On January 8, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported corporate updates and highlighted upcoming milestones for 2025 (Press release, Adicet Bio, JAN 8, 2025, View Source [SID1234649523]).

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"2024 was a momentous year for Adicet as we amplified our efforts in autoimmune diseases and solid tumors. We dosed our first patients in our clinical trials evaluating our gamma delta 1 chimeric antigen receptor (CAR) T cell candidates, ADI-001 in LN and ADI-270 in ccRCC. Notably, ADI-270 is the first gamma delta CAR T cell therapy to enter clinical development for solid tumors, underscoring our commitment to pioneering innovative treatments. In the first half of 2025, we look forward to reporting preliminary data for both programs," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "Within our autoimmune portfolio, the successful expansion of our Phase 1 trial of ADI-001 into six autoimmune indications, building upon clinical biomarker data demonstrating ADI-001’s robust tissue trafficking and complete CD19+ B cell depletion in secondary lymphoid tissue, further reinforces ADI-001’s potential as an off-the-shelf treatment option.

Mr. Schor continued: "In our oncology pipeline, the initiation of our Phase 1 trial of ADI-270 in ccRCC patients marked a crucial achievement as the first gamma delta 1 CAR T cell product candidate for the treatment of solid tumors. As we look ahead to 2025, we believe we are well positioned to build on this momentum to advance our product candidates to patients living with autoimmune diseases and cancer."

Clinical Program Progress and Upcoming Milestones:

Autoimmune Diseases Clinical Programs

In June 2024, the Company announced that the Food and Drug Administration (FDA) had granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV LN.
In September 2024, Adicet presented clinical biomarker data from the Phase 1 GLEAN trial of ADI-001 at the 9th Annual CAR-TCR Summit demonstrating robust tissue trafficking resulting in high levels of ADI-001, significant CAR T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue.
In October 2024, the Company received FDA clearance for an amendment to its Investigational New Drug (IND) application to evaluate ADI-001 in IIM and SPS as part of the Phase 1 trial of ADI-001 in autoimmune diseases. This followed the clearance of an IND amendment in August 2024 to expand clinical development of ADI-001 in the Phase 1 trial beyond LN to include SLE, SSc and AAV.
In November 2024, Adicet announced the dosing of the first LN patient in the Phase 1 trial of ADI-001 in autoimmune diseases. The Company expects to initiate enrollment for patients with SLE, SSc, IIM, and SPS in the first quarter of 2025, and for patients with AAV in the second half of 2025.
Preliminary clinical data from the Phase 1 trial of ADI-001’s LN patient cohort are anticipated in the first half of 2025. Preliminary data from the Phase 1 trial’s other patient cohorts are expected in the second half of 2025.
Hematologic Malignancies and Solid Tumor Clinical Programs

In April 2024, Adicet presented preclinical data for ADI-270 at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) showing robust anti-tumor activity in an in vivo model of ccRCC, including tumor infiltration, resistance to the immunosuppressive tumor microenvironment, and potent activity via CAR and innate-mediated targeting.
In July 2024, the Company announced that FDA Fast Track Designation had been granted to ADI-270 for the potential treatment of patients with metastatic/advanced ccRCC who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.
In December 2024, Adicet announced the dosing of the first patient in the Phase 1 clinical trial evaluating ADI-270 in patients with metastatic/advanced ccRCC.
Preliminary clinical data from the ADI-270 Phase 1 trial in ccRCC are expected in the first half of 2025.

On January 8, 2025 Annals of Oncology (IF: 56.7), a top oncology journal globally, reported remarkable long-term follow-up results of a phase 1b/2 clinical trial on Disitamab Vedotin (DV) (developed by Remegen Co., Ltd) combined with Toripalimab in treating locally advanced or metastatic urothelial carcinoma (la/mUC) (NCT04264936, study ID: RC48-C014) (Press release, RemeGen, JAN 8, 2025, View Source [SID1234649522]). This trial was supervised by Professor Jun Guo and Professor Xi’nan Sheng’s teams from Peking University Cancer Hospital.

