On October 10, 2022 IconOVir Bio, Inc. (IconOVir), a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, reported the appointment of Julia (Julie) Maltzman, M.D., as its Chief Medical Officer (Press release, IconOVir Bio, OCT 10, 2022, View Source [SID1234621859]). Dr. Maltzman brings over three decades of experience as a distinguished medical oncologist with deep scientific and clinical knowledge of drug development in the oncology space and significant leadership experience overseeing all aspects of clinical, medical and regulatory affairs. At IconOVir, Dr. Maltzman will lead all activities associated with the clinical development of the IconOVir’s emerging OV-based therapeutic pipeline, including clinical development, clinical operations, medical affairs and pharmacovigilance activities.

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"We are thrilled to welcome Julie to our team as we prepare to advance ICVB-1042, our lead product candidate, into first-in-human Phase 1 studies next year," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir. "Julie is an accomplished leader in oncology drug development, and we believe that her extensive clinical experience, coupled with her background as a medical oncologist, will be instrumental in our efforts to unlock the full potential of ICVB-1042, while also supporting the growth of our broader OV-based therapeutic pipeline. We look forward to benefiting from Julie’s leadership as we finalize the design of our Phase 1 trials, continue preparations to become a clinical-stage biopharmaceutical company and advance our mission to cure cancer and restore life to every patient, everywhere."

Dr. Maltzman joins IconOVir from Genentech, where she most recently served as Franchise Head, Vice President and Global Head of Gastrointestinal (GI) and Cancer Immunotherapy. In this role, Dr. Maltzman provided enterprise-level strategic and operational development leadership for late-stage GI and cancer immuno-oncology combinations across all tumor types worldwide. Prior to joining Genentech, she was a Vice President of Clinical Development at Nektar Therapeutics, where she led clinical development and pharmacovigilance, setting strategy and direction for several clinical development teams in oncology. Before that, Dr. Maltzman held positions of increasing responsibility at Gilead Sciences, Morphotek, Inc. and Glaxo Smith Kline, in addition to holding a faculty appointment at the University of Pennsylvania. Dr. Maltzman received her B.A and M.D. from the University of Colorado. She completed her internship and residency in internal medicine at the University of Chicago Hospital, and her fellowship in hematology/oncology at the Hospital of the University of Pennsylvania.

"It is an honor to join IconOVir at such a pivotal time in its growth as it prepares to initiate Phase 1 clinical trials evaluating ICVB-1042 in patients with solid tumors," said Dr. Maltzman. "IconOVir’s unique modular approach to developing the next generation of OV therapy has the potential to transform the landscape of cancer therapy and the lives of countless patients currently suffering from these diseases. I look forward to bringing my experience as a medical oncologist and drug developer to IconOVir and supporting the expansion and acceleration of IconOVir’s pipeline to bring novel therapies to the patients that inspire our work."

On October 10, 2022 JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, reported that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (hereafter abbreviated as relma-cel, trade name: Carteyva) for the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL) (Press release, JW Therapeutics, OCT 10, 2022, View Source [SID1234621858]). This is the second approved indication for relma-cel following its initial approval and launch in September last year, and makes it the first cell immunotherapy product approved in China for the treatment of r/r FL patients.

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This approval is based on the 6 months clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-Hodgkin lymphoma in China. The 3 months data were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021. The cohort B results showed that Carteyva demonstrated very high rates of durable disease response (overall response rate (ORR)=100%, complete response rate (CRR)=85.19% at month 3; ORR=92.58%, CRR=77.78% at month 6) and controllable CAR-T associated toxicities in patients with r/r FL. Given the currently available treatments in China, Carteyva may become a treatment option with a higher benefit-risk ratio for patients with r/r FL, and has the potential to become a best-in-class CAR-T product.

Professor Yuqin Song, the principal investigator of RELIANCE study, Deputy Director of Lymphoma Department, Vice President of Peking University Cancer Hospital, commented, "The overall response rate (ORR) of the efficacy endpoint was over 90%, and the overall safety profile was manageable. Remal-cel has become the first CAR-T cell immunotherapy product for the treatment of the r/r FL in China."

James Li, Co-founder, Chairman and CEO of JW Therapeutics, said, "Thanks to the patients and investigators who contributed to the clinical studies of Carteyva, and thanks to the regulators for the recognition of Carteyva. We are pleased with the second approved indication, which provides a new and breakthrough treatment option for r/r FL patients. JW Therapeutics is committed to maximizing the value of Carteyva, continuously advancing technology innovation and pipeline development, and improving the accessibility of cell immunotherapy products.

