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Adicet Bio, Inc. (Nasdaq: ACET) is a clinical-stage biotechnology company engaged in the discovery and development of novel allogeneic gamma delta T cell therapies for the treatment of autoimmune diseases and cancer. Leveraging advanced immunotherapy techniques, Adicet Bio is pioneering the use of gamma delta T cells engineered with chimeric antigen receptors (CARs) and T cell receptors (TCRs) to create 'off-the-shelf' therapies aimed at providing durable and effective treatments for patients.
Core Products and Pipeline:
- ADI-001: A first-in-class allogeneic gamma delta T cell therapy expressing a CAR targeting CD20, currently in a Phase 1 clinical trial for relapsed or refractory aggressive B cell non-Hodgkin's lymphoma and autoimmune diseases such as lupus nephritis.
- ADI-270: An armored gamma delta CAR T cell product candidate targeting CD70, in preclinical development for renal cell carcinoma and other CD70+ solid and hematological malignancies.
Recent Achievements and Collaborations:
- FDA clearance of the Investigational New Drug (IND) application for ADI-001 in lupus nephritis and initiation of Phase 1 clinical trial expected in 2Q 2024.
- Strategic collaboration with Regeneron Pharmaceuticals, Inc. to develop next-generation engineered immune-cell therapeutics.
- Successful Series A financing round, raising $51 million led by Orbimed Partners, Orbimed Israel, and Novartis Ventures.
- Inducement awards granted to new employees as material inducements for employment, signifying ongoing growth and talent acquisition within the company.
- Presentation of promising preclinical data on ADI-270 at major scientific annual meetings, indicating robust anti-tumor activity and potential clinical benefits.
Financial Overview: Adicet Bio maintains a strong cash position with $247.6 million in cash and cash equivalents as of March 31, 2024, providing sufficient funding to support operations into the second half of 2026. The company continues to strategically invest in research and development, as well as in expanding its organizational capabilities.
Adicet Bio is at the forefront of innovation in the biotechnology space, striving to bring transformative therapies to patients with unmet medical needs. For more information, please visit Adicet Bio's official website.
Adicet Bio (Nasdaq: ACET), a clinical stage biotechnology company, has dosed the first patient in its Phase 1 clinical trial of ADI-270 for metastatic/advanced clear cell renal cell carcinoma (ccRCC), marking a significant milestone. ADI-270, an allogeneic gamma delta T cell therapy, aims to address the high unmet need for effective treatments in ccRCC, the most common type of kidney cancer. Preclinical data suggest ADI-270 has significant tumor infiltration capabilities, resistance to the immunosuppressive tumor microenvironment, and potent activity via CAR and innate-mediated targeting. Preliminary clinical data from the trial are expected in the first half of 2025.
Adicet Bio (NASDAQ: ACET) has appointed Julie Maltzman, M.D. as Chief Medical Officer, effective January 13, 2025. Dr. Maltzman will lead the clinical development strategy for Adicet's autoimmune and oncology pipeline. She brings over 20 years of experience in clinical development across oncology and autoimmune diseases, from early-phase trials to global approvals.
The company reports significant momentum in clinical trial enrollment for both ADI-001 and ADI-270 programs, with increasing site activations and patient enrollment. Dr. Maltzman succeeds Dr. Francesco Galimi, who completed his tenure this month. Prior to joining Adicet, Dr. Maltzman served as Chief Medical Officer at IconOVir Bio and held leadership positions at Roche/Genentech, where she oversaw the successful registration of Tecentriq+Avastin® combination therapy.
Adicet Bio (Nasdaq: ACET) announced an inducement grant awarded on November 29, 2024. The company granted one new employee non-qualified stock options to purchase 6,000 shares at an exercise price of $1.13 per share. The shares will vest over four years, with 25% vesting after one year and the remaining 75% vesting monthly over the following three years. The grant was made under Adicet's 2022 Inducement Plan and approved by the compensation committee as a material inducement for employment in accordance with Nasdaq Rule 5635(c)(4).
