On June 6, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported a poster and a publication in abstract book featuring Tedopi, an immunotherapy activating tumor specific T-cells, in non-small cell lung cancer (NSCLC) and in ovarian cancer at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held June 2 – 6 (Press release, OSE Immunotherapeutics, JUN 6, 2023, View Source [SID1234632542]).

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ADDITIONAL DATA FROM THE POSITIVE PHASE 3 CLINICAL TRIAL IN NSCLC, ATALANTE-1

The publication- abstract "# e21037", "Prognostic factors of overall survival (OS) in non-small cell lung cancer (NSCLC) patients after failure on immune checkpoint inhibitors (IO) treated with anticancer vaccine OSE2101 or chemotherapy (CT) in phase 3 ATALANTE-1 randomized trial", reported an analysis performed to identify the prognostic factors of overall survival (OS) in each treatment group of the Phase 3 clinical trial of Tedopi (Atalante-1) in HLA-A2+ patients with advanced or metastatic non-small cell lung cancer (NSCLC), led by Pr. Benjamin Besse, Gustave Roussy cancer center, Principal Investigator of the study.

Tedopi is the first cancer vaccine that has shown positive and clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) in third line with secondary resistance to immune checkpoint inhibitors in advanced or metastatic NSCLC (Phase 3 trial ATALANTE-1). Classical baseline factors (disease stage, histology) and treatment effect including best response, safety and ECOG* Performance Status (PS) deterioration were studied in this analysis and correlated to OS.

The analysis concludes that prognostic factors of OS differ between the cancer vaccine Tedopi and the standard chemotherapy treatment. The maintenance of a good ECOG PS was associated with longer survival for Tedopi, and the best response to treatment was the main prognostic factor for chemotherapy. These results support the mechanism of action of Tedopi in improving OS by controlling tumor growth regardless of best response.

Dr. Silvia Comis, Head of Clinical Development of OSE Immunotherapeutics, commented: "Following the positive results presented at the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) 2022, these additional data showing how Tedopi improves OS strengthen the data basis to better understand the benefit of Tedopi on OS in NSCLC patients with secondary resistance to anti-PD-1 treatments. We look forward to advancing the clinical development of Tedopi in second line through a confirmatory pivotal Phase 3".

TEDOVA PHASE 2 CLINICAL TRIAL IN OVARIAN CANCER

The poster entitled, "TEDOVA/GINECO-OV244b/ENGOT-ov58 trial: Neo-epitope-based vaccine OSE2101 alone or in combination with pembrolizumab vs best supportive care (BSC) as maintenance in platinum-sensitive recurrent ovarian cancer with disease control after platinum", presented by Dr. Alexandra Leary, from Gustave Roussy cancer center (Villejuif, France) and Principal Investigator of TEDOVA study, featured the ongoing Phase 2 international randomized open-label clinical trial, sponsored and conducted by ARCAGY-GINECO (Poster Bd # 310a).

Dr Alexandra Leary commented: "Our patients with ovarian cancer do not respond to checkpoint inhibitors alone as these tumors are ‘immune cold’, not likely to trigger a strong immune response and usually not responding to immunotherapy. The objective of TEDOVA is to turn ovarian cancer into an ‘immune hot’ tumor by using Tedopi, a combination of tumor associated neo-epitopes that have been optimized to break immunological self-tolerance. TEDOVA is the first trial evaluating such an innovative approach in ovarian cancer. We thank the international gynecological oncology community for their support and enthusiasm in promoting and conducting this research, moreover, helping to better understand this particularly aggressive disease."

* The ECOG score is a performance scale used to quantify the general health condition of a patient.
It is subdivided into 5 grades from 0 to 5, ranging from fully active (0) to fully disabled, then to death (5).

PRESENTATION DETAILS

"Prognostic factors of overall survival (OS) in non-small cell lung cancer (NSCLC) patients after failure on immune checkpoint inhibitors (IO) treated with anticancer vaccine OSE2101 or chemotherapy (CT) in phase 3 ATALANTE-1 randomized trial." [NCT02654587]

Benjamin Besse, Paris-Saclay University, Institut Gustave Roussy, Villejuif, France

– Date: June 4, 8:00 – 11:00 am CET
– Abstract # e21037
– Session Type: Publication Only
– Session Title: Publication Only: Lung Cancer—Non-Small Cell Metastatic
– Track: Lung Cancer
– Sub Track: Non-Small Cell Lung Cancer – Advanced/Metastatic Disease

"TEDOVA/GINECO-OV244b/ENGOT-ov58 trial: Neo-epitope-based vaccine OSE2101 alone or in combination with pembrolizumab vs best supportive care (BSC) as maintenance in platinum-sensitive recurrent ovarian cancer with disease control after platinum." [NCT04713514]

Alexandra Leary, Gustave-Roussy Cancer Campus, Villejuif, and GINECO, Paris, France

– Date: June 5, 1:15 – 4:15 pm CET
– Abstract # TPS5618
– Poster Bd # 310a
– Session Type: Poster Session
– Session Title: Gynecologic Cancer
– Track: Gynecologic Cancer
– Sub Track: Ovarian Cancer

