On November 9, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company," 6990.HK) reported results from multiple clinical studies on its TROP2 ADC sacituzumab tirumotecan (sac-TMT) as oral presentations. From November 6 to 9, the 2025 Chinese Congress on Holistic Integrative Oncology (CCHIO) was held in Kunming, Yunnan. This conference was jointly organized by the Chinese Anti-Cancer Association (CACA), the Tengchong Science Forum Organizing Committee Office, the World Association for Integrative Oncology (WAIO), and the China Institute for Integrative Medicine Development Strategy. Academicians, experts, and scholars from across the nation gathered to focus on innovations in cancer diagnosis and treatment while sharing scientific breakthroughs.

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KL264-01/MK-2870-001

On November 7, Professor Sheng Jindong from Tianjin Cancer Hospital presented oral results on the efficacy and safety of sacituzumab tirumotecan (sac-TMT) monotherapy for locally advanced or metastatic endometrial cancer (EC) in a Phase II study at the conference. The endometrial carcinoma (EC) cohort in this study enrolled a total of 158 patients, with 114 patients assigned to the sac-TMT 4 mg/kg group and 44 patients to the sac-TMT 5 mg/kg group.

At data cutoff (May 21, 2025), median (range) follow-up was 11.7 months in the 4 mg/kg group and 21.8 months in the 5 mg/kg group. Confirmed objective response rate (ORR) was 30.7% and 34.1% in the 4 mg/kg and 5 mg/kg groups; all responses were partial response (PR). Confirmed and unconfirmed ORR was 35.1% and 36.4% in the 4 mg/kg and 5 mg/kg groups. Median duration of response (DOR) was 9.3 months and 8.7 months in the 4 mg/kg and 5 mg/kg groups. Median progression free survival (PFS) was 6.0 months and 7.3 months in the 4 mg/kg and 5 mg/kg groups.

Grade ≥3 treatment-related AEs (TRAEs) occurred in 59 patients (51.8%) and 34 patients (77.3%) in the 4 mg/kg and 5 mg/kg groups respectively; Treatment-related AEs that led to treatment discontinuation was 2 and 1 patient in each group, respectively.

In patients with advanced EC, sac-TMT monotherapy showed promising antitumor activity in the ≥2L advanced/metastatic setting and manageable safety. Both the 4 mg/kg and 5 mg/kg groups exhibited manageable safety and tolerability profiles consistent with the known safety characteristics of sac-TMT. These data led to initiation of two ongoing global Phase 3 studies of sac-TMT 4 mg/kg Q2W in advanced EC, which were sponsored and led by MSD.

OptiTROP-Lung03

On November 8, Professor Fang Wenfeng from the Cancer Center of Sun Yat-sen University delivered an oral presentation at the conference on preliminary results from a Phase II study evaluating sac-TMT in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations in previously treated patients. As of Dec 01, 2024, 42 patients were enrolled, including 23 patients with EGFR uncommon non-ex20ins mutations and 19 patients with EGFR ex20ins. Patients received sac-TMT 5 mg/kg Q2W until disease progression or unacceptable toxicity. After a median follow-up of 9.9 months, the ORR was 35.7% (15/42, 3 pending confirmation). The disease control rate (DCR) was 85.7%. Responses were durable with the median duration of response (mDoR) not yet reached, and the 6-month DoR rate was 90.9%. The median progression-free survival (mPFS) was 9.5 months (95% CI: 5.6, 10.9).

In the subset of patients with uncommon non-ex20ins, the ORR was 34.8% (8/23, 1 pending confirmation); the mPFS was 10.9 months (95% CI: 5.6, NE). In the subset of patients with ex20ins, the ORR was 36.8% (7/19, 2 pending confirmation); the mPFS was 9.0 months (95% CI: 2.4, NE). Grade ≥3 treatment-related adverse events occurred in 52.4% of pts. No TRAE led to treatment discontinuation or death. No cases of interstitial lung disease/pneumonitis were reported.

Sac-TMT monotherapy demonstrated promising clinical activity with a manageable safety profile in previously treated advanced NSCLC patients with uncommon EGFR mutations. These findings warrant further investigation of sac-TMT as a potential therapy for this population.

