AGC Biologics A/S

Essential Pharma reaches agreement with AGC Biologics for late phase clinical manufacturing of its immunotherapy candidate for the treatment of high-risk neuroblastoma 11 June, 2024 – Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, today announced its rare disease business has signed a strategic agreement with AGC Biologics. As a leading global biopharmaceutical contract development and manufacturing organisation (CDMO), AGC Biologics will produce Hu1418K322A (Hu14.18), a humanised monoclonal antibody being developed for Essential Pharma for the treatment of high-risk neuroblastoma (HRNB). Under the agreement, AGC Biologics will support the process development, scale-up and manufacturing as Essential Pharma plans to commence clinical activities and ongoing regulatory agency interactions over the coming months. Simon Ball, Vice President of the rare disease business at Essential Pharma, commented: "This partnership is a tremendous milestone in the development of Hu14.18 and its path to commercialization. The prospect of building an inventory of Hu14.18 is very exciting. Ahead of us is a period of intense regulatory agency interaction, which will take place alongside late-stage clinical development, and we are a step closer to providing this high-potential antibody to a patient group that is desperately in need of more optimal treatments and better outcomes.” "AGC Biologics is a global leader in contract antibody development and manufacturing,” stated Emma Johnson, CEO of Essential Pharma. “This partnership will help us to accelerate the late-stage development of Hu14.18, which shows therapeutic promise for high-risk neuroblastoma patients, the majority of whom are young children. We look forward to working closely with AGC to deliver this potentially transformative therapy in an area of significant unmet need.” Christoph Winterhalter, CBO at AGC Biologics, said: “We are very pleased that Essential Pharma has chosen us to manufacture this innovative therapy. Our Copenhagen site has the expertise and experience in therapeutic antibodies to accelerate the late-stage development and manufacturing of Hu14.18. We look forward to partnering with Essential Pharma and working together to ensure the product meets the high level of quality, yield and all data packages needed to successfully master future clinical trials and regulatory agency submissions to supply patients across the globe with this life-saving product.” Essential Pharma acquired Renaissance Pharma in April 2024 and is now responsible for the development of Hu14.18. A Phase II trial incorporating Hu14.18 into first-line therapy, and additionally within post-consolidation therapy for HRNB patients, demonstrated positive patient outcomes with 3-year event-free survival (EFS) of 73.7% and overall survival (OS) of 86.0%. Data from this study were published in the Journal of Clinical Oncology in December 2021 and are approaching five-year OS readouts.1 Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. The group has been an important and valued partner to healthcare providers for over 20 years by giving underserved patient populations access to medicines that otherwise might not be available, and addressing clinical unmet needs. Essential Pharma operates globally in more than 70 countries, supplying a portfolio of products with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare disease. The group’s growth strategy is centred on portfolio optimisation and a targeted M&A approach to acquire commercial and late-clinical stage assets in the four therapeutic areas of focus. It is a trusted partner to pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous and sustainable supply to patients. Essential Pharma is backed by Gyrus Capital, an investment firm dedicated to transformational investments in sectors with long-term sustainable growth, including healthcare. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs ten different facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. 1 Furman WL, McCarville B, Shulkin BL, Davidoff A, Krasin M, Hsu CW, et al. Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. Journal of Clinical Oncology [Internet]. 2022 Feb 1;40(4):335–44. Available from: http://dx.doi.org.libproxy1.nus.edu.sg/10.1200/jco.21.01375 The content above comes from the network. if any infringement, please contact us to modify.

