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Triumvira Immunologics Demonstrates Strength of Preclinical Research Pipeline for Gastric and Colorectal Cancers in Three Posters at SITC 2022

On November 10, 2022 Triumvira Immunologics ("Triumvira"), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with cancer, reported preclinical data for its investigational TAC-T cell therapies CLDN18.2-TAC T and GUCY2C-TAC T, and data on HER2-specific TAC-T products. Data was shared in three posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting being held virtually and in person in Boston (Press release, Triumvira Immunologics, NOV 10, 2022, View Source [SID1234623694]).

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"We are encouraged by our preclinical results to date, which further demonstrate that our proprietary T cell Antigen Coupler (TAC) technology is versatile, and can achieve effective and specific tumor targeting," said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira. "We are excited to be one step closer to moving CLDN18.2-TAC T towards entering clinical development. The data showed that CLDN18.2-TAC T and GUCY2C-TAC T could be an effective treatment for hard-to-treat solid tumors."

EOM PHARMACEUTICAL HOLDINGS, INC. ANNOUNCES NAME CHANGE FROM IMMUNOCELLULAR THERAPEUTICS, LTD.

On November 10, 2022 EOM Pharmaceutical Holdings, Inc. ("EOM"), a clinicalstage pharmaceutical company, reported its name change from ImmunoCellular Therapeutics Ltd., to EOM Pharmaceutical Holdings, Inc. EOM’s Common Stock will continue to be quoted on the OTC Markets under the ticker symbol "IMUC" while the company completes the process of changing the principal listing of its common stock to a national exchange (Press release, EOM Pharmaceuticals, NOV 10, 2022, View Source [SID1234623693]). No action is required to be taken by company stockholders with respect to the name change.

The company name change follows the merger of EOM Pharmaceuticals, Inc. and ImmunoCellular Therapeutics Ltd. on December 1, 2021, in which the shareholders of EOM Pharmaceuticals became the majority shareholders of the combined company. The merger created a public company that will focus on advancing immunomodulatory and retinal disease investigational drug agents to address a range of inflammatory, viral, retinal, and other diseases.

Management and Organization
The senior leadership team at EOM Pharmaceutical Holdings, Inc. includes Chief Executive Officer Irach Taraporewala, Ph.D.; EOM Founder, Board Chairman, and Chief Operating Officer Eli Goldberger; EOM Co-founder, Chief Scientific Officer and Medical Director Shalom Z. Hirschman, M.D; and Wayne I. Danson, Chief Financial Officer and Secretary.

Prestige Biopharma Obtains PBP1510 Patent in Indonesia, Marking the Tenth

On November 10, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company specializing in antibody drug development, reported that the company has obtained a patent in Indonesia for PBP1510 (INN-ulenistamab), the company’s first-in-class anti-PAUF monoclonal antibody (Press release, Prestige BioPharma, NOV 10, 2022, View Source [SID1234623692]).

PBP1510 has thus far been patented in a total of ten countries including Indonesia, Korea, United States, Japan, Australia, Taiwan, Russia, South Africa, Singapore, and Malaysia. In addition, it is currently under review for patent registration in 14 countries such as Canada and New Zealand.

Being a first-in-class anti-PAUF treatment, PBP1510 prevents the progression and metastasis of the cancer induced by PAUF (Pancreatic Adenocarcinoma Up-regulated Factor) and creating a more responsive environment for antitumor immunotherapy. Thus, it is expected to provide significant benefit to patients suffering from PAUF-positive pancreatic cancer.

In 2020, PBP1510 was granted Orphan Drug Designation by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Korea Ministry of Food and Drug Safety (MFDS). Currently, it is undergoing phase 1/2a clinical trial in Europe and U.S.

To bring the new promising drug to patients as early as possible, Prestige Biopharma is planning to apply for FDA’s Fast Track program, a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

BlueSphere Bio Presents Data Demonstrating the Potential of Lead Product Candidate at 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 10, 2022 BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company developing a powerful TCR discovery platform and novel therapeutic candidates for patients with hematologic malignancies and solid tumors, reported the presentation of data supporting the potential of its first and lead product candidate, BSB-1001, at the 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, being held virtually and in Boston, MA from November 8-12, 2022 (Press release, BlueSphere Bio, NOV 10, 2022, View Source [SID1234623691]).

