On February 14, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported Phase 1 data on its allogeneic gamma-delta T cell therapy, INB-100, at the 2025 Transplantation & Cellular Therapy (TCT) Meetings in Hawaii (Press release, In8bio, FEB 14, 2025, View Source [SID1234650285]). The data, previously announced, reinforce INB-100’s potential to significantly reduce post-transplant relapse in high-risk acute myeloid leukemia (AML) patients, positioning this gamma-delta T cell therapy as a promising approach in hematologic oncology.

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The latest findings demonstrate that INB-100 continues to deliver long-term remissions, with no AML patient relapses observed to date with a median follow-up of 20.1 months. The 1-year progression-free survival (PFS) rate across all leukemia patients stands at 90.9%, and 1-year overall survival (OS) is 100%, outperforming real-world historical controls. These data demonstrate that results for INB-100 do not appear to be due to imbalances in patient selection criteria, the performance of the individual clinical centers or driven by specific transplant or lymphodepletion protocols. These data underscore INB-100’s potential to reshape post-transplant care by leveraging gamma-delta T cells to enable sustained cancer cell surveillance and long-term remissions.

"AML patients undergoing allogeneic HSCT face high relapse rates with limited post-transplant therapeutic options," said William Ho, Chief Executive Officer and co-founder of IN8bio. "The durability of response and safety profile observed to date with INB-100 support its potential to set a new standard in post-transplant leukemia management."

"Despite decades of progress in transplantation, relapse remains the primary driver of mortality in AML patients post-HSCT. The INB-100 data showing durable remission without maintenance therapy is highly encouraging," said Dr. Michael Bishop, Director of the Hematopoietic Cellular Therapy Program, Director of the David and Etta Jonas Center for Cellular Therapy, and Professor of Medicine at the University of Chicago and IN8bio Scientific Advisory Board member.

Key Phase 1 INB-100 Findings:

Zero Relapses in AML Patients: No relapses observed in any AML patient treated with INB-100, with a median follow-up of over 20 months.
Superior 1-Year Survival Rates: PFS at 90.9%, OS at 100%.
Favorable Safety Profile: No cytokine release syndrome (CRS), neurotoxicity (ICANS), or Dose Limiting Toxicities (DLT’s). No treatment-related deaths.
Gamma Delta T Cell Persistence and Expansion: Evidence of in vivo expansion and long-term persistence, reinforcing the therapy’s potential to maintain immune surveillance against residual leukemic cells.
With approximately 20,000 new AML cases and ~11,500 deaths annually in the U.S., AML remains an area of high unmet medical need. Post-HSCT relapse occurs in up to 50% of patients, highlighting the urgency for novel, more durable therapeutic approaches. INB-100 harnesses the innate tumor-targeting properties of gamma-delta T cells to improve long-term outcomes, potentially filling a critical treatment gap.

IN8bio is accelerating patient enrollment in the INB-100 program and expects to complete enrollment of the expansion cohort in 2025. The company’s FDA discussions confirmed that relapse-free survival (RFS) is an acceptable primary endpoint for a future potentially pivotal randomized controlled trial in AML patients.

IN8bio recently hosted a Key Opinion Leader webinar discussing the latest developments in gamma-delta T cell therapy and the promising INB-100 clinical data. The webinar featured insights including Dr. Michael Bishop. A replay of the February 11, 2025 webinar is accessible here on the company’s website.

On February 14, 2025 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that the Company will participate in the following upcoming investor conferences (Press release, Fate Therapeutics, FEB 14, 2025, View Source [SID1234650284]):

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H.C. Wainwright 3rd Annual Cell Therapy Virtual Conference, including a fireside chat at 1:30 PM ET on Tuesday, February 25, 2025
TD Cowen 45th Annual Health Care Conference, including a company presentation at 11:50 AM ET on Monday, March 3, 2025 in Boston, Massachusetts
Barclays 27th Annual Global Healthcare Conference, including a fireside chat at 8:30 AM ET on Tuesday, March 11, 2025 in Miami, Florida
Leerink Partners Global Healthcare Conference, including a fireside chat at 11:20 AM ET on Wednesday, March 12, 2025 in Miami, Florida
A live webcast, if recorded, of each presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website shortly after the event.