AGC Biologics has reached an inflection point where it needs to adjust business priorities and “right size and rebalance the resources of our organization," a spokesperson said. While some biopharma contract manufacturers have been able to weather a tough business environment in recent months, many others continue to struggle against financing headwinds affecting the greater biotech industry. Take for example Seattle’s AGC Biologics, which this week made the difficult decision to lay off just under 4% of its global workforce as it navigates those challenges. AGC Biologics, which employs more than 2,500 workers worldwide, has “had to reduce positions at our Seattle and Colorado sites and global functional areas,” a spokesperson confirmed Friday in an emailed statement. The percentage of planned cuts suggests AGC could ultimately lay off around 100 employees. AGC's Seattle campus serves as the CDMO's global headquarters, as well as a key site for its global formulation services. The site, which has been producing biologics for three decades, features multiple manufacturing lines and a range of scales for mammalian and microbial-based drugs, AGC says on its website. Meanwhile, the company’s Boulder site in Colorado—which it acquired from AstraZeneca in 2020—helps crank out mammalian-based products at larger scales needed for late-phase and commercial projects. AGC in 2021 also purchased a former Novartis cell and gene therapy production plant 16 miles away from the Boulder site in Longmont, Colorado. Elsewhere, the company operates facilities in Denmark, Germany, Italy and Japan. Endpoints News first was first to report the news of AGC’s planned staff reduction. Citing “changing economies” and “other external factors” affecting AGC Biologics and many of its manufacturing partners, the CDMO's spokesperson told Fierce the company has reached an inflection point where it needs to adjust business priorities and “right size and rebalance the resources of our organization.” “While these are never easy decisions, we believe these changes will help us refocus resources and operate more effectively as the company navigates a changing biopharma industry,” the spokesperson added. AGC Inc., AGC Biologics’ Japanese parent, provided more clarity on the tough contract manufacturing environment earlier this week as it reported a 7% sales decline to 32.5 billion Japanese yen (around $209 million) for its life science business in the first quarter of the 2024 fiscal calendar. Net sales decreased in part due to the “disappearance of COVID-related special demand” and “reduced capital inflows into biotech ventures,” the company explained. On the COVID piece, AGC Biologics has helped supply BioNTech with plasmid DNA from its Heidelberg, Germany, facility as the starting material for the Pfizer-partnered COVID-19 vaccine Comirnaty. With regards to biotech funding, meanwhile, AGC said the business environment—and demand from clients—is starting to rebound, though the “recovery pace requires close monitoring.”  AGC Biologics was founded as a global CDMO in 2018 through the fusion of Asahi Glass Company (AGC) Bioscience, Germany’s Biomeva and U.S.-based CMC Biologics. Asahi Glass had previously purchased all of CMC’s shares in December 2016. AGC Biologics is far from the only CDMO to suffer a contract manufacturing whiplash in recent years. On a recent Evaluate webinar addressing the state of the manufacturing industry in 2024, Jenny Gattari, CDMO sales lead for North America at Pfizer CenterOne, noted that following a surge in venture capitalist interest in small and mid-sized biotechs during the pandemic, much of that funding has dried up. In turn, many CDMOs are receiving fewer contracts from up-and-coming companies in need of production partners. Late last year, Chinese CDMO WuXi Biologics warned that the wider contract manufacturing industry had slowed to single-digit growth in 2023 compared with roughly 15% growth in previous years. The life science services and process solutions units of Germany’s Merck KGaA have reported similar problems.