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It is the first time that long-term follow-up data has been released for a HER2-targeted antibody-drug conjugate (ADC) and PD-1 inhibitor combination therapy in treating la/mUC, marking it a significant milestone. The nearly-three-year follow-up data revealed an objective response rate (ORR) of 73.2% and median overall survival (OS) of 33.1 months, superior to data published from any other prospective clinical studies on ADC plus PD-1 combination therapies for la/mUC.

New Treatment Options for Patients with La/mUC

UC is the sixth most common cancer worldwide. GLOBOCAN 2022 estimated the year 2021 saw 614,298 new cases and 220,596 deaths of UC. In recent years, the prognosis for patients with la/mUC has significantly improved with new drugs and combination therapies approved, among which ADCs demonstrated outstanding potential.

As a HER2-targeted ADC, DV has been approved in China for patients with HER2-overexpressing (defined as immunohistochemistry [IHC] test results of 2+ or 3+) la/mUC previously treated with platinum-containing chemotherapy. The approval is based on the pooled results of two studies (NCT03507166 and NCT03809013, study IDs: RC48-C005 and RC48-C009) where the ORR registered 50.5% and the median duration of response (DOR) registered 7.3 months.

Multiple clinical studies on la/mUCin recent years have confirmed the synergistic antitumor effects of ADC combined with immunotherapy. NCT04264936 offered stronger evidence as its long-term follow-up results published in the Annals of Oncology demonstrated the high response rate, significant survival benefits, and manageable safety profile of the DV and Toripalimab combination therapy.

DV Combined with Toripalimab: High Response Rate and Prolonged Survival

NCT04264936 is an open-label, multicenter, investigator-initiated phase 1b/2 clinical trial investigating the safety and efficacy of DV in combination with Toripalimab for the treatment of patients with HER2-expressing la/mUC. The dose-escalation study (phase 1b) assessed two dose levels of DV (1.5 and 2.0 mg/kg) combined with Toripalimab (3.0 mg/kg) to determine the recommended phase 2 dose which was then evaluated in the dose-expansion stage (phase 2).

From August 2020 to December 2021, 41 patients were enrolled with a median age of 66 years. 53.7% of the participants were male, 70.7% had an ECOG performance status score of 1, 17 (41.5%) had lung metastasis, and 10 (24.4%) had liver metastasis.

As of March 1, 2024, among all participants, the ORR was 73.2% with 4 (9.8%) achieving complete response and 26 (63.4%) achieving partial response, the DCR was 90.2%, the median progression-free survival (PFS) was 9.3 months, the median DOR was 8.6 months, the median OS was 33.1 months and the 36-month OS rate was 49.2%.

Subgroup analysis revealed ORR benefits across all subgroups regardless of the number of prior lines of systemic treatments, HER2 expression (IHC 1+/2+/3+), and PD-L1 expression status. The ORRs for chemotherapy-naïve patients and those who progressed on platinum-based chemotherapy were 76.0% (19/25) and 68.8% (11/16), respectively. The ORRs for patients with HER2 IHC 3+, 2+, 1+, or 0 were 80.0%, 84.2%, 64.3%, and 33.3%, respectively. Compared with the three HER2 IHC 0 participants (one of whom achieved partial response), those with HER2 expression (IHC 1+/2+/3+) had a higher ORR (76.3% vs 33.3%) and longer PFS (median PFS: 9.3 vs 1.7 months).

In summary, the DV and Toripalimab combination therapy has preliminarily demonstrated promising efficacy and manageable safety profile among patients with la/mUC, wherein those with HER2 expression (IHC 1+/2+/3+) achieved high response rates and long-term survival benefits. These findings support the further exploration and validation of the benefits of DV combined with PD-1 inhibitors in treating la/mUC.

On January 8, 2025 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage immunology company advancing RNA therapeutics to conquer cancer, reported its participation at the 43rd Annual JP Morgan Healthcare Conference, taking place January 13-16, 2025 (Press release, Myeloid Therapeutics, JAN 8, 2025, View Source [SID1234649521]).

