On September 7, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, reported that the Company will participate in the Morgan Stanley 20th Annual Global Healthcare Conference on Wednesday, September 14th, 2022 with a fireside chat at 9:10 a.m. ET (Press release, BeiGene, SEP 7, 2022, View Source [SID1234619198]).

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A live webcast can be accessed from the investors section of BeiGene’s website at View Source An archived replay will be available for 90 days following the event.

On September 7, 2022 Genexine (KOSDAQ: 095700), a publicly traded, clinical-stage Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported that GX-188E, its first-in-class proprietary DNA vaccine, demonstrated potent efficacy and favorable safety in patients with advanced cervical cancer in a phase 2 study when given in combination with KEYTRUDA (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy (Press release, Genexine, SEP 7, 2022, View Source [SID1234619197]).

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A total of 60 patients with HPV 16- and/or 18- positive advanced cervical cancer were analyzed in the phase 2 treatment group. Top line results showed a Best Overall Response Rate (BORR) of 31.7% (19 of 60 patients). 6 patients (10.0%) had a complete response and 13 patients (21.7%) had a partial response. Median duration of response (DOR) was 12.3 months and overall survival (OS) was 17.2 months.

The BORR increased to 38.5% in PD-L1 positive patients with HPV 16+ and Squamous Cell Carcinoma. Importantly, PD-L1 negative patients showed an ORR of 25.0%, which is extremely encouraging for this patient population, as it demonstrates potential improvement in efficacy compared to monotherapy of immune checkpoint inhibitors, suggesting a beneficial effect of the combination therapy.

In the safety analysis (n=65) 22 of 65 patients (33.8%) had treatment-related adverse events (TRAEs) of any grade and three (4.6%) had grade 3 or 4 TRAEs. The combination therapy was found to be safe and tolerable with a similar safety profile to that of pembrolizumab monotherapy.

"There is an urgent need for better therapies for patients with advanced cervical cancer and the combination of a therapeutic DNA vaccine together with checkpoint inhibition could be a strong alternative," said professor Sung-Jong Lee of the Catholic University of Korea, College of Medicine and Investigator in the trial. "The data are very encouraging and appear to show a clear efficacy signal and the product appears safe and well tolerated. I am particularly pleased to see a clear efficacy signal in all patients, regardless of PD-L1 expression. Genexine’s combination therapy has strong appeal from a mechanistic perspective. This approach of using checkpoint inhibition to restore immune system function combined with the vaccine’s effect of upregulating and increasing the influx of CD8+ and other immune cells into the tumor microenvironment, appears to result in a strong, beneficial effect as demonstrated by major outcome measures such as BORR (31.7%) and OS (17.2 months) through the elimination of tumor cells and tumors."

"We are very pleased to have been invited to present our phase 2 top-line data at ESMO (Free ESMO Whitepaper) and encouraged by the efficacy and safety shown in this study," said Neil Warma, President and CEO of Genexine. "The combination of GX-188E, our unique DNA vaccine, with pembrolizumab could represent a new standard of care for patients with HPV 16/18 related recurrent or metastatic cervical cancer, regardless of PD-L1 expression. We are encouraged by the ORR of over 31% but particularly excited by the efficacy signal observed in PD-L1 negative patients. This could open the door to a new therapy for this patient population that previously had limited treatment options available."

The clinical trial was an open-label, single-arm, phase 2 trial conducted in South Korea in patients with HPV-16 or HPV-18 positive advanced cervical cancer, and who had progressed after standard-of-care therapy. Patients received intramuscular 2 mg GX-188E at weeks 1, 2, 4, 7, 13, 19, and optional dose at week 46, and intravenous pembrolizumab 200 mg every 3 weeks for up to 2 years or until disease progression. The primary endpoint was ORR assessed by the blinded independent central reviewers (BICR) using RECIST version 1.1.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ.

On September 7, 2022 CytoImmune Therapeutics, a clinical-stage immuno-oncology company that is developing a novel class of engineered natural killer (NK) cell-based cancer therapies, reported the appointment of Remus Vezan, M.D., Ph.D., as Chief Medical Officer (Press release, CytoImmune Therapeutics, SEP 7, 2022, View Source [SID1234619196]). Dr. Vezan is an industry leader who has been responsible for the successful advancement of numerous cell therapies from early-stage development through commercialization, including one of the first U.S. Food and Drug Administration (FDA)- approved CAR T-cell therapies for hematologic malignancies.

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"Remus brings an ideal combination of expertise to CytoImmune, having led the successful implementation and execution of clinical development strategies for several biopharmaceutical companies focused on both immuno-oncology and cell therapies," said Christina Coughlin, M.D., Ph.D., Chief Executive Officer of CytoImmune. "We recently made the important transition to a clinical-stage company with the initiation of our Phase 1 trial of CYTO-102 for non-small cell lung cancer, and I am excited to partner with Remus as we advance this program and others in our pipeline."