ABOUT NON-SMALL CELL LUNG CANCER

Lung cancer is the leading cause of cancer mortality (18.0% of the total cancer deaths) with an estimated 2.2 million new cancer cases per year and with 1.8 million deaths. Lung cancer is the second most commonly diagnosed form of cancer after prostate cancer in men, and the third one in women, after breast and colorectal cancers. Among this population, 85% of lung cancer fall into the non-small cell lung cancer (NSCLC) form. About 58% are diagnosed at metastatic stage with a 5-year survival rate at 7%. Patients with HLA-A2 positive NSCLC represent 45% of this population. Over half of the patients will eventually develop secondary resistance to ICIs. Median overall survival after failure to immunotherapy is low with significant adverse events, thus a high unmet need for innovative therapeutic strategies to improve patient outcomes and enhance their quality of life. The targeted population for Tedopi in second line could be estimated up to 100,000 patients per year in 7 major markets across the US, Europe, China and Japan.

ABOUT OVARIAN CANCER

Worldwide, ovarian cancer is the seventh most common cancer and the eighth leading cause of cancer death in women. The five-year survival rate for ovarian cancer worldwide is 30-40%. In 2020, there were nearly 313,000 new cases diagnosed*. Once the first relapse has occurred, ovarian cancer is managed as a chronic disease, requiring iterative lines of platinum-based chemotherapy. After 6 cycles, chemotherapy is stopped and one of the major priorities is to extend "chemotherapy-free" intervals for the patients by proposing maintenance strategies with targeted therapies (PARP inhibitors or bevacizumab). By the time patients with ovarian cancer present with first or second relapse, they will have received BOTH a PARP inhibitor and bevacizumab, thus patients progressing post-PARP inhibitors and bevacizumab represent an area of unmet medical need, they are offered chemotherapy alone with no maintenance strategy. The TEDOVA trial adresses these women.

On June 6, 2023 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that data from the ongoing Phase 1/2 TRESR clinical trial evaluating camonsertib (RP-3500/RG6526, partnered with Roche), a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), were published in Nature Medicine (Press release, Repare Therapeutics, JUN 6, 2023, View Source [SID1234632541]).

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The article, entitled "Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results" can be accessed here.

"The results of the TRESR trial demonstrate not only the single agent activity of camonsertib, a potent and selective ATR inhibitor, but also define the importance of enhanced precision medicine approaches, such as the identification of bi-allelic alterations affecting the target DNA repair genes and other biomarkers, as well as the use of longitudinal liquid biopsies to guide its delivery to the right patients," said Maria Koehler, MD, PhD, EVP and Chief Medical Officer of Repare. "This study provides a framework for the testing of novel therapeutic approaches based on the principles of synthetic lethality and informed by genome-wide CRISPR screens."

TRESR (NCT04497116) is a first-in-human, multi-center, open-label Phase 1/2 dose-escalation and expansion study, designed to establish the recommended Phase 2 dose and schedule, evaluate safety and pharmacokinetics and identify preliminary anti-tumor activity associated with camonsertib, given alone and in combination with talazoparib or in combination with gemcitabine. Clinical data were most recently presented at the 2022 and the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meetings, demonstrating the promising safety and efficacy profile of camonsertib, both as a monotherapy and in combination with a poly (ADP-ribose) polymerase inhibitor.

On June 6, 2023 BPGbio, Inc., a leading AI-powered biopharma that focuses on oncology, neurology and rare diseases, reported that patients have been initially dosed in its Phase 2 trial for BPM 31510 for Glioblastoma Multiforme (GBM), a fast-growing and aggressive form of brain cancer (Press release, BPGbio, JUN 6, 2023, View Source [SID1234632540]).

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BPM 31510, the company’s lead drug candidate, acts by targeting the mitochondrial machinery and tumor microenvironment (TME) to create a metabolic shift in cancer cells, leading to cancer cell death. BPM 31510 for GBM is one of the three oncology drug assets in clinical phase that BPGbio developed on its AI-driven Interrogative Biology platform.

GBM is one of the most aggressive forms of brain cancer with survival times averaging only 15-18 months from diagnosis, the 5 year survival rate is under 10 percent. There are approximately 13,000 new cases of GBM-related tumors annually in the US, occuring more frequently in patients over 60.

In preclinical studies in orthotopic models of GBM, pre-treatment with BPM 31510 followed by radiation therapy was associated with significant long-term survival compared to radiation alone, while BPM 31510 showed an anti-cancer effect in GBM patients without damaging normal brain cells. A Phase 1 trial in advanced, refractory GBM patients completed at Stanford Medicine demonstrated a favorable safety profile of BPM 31510, supporting Phase 2 trial advancement.

"This milestone is a testament to the value of our Interrogative Biology platform and its capability to develop drugs for the treatment of deadly diseases where patients desperately need better therapeutics," said Niven R. Narain, Ph.D., President and CEO of BPGbio. "Advancing this candidate into Phase 2 human trials is a big step of progress for both the company and patients suffering from GBM."

