Immunotherapy

Calidi Biotherapeutics (NYSEAM: CLDI) Presents Data on CLD-201 Demonstrating Inhibition of Tumor Growth and Induction of Robust Anti-Tumor Immunity at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC 2023)

Retrieved on: 
Friday, November 3, 2023

CLD-201 consists of allogeneic mesenchymal stem cells loaded with the oncolytic vaccinia virus CAL1, which has the potential to target a variety of solid tumors.

Key Points: 
  • CLD-201 consists of allogeneic mesenchymal stem cells loaded with the oncolytic vaccinia virus CAL1, which has the potential to target a variety of solid tumors.
  • Tumor growth inhibition and induction of anti-tumor immunity were compared in mice treated with unprotected CAL1 virus and CLD-201.
  • Additionally, the poster presents the readiness of the product and plans to launch clinical trial in 2024.
  • CLD-201 has been successfully GMP manufactured, and its safety profile has been analyzed in both immunocompetent and immunocompromised pre-clinical models.

Onchilles Pharma Presents at SITC 2023 New Preclinical Data for N17350, a Potential Pan-Cancer Therapeutic

Retrieved on: 
Friday, November 3, 2023

The data presented show the potential for N17350, a first-in-class biologic therapeutic inspired by the immunobiology of neutrophils, to become a major new treatment modality for a wide range of cancer types.

Key Points: 
  • The data presented show the potential for N17350, a first-in-class biologic therapeutic inspired by the immunobiology of neutrophils, to become a major new treatment modality for a wide range of cancer types.
  • This builds upon previously presented data at AACR 2023 showing N17350 efficacy in syngeneic colon (CT26) and metastatic breast (4T1) cancer models.
  • Taken together, these findings support a potential broad therapeutic window for this innovative cancer cell-killing mechanism.
  • “The new preclinical data reported further highlights the broad clinical potential of our lead candidate, N17350, for a wide range of cancer types,” said Court R. Turner J.D., Co-Founder and Executive Chair of Onchilles Pharma.

Fulgent Shares Data from Two Poster Presentations at SITC 2023 Annual Meeting

Retrieved on: 
Friday, November 3, 2023

Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today announced data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.

Key Points: 
  • Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today announced data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.
  • The study calls for the involvement of certified labs, highlighting the need for stringent quality management and regulatory alignment.
  • The poster titled, “FID-007: Nanoencapsulated Paclitaxel Derived from a Novel Nano-Drug Delivery Platform,” highlights progress for Fulgent Pharma’s lead therapeutic oncology candidate, FID-007, in various cancers.
  • Preliminary clinical data suggests FID-007 may have anti-tumor activity in heavily pre-treated patients across various tumor types.

Laura Chow, MD, Cancer Immunotherapy Trailblazer, Joins Summit as Senior Vice President of Clinical Development

Retrieved on: 
Thursday, November 2, 2023

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that Laura Chow, MD, has joined Summit Therapeutics as Senior Vice President of Clinical Development.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that Laura Chow, MD, has joined Summit Therapeutics as Senior Vice President of Clinical Development.
  • We are very excited to welcome Laura to our team.”
    Dr. Chow remains in active clinical practice as a medical oncologist specialized in lung and head and neck cancers.
  • She joins Summit from Fate Therapeutics, where she was the Vice President of Clinical Development in Solid Tumors.
  • Chow’s experience being on the ground floor of cancer immunotherapy is unmatched,” added Dr. Allen S. Yang, Chief Medical Officer at Summit.

Prokarium Achieves Major Milestone with FDA's IND Approval for Bladder Cancer Program

Retrieved on: 
Thursday, November 2, 2023

Prokarium, a biopharmaceutical company at the forefront of applying synthetic biology to create novel cancer treatments, today announces that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for their immunotherapy ZH9.

Key Points: 
  • Prokarium, a biopharmaceutical company at the forefront of applying synthetic biology to create novel cancer treatments, today announces that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for their immunotherapy ZH9.
  • The approval enables initiation of the clinical development program for ZH9 in the U.S., focusing on patients with non-muscle invasive bladder cancer.
  • "The FDA’s approval of our IND application is an important milestone and a clear recognition of the preclinical data already generated for ZH9,” stated Prokarium’s CEO, Kristen Albright, PharmD.
  • Dara brings over two decades of experience in biotech and large pharma.