OptiTROP-Lung01

Professor Fang Wenfeng also presented results from the non-squamous cohort in the Phase II study evaluating the combination of sac-TMT and tagitanlimab (anti-PD-L1) as first-line therapy for advanced NSCLC during the oral presentation session. As of Dec 30, 2024, 81 patients with non-squamous histology were enrolled. Patients receive sac-TMT (5 mg/kg Q3W or Q2W) plus tagitanlimab (1200 mg Q3W or 900 mg Q2W) until disease progression or unacceptable toxicity. After median follow-up of 17.1 months, the confirmed ORR was 59.3%; The DCR was 91.4%; mDOR was 16.5 months (95% CI: 11.7, 22.1); mPFS was 15.0 months (95% CI: 10.8, 24.8). Among pts with PD-L1 TPS< 1%, the confirmed ORR was 47.1%; mPFS was 12.4 months (95%CI: 7.6, 15.4); while for patients with PD-L1 TPS≥ 1%, the confirmed ORR was 68.1%; mPFS was 17.8 months (95%CI: 14.5, NE). Among patients with PD-L1 TPS≥ 50%, the confirmed ORR was 77.8%; mPFS was 17.8 months (95% CI: 10.8, NE). No TRAE led to treatment discontinuation or death.

Sac-TMT in combination with tagitanlimab demonstrated promising antitumor activity in treatment-naive advanced non-squamous NSCLC. The durable clinical activities were observed regardless of PD-L1 expression. This combination therapy showed a tolerable safety profile based on known profiles of the individual agents, with no new safety signals observed.

Currently, two Phase 3 registrational studies of sac-TMT, namely (i) sac-TMT in combination with pembrolizumab (KEYTRUDA1) versus pembrolizumab for first-line treatment of patients with PD-L1 positive locally advanced or metastatic NSCLC, and (ii) sac-TMT in combination with pembrolizumab versus chemotherapy combined with pembrolizumab as first-line treatment for patients with PD-L1 negative locally advanced or metastatic non-squamous NSCLC are in progress.

With the goal of addressing patients’ urgent clinical needs, Kelun-Biotech has initiated over 30 clinical studies across multiple disease areas including lung cancer, breast cancer, and gynecological tumors. Leveraging its proprietary ADC and novel DC platform, OptiDC, the Company will continue developing innovative drugs with significant clinical value. This commitment aims to further enhance patient outcomes and contribute corporate strength to advancing the Healthy China initiative.

About Sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, three indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy and EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. Sac-TMT is the first TROP2 ADC drug approved for marketing in lung cancer globally. In addition, the new indication application for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the Center for Drug Evaluation of the NMPA, and was included in the priority review and approval process.

As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase Ⅲ global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, NOV 9, 2025, View Source [SID1234659674])

On November 7, 2025 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported new data from its ongoing Phase 2 clinical trial evaluating vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab (Tecentriq) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC). A 40% objective response rate (ORR) was demonstrated in heavily pre-treated patients with MSS mCRC without liver metastases and with high plasma TMB (≥10 mutations/Mb), as well as a statistically significant correlation between plasma TMB status and response. These new clinical data are being presented in a late-breaking poster presentation (Abstract # 1315) today at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, taking place from November 5-9, 2025, in National Harbor, Maryland.

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"These compelling new Phase 2 data for vilastobart in combination with atezolizumab demonstrated a 40% objective response rate in heavily pre-pretreated patients with MSS mCRC without liver metastases and with high plasma TMB, signifying an important advance in our understanding of response to novel immunotherapy in MSS mCRC," said Katarina Luptakova, M.D., chief medical officer of Xilio. "In addition, these data showed a statistically significant correlation between plasma-based TMB and response. We estimate that approximately 55% of patients with MSS CRC have high plasma TMB, representing a meaningful patient population who could ultimately benefit from combination treatment with vilastobart and a substantially greater prevalence of patients with high TMB than previously estimated using traditional tissue-based assays."

"These new data highlight the potential to use plasma TMB as a predictive biomarker and identify patients with MSS mCRC who may benefit from treatment with vilastobart, a tumor-activated anti-CTLA-4, in combination with a PD-(L)1," said Diwakar Davar, M.D., Associate Professor of Medicine, Clinical Director of the Melanoma Program and Medical Oncologist/Hematologist at the UPMC Hillman Cancer Center. "This biomarker guided approach, utilizing a feasible and reproducible biomarker, together with vilastobart’s differentiated safety profile, continue to support the promising opportunity for vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS mCRC, as well as other tumor types."

