Summit Therapeutics, Inc.

HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso's next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The AK117-302 study represents a significant milestone as the first Phase III clinical trial globally to investigate a CD47 monoclonal antibody therapy for solid tumors. This trial is the fifth Phase III study for ivonescimab, utilizing PD-1/L1 monoclonal antibody therapy as a positive control, and the third Phase III study comparing ivonescimab with pembrolizumab. The AK117-302 trial underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights our capability to maximize the number of cancer patients globally that can benefit from our product portfolio through a strategic approach to clinical development. In 2022, there were 770,000 new cases of head and neck cancer globally, with 84,000 cases reported in China. Squamous cell carcinoma of the head and neck (HNSCC) accounts for over 90% of these cancers. Unfortunately, the five-year survival rate for patients with recurrent/metastatic HNSCC (R/M HNSCC) is just 3.6%. While targeted therapies and immunotherapies have improved treatment options, the median overall survival (OS) remains below one year. Pembrolizumab has emerged as the first-line standard treatment for R/M HNSCC and is recommended in both CSCO and NCCN guidelines. However, many patients do not respond adequately, and the overall survival benefit remains limited. There is a critical unmet need for more effective therapies to help HNSCC patients achieve long-term survival. At the 2024 European Society for Medical Oncology (ESMO) Congress, Akeso reported initial positive data on its combination therapy of ivonescimab and ligufalimab. This combination demonstrated significant tumor reduction and survival benefits, particularly for HNSCC patients, who require rapid tumor shrinkage. The preliminary efficacy data from this therapy surpassed that of previously disclosed PD-1 studies, positioning it as a potentially new immunotherapy option for HNSCC patients. About Ligufalimab (AK117) AK117, independently developed by Akeso, is a next-generation humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors. Currently, several phase II clinical trials are underway to investigate the potential of AK117 in combination with azacitidine for hematological tumors, as well as AK117 alone or in combination with ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles, with no observed dose-limiting toxicity events. Additionally, the Chinese Phase II clinical study of the first-line treatment for unfit AML using AK117 in combination with venetoclax and zzacitidine, as well as the international multicenter Phase II clinical study of AK117 for treating MDS, are both ongoing with patient enrollment. About Ivonescimab (AK112/SMT112) Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them , 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Antibody maker Paragon Therapeutics has formed another company, this time in the bustling cancer space of PD-1xVEGF, and it will go straight onto the public markets. The new biotech, named Crescent Biopharma, will take the place of GlycoMimetics on the Nasdaq, the companies said Tuesday morning. GlycoMimetics has failed multiple mid- and late-stage trials in recent months, including one for acute myeloid leukemia . The PD-1xVEGF space has become quite popular in recent months thanks to Keytruda-beating data from Summit Therapeutics and its Chinese partner Akeso. Former Seagen CEO David Epstein also joined a preclinical biotech, named Ottimo Pharma , on Monday that hopes to get bought out after Phase 1 data. BioNTech is also in the race. Crescent’s program, codenamed CR-001, will have initial proof of concept data in the second half of 2026, the company said. It also has two antibody-drug conjugates, another en-vogue area for oncology R&D. “This transaction and financing enable a potentially rapid development path for CR-001, and for the antibody-drug conjugate programs CR-002 and CR-003,” Crescent interim CEO Jonathan Violin said in a statement. Violin is also a venture partner at Fairmount, which is one of the investors supporting a concurrent $200 million financing for the merger, which will keep the R&D engine humming “through 2027,” the company said. Paragon has formed multiple autoimmune-focused biotechs over the past two years. Apogee went public via a traditional IPO, whereas other startups from its universe have landed on the public markets by way of reverse mergers, including Oruka and Spyre . In August, Paragon debuted another offshoot, named Jade Biosciences , with just a chief scientific officer and $80 million. Crescent’s shareholders will own almost all of the combined company, at 96.9%. The deal is anticipated to close in the second quarter of 2025.

