PhotonPharma, Inc. Receives FDA Clearance for a First in Human Clinical Study for Stage III/IV Ovarian Cancer Treatment with the Investigational Autologous Vaccine Therapy, Innocell

On March 5, 2024 PhotonPharma, a biotechnology company dedicated to revolutionizing cancer treatment, reported that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with its Phase I clinical study for the treatment of Stage III/IV ovarian cancer using Innocell, its investigational groundbreaking autologous cell-based vaccine therapy (Press release, PhotonPharma, MAR 5, 2024, View Source;receives-fda-clearance-for-a-first-in-human-clinical-study-for-stage-iiiiv-ovarian-cancer-treatment-with-the-investigational-autologous-vaccine-therapy-innocell-302079350.html [SID1234640820]). This therapeutic approach employs inactivated tumor cells, prepared by a proprietary process based on UV light and riboflavin, after isolation of the cells from a patient’s tumor. These inactivated cells are used in a treatment designed to recruit the patient’s own immune system to fight the cancer. The vaccine therapy will be manufactured at City of Hope’s Los Angeles campus in its Biological and Cellular GMP Manufacturing Facility.

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This milestone achievement underscores PhotonPharma’s commitment to advancing innovative therapies that have the potential to transform the lives of patients battling aggressive forms of cancer.

PhotonPharma CEO, Alan Rudolph, expressed his enthusiasm, stating, "We are thrilled to have reached this pivotal moment in our journey toward providing a novel treatment option for patients facing advanced ovarian cancer. This milestone speaks to the dedication and expertise of our team, as well as the potential of Innocell to make a meaningful impact in oncology."

Ray Goodrich, CSO and co-founder of PhotonPharma, added, "The FDA’s clearance to proceed into our clinical study with Innocell marks a significant step in developing this new therapy. We remain committed to advancing an innovative therapy that may address unmet needs in cancer treatment."

Taby Ahsan, Ph.D., Vice President of Cell and Gene Therapy Operations at City of Hope in Los Angeles, said, "We are excited to collaborate with PhotonPharma in advancing Innocell towards clinical development. We look forward to contributing our decades of experience in cell- and gene-based therapies to the progress of this important program."

The Phase 1 clinical trial for Innocell will evaluate its safety, tolerability, and potential immune response indicators in patients with Stage III/IV ovarian cancer. PhotonPharma anticipates initiating patient enrollment in the near future, with the aim of profiling the therapeutic potential of this innovative autologous vaccine therapy.

Immunitas Therapeutics to Present Preclinical Data Supporting Combination of IMT-009 with Anti-PD1 Immunotherapy at the AACR 2024 Annual Meeting

On March 5, 2024 Immunitas Therapeutics ("Immunitas"), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, reported it will present preclinical data supporting the combination potential of IMT-009, its first-in-class anti-CD161 antibody under clinical evaluation for use in solid tumor and hematologic malignancies, with anti-PD1 immunotherapy at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR 2024), held April 5-10 in San Diego, California (Press release, Immunitas Therapeutics, MAR 5, 2024, View Source [SID1234640819]).

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Presentation Details for AACR (Free AACR Whitepaper) 2024
Title: Abundance of KLRB1+ (CD161) T cells in anti-PD1 non responders coupled with enhanced tumor cytotoxicity of anti-CD161 (IMT-009) with anti-PD1 makes it a rational target for combination with anti-PD-(L)1 immunotherapy
Abstract Number: 1375
Date/Time: Monday, April 8, 2024, 9:00am – 12:30pm PT

About IMT-009
IMT-009 is a fully human, Fc-attenuated IgG1 monoclonal antibody that binds to CD161 and blocks its interaction with its ligand, CLEC2D. Preclinical data confirm that CD161 blockade with IMT-009 results in enhanced anti-tumor activity. IMT-009 is under evaluation in a Phase 1/2a clinical trial for use as a monotherapy and combination treatment for solid tumor and hematological malignancies. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D).

Hummingbird Bioscience to Present Two Posters on Anti-HER3 and Anti-VISTA Antibody Therapeutics at American Association for Cancer Research (AACR) Meeting 2024

On March 5, 2024 Hummingbird Bioscience, a data-driven precision biotherapeutics company discovering and developing transformative biologic medicines for hard-to-treat diseases, reported two upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting 2024 (April 5-10) in San Diego, California (Press release, Hummingbird Bioscience, MAR 5, 2024, View Source [SID1234640818]).

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The company will present pre-clinical data describing the activity of HMBD-001, a clinical-stage anti-HER3 monoclonal antibody (mAb) currently in Phase I trials (NCT05057013, NCT05910827 and NCT05919537), in tumors with oncogenic HER3 mutations, and pre-clinical data investigating the mechanism of action and anti-tumor response of HMBD-002, a clinical-stage anti-VISTA mAb currently in Phase I trials (NCT05082610).

