On November 10, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported updated results from the phase 1/2 GOBLET study’s first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) cohort (Press release, Oncolytics Biotech, NOV 10, 2022, View Source [SID1234623695]). Patients in this cohort are treated with the combination of pelareorep, Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel. The updated data are featured in a poster presentation at the ongoing Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, which is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA.

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Objective response rate (ORR) and clinical benefit rate (CBR) in GOBLET’s PDAC cohort (n=13) were 69% and 85%, respectively, as of the SITC (Free SITC Whitepaper) poster’s data cutoff date (October 12, 2022). Additional data and conclusions presented in the poster are summarized below.

•One of thirteen evaluable patients achieved a confirmed CR
•Eight of thirteen evaluable patients achieved a PR
•Two of thirteen evaluable patients achieved stable disease (SD)
•The observed ORR of 69% is substantially higher than the average ORR of ~25% reported in historical control trials of gemcitabine and nab-paclitaxel in pancreatic cancer1-4
•GOBLET’s PDAC cohort exceeded the protocol-specified success criterion for Stage 1 of ≥ 3/12 objective responses
•The studied treatment combination has been well tolerated, with no safety concerns identified to date

"GOBLET’s interim results indicate pelareorep may be the key to finally improving the standard-of-care for first-line treatment of pancreatic cancer, a clear need given that treatment options have not changed for many years despite their limited benefits," commented Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc. "The robust efficacy signal in GOBLET markedly exceeded expectations based on historical results and is especially encouraging as most responding patients had their tumor regressions confirmed by subsequent evaluations. We were particularly excited to see a partial response deepen into a confirmed complete response as of the latest data cut, since this further indicates potentially durable anti-cancer effects from the combination therapy."

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., added, "The impressive results being presented at SITC (Free SITC Whitepaper), together with prior clinical data providing a strong mechanistic rationale for the apparent synergies being displayed by pelareorep, PD-L1 inhibition, and chemotherapy, support our pancreatic cancer program’s advancement into a pivotal trial. We look forward to discussions with regulators to enable these efforts and align on the optimal design for a licensure-enabling study. In parallel, we continue to make strong progress with our breast cancer program; and are thrilled to be advancing a pipeline that includes two potentially compelling registration opportunities."

The poster (#650), entitled, Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma

(PDAC) patients – Interim results from the GOBLET study, will be available for live viewing at the SITC (Free SITC Whitepaper) meeting tomorrow, November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET. A copy of the poster will also be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the meeting.

Key Opinion Leader Webinar
Oncolytics will host a key opinion leader (KOL) webinar featuring Dirk Arnold, M.D., Ph.D. (Asklepios Tumorzentrum Hamburg), Andrea Bullock, M.D., MPH (Beth Israel Deaconess Medical Center) and Thomas Seufferlein, M.D., Ph.D. (Ulm University, Germany) on November 14, 2022 at 10 a.m. ET. During the webinar, the KOLs and members of the Oncolytics management team will discuss the current treatment landscape and unmet medical need in pancreatic cancer, as well as the updated interim GOBLET study results being presented at the SITC (Free SITC Whitepaper) meeting. A live question and answer session will follow the formal presentations.

To register for the webinar, please click here.

References
1.Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2.O’Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3.Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4.Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients (n=12);

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

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."

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.

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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.

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]).

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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.

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]).

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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.