CAR

CASI PHARMACEUTICALS ANNOUNCES MARKET APPROVAL OF CNCT19 BY CHINA NMPA

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Wednesday, November 8, 2023

The China National Medical Products Administration (NMPA) has granted market approval for Juventas' investigational cell therapy, Inaticabtagene Autoleucel (CNCT 19), for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China.

Key Points: 
  • The China National Medical Products Administration (NMPA) has granted market approval for Juventas' investigational cell therapy, Inaticabtagene Autoleucel (CNCT 19), for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China.
  • This approval is based on the clinical results from a single-arm, multi-center, pivotal study of 39 adult patients with r/r B-ALL in China.
  • He stated, "The approval of CNCT19 represents a transformative moment not only for CASI and Juventas but for all B-ALL patients in China.
  • CNCT19 offers new hope to patients battling relapsed B-ALL, and this partnership between CASI and Juventas aims to ensure that this innovative therapy reaches those in need across China and beyond."

Scopus BioPharma’s Subsidiary — Duet BioTherapeutics — Presents Compelling New Data for a Novel Treatment for Malignant Glioma at 38th Annual Meeting of the Society for Immunotherapy of Cancer

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Tuesday, November 7, 2023

NEW YORK, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Scopus BioPharma Inc. (OTCQB: “SCPS”) and its majority-owned subsidiary, Duet BioTherapeutics Inc., presented compelling new data that DUET-102 in combination with PD-1 blockade demonstrates significant anti-tumor activity in models of malignant glioma.

Key Points: 
  • DUET-102 is a double-stranded antisense oligonucleotide (“ASO”) STAT3 inhibitor linked to a TLR9 immune activator being developed for the treatment of glioma.
  • Glioma is a common type of tumor originating in the glial cells of the brain.
  • DUET-102, as a monotherapy, inhibited tumor growth and extended survival of mice in U251, GL261, and QPP8 models of glioma.
  • There is an acute need for new treatment options for glioma, which have seen no significant advances in the past decade.

Lyell Immunopharma Reports Business Highlights and Financial Results for the Third Quarter 2023

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Tuesday, November 7, 2023

An approximately 25% reduction in workforce associated with this prioritization is expected to be completed in the fourth quarter of 2023.

Key Points: 
  • An approximately 25% reduction in workforce associated with this prioritization is expected to be completed in the fourth quarter of 2023.
  • Lyell is advancing four wholly-owned product candidates with two product candidates in Phase 1 clinical development, LYL797 and LYL845.
  • Non‑GAAP G&A expenses, which exclude non-cash stock-based compensation, for the third quarter ended September 30, 2023, were $9.5 million, compared to $11.4 million for the same period in 2022.
  • The decrease in third quarter 2023 non-GAAP G&A expenses was driven by a decrease in legal, consulting and other administrative expenses.

Mnemo Therapeutics Announces Publication in Cancer Discovery on Ablation of SUV39H1 for Long-Term Protection Against Solid Tumors

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Tuesday, November 7, 2023

PARIS, Nov. 7, 2023 /PRNewswire/ -- Mnemo Therapeutics, a biotechnology company developing transformational immunotherapies, has announced a new preclinical study showing that CAR T cell memory differentiation and persistence can be enhanced by inactivating SUV39H1, an enzyme (histone methyltransferase) that epigenetically regulates and represses memory-associated genes. The paper, published in Cancer Discovery, is titled "SUV39H1 Ablation Enhances Long-Term CAR-T Function in Solid Tumors."

Key Points: 
  • The paper, published in Cancer Discovery, is titled "SUV39H1 Ablation Enhances Long-Term CAR-T Function in Solid Tumors."
  • SUV39H1-inactivated CAR T cells promote long-term protection against tumor relapses and rechallenges, demonstrated in mouse models of lung cancer and other solid tumors.
  • "T cell exhaustion and lack of persistence impede the long-term success of immunotherapy treatments for tumors," said Mnemo Chief Executive Officer Robert LaCaze.
  • SUV39H1 Ablation Enhances Long-Term CAR-T Function in Solid Tumors.

Allogene Therapeutics Presents Preclinical Data on a Novel Allogeneic CAR T Product Candidate Targeting Claudin18.2 at the Society for Immunotherapy of Cancer Annual Meeting

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Friday, November 3, 2023

Data presented at SITC describes preclinical development of Allogene’s novel allogeneic CLDN18.2 CAR T product candidate with the potential to provide clinical benefit to patients with a single, off-the-shelf infusion.