It’s hard for preclinical biotech companies to go public these days as investors look for human data that can reduce investment risk. Crescent Biopharma is more than a year away from the clinic, but joining the public markets now enables the biotech to capitalize on a recent groundbreaking cancer drug development still fresh in investors’ minds. Crescent is going public in a reverse merger with GlycoMimetics, the companies announced Tuesday. When the transaction is complete, the merged entity will operate under the Crescent Biopharma name. It will be led by Jonathan Violin, Crescent’s current CEO, who is expected to become interim CEO of the combined company. Crescent will also be capitalized with $200 million from agreements with a select group of investors that have pledged to purchase the combined company’s securities. Those purchases will happen immediately after the merger closes in the second quarter of 2025. Crescent’s lead program is CR-001, a bispecific antibody in development for cancer. Most companies trying to build an investment case talk about how their drugs are differentiated from rivals. Crescent’s executives are doing the opposite, touting similarities to another drug: Summit Therapeutics’ ivonescimab. Last month, that drug posted data showing it topped the blockbuster Merck immunotherapy Keytruda in a head-to-head Phase 3 test. In patients with advanced cases of non-small cell lung cancer, treatment with ivonescimab led to a 49% reduction in the risk of disease progression or death compared to treatment with Keytruda, Summit said. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech Keytruda is an antibody designed to block a particular checkpoint protein, which in turn enables immune cells to recognize and go after cancer cells. Ivonescimab, discovered by Summit’s China-based partner Akeso, is a bispecific antibody that blocks two targets: PD-1, the same receptor targeted by Keytruda, and the cancer-driving protein VEGF. Crescent’s CR-001 is also a bispecific antibody designed to block both of those targets. Speaking during a Tuesday conference call, Violin said his company’s drug replicates the properties of ivonescimab. Like Summit’s drug, Crescent’s bispecific antibody works by cooperative binding, meaning it is most active in the presence of both VEGF and PD-1. “This enables the molecule to deliver benefits to patients that are more than the sum of its parts, and to do so safely,” Violin said. “This novel format enables VEGF to create ‘daisy chains’ of drug molecule, linking them together and increasing the potency for PD-1 blockade. This unique design also may enable localization of drug to the tumor microenvironment, which may help reduce systemic toxicity.” CR-001 is undergoing the preclinical research that could support an investigational new drug application, which is expected in the fourth quarter of next year or early 2026. Assuming the application is cleared, preliminary clinical data could come in the second half of 2026, Violin said. Because CR-001 replicates the properties of Summit’s drug, Crescent believes data from a few dozen patients can “connect the dots” back to data from hundreds of ivonescimab-treated patients. “We know the ivonescimab data has catalyzed massive interest in advancing next-generation checkpoint inhibitor therapy — the PD1/PDL1 class is currently a $50 billion market and growing, so when something beats the leader of such a large and important drug class, we expect competition,” Violin said. “We anticipate this will be similar to what we have seen recently in the obesity field — and we believe we have the advantage of strategic design. CR-001 was crafted specifically to thread the same immunotherapy needle as ivonescimab, putting us in a strong competitive position.” presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health Competition includes BioNTech and Instil Bio, both of which struck alliances in the past year with China-based companies for rights to bispecific antibodies that target both PD-1 and VEGF. Both programs are in clinical development in China. Crescent is the fifth company to emerge from Paragon Therapeutics, a firm that conducts biotechnology research and forms new companies around that science. The first Paragon spinout was Apogee Therapeutics, which emerged in late 2022 with a lead drug candidate in development for atopic dermatitis. Last year, Apogee raised more than $300 million in a traditional IPO that came ahead of the start of Phase 1 testing. Crescent’s pipeline of drugs from Paragon includes two preclinical antibody drug conjugates, CR-002 and CR-003. The company isn’t disclosing much detail about either program, but Violin said CR-002 “targets a highly compelling pathway” and the drug offers “the chance to be first in class.” GlycoMimetics was focused on developing treatments for cancer and inflammatory diseases with small molecules that inhibit carbohydrate interactions on the surface of cells. In July, FDA told the company its lead drug candidate, uproleselan, a potential treatment for advanced cases of acute myeloid leukemia, needed an additional clinical trial. Subsequently, the company laid off staff announced it would explore strategic alternatives. Crescent said it intends to determine potential paths forward for uproleselan. The private investment in the newly merged Crescent will be led by Fairmount, Venrock Healthcare Capital Partners, BVF Partners, and an unnamed “large investment management firm.” Other participants include Paradigm BioCapital, RTW Investments, Blackstone Multi-Asset Investing, Frazier Life Sciences, Commodore Capital, Perceptive Advisers, Deep Track Capital, Boxer Capital Management, Soleus, Logos Capital, Driehaus Capital Management, Braidwell LP, and Wellington Management. When the business combination closes, Crescent’s stockholders will own about 96.9% of the company; GlycoMimetics stockholders will own about 3.1%. Crescent believes its capital will be sufficient to last into 2027. By then, Crescent and its peers should have more data demonstrating how their respective bispecific antibody cancer drugs are working in patients. Photo by Flickr user Lengyal Mark via a Creative Commons license