On June 6, 2023 PharmaMar (MSE:PHM) and Luye Pharma Group Ltd. reported that the New Drug Application (NDA) submission of lurbinectedin has been accepted by the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in the People’s Republic of China (China) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after receiving platinum-based chemotherapy (Press release, PharmaMar, JUN 6, 2023, View Source [SID1234632521]).

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In April 2019, PharmaMar and Luye Pharma signed an agreement for the development and commercialization of lurbinectedin in Small Cell Lung Cancer (SCLC), and potentially in other indications in mainland China, Hong Kong and Macao.

In 2020, lurbinectedin received Accelerated Approval from the U.S. Food and Drug Administration (FDA) and subsequently received approvals in 9 other countries for the treatment of metastatic SCLC, and has been filed in several countries.

The NDA is based on data from a single-arm, dose-escalation, and dose-expansion clinical study conducted in China. The study was designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of lurbinectedin in Chinese patients with advanced solid tumors including relapsed SCLC. The results of the study show efficacy and a manageable safety profile of the drug as a second-line therapy at a dose of 3.2mg/m2 in Chinese SCLC patients, the same dose that has been approved in the United States and in other countries. It was confirmed by an Independent Review Committee that the Overall Response Rate (ORR) was 45.5% in subjects with relapsed SCLC.

The clinical study conducted in China was the first study evaluating the efficacy and safety of lurbinectedin in Chinese patients. The preliminary results of this study were presented at the 2022 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), as well as the 25th National Clinical Oncology Conference and the 2022 annual meeting of the Chinese Society of Clinical Oncology.

In addition to mainland China, lurbinectedin is also being reviewed for its NDA in the Hong Kong and Macao SAR of China and has the –authorization for urgent clinical use in Hainan region and Hong Kong.

Lung cancer was China’s No.1 cancer in 2020 in terms of morbidity and mortality, with approximately 815,000 new cases and 714,000 deaths that year. Specifically, SCLC accounted for 13%-17% of all lung cancer cases[1]. Most SCLC patients were already at the advanced stage upon diagnosis, resulting in poor prognosis. Their five-year survival rate was only 7% or as low as 3% for those patients with the extensive stage of the disease. Although SCLC is very sensitive to initial treatments, most patients would experience a relapse or develop drug resistance after initial treatments. According to statistics, approximately 75% of the patients with locally advanced SCLC and more than 90% of those with metastatic SCLC would relapse within two years after receiving treatment. The high relapse rate of SCLC poses a significant challenge to its treatment, and innovative therapies are urgently needed in clinical practice.

On June 6, 2023 Onxeo S.A. (Euronext Growth Paris: ALONX), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) and driver oncogenes, reported that the Annual General Meeting held today at 2pm CEST was able to validly deliberate with a quorum of 44.12% , with 30 shareholders representing 49,072,091 voting rights (Press release, Onxeo, JUN 6, 2023, View Source [SID1234632520]).

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The Annual General Meeting followed the voting recommendations of the Board of Directors for all resolutions, approving the 2022 financial statements and the renewal of the terms of Robert Coleman, independent director, and Nicolas Trebouta, permanent representative of the historical shareholder Financière de la Montagne.

The Annual General Meeting also approved the change of company name to Valerio Therapeutics. This name change is accompanied by a new identity, to be presented in the coming weeks, designed to better represent Valerio Therapeutics’ ability to rapidly advance breakthrough therapeutic candidates through Phase 2 development, and to collaborate with partners for further development and commercialization. The ISIN code will remain unchanged.

Shefali Agarwal, President and Chief Executive Officer, stated: "I would like to thank all our shareholders for their participation and support at this Annual General Meeting, which marks a real milestone for our Company. We are proud to present our new company name today, conveying values of strength, health, resilience, vitality and robustness. In addition, the Valerio name has a timeless, traditional essence that matches the company’s positioning as a clinical-stage biotechnology company focused on developing innovative therapies using cutting-edge technology platforms to revolutionize cancer treatment and improve patient outcomes. Valerio also represents a sense of legacy and endurance, thus becoming part of Onxeo’s history and writing a new page over the long term."

The consolidated result of the vote by resolution and the minutes of the General Meeting will be available within the legal deadlines on the Company’s website, in the General Meetings section.

On June 6, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that the first patient has been dosed in the Phase 1/2 dose escalation/dose expansion study of ONCT-808, the company’s ROR1 targeting autologous CAR T cell therapy (Press release, Oncternal Therapeutics, JUN 6, 2023, View Source [SID1234632519]).