Pictured: A collage of biopharma M&A/ Nicole Bean for BioSpace After a slow 2022 and early part of 2023, the pace of mergers and acquisitions in the pharmaceutical and biotech sectors has accelerated since the middle of last year, highlighted by Pfizer’s $43 billion takeover of Seagen. Since the calendar turned to 2024, we have seen some blockbusters, including Novo Nordisk's $16.5 billion purchase agreement for Catalent and the closing of Bristol Myers Squibb's $4.8 billion acquisition of Mirati Therapeutics. With interest in takeover activity rebounding, BioSpace is pleased to introduce our mergers and acquisitions tracker, which will be updated regularly. Follow along as we keep you up to date on which companies are getting together and which are being absorbed. March March 5 Status: Pending; anticipated closing late Q2 Deal value: Undisclosed Akari Therapeutics and Peak Bio announced an all-stock “merger of equals,” though the combined company will carry the Akari name and continue to be traded on the Nasdaq Capital Market under the AKTX ticker symbol. The new partners plan to focus on business development and licensing across therapeutic areas, including cancer, autoimmune conditions and inflammatory diseases. March 4 Status: Completed Deal value: Undisclosed Eilean Therapeutics said it has purchased privately held startup Ness Therapeutics in an all-equity deal. San Diego–based Ness is developing PTPN2 inhibitors for immuno-oncology. Eilean has been testing small molecule inhibitors that target escape mutations in hematologic and solid tumors. March 4 Status: Pending Deal value: Up to $82 million plus royalties Melbourne, Australia-based Telix Pharmaceuticals will acquire privately held radioisotope production technology company ARTMS, of Burnaby, British Columbia. Telix said that, among other things, ARTMS will be able to support production of Zircaix (TLX250-CDx), its investigational PET imaging agent for identifying clear cell renal cell carcinoma. The deal calls for Telix to pay $42.5 million in stock upfront, $15 million in cash at closing and as much as $24.5 million in contingencies, as well as future royalties. March 1 Status: Pending Deal value: Undisclosed Precisio Biotix Therapeutics announced the purchase of CC Bio, maker of the Zeus bioinformatics platform for antibacterial lysis analysis. Precisio said the Zeus platform is “highly complementary” to its LysiThru lysin screening and engineering system. March 1 Status: Pending Deal value: Up to $31 million Kinnate Biopharma has agreed to sell exarafenib, its investigational pan-RAF inhibitor, to France’s Pierre Fabre Laboratories. Kinnate is in the process of being acquired by Xoma. February Feb. 29 Status: Completed Deal value: Undisclosed JAMP Pharma Group purchased a shuttered drug manufacturing facility in Lévis, Quebec, that belonged to Pharmalab, a company that went out of business in August 2023. Quebec-based JAMP announced plans to rehire a “significant portion” of the 250 former Pharmalab workers at the site to serve the Canadian market. Feb. 28 Status: Pending; anticipated closing early Q2 Deal value: $130 million CoreRx agreed to purchase fellow Florida firm Societal CDMO for $1.10 per share in cash. Societal said the combined company seeks to establish itself as “a preferred CDMO partner in the small molecule space” when the deal closes. Feb. 28 Status: Pending Deal value: Undisclosed Gingko Bioworks announced a trio of acquisitions: Patch Biosciences, Proof Diagnostics and the artificial intelligence and software infrastructure of Reverie Labs. Terms of the sale agreements were not disclosed, but Ginkgo said its board approved stock grants of about $3.5 million to four Reverie employees and nearly $4.3 million to eight Patch Bio employees. Feb. 26 Status: Pending; anticipated closing Q2 Deal value: $135 million NGM Biopharmaceuticals agreed to a buyout by affiliates of venture capital firm The Column Group for $1.55 per share. NGM Bio recently presented data on trials of a dual ILT2/ILT4 antagonist antibody and another compound to treat compensated cirrhosis. Feb. 26 Status: Completed Deal value: $4.1 billion Bristol Myers Squibb closed its previously announced $62.50-per-share takeover of radiopharmaceutical developer RayzeBio. The target company’s portfolio includes RYZ101, an SSTR2-targeting radiotherapeutic that is currently in late-stage testing for gastroenteropancreatic neuroendocrine tumors and is also being trialed for small cell lung cancer. Feb. 22 Status: Pending Deal value: Up to $117.5 million plus royalties Rigel Pharmaceuticals is purchasing the U.S. rights to FDA-approved non-small cell lung cancer drug Gavreto (pralsetinib) from Blueprint Medicines for $15 million. Rigel could be on the hook for an additional $97.5 million in commercial milestone payments and $5 million in regulatory milestone compensation, as well as future tiered royalties. Blueprint regained the global rights to Gavreto from Roche in early 2023. Feb. 22 Status: Completed Deal value: Up to $1.2 billion AstraZeneca closed its acquisition of Chinese cell therapy company Gracell Biotechnologies, giving the British pharma giant ownership of the investigational cell therapy GC012F, a dual-targeting autologous CAR-T therapy, as well as Gracell’s