"CytoImmune is taking a novel approach to developing cell therapies, leveraging NK cells to create medicines that directly attack cancer cells and broadly stimulate both the innate and adaptive arms of the immune system," said Dr. Vezan. "Cell therapies have proven highly effective in treating various hematologic malignancies, with several approved products available today, however, the results obtained in solid tumors to date are underwhelming. Through novel engineering and manufacturing strategies, CytoImmune’s engineered NK cell therapies have the potential to overcome key challenges that have been observed in solid tumors. This will greatly expand the number of patients who could benefit from this therapy. I am pleased to join the team at this exciting time in the evolution of the company."

Dr. Vezan joins CytoImmune from CERo Therapeutics where he served as Chief Medical Officer. Prior to that, he served as Executive Director of clinical development at Kite, a Gilead company, where he oversaw the clinical development of CAR T-cell products, including axi- cell/YESCARTA, the first CAR T-cell therapy approved for relapsed/refractory B-cell lymphoma and brexu-cell/TECARTUS, the first CAR T-cell therapy approved for mantle cell lymphoma and adult acute lymphoblastic leukemia. In this role, Dr. Vezan supported the overall clinical development strategy and execution of numerous registrational clinical trials and under his leadership, YESCARTA and TECARTUS were granted various global approvals. Before Kite, Dr. Vezan served as Medical Director at Pharmacyclics, an AbbVie Company, where he was the clinical lead for HDACi-abexinostat program and ibrutinib (IMBRUVICA) in lymphoplasmacytic lymphomas (Waldenstrom Macroglobulinemia). Dr. Vezan completed his medical training (M.D. and Ph.D.) at the University of Medicine and Pharmacy Cluj, Romania and University of Bern, Switzerland.

On September 7, 2022 BostonGene Corporation reported a Master Agreement with Massachusetts General Hospital Cancer Center, a member of the Mass General Brigham (MGB) healthcare system, to collaborate on multiple research projects (Press release, BostonGene, SEP 7, 2022, View Source [SID1234619195]). The alliance aims to support clinical research utilizing BostonGene’s CLIA-certified and CAP-accredited high complexity molecular laboratory and advanced computational algorithms to identify and validate novel precision medicine approaches.

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Massachusetts General Hospital Cancer Center is among the leading cancer care providers in the United States, offering a vast array of support through its 37 treatment programs within 29 fully integrated, multidisciplinary disease centers. Through a powerful synergy between laboratory scientists and bedside physicians, Massachusetts General Hospital Cancer Center is committed to eradicating cancer by scientific investigation conducted as part of one of the largest hospital-based research programs in the nation.

The strategic alliance between BostonGene and Massachusetts General Hospital Cancer Center builds on research collaborations with several multidisciplinary disease centers. Under the terms of the agreement, parties will apply BostonGene’s innovative computational platform, based on AI-driven molecular and immune profiling, to discover correlations between tumor genomics, a patient’s immune system, and the effectiveness of new and emerging treatments across multiple cancers. The primary goal is to further advance clinical solutions for patients through scientific research and cutting-edge analytics.

"The collaboration is a great expansion of our translational research portfolio. We hope this will enable new biomarker discovery and the identification of next generation precision medicines," said David Ting, MD, Associate Clinical Director of Innovation, Mass General Cancer Center.

"We believe our combined efforts will positively impact patient outcomes," said Joe Lennerz, MD, PhD, Medical Director, Center for Integrated Diagnostics at Massachusetts General.

"It is an incredible opportunity to collaborate with the Mass General Cancer Center in our commitment to improving patient outcomes," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "This effort will expedite the development of innovative solutions, ultimately changing the standard of care."

On September 7, 2022 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, reported it has been awarded a key patent by the European Patent Office, and that the period for parties to oppose the patent has lapsed without opposition (Press release, CytRx, SEP 7, 2022, View Source [SID1234619194]).

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European Patent No. 3310800 covers the incorporation of the LADR backbone in a variety of drug compounds. The LADR backbone is attached to active pharmaceutical agents in order to target the agents to the diseased tissue, which the Company expects to reduce off-target side effects and allow for higher dosing of the active pharmaceutical ingredient. Dose-limiting toxicities are key limitations to untargeted pharmaceuticals.

CytRx notes that a US patent – US Patent No. 11,384,104 – covering the LADR platform has also recently been issued, which when combined with the European patent results in broad international protection of this important new technology.

In addition to intellectual property to protect the LADR platform, CytRx has also pursued patent protection covering certain specific drugs that incorporate the LADR backbone. For example, the Company recently received US patent number 11,377,473, a patent covering one of its lead pre-clinical candidates, which is based on derivatives of auristatin-E attached to the LADR backbone.