CD22

Sana Biotechnology Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates

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星期四, 二月 29, 2024

The Investigational New Drug Application (IND) cleared in 4Q 2023, and Sana expects to share initial data in 2024.

Key Points: 
  • The Investigational New Drug Application (IND) cleared in 4Q 2023, and Sana expects to share initial data in 2024.
  • The Clinical Trial Application (CTA) cleared in 4Q 2023, and Sana expects initial data to be shared in the first half of 2024.
  • Non-GAAP research and development expense in 2023 excludes an expense related to the impairment of certain lab equipment and leasehold improvements, primarily due to the portfolio prioritization in the fourth quarter of 2023.
  • A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.”

Sana Biotechnology Announces FDA Clearance of Investigational New Drug Application for SC262, a Hypoimmune-modified, CD22-directed Allogeneic CAR T Therapy, for Patients with Relapsed or Refractory B-cell Malignancies

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星期五, 一月 5, 2024

Engineered CAR T cell therapies for B-cell malignancies use binders to target proteins expressed on the surface of B cells.

Key Points: 
  • Engineered CAR T cell therapies for B-cell malignancies use binders to target proteins expressed on the surface of B cells.
  • One such protein, CD19, has been the target of all approved autologous CAR T therapies for B-cell lymphoma and B-cell acute lymphoblastic leukemia to date.
  • Unfortunately, incomplete responses or relapses occur in approximately 60% of CD19 CAR T-treated patients.
  • SC262 expresses the same CAR, including the same CD22 binder, used in CD22-directed CAR T therapies tested in multiple academic clinical trials.

ADC Therapeutics Provides Business Updates

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星期四, 一月 4, 2024

LAUSANNE, Switzerland, Jan. 04, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today provided business updates.

Key Points: 
  • ZYNLONTA®1 4Q 2023 net sales expected to be ~$16.5 million, a double-digit percentage increase as compared to 3Q 2023
    ADCT-601 (targeting AXL): Reached MTD and currently in dose optimization; Early signs of antitumor activity in both monotherapy and in combination
    LAUSANNE, Switzerland, Jan. 04, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today provided business updates.
  • “During 2023, we took a number of decisive actions to help position the Company for success in 2024 and beyond.
  • We prioritized our pipeline, strengthened our organization and implemented a disciplined capital allocation model to generate cost efficiencies,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics.
  • The Company ended the fourth quarter of 2023 with cash and cash equivalents of ~$278.5 million.

CARGO Therapeutics Reports Business Updates and Third Quarter 2023 Results

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星期三, 十二月 13, 2023

SAN MATEO, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (Nasdaq: CRGX), a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients, today reported business updates and its financial results for the third quarter ended September 30, 2023.

Key Points: 
  • SAN MATEO, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (Nasdaq: CRGX), a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients, today reported business updates and its financial results for the third quarter ended September 30, 2023.
  • Net loss was $35.5 million, or $47.37 per basic and diluted share, for the quarter ended September 30, 2023.
  • This compares with a net loss of $12.3 million, or $28.38 per basic and diluted share for the quarter ended September 30, 2022.
  • CARGO will participate in the 42nd Annual J.P. Morgan Healthcare Conference, taking place January 8-11, 2024, in San Francisco, California.

Sana Biotechnology Highlights Preclinical Data Supporting Tumor Control and Immune Evasion Capabilities of Hypoimmune-Modified Allogeneic CAR T Cells in Presentations at the American Society of Hematology Annual Meeting

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星期一, 十二月 11, 2023

SEATTLE, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced preclinical data supporting the anti-tumor and immune evasion capabilities of allogeneic CAR T cells engineered with Sana’s proprietary hypoimmune (HIP) technology were presented at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, CA.

Key Points: 
  • “HIP-modified allogeneic CAR T cells remain well-tolerated in preclinical models.
  • CD22 HIP CAR T cells were well tolerated with no signs of graft-versus-host disease (GvHD).
  • Sana submitted the investigational new drug (IND) application and intends to begin human testing of SC262 in early 2024.
  • Additionally, these GPRC5D CAR T cells controlled multiple myeloma tumor cells both in vitro and in vivo, demonstrating efficacy that is on par with clinical benchmark GPRC5D CAR T cells.

CARGO Therapeutics Announces Scientific Advisory Board

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星期三, 十二月 6, 2023

SAN MATEO, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (CRGX), a clinical-stage biotechnology company uniquely positioned to advance next generation, potentially curative cell therapies for cancer patients, today announced the formation of a Scientific Advisory Board (SAB) comprised of distinguished experts in cancer research, immunology, and CAR T-cell therapy.

