Ajinomoto Bio-Pharma Services

COLUMBUS, Ohio--( BUSINESS WIRE )--Forge Biologics, a member of Ajinomoto Bio-Pharma Services and leading manufacturer of genetic medicines, today announced it will be the adeno-associated virus (AAV) development and manufacturing partner for the Muscular Dystrophy Association’s (MDA) Kickstart Program. MDA is the leading nonprofit focused on accelerating research, advancing care, and advocating for the support of people living with muscular dystrophy, ALS, and related neuromuscular diseases. The MDA Kickstart Program is a new research program developed as a strategy to lower commercial barriers and de-risk development of gene therapies for ultra-rare neuromuscular diseases. “Collaborating with the MDA embodies our mission at Forge to help deliver potentially life-changing treatments to patients suffering from rare disease,” said John Maslowski, Chief Commercial Officer at Forge Biologics. “We are excited to support the MDA Kickstart Program and help advance these critical projects to the next stage of development.” Forge will provide process and analytical development manufacturing services, and the partnership will leverage Forge’s platform process, including its proprietary HEK293 suspension Ignition Cells™ and pEMBR™ adenovirus helper plasmid. All development and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy manufacturing facility in Columbus, Ohio. "Forge has proven to be a trusted partner to gene therapy innovators, advancing many critical programs for rare diseases. We look forward to embarking on this manufacturing partnership, leveraging their deep expertise and robust platform to propel our Kickstart Program's goal of accelerating the delivery of treatments and cures to patients with ultra-rare neuromuscular diseases," said Sharon Hesterlee, Ph.D., Chief Research Officer at the Muscular Dystrophy Association. About Forge Biologics Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 200,000L of manufacturing capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com .

Merck and Curon's CD19 bispecific deal, Legend CEO's response to new developments, and a large number of missing adverse events in Amgen's Imdelltra filing made our news this week. Merck licensed a bispecific from a Chinese biotech with plans to target oncology and autoimmune diseases. Legend Biotech is taking a close at its business as M&A has emerged as an option. A large number of missing adverse events in South Korea triggered a full-scale check-up during the FDA's review of Amgen's Imdelltra. And more.1. Merck pays $700M for bispecific, spying autoimmune opening and chance to challenge Amgen in cancerMerck is paying $700 million upfront and committing up to $600 million in milestones to obtain global rights to Curon Biopharmaceutical’s CD19xCD3 bispecific candidate CN201. The Chinese biotech has presented early-stage data for the drug in blood cancers, and Merck is also interested in the T-cell engager’s potential in autoimmune diseases.2. Legend Biotech CEO takes 'close look at business' amid geopolitical risk, M&A rumorRegarding the possibility of a buyout, Legend Biotech’s leaders have been taking a close look at the business, CEO Ying Huang, Ph.D., said during a conference call. The company has evaluated the draft BIOSECURE Act and engaged with lawmakers and decided it’s not too concerned about being targeted by the legislation. These uncertainties come as Legend and partner Johnson & Johnson are busy growing their CAR-T therapy Carvykti.3. To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse eventsAmgen’s original FDA application for the newly approved small cell lung cancer drug Imdelltra had “a large number” of underreported adverse events, the agency noted in its review document. Missing adverse event reports were uncovered during an FDA inspection of a clinical trial site in South Korea. At the FDA’s request, Amgen’s examined all five Korean sites involved in the DeLLphi-301 study and returned 109 missing adverse events, which prompted an all-inclusive reevaluation.4. Ajinomoto will lay off 71 staffers in California to streamline CDMO business following $620M Forge Biologics buyAjinomoto Bio-Pharma Services is laying off 71 staffers in San Diego. The job cuts are part of the Japanese CDMO’s consolidation of its drug substance production unit after last year’s acquisition of viral vector and plasmid specialist Forge Biologics. The move will allow the San Diego site and another plant in Ohio to focus on their respective areas of expertise, the company said.Other News of Note5. Startup Vivint Pharma to spend $48M to build injectables plant in India6. Merck KGaA, NSG BioLabs team up to support biotech R&D in Singapore (release)7. Astellas' CLDN18.2 drug Vyloy wins UK nod for stomach cancer (release)

The layoff round is part of a broader scheme by Ajinomoto to consolidate its drug substance production at the Columbus, Ohio, plant it received in its $620 million buyout of Forge last fall. Moving forward, the San Diego site will focus on fill-finish services. Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego.As a result, 71 California-based staffers—or 13% of the company’s overall U.S. workforce—are set to lose their jobs, Ajinomoto said in a memo viewed by Fierce Pharma. Affected employees are in line to receive severance packages, the company added.The layoff round is part of a broader scheme by Ajinomoto to consolidate its drug substance production at the Columbus, Ohio, plant it received in its $620 million buyout of Forge last fall. Moving forward, the San Diego site will focus on fill-finish services.Ajinomoto says the move will allow both the San Diego and Columbus sites to drill into their areas of focus and better serve the CDMO’s customers. Though Ajinomoto is slimming down in San Diego, the company still plans to carry out antibody-drug conjugate (ADC) work at the site, which comprises three separate facilities.The move will have no bearing on other Ajinomoto Bio-Pharma Services sites around the world, the company stressed.“This was a difficult but necessary decision to ensure that we are positioned for success in the future," Bert Barbosa, chief operating officer at Ajinomoto Bio-Pharma Services US, said in a statement. "I want to acknowledge the impact this decision will have on affected employees and express my sincere gratitude for their hard work and contributions to our organization.”In November, Ajinomoto unveiled a $620 million, all-cash deal to acquire Forge Biologics, along with the fledgling CDMO’s 200,000-square-foot facility known as “the Hearth” in Columbus, Ohio. Three hundred Hearth staffers also came over as part of the transaction. Forge, for its part, was founded in 2020. Shortly afterward, the company secured $120 million in investor cash to boost capacity and triple its workforce.At the time of the buyout deal, Forge’s listed services included scalable, end-to-end manufacturing, including process and analytical development, viral vector manufacturing, final fill, plasmid DNA production and consulting support for gene therapy programs.