On April 11, 2024 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported it has entered into an exclusive strategic license agreement with Novartis (NYSE: NVS) for the worldwide development and commercialization of ARV-766, Arvinas’ second generation PROTAC androgen receptor (AR) degrader for patients with prostate cancer (Press release, Arvinas, APR 11, 2024, View Source [SID1234642006]). The transaction also includes an asset purchase agreement for the sale of Arvinas’ preclinical AR-V7 program to Novartis.

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"We are thrilled to partner with an organization that shares our dedication to delivering transformative medicines to patients with significant unmet need," said John Houston, Ph.D., Chairperson, President and Chief Executive Officer of Arvinas. "We believe the expertise and scale of Novartis will broaden the development of ARV-766 and its potential to be a first- and best-in-class treatment for patients with prostate cancer. This strategic transaction also further validates our innovative PROTAC protein degrader platform and its potential to deliver new treatments."

Under the terms of the transaction agreements, Novartis will be responsible for worldwide clinical development and commercialization of ARV-766 and will have all research, development, manufacturing, and commercialization rights with respect to the preclinical AR-V7 program. Arvinas will receive an upfront payment in the aggregate amount of $150.0 million. Under the License Agreement, Arvinas is eligible to receive additional development, regulatory, and commercial milestones of up to $1.01 billion, as well as tiered royalties for ARV-766.

Closing of the transaction is subject to the parties’ receipt of any necessary consents or approvals, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Arvinas.

About ARV-766
ARV-766 is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Preclinically, ARV-766 has demonstrated activity in models of wild type androgen receptor tumors in addition to tumors with AR mutations or amplification, both common potential mechanisms of resistance to currently available AR-targeted therapies.

On April 10, 2024 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that it will participate in and present at the Stifel 2024 Targeted Oncology Forum, which will be held virtually April 16-17, 2024 (Press release, Summit Therapeutics, APR 10, 2024, View Source [SID1234642002]). Dr. Maky Zanganeh, Chief Executive Officer and President, Robert W. Duggan, Chairman and Chief Executive Officer, Manmeet Soni, Chief Operating Officer & Chief Financial Officer, Dave Gancarz, Chief Business & Strategy Officer, and Dr. Allen S. Yang, Chief Medical Officer, will participate in a fireside chat on behalf of our organization surrounding the development of our innovative investigational bispecific antibody, ivonescimab, on Tuesday April 16, 2024 at 2:30pm ET.

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The presentation will be available live from our website: www.smmttx.com. An archived version will be available on our website following the presentation.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is an investigational, novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays cooperative binding with each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority.

On April 10, 2024 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, reported that David Urso, president and chief executive officer of MEI Pharma, will participate in a fireside chat at the Stifel 2024 Virtual Targeted Oncology Forum on Tuesday, April 16 at 1:30 PM Eastern Time (Press release, MEI Pharma, APR 10, 2024, View Source [SID1234642001]).

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Investors and the general public are invited to listen to a live webcast of the session through the "Investors and Media" section of the Company’s investor relations website View Source A replay of the webcast will be made available following the event.

On April 10, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that first preclinical data for its asset IPH45, a novel and differentiated exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4, were presented in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 (Press release, Innate Pharma, APR 10, 2024, View Source [SID1234642000]).

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In preclinical studies, data demonstrated that IPH45 effectively inhibits Nectin-4 expressing tumor growth both in vitro and in vivo, including in Enfortumab Vedotin (EV) refractory models. Importantly, IPH45 shows stronger activity than EV, in multiple urothelial carcinoma PDX (patient-derived xenografted) mice models, across Nectin-4high and Nectin-4low expression levels. In addition, IPH45 has an additive anti-tumor effect to anti-PD1 treatment in vivo and has a favorable safety profile in relevant animal toxicology models.

