Vertex Enters Into Agreement to Acquire Alpine Immune Sciences

On April 10, 2024 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a biotechnology company focused on discovering and developing innovative, protein-based immunotherapies, reported that the companies have entered into a definitive agreement under which Vertex will acquire Alpine for $65 per share or approximately $4.9 billion in cash. The transaction was unanimously approved by both the Vertex and Alpine Boards of Directors and is anticipated to close later this quarter.

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This press release features multimedia. View the full release here: View Source

Alpine’s lead molecule, povetacicept (ALPN-303), is a highly potent and effective dual antagonist of BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand). Through Phase 2 development, povetacicept has shown potential best-in-class efficacy in IgA nephropathy (IgAN). IgAN is a serious, progressive, autoimmune disease of the kidney that can lead to end-stage-renal disease. There are no approved therapies that target the underlying cause of IgAN. IgAN is the most common cause of primary (idiopathic) glomerulonephritis worldwide, affecting approximately 130,000 people in the U.S. Povetacicept is on track to enter Phase 3 clinical development in the second half of 2024.

Due to its mechanism of action as a dual BAFF/APRIL antagonist, povetacicept holds the potential to benefit patients with other serious autoimmune diseases of the kidney, such as membranous nephropathy and lupus nephritis, as well as autoimmune cytopenias. Clinical studies in renal indications and autoimmune cytopenias are ongoing.

"Alpine is a compelling strategic fit for Vertex and furthers our ambition of using scientific innovation to create transformative medicines targeting serious diseases with high unmet need in specialty markets," said Reshma Kewalramani, M.D., FASN, Chief Executive Officer and President of Vertex. "We look forward to welcoming the talented Alpine team to Vertex and believe that together we can bring povetacicept, a potential best-in-class treatment for IgAN to patients faster. We also look forward to fully exploring povetacicept’s potential as a ‘pipeline-in-a-product’ and adding Alpine’s protein engineering and immunotherapy capabilities to Vertex’s toolbox."

"Today’s announcement marks a new chapter for Alpine," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "It became clear during our discussions with the Vertex team that we share many core values, including a commitment to patients, our employees, and an intense drive for innovation. Povetacicept has demonstrated potential best-in-class attributes in IgA nephropathy and has broad development potential across a number of other autoimmune and inflammatory conditions with significant unmet need. We look forward to the opportunity, now more than ever, to make a meaningful difference in the lives of patients worldwide as part of Vertex."

Transaction Terms

Under the terms of the merger agreement, Vertex will acquire Alpine for $65 per share in cash, for a total equity value of approximately $4.9 billion, or approximately $4.6 billion net of estimated cash acquired. A subsidiary of Vertex will commence a cash tender offer to purchase all outstanding shares of Alpine common stock.

The transaction is expected to close in the second quarter of 2024, subject to certain conditions, including the tender of a majority of the outstanding shares of Alpine common stock and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

Advisors

Lazard is acting as financial advisor to Vertex. Skadden, Arps, Slate, Meagher & Flom is serving as legal counsel to Vertex. For Alpine, Centerview Partners is acting as exclusive financial advisor and Fenwick & West LLP as legal counsel.

About IgA Nephropathy (IgAN)

IgAN is a serious, progressive, life-threatening chronic kidney disease that is the most common cause of primary (idiopathic) glomerulonephritis, affecting people worldwide including approximately 130,000 people in the U.S. IgAN is thought to result from deposition of circulating immune complexes consisting of immunoglobulins and galactose-deficient immunoglobulin A (Gd-IgA1) in the renal glomerular mesangium, triggering kidney injury and fibrosis. A high percentage of people with IgAN progress to end-stage renal disease. There are no approved therapies that target the underlying cause of IgAN.

About Povetacicept (ALPN-303)

Povetacicept (ALPN-303) is a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation and/or survival of B cells, T cells and innate immune cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept has higher binding affinity and greater potency in preclinical studies versus other inhibitors of BAFF and/or APRIL alone and has demonstrated potential best-in-class efficacy in a clinical trial in patients with IgA nephropathy. Povetacicept is also in development for multiple serious diseases including other autoimmune kidney diseases and autoimmune cytopenias. Povetacicept is targeted to enter Phase 3 in the second half of 2024.

Alpine will provide updated clinical data from RUBY-3, a phase 1b/2a study of povetacicept to investors during a conference call scheduled for 5:15 pm ET today, April 10, 2024.

Vertex Conference Call and Webcast

Vertex will host a conference call and webcast at 4:30 pm ET today, April 10, 2024. To access the call, please dial (833) 630-2124 (U.S.) or +1 (412) 317-0651 (International) and reference the "Vertex Pharmaceuticals Conference Call."

The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website in the "Investors" section.

Alpine Conference Call and Webcast

Alpine will host a conference call and webcast at 5:15 pm ET today, April 10, 2024.

The link to the webcast is available in the investor relations section of the Company’s website at View Source and a replay will be available on the Company’s website for 90 days following the live event.

(Press release, Vertex Pharmaceuticals, APR 10, 2024, View Source [SID1234660958])

Summit Therapeutics to Present at the Stifel 2024 Targeted Oncology Forum

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.

MEI Pharma to Present at the Stifel 2024 Virtual Targeted Oncology Forum

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.

Innate Pharma Presents at AACR 2024 Preclinical Efficacy of Its Pre-IND Drug Candidate IPH45, a Novel Nectin-4 Antibody Drug Conjugate

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.

Neuboron Medical Group Advances Cancer Treatment: Introducing Next-Generation Boron Neutron Capture Therapy

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].