EpimAb Biotherapeutics, Inc.

SAN DIEGO & SHANGHAI--( BUSINESS WIRE )--Candid Therapeutics, Inc. (“Candid”), a clinical-stage biotechnology company focused on becoming the leader in advancing T-cell engagers for autoimmune diseases, and EpimAb Biotherapeutics, Inc. (“EpimAb” or “EpimAb Biotherapeutics”) a clinical-stage biopharmaceutical company specializing in the discovery and development of multi-specific antibodies for diseases with high unmet need, announced that the companies have entered a strategic research collaboration to discover and develop novel T-cell Engager program candidates for various autoimmune indications. “EpimAb team has impressed us with their scientific expertise and antibody design capabilities. We are excited to partner with EpimAb as we broaden our pipeline of novel TCEs for autoimmune indications,” said Dr. Ken Song, Chairman, President and CEO of Candid. “We are excited to enter this partnership with Candid, a company with the leadership and resources to realize full potential of TCEs in autoimmune indications,” said Dr. Chengbin Wu, CEO and founder of EpimAb. “We are proud of the versatility of our proprietary bispecific and TCE platforms and the partnership with Candid provides further validation of our approach.” Under the terms of the agreement, EpimAb is entitled to obtain an upfront payment, and development and sales milestones totaling over $1 billion, assuming multiple drug candidates are advanced through commercialization, as well as royalties on net sales. Candid has exclusive worldwide rights to develop and commercialize programs discovered under the collaboration. About Candid Therapeutics, Inc. Candid Therapeutics is a clinical-stage biotechnology company focused on becoming the leader in advancing T-cell engagers for B-cell depletion to treat autoimmune diseases. Candid is advancing two lead B-cell depleting TCE antibody drug candidates, with a goal to broadly explore the potential of TCEs across multiple autoimmune diseases by targeting different B-cell protein targets, as well as evaluating different depths of B-cell depletion. Established in 2024 and headquartered in San Diego, CA, Candid is led by a team of entrepreneurial executives who have a track record of advancing programs into and through development and is supported by a distinguished syndicate of premier life science investors. About EpimAb Biotherapeutics, Inc. EpimAb Biotherapeutics is a clinical-stage biopharmaceutical company specializing in the development of multi-specific antibodies. Utilizing a broad range of in-house research and technology capabilities, including the proprietary FIT-Ig ® (Fabs-In-Tandem Immunoglobulin) and MAT-Fab (Monovalent Asymmetric Tandem Fab) bispecific platform, EpimAb is generating and globally advancing a unique pipeline of transformative preclinical and clinical assets that aim to benefit cancer patients. For further information, please visit: www.epimab.com