Promising Opportunity for Plasma-Based TMB as a Biomarker Predictive of Response to Combination Treatment with Vilastobart in Patients with MSS mCRC

Tissue-based TMB has demonstrated potential as a biomarker predictive of response to immune checkpoint inhibitors in many tumor types. However, tissue-based TMB assays have not shown predictive utility in MSS mCRC historically, and these tissue-based assays may underestimate the mutational burden in patients. In particular, tissue-based assays are limited to evaluating mutations in a single-site biopsy specimen, which is typically taken once at the time of diagnosis, and cannot account for tumor heterogeneity or changes in TMB over time.

Newer plasma-based assays show potential to better assess TMB status and be used as a biomarker predictive of response in patients with MSS mCRC. These plasma-based assays are more sensitive than traditional tissue-based assays in that plasma-based TMB assays provide a comprehensive assessment of mutational load and account for tumor heterogeneity. In addition, plasma can be readily obtained from blood samples throughout the course of treatment, accounting for changes in TMB over time without the need for invasive procedures.

Approximately 55% of non-MSI-H CRC patients were plasma TMB high (>10 mutations/Mb) based on an analysis of the GuardantINFORM real-world clinical-genomic database in approximately 8,000 patients who received the Guardant360 Liquid (Infinity) assay and who had non-MSI-H disease and a reportable TMB result. In contrast, historical data for tissue-based TMB assays have suggested <10% of patients with MSS mCRC were TMB-high.

These data support the meaningful opportunity to use plasma-based TMB as a biomarker predictive of response to combination treatment with vilastobart in patients with MSS mCRC.

New Data from Phase 2 Trial for Vilastobart in Combination with Atezolizumab in Patients with MSS mCRC Without Liver Metastases and with High Plasma TMB

As of a data cutoff date of May 12, 2025, 44 patients with MSS mCRC had been treated with the combination of vilastobart at 100 mg once every six weeks (Q6W) and atezolizumab at 1200 mg once every three weeks (Q3W), including 27 patients without liver metastases. Patients were heavily pre-treated, with 80% having previously received three or more prior lines of anti-cancer therapy.

In a retrospective analysis, 24 patients without liver metastases were evaluable for plasma TMB status. Baseline plasma TMB was assessed using the Guardant360 Liquid (Infinity) assay, and patients with TMB ≥10 mutations/Mb were defined as having high plasma TMB.

Clinical Efficacy Data

40% ORR in patients with MSS mCRC without liver metastases and high plasma TMB, with statistically significant correlation (p=0.05) between plasma TMB status and response.

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40% ORR in plasma TMB-high patients, consisting of six partial responses (PRs), with five confirmed PRs (with one confirmed after the data cutoff date) and one unconfirmed PR.

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In patients evaluable for plasma TMB status, 62.5% were TMB-high. All responders who were evaluable for plasma TMB status were TMB-high, and the correlation between plasma TMB status and response was statistically significant (p=0.05).

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As previously reported, responses were deep and durable, with reductions in target lesions of up to 71% from baseline.

Safety Data

Vilastobart in combination with atezolizumab continued to demonstrate a differentiated and generally well-tolerated safety profile. Treatment-related adverse events (AEs) were primarily Grade 1 or 2, consistent with the tumor-activated design for vilastobart.

As previously reported, across all patients treated as of a data cutoff date of May 12, 2025 (n=44), the combination of vilastobart at 100 mg Q6W and atezolizumab at 1200 mg Q3W was generally well-tolerated. Treatment-related AEs were primarily Grade 1 or 2. Only two patients (5%) discontinued treatment for the combination of vilastobart and atezolizumab due to a treatment-related AE, and only three patients (7%) experienced colitis of any grade.

Clinical Development Plans for Vilastobart

Based on the promising clinical activity and safety profile demonstrated by vilastobart as a combination therapy, including in patients who had high plasma TMB, Xilio is actively seeking a partner to develop vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS CRC and other tumor types.