A2 Bio Presents Oral and Poster Presentations Highlighting BASECAMP-1 and EVEREST-1 Patient Screening at 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting

Retrieved on: 
Thursday, November 2, 2023

Additionally, A2 Bio is presenting two posters on November 4, 2023, detailing the BASECAMP-1 master pre-screening trial and EVEREST-1 CAR T interventional trial.

Key Points: 
  • Additionally, A2 Bio is presenting two posters on November 4, 2023, detailing the BASECAMP-1 master pre-screening trial and EVEREST-1 CAR T interventional trial.
  • “BASECAMP-1 provides patients an early opportunity to be identified and triaged to the appropriate EVEREST logic-gate Tmod™ CAR T trial.
  • A2 Bio has partnered with Tempus, a leader in precision medicine, to bring the latest technology to patient screening.
  • Details of the presentations are below:
    The two posters will be available on the A2 Bio website after November 4, 2023.

ProfoundBio Readies for Next Phase of Growth with Management Team Additions and Advisory Board Appointment

Retrieved on: 
Thursday, November 2, 2023

We are thrilled to welcome Erin and Kevin to our leadership team as we plan for this next stage of growth.

Key Points: 
  • We are thrilled to welcome Erin and Kevin to our leadership team as we plan for this next stage of growth.
  • In addition, as chair of our Scientific Advisory Board, Lori brings decades of clinical thought-leadership and strategic product development experience in ADCs.
  • We look forward to working alongside them.”
    ProfoundBio also announced additional changes to the company's executive team.
  • Co-founders Tae Han and Xiao Shang will take on the roles of chief strategy officer and head of CMC, respectively.

NanoString Customers Present First Data Using the Most Comprehensive Spatial Proteomics Panel Available

Retrieved on: 
Wednesday, November 1, 2023

The GeoMx Immuno-oncology Proteome Atlas (IPA) is the industry’s most comprehensive spatial proteomics panel, enabling unprecedented spatial profiling of more than 570+ relevant targets from FFPE (Formalin-Fixed, Paraffin-Embedded) tissue sections.

Key Points: 
  • The GeoMx Immuno-oncology Proteome Atlas (IPA) is the industry’s most comprehensive spatial proteomics panel, enabling unprecedented spatial profiling of more than 570+ relevant targets from FFPE (Formalin-Fixed, Paraffin-Embedded) tissue sections.
  • Dr. Thompson will share a comparison of early-stage HER2+ tumor biopsies from patients, both responders and non-responders to neoadjuvant treatment.
  • “The ability to interrogate the abundance and spatial distribution of 570 proteins is little short of breathtaking,” said Dr. Thompson.
  • “NanoString is honored to offer customers the unprecedented utility and power encapsulated in the new GeoMx IPA assay.

GE HealthCare Announces New Data Validating Artificial Intelligence Models for Predicting Patient Response to Immunotherapies

Retrieved on: 
Thursday, November 2, 2023

After regional regulatory approvals, GE HealthCare plans to commercialize the models for use both in pharmaceutical drug development and for clinical decision support.

Key Points: 
  • After regional regulatory approvals, GE HealthCare plans to commercialize the models for use both in pharmaceutical drug development and for clinical decision support.
  • To develop the AI models, GE HealthCare and VUMC retrospectively analyzed and correlated the immunotherapy treatment response of thousands of VUMC cancer patients, with their deidentified demographic, genomic, tumor, cellular, proteomic, and imaging data.
  • “These results are a promising development in the journey towards precision care, selecting treatment pathways based on the individual patient’s likely response.
  • The AI models are an integral part of GE HealthCare’s immuno-oncology development portfolio which includes the development of novel PET tracers.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

Retrieved on: 
Wednesday, November 1, 2023

Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.

Key Points: 
  • Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • For gemcitabine, treatment could be continued beyond eight cycles, while for cisplatin, treatment could be administered for a maximum of eight cycles.
  • There was a difference of ≥5% incidence in laboratory abnormalities between patients who received KEYTRUDA plus chemotherapy versus placebo plus chemotherapy for decreased lymphocytes (69% vs. 61%).