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Daniel Getts, Ph.D., CEO of Myeloid, will present on Wednesday, January 15, 2025, at 8:30 am PT. Company management will also participate in one-on-one meetings with investors during the conference.

On January 8, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision T cell activation, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to invikafusp alfa (STAR0602), Marengo’s first-in-class selective dual T cell agonist being studied as a potential new treatment for advanced colorectal cancer with TMB-H (Press release, Marengo Therapeutics, JAN 8, 2025, View Source [SID1234649520]). Fast Track designation is designed to facilitate the development and expedite the review of therapies intended to treat serious or life-threatening conditions with unmet medical needs.

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"The FDA’s Fast Track designation is an important milestone for the STAR0602 program and further positions our unique selective dual T cell agonist platform as a promising solution to address key challenges that perpetuate significant unmet needs in oncology," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "This recognition specifically validates the promise of STAR0602 as a novel treatment option for patients with TMB-H metastatic colorectal cancer, which is insensitive to PD-1 treatment."

The FDA’s decision is informed by the encouraging results from Marengo’s first-in-human Phase 1 clinical study of invikafusp alfa in heavily pretreated cancer patients, which were recently presented during a plenary oral session at the 2024 SITC (Free SITC Whitepaper) Annual Meeting and an oral presentation at the 2024 ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress. The data reinforce invikafusp alfa’s anti-tumor activity and favorable safety profile.

"Marengo’s selective Vβ T cell activation approach targeting specific T cell subsets enriched in Tumor-infiltrating lymphocytes to enhance anti-tumor activity is unique and highly promising," said Bruce Chabner, M.D., Clinical Director Emeritus for the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School. "The Phase 2 clinical investigation of invikafusp alfa is ongoing and this novel treatment could lead to a new class of therapeutics for tumor types that are PD-1 insensitive or resistant, especially in colorectal cancer where current treatment options remain limited."

Marengo is committed to advancing STAR0602 – the asset entered Phase 2 clinical trials at the end of 2024, and the company expects to report additional efficacy results later this year.

On January 8, 2025 Taiho Oncology, Inc. reported presentations at the 2025 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), to be held Jan. 23-25, 2025, in San Francisco (Press release, Taiho, JAN 8, 2025, View Source [SID1234649519]). The poster presentations include a comparison of real-world clinical outcomes of patients with metastatic colorectal cancer (mCRC) who received trifluridine and tipiracil (FTD/TPI) monotherapy or FTD/TPI + bevacizumab (FTD/TPI+bev) combination therapy and an additional analysis of the same dataset on real-world clinical outcomes in 639 black patients with mCRC.

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"Access to real-world clinical outcomes of FTD/TPI monotherapy versus FTD/TPI+bev combination therapy among patients with mCRC, could provide valuable insights to ultimately help improve clinical development and treatment protocols, broadly and in underrepresented populations," said Tehseen Salimi, MD, MHA, Senior Vice President and Head of Medical Affairs, Taiho Oncology. "At Taiho Oncology, our understanding of patient experience is a driving force that allows us to bring innovative cancer therapies to patients."

Details for both studies and data to be presented can be found below:

Title: Real-World Clinical Outcomes of Patients (Pts) with Metastatic Colorectal Cancer (mCRC) Who Received Trifluridine-Tipiracil (FTD-TPI) Monotherapy or FTD-TPI + Bevacizumab (FTD-TPI+bev) Combination Therapy
Abstract Number: 79
Session Name: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date: Jan. 25, 2025
Session Time: 7 – 7:55 a.m. PST
Location: Level 1, West Hall | On Demand
Presenter: Maliha Nusrat, MD, MS

Title: Real-World Clinical Outcomes of Trifluridine-Tipiracil Monotherapy (FTD-TPI) and FTD-TPI + Bevacizumab Combination Therapy (FTD-TPI+bev) in 639 Black patients (pts) with Metastatic Colorectal Cancer (mCRC)
Abstract Number: 81
Session Name: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date: Jan. 25, 2025
Session Time: 7 – 7:55 a.m. PST
Location: Level 1, West Hall | On Demand
Presenter: Maliha Nusrat, MD, MS