On January 4, 2023 Hadasit, the Innovation Engine of Hadassah Medical Organization and BIRAD, the Commercialization arm of Bar-Ilan University reported that they have entered into the research and license agreement with Immix BioPharma, for the development and commercialization of novel tissue specific therapeutics based on anti-BCMA CAR-T cells targeting plasma cell (Press release, , JAN 4, 2023, View Source [SID1234625842]). This technology has been developed as the result of a collaboration between Prof. Polina Stepensky, of Hadassah Medical Center, Jerusalem and Prof. Cyrille J. Cohen, of Bar-Ilan University, Ramat Gan. Dr. Shlomit Kfir-Erenfeld and Dr. Nathalie Asherie, of Hadassah Medical Center, and Ortal Harush, of Bar-Ilan University, also participated in the research.

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As of December 20, 2022, cutoff date, a total of 56 patients, including 50 multiple myeloma patients and 6 AL Amyloidosis patients, have received HBI0101, anti-BCMA CAR-T cells, as part of the ongoing Phase 1b clinical trial at Hadassah Medical Organization. At the current stage of the clinical study, when the patients received a target dose of 800M CAR-T positive cells, the overall response rate of the relapsed/refractory multiple myeloma patients reached 90%. The complete response rate of the AL amyloidosis patients reached 100%. In both patient populations, no significant unexpected side effects were observed.

Prof. Polina Stepensky, Head of Hadassah’s Department of Bone Marrow Transplantation and Cancer Immunotherapy and her team are responsible for the selection of B-cell maturation antigen (BCMA) as the optimal target for the treatment of multiple myeloma and are evaluating this novel CAR-T technology in the clinic.

Prof. Polina Stepensky, said, "We are very excited with the outstanding interim results of our ongoing Phase 1b study in multiple myeloma and amyloidosis AL patients. The licensing agreement will enable us to continue to advance the clinical studies. Our new adoptive cell transfer technology could become one of the first CAR-T treatments for these indications and other BCMA-positive malignancies and has the potential to improve the lives of so many patients globally."

Prof. Stepensky joined forces with Prof. Cyrille J. Cohen, Head of the Tumor Immunology and Immunotherapy Lab at Bar-Ilan University and a renowned scientist in the field of immune cells engineering, who designed the novel vector in this exciting collaboration. Prof. Cohen and his team built the optimal anti-BCMA CAR construct with proprietary design adaptations. They demonstrated the biological activity of CAR-T cells in the first preclinical studies, leading to establishment of the mutual invention of the researchers.

Prof. Cohen commented, "For the first time, we successfully reprogrammed a patient’s immune system with a proprietary receptor that we developed in our lab at Bar-Ilan University. Through this collaboration with Hadassah Medical Center, dozens of patients have the future promise of a better treatment option. This successful treatment encourages us to continue developing new approaches for the treatment of cancer and autoimmune diseases."

Further development of the technology was led by the Hadassah team, including extensive proof of concept preclinical studies, establishment of the GMP graded master cell bank, construction of a GMP manufacturing facility, implementation of SOPs and receiving the regulatory approval of the Israeli MOH to conduct clinical trial on humans.

"Hadassah Medical Organization, as one of the leading medical centers in Israel, is devoted to bringing to the Israeli population the most advanced healthcare technology in an affordable fashion," said Prof. Yoram Weiss, Director General of Hadassah Medical Organization. "Hadassah has invested millions of dollars of its donors’ money to support this technology during the first crucial stages of development, with the ultimate goal of bringing life-saving CAR-T therapy to cancer patients. I would also like to thank Israel’s Ministry of Health for its support of this project, in recognition of its innovation and importance for Israeli patients. We are delighted that we are able to share this technology at this point in time with the international community."

Zohar Yinon, CEO and SVP, Bar-Ilan University, commented, "I am proud of the scientific excellence of Prof. Cohen and the collaboration with Hadassah Medical Center. This is an example of the variety of research in the fields of health and medicine taking place in Bar-Ilan University’s labs, and of our eco-system that produces cutting-edge research and initiatives that are ready for commercialization by scientists at the faculties of medicine, life sciences, and engineering, the brain center, and the Institute of Nanotechnology and Advanced Materials (BINA)."

