikhael et al., Blood Cancer Journal 2021).

  • A 72-year-old patient with ultra-high-risk cytogenetics, bulky extramedullary disease, and 10 prior lines of therapy, including BCMA CAR-T and two T-cell engagers, achieved a stringent complete response for > 1 year, with complete resolution of extramedullary disease on PET/CT.

  • Treatment was generally well-tolerated, with no dose-limiting toxicities through dose level 3 (20 billion cells, the maximum dose tested), no treatment-related deaths or discontinuations, and no clinically significant cytokine release syndrome, ICANS, infections, or bleeding. The most common adverse events were cytopenias related to lymphodepleting chemotherapy, which had predictable onset and from which all patients recovered.

  • Analysis of paired pre- and post-treatment bone marrow samples from 12 patients showed a trend toward increased CD8+ and gamma-delta T cells and decreased myeloid-derived suppressor cells following IDP-023, suggesting that IDP-023 may remodel the tumor microenvironment in a manner that supports durable responses and could complement subsequent T-cell-directed therapies such as T-cell engagers.

Based on these results and an End-of-Phase 1 Type B meeting with the U.S. Food and Drug Administration (FDA) in July 2026, Indapta plans to extend its Phase 1 trial to include a cohort of 15–20 highly refractory patients matching its proposed indication, using a fixed dose and schedule of up to three treatment cycles.

Indapta’s Proprietary g-NK Cell Therapy

Indapta’s universal, allogeneic NK cellular immunotherapy 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 cells 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/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 cellular immunotherapies 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.

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