Plus, news about Foghorn Therapeutics, Incyte, BioNTech, Galderma, Basilea, Innovia, Pharming, bit.bio, Promise Bio, Outlook Therapeutics and Trevi Therapeutics: Candid Therapeutics’ trio of T cell engager deals: The company is paying up to $320 million in upfront and milestones to Nona Biosciences to develop next-generation T cell engagers. It’s also partnering with Ab Studio to discover T cell engagers that treat autoimmune diseases. No terms were disclosed. And, in its third announcement, Candid also said Monday that it will spend up to $1 billion in a deal with EpimAb Biotherapeutics that also aims to develop T cell engagers in the autoimmune category. — Jaimy Lee PepGen’s Duchenne trial put on hold: The biotech said the FDA put its CONNECT2-EDO51 study on hold. It’s a Phase 2 trial assessing multiple ascending doses in patients with Duchenne muscular dystrophy. Its stock $PEPG sank 28% on Monday morning. — Jaimy Lee Foghorn to drop AML candidate: The company is stopping work on an experimental drug for acute myeloid leukemia called FHD-286, and it’s seeking a potential partner for the drug. Foghorn said that it saw responses to the drug in a Phase 1 study, but “the observed response rate did not meet the company’s threshold to continue development by Foghorn alone.” — Lei Lei Wu Incyte stops developing anemia drug for patients with myelofibrosis: During an investor day last week, the company said zilurgisertib “does not significantly improve anemia in patients with myelofibrosis,” and it had halted work on the drug. — Katherine Lewin BioNTech, OncoC4’s partial clinical hold is lifted: The FDA gave the go-ahead to the partners to continue a Phase 3 lung cancer trial of an anti-CTLA-4 antibody called gotistobart, but only in a subset of patients, BioNTech disclosed Friday. In October, the study was put on partial clinical hold due to a “a possible variance in results between the squamous and non-squamous NSCLC patient populations.” The study will now only enroll squamous NSCLC patients. — Lei Lei Wu FDA approves Galderma’s Nemluvio in moderate-to-severe atopic dermatitis: The drug is now approved to treat patients 12 years and older. Nemluvio is also approved for prurigo nodularis, another chronic skin condition. According to Galderma, Nemluvio is the first approved monoclonal antibody that specifically targets the cytokine IL-31, which causes the itching and inflammation associated with the disease. Its Swiss-listed shares $GALD were up about 7% on Monday. — Katherine Lewin Basilea inks deal with Innoviva to market antibiotic: Innoviva is paying Basilea $4 million upfront and up to $223 million in sales milestones, plus royalties, to commercialize Zevtera in the US. The anti-MRSA antibiotic received FDA approval in April. — Jaimy Lee Pharming’s $66M offer to buy Abliva: Pharming wants to buy the Swedish company, which is developing a treatment for mitochondrial disease. The lead asset is currently in a pivotal trial. — Jaimy Lee Bit.bio raises $30M for cell therapy pipeline: The biotech plans to use the proceeds to invest in new tools for drug discovery and research. The fundraise was led by M&G Investments, with support from backers including ARCH Venture Partners and Milky Way. The company unveiled its lead program , which is designed to regenerate the liver, a year ago. — Ayisha Sharma Israeli biotech secures $8.3M in seed funding: Promise Bio expects to use the cash to develop a computational platform powered by AI and epiproteomics that could help predict patient responses to treatment. The round was led by Awz Ventures. AION Labs also invested. — Ayisha Sharma Outlook to cut 23% of its workforce: The company underwent a strategic review as it aims to shore up funds to support the launch of its new wet AMD treatment, which was approved in Europe and the UK this year. The company plans to submit its formulation of bevacizumab to the FDA in the first three months of next year after receiving a complete response letter last year. Outlook had 24 full-time employees, as of September 2023.— Jaimy Lee Trevi is selling 12.5 million shares at $4.00 apiece to raise $50 million. — Jaimy Lee

iStock, Artur Plawgo Candid Therapeutics, which is repositioning two antibodies for autoimmune indications, will be led by Ken Song who was previously CEO of RayzeBio and oversaw its $4.1 billion acquisition by Bristol Myers Squibb. Candid Therapeutics officially launched on Monday with a strong capital raise that the startup hopes will help drive it to frontrunner status in the T cell engager market. Aiming to develop “potentially transformative” therapies for autoimmune diseases, Candid is debuting with more than $370 million in seed funding from a high-powered roster of backers, including Third Rock Ventures, OrbiMed, Foresite Capital and LifeSci Venture Partners. Venrock Healthcare Capital Partners, Fairmount, TCGX and venBio Partners co-led Candid’s funding. For its initial pipeline, Candid pulled off a three-way merger by acquiring Vignette Bio and TRC 2004, giving it two bispecific T cell engagers. The first, dubbed CND106, targets the B-cell maturation antigen, a protein typically found in mature B cells and when overexpressed is usually a driving factor of multiple myeloma. Vignette last week licensed CND106 from Shanghai-based EpimAb for $60 million upfront and $575 million in potential milestones. Candid’s second pipeline asset is CND261, which comes from TRC 2004. It binds to the CD20 antigen, which is also found on B cells and may be expressed in abnormal levels in certain lymphomas and leukemias. CND261 comes from another Chinese biotech, Genor Biopharma, and was also licensed by TRC last month . Both CND106 and CND261 also target the CD3 antigen on T-cells, allowing them to bridge the body’s immune system with the target B cells. Candid has yet to reveal what specific indications these candidates will target, but CEO Ken Song revealed that the startup will focus its efforts on autoimmune diseases. “The drugs we are developing at Candid have the potential to go above and beyond the clinical and commercial success of Humira and Rituxan,” Song said in a statement. “We can possibly make history by changing the paradigm in how autoimmune diseases are treated.” For Song, Candid’s launch comes just months after he successfully wrapped up the $4.1 billion acquisition deal involving RayzeBio—which he previously led as its president and CEO—and Bristol Myers Squibb. The agreement was first announced in late December 2023 and was closed in February 2024 . To help lead Candid, Song will be joined by Timothy Lu, chief medical and scientific officer, who was involved in the development of oral IL-17 therapies at DICE Therapeutics, which was acquired in June 2023 by Eli Lilly for $2.4 billion. Viridian Therapeutics alum Bernie Hyunghe will serve as Candid’s chief technology officer, while Arvind Kush will act as its chief financial and business officer.