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"We are excited to announce the first patient, who had failed previous CD19 CAR T therapy, has been treated with ONCT-808," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We believe ONCT-808 has the potential to produce robust and durable responses for patients suffering from aggressive lymphoma. It builds on our extensive clinical experience with zilovertamab, as well as that with zilovertamab vedotin, an antibody drug conjugate, which has shown that ROR1 can be targeted without unwanted off-tumor, on-target activity. We particularly appreciate that this first patient is under the care of Dr. Michael Wang, Endowed Professor in the Department of Lymphoma & Myeloma at the MD Anderson Cancer Center in Houston, Texas."

ONCT-808 is a ROR1 targeting autologous CAR T cell therapy that is being tested in a Phase 1/2 clinical trial for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including those who have failed previous CD19 CAR T therapy. Preclinical models show robust and specific activity against ROR1 expressing cells from multiple tumor types. Oncternal has developed a manufacturing process that is reproducible, scalable, and only 8 days in duration. The company expects to present initial clinical data in late 2023, with additional clinical data readouts in 2024.

About Study ONCT-808-101
Study ONCT-808-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and anti-tumor activity of ONCT-808 in subjects with aggressive B cell lymphoma, including large B-cell lymphoma (LBCL) and mantle cell lymphoma (MCL). After the safety and tolerability of ONCT-808 have been assessed to select the recommended Phase 2 dose (RP2D) in Phase 1, Phase 2 will commence to further validate the dose and evaluate the safety and efficacy of ONCT-808. In Phase 2, subjects with LBCL or MCL will be enrolled into 2 separate dose expansion cohorts. Current leading clinical sites for ONCT-808-101 are the MD Anderson Cancer Center in Houston, TX, the Dana-Farber Cancer Institute in Boston, MA, the City of Hope Comprehensive Cancer Center in Duarte, CA and the Mass General Cancer Center in Boston, MA.

On June 6, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Caroline Litchfield, executive vice president and chief financial officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Goldman Sachs 44th Annual Global Healthcare Conference on Monday, June 12, 2023, at 4:00 p.m. PDT / 7:00 p.m. EDT (Press release, Merck & Co, JUN 6, 2023, View Source [SID1234632517]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

On June 6, 2023 ISA reported the first clinical data of the combination of ISA101b (peltopepimut-S) and Regeneron’s anti-PD-1 Libtayo (cemiplimab) at the ASCO (Free ASCO Whitepaper) annual meeting in Chicago (Press release, ISA Pharmaceuticals, JUN 6, 2023, View Source [SID1234632516]).

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Dr. Kong presented data regarding 26 patients with recurrent and/or metastatic Human Papilloma Virus type 16 (HPV16) positive oropharyngeal cancer (OPC, a form of head and neck cancer) who progressed on pembrolizumab or nivolumab, and were followed for at least 6 months. This population included patients that have never responded to prior anti-PD1 therapy. Patients were treated until disease progression, toxicity, treatment withdrawal or up to 24 months. Recruitment in this study is ongoing. Further information can be found on clinicaltrials.gov (NCT04398524).

The combination of ISA101b and cemiplimab in these patients resulted in an overall response rate (ORR) of 15.4%, as per investigator assessment. Long term (≥6 months) disease stabilization was achieved in 26.9% of all patients. The combination of cemiplimab and ISA101b was generally well tolerated with a safety profile resembling that of anti-PD-1 monotherapy. There were two grade 3 adverse events related to ISA101b. Grade 4-5 events related to study treatment did not occur. Re-ignition of an anti-tumor effect of anti-PD-1 therapy after failure of checkpoint inhibition by the addition of a therapeutic vaccine is a unique feature.

Dr. Anthony Kong, Principal Investigator and Medical Oncologist at King’s College in London, said: "The initial results of this study are promising, given the high unmet medical need in this difficult-to-treat patient population."

Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals, said: "The most impressive element of this data-set of anti-PD1 therapy-resistant head and neck cancer patients is the 6 months’ Disease Control Rate’ (DCR): it appears that the targeted therapeutic cancer vaccine ISA101b together with an anti-PD1 antibody can have a real stabilizing effect in a fair proportion of these sick patients."

Head-and-neck cancer can be a severe and life-threatening disease. HPV16 is a major cause of head-and-neck cancer. Recurrent and metastatic HPV16 positive OPC is a form of head-and-neck cancer with a high unmet medical need. In September 2021 the FDA granted Fast Track designation to ISA101b for the treatment of recurrent and metastatic HPV16 positive OPC.

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