Key Points: 
  • Data presented at SITC describes preclinical development of Allogene’s novel allogeneic CLDN18.2 CAR T product candidate with the potential to provide clinical benefit to patients with a single, off-the-shelf infusion.
  • CLDN18.2 has emerged as a promising therapeutic target, with high expression in many types of epithelial tumors including gastric, esophageal, pancreatic and ovarian cancers.
  • We believe these preclinical data support a pathway to targeting CLDN18.2-positive solid tumors with an AlloCAR T product.
  • ALLO-182 together with ALLO-213, an allogeneic CAR T targeting DLL3, represent the company’s early-stage solid tumor product candidates.

Allogene Therapeutics Presents Preclinical Data on Next Generation Cloak™ and Dagger™ Technologies at the Society for Immunotherapy of Cancer Annual Meeting

Retrieved on: 
Friday, November 3, 2023

The development of “off-the-shelf” CAR T products that utilize cells from healthy donors has the potential to make CAR T therapies scalable and accessible to more patients.

Key Points: 
  • The development of “off-the-shelf” CAR T products that utilize cells from healthy donors has the potential to make CAR T therapies scalable and accessible to more patients.
  • However, the effectiveness of allogeneic CAR T cells requires controlling rejection of the allogeneic CAR T cells by the patient’s immune system.
  • Allogene’s proprietary Cloak and Dagger technologies are two novel strategies the Company is investigating to help control immune rejection and enhance expansion, persistence, and performance of AlloCAR T cells with the use of standard lymphodepletion regimens.
  • In the study, the survival of “cloaked” cells was assessed in mixed lymphocyte reaction assays with T cells and NK cells.

Umoja Biopharma Announces Oral Presentation at the 65th American Society of Hematology Annual Meeting

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Thursday, November 2, 2023

SEATTLE, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers, today announced that its abstract, VivoVec™ Surface-Engineered Lentiviral Particles Mediate In Vivo CAR T Generation with Potent and Highly Durable Activity in Non-Human Primates and Tumor-Bearing Humanized Mice, has been selected for an oral presentation at the 65th American Society of Hematology Annual Meeting to be held December 9-12, 2023, in San Diego, California.

Key Points: 
  • SEATTLE, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers, today announced that its abstract, VivoVec™ Surface-Engineered Lentiviral Particles Mediate In Vivo CAR T Generation with Potent and Highly Durable Activity in Non-Human Primates and Tumor-Bearing Humanized Mice, has been selected for an oral presentation at the 65th American Society of Hematology Annual Meeting to be held December 9-12, 2023, in San Diego, California.
  • Umoja’s presentation will discuss the development of the Company’s novel lentiviral in vivo delivery platform, VivoVec™, and additional data from ongoing NHP studies demonstrating best-in-class in vivo CAR T cell generation will be provided at the time of presentation.

Autolus Therapeutics to Present Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2023 in Two Oral Presentations and Two Poster Presentations

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Thursday, November 2, 2023

Additionally, we will be presenting the first AUTO8 clinical data from the MCARTY Phase I study in multiple myeloma.”

Key Points: 
  • Additionally, we will be presenting the first AUTO8 clinical data from the MCARTY Phase I study in multiple myeloma.”
    Session Title: 704.
  • In this session, pooled analysis of data from all patients treated to date in the FELIX study will be presented, with an extended follow up.
  • In the MCARTY study, we demonstrate dual CD19/BCMA targeting, alongside feasibility of clinical grade manufacture by double-transduction.
  • Additionally, obe-cel has been tested in patients with R/R B-cell chronic lymphocytic leukemia (B-CLL) and R/R B-cell non-Hodgkin lymphoma (B-NHL).

Autolus Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Thursday, November 2, 2023

Patients continue to be enrolled and initial data will be presented at ASH in December 2023.

Key Points: 
  • Patients continue to be enrolled and initial data will be presented at ASH in December 2023.
  • Financial Results for the Third Quarter Ended September 30, 2023
    Cash and cash equivalents at September 30, 2023, totaled $256.4 million, as compared to $382.4 million at December 31, 2022.
  • Autolus estimates that its current cash and cash equivalents on hand and anticipated future milestone payment from Blackstone will extend the Company’s cash runway into 2025.
  • Unaudited Financial Results for the Third Quarter Ended September 30, 2023

Allogene Therapeutics Reports Third Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, November 2, 2023

Following the close of the third quarter, the Company announced Geoffrey Parker as Executive Vice President, Chief Financial Officer, overseeing the Company’s financial operations and business development activities.

Key Points: 
  • Following the close of the third quarter, the Company announced Geoffrey Parker as Executive Vice President, Chief Financial Officer, overseeing the Company’s financial operations and business development activities.
  • Research and development expenses were $46.0 million for the third quarter of 2023, which includes $6.7 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $17.0 million for the third quarter of 2023, which includes $8.6 million of non-cash stock-based compensation expense.
  • Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update.