Adicet Bio (Nasdaq: ACET) has initiated enrollment for a Phase 1 clinical trial of ADI-270, their gamma delta CAR T cell therapy targeting metastatic/advanced clear cell renal cell carcinoma (ccRCC). This marks the first gamma delta CAR T cell therapy aimed at treating solid tumors. The company's ADI-270 is an armored allogeneic 'off the shelf' gamma delta 1 CAR T cell therapy targeting CD70 positive cancers. Preliminary Phase 1 clinical data is expected in the first half of 2025. Recent preclinical data presented at the ASGCT conference showed ADI-270's potential for significant tumor infiltration, resistance to immunosuppressive tumor microenvironment, and potent activity.
Adicet Bio (NASDAQ: ACET) has dosed its first lupus nephritis patient in the Phase 1 clinical trial of ADI-001 for autoimmune diseases. The company expects to share preliminary clinical data in 1H25. Additional patient enrollment for systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, and stiff person syndrome is planned for 1Q25, with ANCA-associated vasculitis enrollment expected in 2H25. The FDA has granted Fast Track Designation to ADI-001 for relapsed/refractory class III or IV lupus nephritis, and cleared the IND amendment for stiff person syndrome and idiopathic inflammatory myopathy treatment.
Adicet Bio (NASDAQ: ACET) presented clinical biomarker data for ADI-001, their off-the-shelf gamma delta CAR T cell therapy, at ACR Convergence 2024. The data showed robust tissue homing and complete CD19+ B cell depletion in secondary lymphoid tissue, with CAR T cell activation levels of 27-64% at the 1E9 dose. The company is advancing ADI-001 in a basket study across six autoimmune indications, including lupus nephritis, systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, stiff person syndrome, and ANCA-associated vasculitis.
Adicet Bio expanded its ADI-001 Phase 1 clinical trial to include six autoimmune disease indications, with preliminary lupus nephritis data expected in 1H25. The company reported Q3 2024 financial results with a net loss of $30.5 million ($0.34 per share). R&D expenses were $26.3 million, while G&A expenses reached $6.9 million. The company maintains a strong financial position with $202.1 million in cash and equivalents, expected to fund operations into 2H26. FDA granted Fast Track Designation for ADI-270 in metastatic/advanced clear cell renal cell carcinoma.
Adicet Bio (NASDAQ: ACET) has announced its upcoming participation at the American College of Rheumatology (ACR) Convergence 2024 meeting in Washington, D.C., scheduled for November 14-19, 2024. The company will deliver an oral presentation about ADI-001, their allogeneic CD20-targeted γδ CAR T cell therapy, which shows potential for improved tissue homing in autoimmune indications. The presentation, titled under abstract number 1866169, will be delivered by Dr. Monica Moreno on November 19, 2024, at 12:00 p.m. ET during the Miscellaneous Rheumatic & Inflammatory Diseases II session.
Adicet Bio (ACET), a clinical-stage biotechnology company focused on allogeneic gamma delta T cell therapies, announces its participation in three major investor conferences in November 2024. The company will attend the Truist Securities BioPharma Symposium in New York for 1x1 meetings, the Guggenheim Securities Healthcare Innovation Conference in Boston featuring a fireside chat, and the Jefferies London Healthcare Conference. CEO Chen Schor will lead fireside discussions at both the Guggenheim and Jefferies events. Live webcasts will be available on Adicet's website with 30-day replay access.
Adicet Bio (Nasdaq: ACET) announced inducement grants to three new employees hired in October 2024. The company granted non-qualified stock options to purchase 59,800 shares at an exercise price of $1.28 per share. The vesting schedule includes 25% after one year, with the remaining 75% vesting monthly over three years. These awards were granted under Adicet's 2022 Inducement Plan, approved by the compensation committee as material inducement for employment in accordance with Nasdaq Rule 5635(c)(4).
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