HMBD-001 is shown to potently block oncogenic signaling driven by HER3 mutations and could offer significant clinical benefit for patients with HER3 mutations across cancer types. The poster will highlight that more than 80% tumor growth inhibition is seen across multiple preclinical models with common HER3 mutations. The data also confirms that HMBD-001’s binding epitope does not overlap with these mutations in HER3.

HMBD-002 selectively blocks VISTA while avoiding depletion of important immune cell populations, holding significant promise for patients with aggressive cancers, including triple-negative breast cancer and non-small cell lung cancer. The HMBD-002 poster will highlight the molecular and cellular mechanisms driving HMBD-002’s specific and potent anti-tumor response via VISTA blockade. These insights will help to identify and target patients that are most likely to benefit from HMBD-002.

"These translational studies exemplify Hummingbird Bio’s commitment to precision oncology. Through better understanding of disease biology and the mechanisms underlying the efficacy of our therapies, we can more precisely define the patient populations that will benefit from those therapies. We look forward to discussing our recent advancements with the oncology research community at AACR (Free AACR Whitepaper)," said Jerome Boyd-Kirkup, Ph.D., Chief Scientific Officer, Hummingbird Bioscience.

Hummingbird Bioscience is recruiting patients with aberrant HER3 signaling, which includes selected HER3 mutations, in the company’s ongoing Phase Ib trial (NCT05919537).

HMBD-001
Presentation

Title: A HER3 antibody that uniquely
blocks the HER3 heterodimerization
interface effectively inhibits tumor
growth in pre-clinical models with
potentially oncogenic HER3
mutations

Session Category: Experimental and
Molecular Therapeutics

Session Title: Cancer Treatment: New
Technologies

Session Date and Time: Tuesday Apr 9,
2024, 1:30 PM – 5:00 PM

Location: Poster Section 22

Poster Board Number: 5

Published Abstract Number: 5796

HMBD-002
Presentation

Title: The VISTA blocking antibody
HMBD-002 promotes type-I
interferon signaling and drives anti-
tumor responses through
macrophage reprograming and
cytotoxic CD8+ T cell activation

Session Category: Immunology

Session Title: Immune Checkpoints and
Inhibitory Molecules 1

Session Date and Time: Monday Apr 8,
2024, 9:00 AM – 12:30 PM

Location: Poster Section 3

Poster Board Number: 7

Published Abstract Number: 1356

Fusion Pharmaceuticals to Present Interim Data from the Phase 2 TATCIST Clinical Trial Evaluating FPI-2265 at the 2024 AACR Annual Meeting

On March 5, 2024 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that interim efficacy and safety data from the Phase 2 TATCIST clinical trial evaluating FPI-2265 in patients with metastatic castration-resistant prostate cancer (mCRPC) has been selected for a clinical trial poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, being held April 5-10 in San Diego, California (Press release, Fusion Pharmaceuticals, MAR 5, 2024, View Source [SID1234640817]).

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Presentation at AACR (Free AACR Whitepaper) Annual Meeting 2024:

Title: Preliminary efficacy and safety results from the (TATCIST) trial: A PSMA-directed targeted alpha therapy with FPI-2265 (225Ac-PSMA-I&T) for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
Session: Phase II Clinical Trials 1
Session Date and Time: Tuesday April 9, 2024, 9:00 a.m – 12:30 p.m. PT
Location: Poster Section 49
Abstract Number: CT224

The poster will be available on Fusion’s website following the presentation. For more details about the AACR (Free AACR Whitepaper) Annual Meeting, please visit: View Source

Elevation Oncology to Present Preclinical Proof-of-Concept Data for HER3-ADC Program at the American Association for Cancer Research (AACR) Annual Meeting 2024

On March 5, 2024 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical need, reported that it will present preclinical proof-of-concept data for its differentiated HER3-targeting antibody-drug conjugate (ADC) program in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, being held April 5-10 in San Diego, California (Press release, Elevation Oncology, MAR 5, 2024, View Source [SID1234640816]).

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"We are excited to share preclinical proof-of-concept data for our HER3-ADC program. HER3 is a clinically validated oncology and ADC target, which is overexpressed across a range of solid tumors, and is often associated with a poor clinical outcome," said David Dornan, Ph.D., Chief Scientific Officer of Elevation Oncology. "At AACR (Free AACR Whitepaper), we plan to share preclinical proof-of-concept data highlighting our progress towards the development of a differentiated HER3-ADC. We look forward to nominating a development candidate this year and to the advancement of our HER3-ADC program toward the clinic, with the goal of improving patient outcomes."

Details of the poster presentation at AACR (Free AACR Whitepaper) 2024 are as follows:

Title: Therapeutic potential of a HER3 antibody-drug conjugate for the treatment of HER3-expressing cancers

Abstract: #3121
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody-Drug Conjugates
Session Date and Time: Monday, April 8, from 1:30 p.m. to 5 p.m. PT