Key Points: 
  • SAN MATEO, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (CRGX), a clinical-stage biotechnology company uniquely positioned to advance next generation, potentially curative cell therapies for cancer patients, today announced the formation of a Scientific Advisory Board (SAB) comprised of distinguished experts in cancer research, immunology, and CAR T-cell therapy.
  • The SAB will provide strategic counsel and critical expertise as CARGO advances its mission to develop the next generation of transformational CAR T-cell therapies.
  • “The SAB stands out by bringing together several highly accomplished translational investigators each with CAR T-cell experience that bridges both the laboratory and the clinic,” said Robbie Majzner, MD, co-founder of CARGO and Scientific Advisory Board Chair.
  • “They are uniquely suited to advise CARGO on their scientific goals and directions that will lead to better outcomes for patients.”
    Members of the CARGO Scientific Advisory Board are listed below; full bios are available on the CARGO website .

ADC Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Updates

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星期二, 十一月 7, 2023

LAUSANNE, Switzerland, Nov. 07, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the third quarter 2023 and provided business updates.

Key Points: 
  • Net product revenues were $14.3 million for the quarter ended September 30, 2023, compared to $21.3 million for the same quarter in 2022.
  • S&M expenses were $13.7 million for the quarter ended September 30, 2023, compared to $16.8 million for the same quarter in 2022.
  • G&A expenses were $9.4 million for the quarter ended September 30, 2023, compared to $19.6 million for the same quarter in 2022.
  • ADC Therapeutics management will host a conference call and live audio webcast to discuss third quarter 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time.

Cellectis to Present Preliminary Results of NATHALI_01 and Updated Results of the BALLI_01 Phases I Trials at the American Society of Hematology (ASH) 65th Annual Meeting

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星期四, 十一月 2, 2023

Cytokine release syndrome (CRS) Grade 1 or 2 occurred in all patients, and all CRS resolved with treatment.

Key Points: 
  • Cytokine release syndrome (CRS) Grade 1 or 2 occurred in all patients, and all CRS resolved with treatment.
  • No immune effector cell associated neurotoxicity (ICANS) or graft versus host disease (GvHD) was observed.
  • There were no UCART20x22 dose limiting toxicities (DLTs), and there was 1 DLT in connection with CLLS52 (alemtuzumab).
  • The study continues to enroll patients at dose level 2i (2.5 million cells/kg) with UCART22 P2.

Tallac Presents First Clinical Data for TAC-001 at SITC 2023

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星期五, 十一月 3, 2023

“These TAC-001 clinical data provide evidence that systemic administration of a TLR9 immune agonist targeting and activating B cells is generally well tolerated and induces immune activation consistent with preclinical studies.

Key Points: 
  • “These TAC-001 clinical data provide evidence that systemic administration of a TLR9 immune agonist targeting and activating B cells is generally well tolerated and induces immune activation consistent with preclinical studies.
  • TAC-003 has completed pre-clinical testing, including exploratory toxicological studies in cynomolgus monkeys, and has been selected as the Company’s third clinical candidate.
  • “We are excited to see these initial clinical data with TAC-001, the first program from Tallac’s TRAAC platform,” said Dr. Hong I. Wan, president, CEO and co-founder of Tallac Therapeutics.
  • Tallac Therapeutic’s TRAAC platform is designed to deliver a potent and differentiated TLR9 agonist (T-CpG) for targeted immune activation via systemic administration.

Florida Cancer Specialists & Research Institute Physicians Contribute to Immunotherapy Treatment Advances at Global Meeting

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星期五, 十一月 3, 2023

FORT MYERS, Fla., Nov. 3, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute (FCS) physicians will present at the Society for Immunotherapy of Cancer Annual Meeting this week in San Diego.

Key Points: 
  • FORT MYERS, Fla., Nov. 3, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute (FCS) physicians will present at the Society for Immunotherapy of Cancer Annual Meeting this week in San Diego.
  • They will join stakeholders across the immune-oncology field worldwide to advance the science, discover breakthroughs and enhance education on cancer immunotherapy, which uses the body's own immune system to find, target and fight many forms of the disease.
  • "Immunotherapy is one of the most promising and successful treatment areas for cancer, even at the most advanced stages, said Lucio N. Gordan, MD , FCS President & Managing Physician.
  • "Through our robust and far-reaching clinical trials research program, FCS continues to contribute to cutting-edge research that is providing hope and improving outcomes for cancer patients worldwide."