On January 4, 2023 Nuvalent, Inc., (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, will present at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 7:30 a.m. PT in San Francisco (Press release, Nuvalent, JAN 4, 2023, View Source [SID1234625841]).

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

On January 4, 2023 IntoCell reported the signing of a Material Transfer Agreement (MTA) with option to license with ADC Therapeutics SA (NYSE: ADCT) (Press release, IntoCell, JAN 4, 2023, View Source [SID1234625840]).

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Under the agreement, IntoCell, a South Korean biotech developing novel antibody drug conjugate (ADC) platform technologies, will provide proprietary drug-linkers developed using their proprietary Ortho-Hydroxy Protected Aryl Sulfate (OHPASTM) system and payload modification technology (PMT). ADC Therapeutics, a commercial-stage biotechnology company developing next-generation ADCs, will conjugate its antibodies to IntoCell’s drug-linker and perform in vitro, in vivo, and toxicology experiments.

Upon successful completion of the evaluation, ADC Therapeutics will have an option to license the technology to develop ADCs for up to six targets for global development and commercialization. IntoCell reserves all global rights for its platform technologies beyond ADC development for targets reserved by ADC Therapeutics and will receive a fee upon signing of the MTA. For each target option exercised by ADCT, IntoCell is also entitled to receive a target selection fee, potential development, regulatory, and commercial milestone payments, as well as royalties in the future upon successful achievement of each applicable milestone.

"We are pleased to be collaborating with ADC Therapeutics, one of the leading companies in the ADC area. We hope to leverage ADC Therapeutics’ experience with the development and commercialization of its own ADC ZYNLONTA," said Tae Kyo Park, Founder and CEO of IntoCell. "IntoCell’s linker is highly stable and soluble, and our modified payload has the potential to substantially improve the therapeutic window of various payload classes. We are excited to see how our drug-linker technologies will perform with ADC Therapeutics’ antibodies."

"IntoCell’s innovative platform technologies have the potential to be valuable additions to ADC Therapeutics’ toolbox as we continue to maximize our ADC platform," said Patrick van Berkel, PhD, Chief Scientific Officer of ADC Therapeutics. "We look forward to evaluating our antibodies with IntoCell’s drug-linker technologies in the pursuit of developing differentiated ADCs."

IntoCell was advised by PharmaVentures Ltd., a UK-based premier transaction advisory firm, for this collaboration and the ongoing partnering efforts for IntoCell’s platform technologies and their lead programme, B7-H3 ADC

On January 4, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI351 (GFH925) for the treatment of advanced non-small cell lung cancer patients with KRASG12C mutation that have received at least one prior line of systemic therapy (Press release, Innovent Biologics, JAN 4, 2023, View Source [SID1234625839]).

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The NMPA BTD for IBI351 was based on the results from a phase I/II trial (CDE Registration No. CTR20211933). This study aims to evaluate the safety, tolerability and efficacy of IBI351 monotherapy in patients with advanced solid tumors who failed or intolerant to standard of care treatment.

The latest results of IBI351 from the phase I study were presented at the 2022 Chinese Society of Clinical Oncology (CSCO) Annual Meeting. As data cutoff (29 July 2022), of 55 evaluable NSCLC patients, the investigator assessed objective response rate (ORR) was 50.9% and disease control rate (DCR) was 92.7%. Of 21 patients with NSCLC treated at 600mg BID (the recommended phase 2 dose), better efficacy signal was observed, with investigator assessed ORR 61.9% and DCR 100%. Median duration of response (DOR) and median progression free survival (PFS) were not reached yet.

As data cutoff date, IBI351 was well tolerated. No DLT was reported and MTD was not reached. Treatment-related adverse events (TRAEs) occurred in 92.5% (62/67) patients and the most common TRAEs were anemia, transferase increased, bilirubin increased, pruritus and fatigue. The majority of the TRAEs were grade 1-2 with 19.4% (13/67) of patients reporting grade 3 or higher TRAEs. There were no grade 5 TRAEs or TRAEs led to treatment discontinuation.

Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed. The single-arm registrational trial of IBI351 monotherapy in previously-treated advanced non-small cell lung cancer patients with KRASG12C mutation is ongoing. Relevant updated study results will be published at an upcoming medical conference in 2023.

"We are glad to see the NMPA grants Breakthrough Therapy Designation based on the results of Phase I data of IBI351," said Dr. Hui Zhou, Senior Vice President of Innovent. "KRASG12C mutated NSCLC patients have limited treatment options. IBI351 demonstrated encouraging efficacy and safety data in Phase I study. A single arm registrational trial of IBI351 monotherapy in previously-treated advanced NSCLC is ongoing. We are working to advance into late stage clinical development to explore the potential of IBI351 as monotherapy and in combo-therapy."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of an investigational drug to treat a serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but it will also allow the sponsor to obtain timely advice and communication from the CDE to accelerate the approval and launch to address the unmet clinical need of patients at an accelerated pace. Click here for the published list of drugs which have been granted BTD by NMPA.

About Non-small Cell Lung Cancer

Lung cancer is one of the malignancies with the highest incidence and mortality worldwide, among which non-small cell lung cancer (NSCLC) is the most common pathological type, accounting for about 85% of all lung cancers. KRAS mutations are common driver gene mutations in NSCLC, most of which occur in lung adenocarcinoma. KRAS mutations rarely co-exist with driver mutations such as EGFR and ALK, and patients with advanced NSCLC with KRASG12C mutations are often unable to benefit from the multiple drugs already on the market that target these mutations or rearrangements. After the progress of first-line standard treatment in this population, there are limited second-line treatment options with low effective rate and poor prognosis.

About IBI351/GFH925(KRASG12C Inhibitor)

Discovered by GenFleet Therapeutics, GFH925 (Innovent R&D code: IBI351) is a novel, orally active, potent KRASG12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRASG12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of IBI351 towards KRASG12C. Subsequently, IBI351 effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest.

In September 2021, Innovent and GenFleet Therapeutics entered into an exclusive license agreement for the development and commercialization of IBI351 in China (including mainland China, Hong Kong, Macau and Taiwan) with additional option-in rights for global development and commercialization.

On January 4, 2023 WuXi Biologics ("WuXi Bio") (2269. HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), reported a license agreement with GSK plc (LSE/NYSE: GSK) under which GSK will have exclusive licenses for up to four bi- & multi-specific TCE antibodies developed using WuXi Biologics’ proprietary technology platforms (Press release, WuXi Biologics, JAN 4, 2023, View Source;multi-specific-t-cell-engagers-301713506.html [SID1234625838]).

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Under the terms of the agreement, GSK will be granted an exclusive global license for the research, development, manufacturing, and commercialization of a pre-clinical bispecific antibody that crosslinks tumor cells and T cells by targeting a tumor-associated antigen (TAA) on tumor cells and CD3 expression on T cells and up to three additional pre-clinical TCE antibodies currently at an earlier discovery stage. WuXi Biologics will receive a $40 million upfront payment and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. WuXi Biologics is also eligible to receive tiered royalties on net sales.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "This license agreement with GSK represents an important validation of our potential best-in-class CD3 platform and WuXiBody platform, the ‘R’ in our CRDMO business model. This also demonstrates our efforts in offering global open-access technology platforms with premier quality and excellent execution. We are looking forward to enabling GSK to bring these potentially life-saving therapeutics to more patients worldwide."

John Lepore, Senior Vice President, Head of Research GSK, said, "This agreement with WuXi Biologics builds on our oncology portfolio of tumor cell targeting agents by providing GSK with access to potential best-in-class T-cell engaging antibodies that have been optimized for effective tumor killing with a desirable safety profile, offering the potential to address significant unmet medical need in patients with multiple tumor types."