Investor Conference Call Information

Xilio will host a conference call and webcast on Monday, November 10, 2025, at 4:30 p.m. ET. The webcast will feature a discussion with expert clinicians Aparna Parikh, M.D., Associate Professor of Medicine, Harvard Medical School, Program Director, GI Medical Oncology, Colorectal, Anal, and Neuroendocrine, Director of the MGB Global Cancer Care Program, Mass General Brigham Cancer Institute, Boston, MA, and Diwakar Davar, M.D., Associate Professor of Medicine, Clinical Director of the Melanoma Program and Medical Oncologist/Hematologist at the UPMC Hillman Cancer Center, Pittsburgh, PA. During the webcast, Xilio will discuss the new Phase 2 combination data for vilastobart and the promising opportunity to use high plasma TMB as a predictive biomarker for response, as well as briefly highlight additional data updates presented at SITC (Free SITC Whitepaper) across the company’s portfolio of differentiated masked immunotherapies.

Viewers can access the webcast by using this link. Listeners are encouraged to join at least 15 minutes prior to the scheduled start time. The webcast will also be accessible under "Events & Presentations" in the "Investors & Media" section of the Xilio Therapeutics website at ir.xiliotx.com. A replay of the webcast will be archived on the website for 30 days following the presentation.

About Vilastobart and the Phase 1/2 Combination Clinical Trial

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the efficacy and safety of the combination in Phase 2 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

(Press release, Xilio Therapeutics, NOV 7, 2025, View Source [SID1234659642])

On November 7, 2025 Biomunex Pharmaceuticals, a French biopharmaceutical company specializing in the development of next generation immunotherapies based on the discovery and development of bispecific and multispecific antibodies, reported presentation of preclinical data from its MAIT engager platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s ("SITC") 40th Annual Meeting being held in National Harbor, USA, from November 5th-9th, 2025.

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MAIT engagers: a new class of bispecific antibodies for cancer treatment

Invited to present an oral communication on November 8th, Dr Simon Plyte, Biomunex CSO (Chief Scientific Officer), will make a presentation entitled: "The MAIT Engager platform : rapid generation of several MAIT T cell engagers with significantly improved safety profile and large therapeutic window (Abstract 1197)." He is also presenting a Poster regarding the topic on November 7th.

Biomunex is developing a large portfolio of MAIT engager drug candidates, a new therapeutic class in immuno-oncology, that is differentiated from classical TCEs ("T cell engagers"). MAIT engagers are bispecific antibodies that identify, mobilize and bridge MAIT cells (Mucosal-Associated Invariant T cells) to cancer cells resulting in MAIT activation and directed killing of tumors; MAIT engagers could become a breakthrough approach in the treatment of many cancers, particularly in solid tumors.

The presentation at SITC (Free SITC Whitepaper) Annual meeting will focus on the MAIT engager differentiation from classical CD3+ TCEs and highlight the superior safety of MAIT engagers. MAIT engagers are expected to overcome some of the limitations of current CD3+ TCE therapies, including activation of regulatory T cells (Tregs) and cytokine release syndrome, serious side effects that are difficult to manage for cancer patients.

The Biomunex platform enables rapid generation of several MAIT engagers, that are not only as potent at classical CD3+ T cell engagers but also bring significantly improved safety profile and have the potential to provide a larger therapeutic window in specific tumor types. Moreover, MAIT engagers can effectively induce the "SPARK effect", enabling long-term durable anti-cancer response.

Based on preclinical data, Biomunex expects the first MAIT engager to enter clinical trials soon. The MAIT engager platform paves the way for a series of innovative new immunotherapeutics targeting many cancers. "MAIT engagers are an attractive approach for the treatment of cancer with breakthrough potential for redefining the standard of care for solid tumors," comments Dr. Simon Plyte, Biomunex’s CSO. "Presenting those preclinical data as an oral communication and a poster during the 40th SITC (Free SITC Whitepaper) meeting is a unique opportunity in sharing the scientific and medical potential of this innovative approach with the scientific community".