The open-label, multi-cohort Phase 2 study for BPM 31510 for treatment of GBM is led by Seema Nagpal, MD, Clinical Associate Professor, Division of Neuro-Oncology at Stanford Medicine. The study will include planned interim analyses primary, secondary and exploratory endpoints. Current clinical sites include lead site Stanford Medicine, Cedars-Sinai Medical Center in Los Angeles and Mt. Sinai Medical Center in New York. Additional sites are currently being assessed in the United States and the United Kingdom.

"The combined preclinical and phase 1 safety and tolerability data provided valuable insights into treatments for Glioblastoma Multiforme. Leveraging the results from the phase 1 clinical trial, we are looking forward to further advance our discoveries using neoadjuvant BPM 31510 in phase 2," said Seema Nagpal, MD.

On June 6, 2023 Amphera B.V., a late-stage biotechnology company developing MesoPher cell therapy to treat cancer, reported that the EMA Committee for Orphan Medicinal Products (COMP) has recommended the granting of orphan medicinal product designation for MesoPher in pancreatic cancer (Press release, Amphera, JUN 6, 2023, View Source [SID1234632539]).

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MesoPher is comprised of autologous dendritic cells loaded with PheraLys, a lysate of tumour cell lines. PheraLys contains a broad repertoire of tumour-associated antigens, many of which are present in pancreatic cancer and other cancers.

In December 20221, Amphera reported topline results from the phase II REACTIVE trial in patients with resected pancreatic cancer. MesoPher demonstrated a statistically significant 2-year Recurrence Free Survival of 60% and an excellent safety profile.

1) View Source

Notes to Editors

About EMA Orphan Designation

Source: View Source

"The EU offers incentives to encourage companies to research and develop medicines for rare diseases that otherwise would not be developed. To access these incentives, companies can apply for orphan designation for their medicine, provided certain criteria are met.

Criteria for orphan designation:

The medicine must treat, prevent, or diagnose a disease which is life-threatening or chronically debilitating, or it is unlikely that the medicine will generate sufficient returns to justify the investment needed for its development
The disease must not affect more than 5 in 10,000 people across the EU
No satisfactory method of diagnosis, prevention or treatment exists, or if such a method already exists, the medicine must be of significant additional benefit to those affected by the condition
During an orphan medicine’s research and development, the company can benefit from incentives such as scientific advice on study protocols, various fee reductions and access to EU grants. Orphan-designated medicines that eventually make it to the market, and for which it can be demonstrated that they maintain the criteria for the designation, are granted 10 years of market exclusivity.

Orphan designation is not an authorization: Not all orphan-designated medicines reach the marketing authorisation application stage. Those that do, are evaluated by EMA’s Committee for Medicinal Products for Human Use (CHMP) using the same strict safety and efficacy standards that apply to all medicines evaluated by EMA.

On June 6, 2023 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat cancer, reported that the California Institute for Regenerative Medicine (CIRM) awarded the Company a $10.6 million grant to support its ongoing ARYA-2 Phase I study of ET140203 for the treatment of pediatric patients with refractory/relapsed liver cancer, including hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), and hepatocellular carcinoma (HCC) (Press release, Eureka Therapeutics, JUN 6, 2023, View Source [SID1234632538]).

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"We are delighted to partner with CIRM and are honored by their recognition of the potential of our ET140203 ARTEMIS T-cell therapy program," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "Pediatric liver malignancies are rare, have no FDA-approved treatment options, and remain difficult to treat. This partnership will allow us to accelerate the development and clinical translation of a promising new treatment and potentially improve the prognosis and survival outcome of pediatric patients with liver cancer."

ET140203 ARTEMIS T cells are produced by extracting T cells from a patient’s blood and genetically modifying them to specifically target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex found on liver cancer cells. These engineered T cells are then expanded in the laboratory and reinfused into the patient’s body to selectively seek out and kill AFP expressing liver cancer cells.

"We are deeply appreciative of the CIRM Application Review Subcommittee members’ unanimous vote to support our effort to make novel cellular therapies available to the medically underserved pediatric liver cancer population," said Dr. Pei Wang, Vice President of Clinical Development and Principal Investigator under the CIRM grant. "We look forward to collaborating with our clinical partners and the CIRM team to bring ET140203 to patients."

The ARYA-2 study of ET140203 is part of Eureka’s liver cancer portfolio, and is being run in parallel with Eureka’s ongoing ARYA-1 and ARYA-3 studies of adult patients with HCC. The ARYA-1 and ARYA-2 studies use ET140203 ARTEMIS T cells to target AFP-positive liver cancer cells. The ARYA-3 study uses ECT204 ARTEMIS T cells to target the Glypican 3 (GPC3) protein expressed on the surface of liver cancer cells.

Patients, caregivers and health care professionals interested in Eureka’s clinical trials and technology can find more information by visiting eurekaconnectme.com.

ABOUT THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE (CIRM)

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission.

To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.

With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality.

For more information go to www.cirm.ca.gov