On February 14, 2025 Amgen (NASDAQ: AMGN) reported that it will present at Citi’s 2025 Virtual Oncology Leadership Summit at 3:00 p.m. ET on Wednesday, Feb. 19, 2025 (Press release, Amgen, FEB 14, 2025, View Source [SID1234650283]). Jean-Charles Soria, senior vice president of oncology within global development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On February 14, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported more positive results from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Imugene, FEB 14, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/7cb7e5ac-c469-4c73-907d-5e7846ef78e9/Azer_cel_demonstrates_two_additional_Complete_Responses.pdf [SID1234650267]). Following the previously reported results on 2 September 2024, two additional patients in the previously reported Cohort B – treatment with azer-cel, lymphodepletion (chemotherapy), and interleukin 2 (IL -2) – have now achieved a Complete Response (CR, being the disappearance of all signs of cancer in response to the treatment), bringing the total to four out of seven evaluable patients in this cohort.

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"All four Complete Responses in Cohort B were achieved in patients who had failed at least 4 lines of therapy in this hard-to-treat population, including autologous CAR T therapy," said Dr Paul Woodard, Chief Medical Officer of Imugene. "This suggests that azer-cel, in combination with IL-2, may offer a meaningful therapeutic option where other treatments have not succeeded. We are continuing to monitor these patients for persistence of response, with the longest durability ongoing at 10 months. We look forward to providing further updates as data matures."

The company remains focused on continuing enrolment in Cohort B and evaluating the long-term durability of responses. Azer-cel is being developed as a potential off-the-shelf CAR T-cell therapy, addressing key limitations of autologous CAR T approaches, including treatment accessibility and manufacturing constraints.

The 2025 Tandem Meetings event for the Transplantation & Cellular Therapy Meetings of ASTCT (American Society for Transplantation and Cellular Therapy) and CIBMTR (Center for International Blood and Marrow Transplant Research) highlights the latest research breakthroughs in hematopoietic cell transplantation (HCT), cellular therapy and gene therapy. Imugene poster presentation at this event takes place at 6:45pm Hawaii Standard Time on 13 February (3:45pm AEDT 14 February) can be viewed at the same time on Imugene’s website at View Source

The poster presentation is titled: Administration of Low-Dose, Subcutaneous (SC) Interleukin-2 (IL-2) Markedly Enhances the Pharmacokinetic (PK) Profile of Azercabtagene Zapreleucel (azer-cel), an Allogeneic Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, without Compromising Safety and Early Evidence of Clinical Activity in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Who Have Relapsed after Prior CD19-Directed CAR T-Cell Products.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for patients with DLBCL, an aggressive type of non-Hodgkin’s lymphoma blood cancer (NHL), who relapsed after prior treatment with autologous CAR T therapies. Treatment with azer-cel, lymphodepletion (LD) and IL-2 in Cohort B is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

About diffuse large B cell lymphoma (DLBCL)

DLBCL is an aggressive and fast-growing type of non-Hodgkin’s lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 80,500 cases per year and approximately 30,000 new cases per year in the U.S.

Relapsed/refractory DLBCL has a high unmet medical need; 60-65% of patients treated with approved therapies, including autologous CD19 CAR T, relapse.

About Interleukin 2 (IL-2)

IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells.

On February 13, 2025 Alphamab Oncology (stock code: 9966.HK) reported that the first patient has been successfully dosed in the Phase III clinical study (Study ID: JSKN003-306) of anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003. The study aims to compare the efficacy of JSKN003 versus investigator-selected chemotherapy for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

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JSKN003 is an anti-HER2 biparatopic ADC, which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. In 2022, JSKN003 initiated monotherapy dose-escalation and dose-expansion clinical studies in Australia and China (Study IDs: JSKN003-101, JSKN003-102). Results from the pooled analysis of both studies demonstrated a favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with platinum-resistant recurrent ovarian cancer. Notably, efficacy was observed in both HER2-expressing (IHC 1+/2+/3+) and HER2-negative (IHC 0) patients.

JSKN003-306 is a randomized, open-label, parallel-controlled, multi-center Phase III clinical study for patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels. The study aims to compare the efficacy and safety of JSKN003 versus investigator-selected chemotherapy in this patient population.

About JSKN003

JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exert anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.

Multiple clinical studies at various stages of JSKN003 are currently being conducted in China and Australia. Clinical research results have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with HER2-expressing breast cancer, platinum-resistant ovarian cancer (PROC) or high HER2-expressing solid tumors.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.

(Press release, Alphamab, FEB 13, 2025, View Source [SID1234657005])