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."

On January 4, 2023 Caris Life Sciences (Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, reported that the company will present at the 41st Annual J.P. Morgan Healthcare Conference, which is being held January 9-12, 2023 in San Francisco (Press release, Caris Life Sciences, JAN 4, 2023, View Source [SID1234625837]). Caris will present at 11:00 a.m. (PST) on Tuesday, January 10, and will provide an overview of the business and discuss recent corporate achievements that position the organization to further extend its leadership position in the market.

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Caris will be represented by David D. Halbert, Founder, Chairman and Chief Executive Officer; Brian J. Brille, Vice Chairman; David Spetzler, MS, MBA, Ph.D., President and Chief Scientific Officer; Brian Lamon, Ph.D., Chief Business Officer, Head of BioPharma Business Development; Milan Radovich, Ph.D., Chief Precision Medicine Officer; Luke Power, Interim CFO and Chief Accounting Officer; and Narendra Chokshi, Corporate Vice President, Corporate Development.

On January 4, 2023 Immunitas Therapeutics ("Immunitas"), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, reported the first patient has been dosed in a Phase 1/2a clinical trial evaluating use of novel cancer immunotherapeutic IMT-009 in solid tumors and hematologic malignancies. The company also announced the addition of James Wooldridge, M.D., to their Clinical Advisory Board (Press release, Immunitas Therapeutics, JAN 4, 2023, View Source [SID1234625836]).

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"Despite significant therapeutic advancements, there are still a substantial number of patients who remain unresponsive to standard treatments and would benefit from more effective cancer immunotherapies," said Melissa L. Johnson, M.D., Director of Lung Cancer Research for Sarah Cannon Research Institute at Tennessee Oncology, Study Chair and Principal Investigator for the study. "IMT-009 inhibits the CD161/CLEC2D axis, a novel cancer immunotherapeutic target, and has been shown to re-stimulate the anti-cancer activity of key immune cell populations with a reasonable safety profile in preclinical studies. We look forward to further investigation of IMT-009 and its potential for patients awaiting improved treatment options."

The Phase 1 study (NCT05565417) is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D) for treatment of patients with advanced solid tumors or lymphomas. The trial will subsequently transition into Phase 2 to assess the safety and efficacy of IMT-009 as a monotherapy and in combination with another anticancer agent.

"The successful dosing of the first patient in this trial of IMT-009 marks an important milestone for Immunitas and, most importantly, brings us one step closer to delivering novel differentiated therapeutics to patients in need," said Amanda Wagner, Chief Executive Officer of Immunitas. "The timing is ideal for adding James Wooldridge, M.D., to our Clinical Advisory Board. Jim has extensive immuno-oncology development expertise and brings important clinical insight to our pipeline. We are excited to be working with him and look forward to the continued enrollment and dosing of patients in this inaugural trial of IMT-009."

Dr. Wooldridge has more than 20 years of experience in clinical oncology research and drug development, spanning the biotechnology, pharmaceutical, and academic sectors. He previously served as the Chief Medical Officer at Checkmate Pharmaceuticals before the company’s acquisition by Regeneron. He also held the role of Chief Medical Officer at Aeglea BioTherapeutics, where he oversaw development of enzyme-based treatments for rare genetic diseases. Prior to his work as a biotech executive, Dr. Wooldridge spent nearly 11 years heading cancer therapeutic development through various roles at Eli Lilly, most recently serving as Chief Scientific Officer, Immuno-oncology Clinical Development. Dr. Wooldridge also previously conducted clinical and translational cancer research as a faculty member at the University of Iowa and the University of Missouri. He earned his M.D. at the Tulane University School of Medicine and completed post-graduate training in internal medicine and medical oncology at the University of Iowa.

About IMT-009
IMT-009 is a fully human, Fc-attenuated IgG1 monoclonal antibody that binds to CD161 and blocks its interaction with its ligand, CLEC2D. Preclinical data confirm that CD161 blockade with IMT-009 results in enhanced anti-tumor activity. IMT-009 is under evaluation in a Phase 1/2a clinical trial for use as a monotherapy and combination treatment for solid tumor and hematological malignancies. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D). The trial will then transition into Phase 2 with multiple expansion cohorts to assess the safety and efficacy of IMT-009 alone or in combination with another antineoplastic agent.