On November 10, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported updated safety, immunogenicity and efficacy data of its Phase 1/2 clinical trial of EO2401 in combination with an immune checkpoint inhibitor (nivolumab) +/- an anti-VEGF therapy (bevacizumab), for the treatment of patients with first progression/recurrence of glioblastoma (ROSALIE trial) (Press release, Enterome, NOV 10, 2022, View Source [SID1234623696]). The data were presented in an oral and a poster presentation at the 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Boston, MA, US, today.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jan Fagerberg, Chief Medical Officer of Enterome said, "We are very excited to present these updated data from the ROSALIE trial, evaluating EO2401 in combination with checkpoint blockade, and with checkpoint blockade plus anti-VEGF therapy, at SITC (Free SITC Whitepaper) 2022. These new data show that the memory CD8+ T cell response was found as early as two weeks after the first administration and that a strong and stable immune response continued to be detected for more than 10 months. Additionally, the observation that some patients exhibit up to 5% of circulating specific CD8+ T cells following administration is remarkable, and together with the clinical responses seen, reinforces the strong potential of our OncoMimics peptide-based immunotherapy in this difficult-to-treat patient population."

EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics peptide-based immunotherapy. It is designed to activate the patient’s memory T cells that cross-react with tumor associated antigens (TAAs) present on the cancer being treated. EO2401 includes synthetically produced HLA-A2 peptides with molecular mimicry to TAAs upregulated in glioblastoma (IL13Ra2, BIRC5 and FOXM1) and the CD4 helper peptide UCP2.

Enterome selected these OncoMimics peptides using its Mimicry platform, which applies best-in-class biocomputational tools and bioassays to identify novel therapeutics from its proprietary database of 20+ million bioactive peptides and proteins isolated from gut bacteria.

Key highlights from the EO2401 oral and poster presentation covering the Phase 1/2 ROSALIE trial were:

Data published to date confirm that EO2401 in combination with nivolumab +/- bevacizumab is well tolerated with a safety profile consistent with the safety profiles of nivolumab and bevacizumab, with the addition of local administration site reactions.
EO2401 in combination with nivolumab generated strong systemic immune responses through activation of specific effector memory CD8+ T cells, corresponding with clinical efficacy.
As compared to the administration of EO2401 in combination with nivolumab without the addition of the strong anti-edema compound bevacizumab, the symptom-driven addition of low-dose, time-limited, bevacizumab (LDB) resulted in longer treatment durations (median treatment duration 3.2 months with LDB vs 1.4 months without LDB), and some improvement of efficacy (ORR 20% vs 13%, median PFS 3.6 months vs 1.6 months).
In a subsequent cohort, the addition of continuous standard bevacizumab (as labelled in the USA) to EO2401 in combination with nivolumab further improved median treatment duration (to 5.0 months), objective response rate (to 55%), and median PFS (to 5.5 months).
Median survivals have not yet been reached for both EO2401 in combination with nivolumab and with LDB (median follow-up 7.8 months) or EO2401 in combination with nivolumab and bevacizumab (median follow-up 14.1 months).
CD8+ T cells against at least one of the EO2401 peptides was detected in 26 out of 28 patients with some patients exhibiting up to 5% of circulating specific CD8+ T cells. Memory specific CD8+ T cells response were found as early as two weeks after the first vaccination and maintenance of a strong and stable immune response could be detected for more than 10 months.
Additional patients are to be treated with triple combination of EO2401 in combination with nivolumab and bevacizumab to support final regimen selection.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.