FasTCAR platform for CAR-T development. The deal, announced Dec. 23, is valued at $2 per share. Unspecified regulatory milestone payments could bring the total value to $1.2 billion. Feb. 21 Status: Completed Deal value: $1 million plus contingencies BioVaxys Technology completed the purchase of the discovery, preclinical and clinical assets of bankrupt Canadian immuno-oncology developer Immunovaccine Technologies (IMV). BioVaxys made $750,000 in upfront payments and issued $250,000 in stock to IMV creditors. The company also agreed to make unspecified milestone payments, share licensing revenues and offer royalty payments to the creditors. IMV initiated U.S. bankruptcy proceedings in May 2023, Pharmaceutical Technology reported. Feb. 20 Status: Completed Deal value: $28.2 million Syncona closed its acquisition of Freeline Therapeutics for $6.50 per share in cash, in a deal that had been announced in November. Freeline had been in early-stage trials of FLT201, an adeno-associated virus (AAV) candidate gene therapy for Gaucher disease. Feb. 16 Status: Pending Deal value: $120 million Biotech royalty aggregator Xoma announced an agreement to take over precision oncology firm Kinnate Biopharma for an estimated $120 million in cash. Kinnate's pipeline includes a brain-penetrant MEK inhibitor, a highly selective c-MET inhibitor and exarafenib, a pan-RAF inhibitor in early-stage trials. Feb. 14 Status: Completed Deal value: $180 million Concentra Biosciences completed its acquisition of Theseus Pharmaceuticals, first disclosed Dec. 22. The $4.05-per-share price was at the top end of a previously announced range to purchase Theseus, a clinical-stage company developing pan-variant tyrosine kinase inhibitors and other targeted therapies. Feb. 12 Status: Pending; anticipated closing Q1 Deal value: $4.3 billion Gilead Sciences announced plans to acquire CymaBay Therapeutics for $32.50 per share in cash. The news broke the same day CymaBay announced that the FDA accepted the New Drug Application for its lead candidate seladelpar for the management of primary biliary cholangitis. Feb. 7 Status: Pending Deal value: Up to $123.1 million Telix Pharmaceuticals agreed to purchase QSAM Biosciences in an all-stock transaction. Contingent value rights could be worth as much as $90 million on top of the base price. Telix highlighted QSAM’s lead asset, an investigational radiopharmaceutical treatment for primary and metastatic bone cancer called CycloSam (Samarium-153-DOTMP). QSAM had signed a term sheet for the planned acquisition in November that included a $2 million pre-closing collaboration fee from Australia-based Telix to continue its development work. Feb. 7 Status: Pending Deal value: Up to $880 million Jazz Pharmaceuticals signed a definitive agreement to purchase the proprietary Kirsten rat sarcoma virus (KRAS) inhibitor program of Redx Pharma for $10 million upfront and as much as $870 million in development, regulatory and commercial milestone payments, as well as potential royalties. The next milestone is FDA Investigational New Drug clearance, the companies said. Feb. 6 Status: Pending Deal value: Up to $87.5 million Immunome said it would acquire the AL102 investigational small molecule gamma secretase inhibitor and a related drug candidate from Ayala Pharmaceuticals for $50 million in cash and stock, with contingencies for an additional $37.5 million in milestone payments. Ayala subsequently announced that it had completed enrollment in a Phase III study to evaluate AL102 in desmoid tumors. Feb. 5 Status: Pending; anticipated closing in first half of 2024 Deal value: $2.9 billion Novartis reached an agreement with MorphoSys to acquire the German biotech for more than $73 per share in cash. At the center of the merger is pelabresib, an investigational small molecule inhibitor of the BET protein which suppresses the expression of abnormal genes involved in cancer development. The companies expect the acquisition to close in the first half of the year. Feb. 5 Status: Pending; anticipated closing late 2024 Deal value: $16.5 billion Novo Nordisk made a splash with a $16.5 billion offer—the largest new M&A announcement in the biotech sector so far this year—to take over troubled CDMO Catalent. Novo Holdings, the investment arm of the Novo Nordisk Foundation, will purchase all outstanding Catalent shares for $63.50 each and flip three manufacturing plants to Novo Nordisk for $11 million as the latter seeks to ramp up production of its blockbuster diabetes drug Ozempic and weight-loss medication Wegovy. Neil Versel is the business editor at BioSpace. You can reach him at neil.versel@biospace.com. Follow him on LinkedIn or X.