Biomunex accelerates development of its disruptive immunotherapies pipeline

Biomunex is becoming a major innovative player in oncology. Bi- and multi-specific antibodies and T cell engagers are attracting considerable interest from pharmaceutical companies, with the recent signing of many licensing and partnership agreements, including for Biomunex. "The last few months have marked the beginning of a new chapter in Biomunex’s development with the signing of a major agreement with Ipsen, following other licensing or partnership deals, demonstrating the team’s ability to develop drugs and technologies of interest for the pharmaceutical industry, such as the MAIT engagers presented at 2025 SITC (Free SITC Whitepaper) Annual meeting, to treat cancer patients, but also to establish leading licensing agreements and partnerships with the industry," comments Dr. Pierre-Emmanuel Gerard, Biomunex’s founder and President.

In addition to BMX-502 licensed to Ipsen, Biomunex is developing a portfolio of MAIT engager drug candidates and innovative new therapeutic approaches with high potential, based on its proprietary "Plug-and-Play" BiXAb platform. This technology enables the generation of breakthrough immunotherapies faster than most other platforms in the field, with excellent drug-like properties and high industrial yield. Biomunex’s first BiXAb drug candidate is currently in Phase 1 clinical development in partnership, as a monotherapy or in combination, in patients with certain solid tumors or hematological malignancies.

(Press release, BIOMUNEX Pharmaceuticals, NOV 7, 2025, View Source [SID1234659658])

On November 7, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that it will present clinical data from its ongoing Phase 1b clinical trial at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which will be held in National Harbor, Maryland from November 7-9, 2025.

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Phio’s poster presentation will highlight the clinical results from the ongoing Phase 1b dose escalation clinical trial. This clinical trial is designed to evaluate the safety and tolerability of intratumoral injection of PH-762 in patients with cutaneous squamous carcinoma, Merkel cell carcinoma, and melanoma.

Presentation Details are as follows:

Title: PD-1 Directed Intratumoral Immunotherapy for Cutaneous Carcinomas: A Clinical Study of INTASYL PH-762
Abstract Number: 610
Presenting Author: Mary Spellman, M.D.
Date: Saturday November 8, 2025
Location: Prince George ABC Exhibit Halls Gaylord National Resort and Convention Center

(Press release, Phio Pharmaceuticals, NOV 7, 2025, View Source [SID1234659643])

On November 7, 2025 Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation differentiated immunotherapies for the treatment of cancer and autoimmune diseases, reported the presentation of data highlighting the clinical activity of IDP-023, the Company’s allogeneic g-NK cell therapy, in patients with relapsed/refractory multiple myeloma. IDP-023 treatment was given as a standalone therapy and in combination with isatuximab, an anti-CD38 monoclonal antibody approved for the treatment of multiple myeloma.

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"We are encouraged to observe this degree of clinical activity of IDP-023 alone and in combination with isatuximab," said Dr. Mark Frohlich, CEO of Indapta. "This is particularly noteworthy given the extent of prior therapies and adverse prognostic features of the patients treated. We look forward to treating additional patients to better characterize the response proportion and durability of treatment effect."

The data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting, taking place November 7-9, 2025, in Washington, DC. The presentation (Abstract #1322), entitled "IDP-023 Allogeneic g-NK-cells +/- Anti-CD38 Monoclonal Antibody for the Treatment of Relapsed/Refractory Multiple Myeloma: Safety, Efficacy and Determination of Recommended Phase 2 Dose," summarizes the data from the safety run-in of the Phase 1 trial as well as the initial cohort of patients treated with IDP-023 in combination with an anti-CD38 monoclonal antibody. Patients received one to three doses of IDP-023, with or without interleukin-2 (IL-2).

Key highlights from the data presentation include:

Marked tumor reduction was observed in patients treated with IDP-023 alone and in combination with isatuximab.
In patients treated with IDP-023 at the second dose level of 10 billion cells/dose in combination with isatuximab, confirmed responses were observed in 4 of 5 response evaluable patients. These patients were heavily pre-treated with high-risk and ultra high-risk cytogenetics.
Responses included a stringent complete response in a patient with extramedullary disease who experienced prior progression following treatment with both CAR-T and T-cell engager therapy.
A second cycle of IDP-023 in combination with isatuximab in select patients appeared to improve the depth and duration of response.
Treatment was generally well-tolerated with no dose limiting toxicities. The most common adverse events were cytopenias related to the conditioning chemotherapy.
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 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, View Source). 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.

(Press release, Indapta Therapeutics, NOV 7, 2025, View Source [SID1234659659])