"IPH45 is a novel and differentiated Nectin-4 ADC with preclinical efficacy in tumor types with various expression levels of Nectin-4. Its exatecan payload allow for higher bystander-effect and a broader therapeutic index than MMAE-ADCs," commented Prof. Eric Vivier, DVM, PhD, Chief Scientific Officer at Innate Pharma. "These promising results underscore the potential of IPH45 to provide new solutions for patients in a variety of Nectin-4 expressing cancers, beyond Nectin-4high expressing bladder. Based on these encouraging data, we are eagerly advancing IPH45 towards clinical trials."

The presentation is available on Innate Pharma’s website.

About IPH45

Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues. IPH45 is a novel exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4. In non-clinical models, IPH45 is well tolerated and shows anti-tumor efficacy in vitro and in vivo. IPH45 is progressing towards First in Human study.

On April 10, 2024 Neuboron Medical Group (Neuboron) reported significant progress in the commercialization of its comprehensive Boron Neutron Capture Therapy (BNCT) solution, marking a new era in the treatment of refractory tumors. On March 26, the Beijing Institute of Medical Device Testing (BIMT) granted Neuboron’s NeuPEX Block-I, an electrostatic accelerator-based BNCT system, its Medical Device Testing Reports (Press release, Neuboron Medtech, APR 10, 2024, View Source [SID1234641999]). Concurrently, the Center of Drug Examination of the National Medical Product Administration, China, approved the Investigational New Drug (IND) application for Neuboron’s boronophenylalanine (NBB-001, also known as BPA). This approval facilitates the commencement of Phase-I Clinical Trials targeting recurrent head-and-neck cancer at the Xiamen Humanity Hospital, the premier operational BNCT Center in China.

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Founded in 2014, Neuboron stands at the forefront of BNCT innovation, dedication, and patient care. Neuboron’s decade of research and development has established Neuboron as the only entity globally to develop a proprietary Accelerator-Based BNCT (AB-BNCT) system alongside boron drugs, offering hospitals a complete BNCT solution. This solution encompasses the NeuPEX AB-BNCT System, the NeuMANTA Treatment Planning System, treatment boron drug NBB-001 (BPA), and diagnostic NBB-002 (18F-BPA).

Neuboron’s inaugural AB-BNCT System, NeuPEX Block-I, was operational by 2021, and by October 2022, it had successfully administered its first patient treatment under an Investigator Initiated Trial (IIT), marking China as the second nation to achieve a full spectrum of BNCT clinical capabilities. NeuPEX distinguishes itself by its efficiency and ‘green’ credentials, capable of conducting over 2,400 irradiation sessions annually, thanks to its advanced patient positioning and simulation capabilities. The NeuMANTA Treatment Planning System, with its COMPASS Monte Carlo dose engine, delivers swift and precise dose calculations, reducing processing times to approximately five minutes.

A pivotal advancement has been the development of a high-yield, nucleophilic reaction process for synthesizing 18F-BPA for PET scans, enhancing availability and critical diagnostic and treatment planning capabilities. Additionally, Neuboron’s BPA formulation as a freeze-dried powder ensures ease of transport and extended shelf life, preventing Maillard reactions.

Prof. Yuan-Hao Liu, Founder and CEO of Neuboron, anticipates the initiation of its first clinical trial this April, with Phase I completion expected within the year. "Our entry into the Phase-I trial represents a significant stride towards our commitment to making BNCT accessible, affordable, and advanced," Prof. Liu remarked. "Our collaboration with global academic, research, and healthcare institutions, alongside industrial partners like TAE Life Sciences, underscores our dedication to fostering an open, cooperative BNCT ecosystem."

Looking forward, Neuboron, in collaboration with the Xiamen Humanity Hospital, will extend its IIT trials to explore BNCT applications across a broader range of solid tumors and refine treatment methodologies. While the IND trial is restricted to domestic patients, the IIT trials are open internationally, widening access to this innovative treatment modality. Neuboron aims for market approval by late 2025 to early 2026.

Discover more about Neuboron Medical Group’s revolutionary impact on cancer therapy at www.neuboron.com. New drug cooperation please contact [email protected]. BNCT system cooperation please contact [email protected].