As the first product of JW Therapeutics and the first CAR-T product approved as a Category 1 biologics product in China, relma-cel has been approved for two indications in China, including for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL). Currently, to fully explore the clinical potential of Carteyva, JW Therapeutics is conducting or planning to conduct more clinical studies on hematologic malignancies and autoimmune diseases, including third-line mantle cell lymphoma (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.

On October 10, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call and webcast on Tuesday, November 1, 2022, at 8:00 a.m. CDT to review first quarter 2023 financial results (Press release, Bio-Techne, OCT 10, 2022, https://investors.bio-techne.com/news/detail/330/bio-techne-to-host-conference-call-on-november-1-2022-to-announce-first-quarter-2023-financial-results [SID1234621857]).

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A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13733551.

The replay will be available from 11:00 a.m. CDT on Tuesday, November 1, 2022, until 11:00 p.m. CST on Thursday, December 1, 2022.

On October 10, 2022 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that an article highlighting preclinical data from BT8009, a Nectin-4 targeting Bicycle Toxin Conjugate, was published in the Journal of Medicinal Chemistry (Press release, Bicycle Therapeutics, OCT 10, 2022, View Source [SID1234621855]). The article, titled "Discovery of BT8009: a Nectin-4 Targeting Bicycle Toxin Conjugate for the Treatment of Cancer" is available at the publications section of the Bicycle website at this link.

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"The pre-clinical data published in the Journal of Medicinal Chemistry describe the discovery of our clinical-stage Bicycle Toxin Conjugate candidate targeting Nectin-4 expressing tumors," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "Together with our study published recently in Molecular Cancer Therapeutics, these articles describe the preclinical work supporting the development of BT8009, which we are currently evaluating in a Phase I/II clinical trial across a number of solid tumor cancers. Nectin-4 is a validated tumor antigen target and we are excited to develop a novel approach to Nectin-4 expressing tumors."

On October 10, 2022 Aravive Inc. (Nasdaq: ARAV), a late clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases, reported that it received a $6 million development milestone payment from its licensee, 3D Medicines Inc (Press release, Aravive, OCT 10, 2022, View Source [SID1234621854]). This milestone is based on the initiation of the global Phase 3 platinum resistant ovarian cancer (PROC) clinical trial in China for the development of Aravive’s batiraxcept.

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Gail McIntyre, Ph.D., DABT, Chief Executive Officer, said, "Our partnership with 3D Medicines continues with positive progress as they move forward with enrollment in the Phase 3 Trial for batiraxcept (3D-299) in China. Their enrollment of patients will support Aravive’s potential marketing application for batiraxcept in the United States, as well as their potential marketing application in China. This is our third milestone achieved since entering our agreement with 3D Medicines in November 2020 and we look forward to continued advancement towards the potential approval of batiraxcept in both the United States and China. Our companies are dedicated and working together to improve patient survival and bring hope to women with advanced ovarian cancer."

Aravive’s collaboration and license agreement with 3D Medicines Inc. is for the development and commercialization of batiraxcept in oncology indications in Greater China. Under the terms of the agreement, Aravive is eligible to receive up to an aggregate of $207 million in development and commercial milestone payments and royalties. In addition to achieving this $6 million development milestone, the Company had previously received a $9 million in development milestones related to development of batiraxcept for platinum resistant ovarian cancer in the United States and China, as well as a $12 million upfront payment in 2020, totaling $27 million that has been achieved by Aravive from 3D Medicines.

About the Phase 3 PROC Trial

The global, randomized, double-blind, placebo-controlled trial (GOG-3059/ENGOT OV-66) is designed to evaluate efficacy and safety of batiraxcept at a dose of 15 mg/kg in combination with paclitaxel. The trial is expected to enroll approximately 300-400 patients with high-grade serous ovarian cancer who have received one to four prior lines of therapy at approximately 150 sites in North America, Europe, and Asia. The primary endpoint for the trial is progression free-survival and the secondary endpoint is overall survival. Exploratory endpoints include objective response rate, duration of response, quality of life, clinical benefit rate, pharmacokinetic and pharmacodynamic profile, and sAXL/GAS6 ratio. This trial is being conducted in partnership with The GOG Foundation, Inc. (GOG-F), through the GOG Partners program in the USA, and in partnership with the European Network for Gynaecological Oncological Trial (ENGOT) groups in Europe. The Phase 3 trial is listed on clinicaltrials.gov NCT04729608.