BSB-1001 is the first TCR-T cell therapy candidate generated using the Company’s TCXpress platform and is in development for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS) in conjunction with allogenic hematopoietic stem cell transplantation (alloSCT). BSB-1001 is designed to provide durable responses by eliminating graft-versus-host-disease while eradicating residual cancer cells in AML, ALL and MDS patients receiving alloSCT. Specifically, BSB-1001 targets the minor histocompatibility antigen-1 (HA-1), whose expression is largely limited to hematopoietic cells. The company anticipates filing its first IND for this drug candidate by 1Q 2023.

The TCXpress platform has also enabled the discovery of several new TCRs reactive against other clinically relevant miHAs, in addition to HA-1. These additional TCRs will become part of a panel that positions BlueSphere with best-in-class population coverage in these indications. BlueSphere plans to announce details on these other targets in the coming months.

Presentations Highlights:

Title: Manufacture of allogeneic, HLA-matched, TCR-edited T-cell therapy reactive against minor histocompatibility antigen 1 to treat Acute Myeloid Leukemia in combination with CD34 HSCT with the potential for high potency and durability

Presenter: Robert Keefe, Ph.D., Chief Development Officer

Data Highlights:

BSB-1001 is a highly potent cell therapy with the potential to be an effective in treatment for patients with AML undergoing alloSCT.
BSB-1001 demonstrated robust cancer cell killing in vitro, even at low doses relative to target cells.
Genetic manipulations to remove the endogenous TCR had no impact on BSB-1001, supporting the manufacturing process’ ability to generate a high-quality product.
Multiple analyses indicate BSB-1001 is highly renewable and expandable following freeze thaw, highlighting the quality and potency of the final cell therapy product.

Biodesix Presents New Data from the INSIGHT Study at the 2022 Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

On November 10, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that Wallace Akerley, MD, medical oncologist at the University of Utah Huntsman Cancer Institute, will present new interim data from the large multi-center prospective observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting (Press release, Biodesix, NOV 10, 2022, View Source [SID1234623690]). The data highlights the ability of the VeriStrat test, a novel predictive and prognostic blood-based host immune classifier, to stratify immune checkpoint inhibition (ICI) treatment response in patients with advanced non-small cell lung cancer (NSCLC). The poster, titled "Host Immune Profiling in First-line Immunotherapy Treated Advanced Stage Non-Small Cell Lung Cancer: Results from the INSIGHT Registry Study," will be presented on Friday, November 11th, 2022.

Results from a prior analysis of the VeriStrat test published in the Journal for ImmunoTherapy of Cancer (JITC) in October 2021 demonstrated that approximately 2,000 patients with at least one year of follow up classified by VeriStrat as host immune classifier hot (HIC-Hot) had better outcomes, on average living 2-3 times longer when compared to patients classified by VeriStrat as host immune classifier cold (HIC-C). A classification of HIC-H, also known as VeriStrat Good, implies that the normal tumor directed immunity is active and patients are potentially responsive to therapies that boost immune response. HIC-C classification, also known as VeriStrat Poor, correlates to what experts refer to as an "immune desert," where tumor directed immunity is compromised.

The new data expands the analysis population to a total of 3,040 patients and confirms the ability of the VeriStrat test to predict outcomes in patients treated with immunotherapy regimens. Patients with HIC-C classification had superior median overall survival when receiving ICI plus chemotherapy versus ICI alone (8.2 months versus 5.6 months, respectively). Furthermore, patients with high PD-L1 expression and with HIC-C classification had superior median overall survival when receiving ICI plus chemotherapy versus ICI alone (14.3 months versus 3.3 months, respectively).

"Real World data can answer questions not addressed by registrational studies. HIC (VeriStrat) is a biomarker of immune therapy and these results suggest that HIC-C (VeriStrat Poor) patients should not be treated with single agent ICI therapy regardless of their PD-L1 expression," said Dr. Akerley, principal investigator of the INSIGHT study. "Immunotherapy has transformed treatment options for patients with non-small cell lung cancer, but it is challenging to know which standard of care regimens will be most effective. This new data from the INSIGHT study shows how a biomarker-driven strategy can help determine optimal treatment approaches for these patients."