Sutro Biopharma, Inc.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Samsung Biologics has extended its collaboration with LigaChem Biosciences to manufacture ADCs for LigaChem, according to a Wednesday release. Veeda Lifesciences is rebranding with a new logo as it transitions from a generics CRO to a CDMO with services across small molecules to biologics, it said Sunday. Boehringer Ingelheim BioXcellence and Sutro Biopharma announced Tuesday they have scaled up Sutro’s cell-free protein synthesis tech to a commercial level. The companies used the approach to manufacture Sutro’s ADC asset luveltamab tazevibulin. Manufacturing was done at Boehringer’s facility in Vienna, Austria. Pharma Logistics and Rx Reverse Distributors are merging into one business, the companies said Monday. Rx Reverse will move into Pharma Logistics’ facility in Libertyville, IL. Both companies offer pharma distribution products. Santhera Pharmaceuticals and Clinigen have signed a supply agreement to distribute Santhera’s drug Agamree in countries where it’s not currently commercially available, according to a Monday release. Agamree is used for Duchenne muscular dystrophy. Indian API manufacturer Indoco Remedies was issued an FDA warning letter on Dec. 16, after a July 2024 inspection. The letter, published Tuesday, outlined five repeated violations including lack of microbiological testing, rough metal surfaces and excessive smoke that disrupts airflow. The observations had been also noted after a February 2023 inspection. Meanwhile, Indian manufacturer Bhargava Phytolab was also issued an FDA warning letter, published Dec. 31, over four issues found at its facility in Rajasthan. One of the violations was the failure to properly test the quality of raw materials. The FDA published its final guidance for its Advanced Manufacturing Technologies Designation Program on Jan. 2. The guidance was first introduced in February 2024 and aims to encourage manufacturers to implement “advanced” technology to improve production process. Arab API and Egypt’s Suez Canal Economic Zone (SCZONE) have signed an agreement to build a new $120 million facility in the Sokhna Industrial Zone. The new site will manufacture raw materials, chemicals and intermediates, according to a Dec. 31 release. Evonik has partnered with South Korean CDMO ST Pharm, the companies said Wednesday. Evonik can now offer its customers nucleic acids from ST Pharm. UPS has completed its acquisition of logistics company Frigo-Trans and its sister company BPL, expanding UPS’ services in cryopreservation and cold chain supply, the company said Wednesday.

Pharma and biotech have long been collaborators on the cutting-edge of innovation, forming partnerships that have translated the latest science into life-changing therapies for patients. Today, these collaborations are essential as companies aim to navigate the complex challenges in advancing potentially transformational medicines such as cell and gene therapies. No one company can tackle these alone. At Astellas, strong and meaningful partnerships are foundational for turning innovative science into VALUE for patients. By focusing our approach and pooling strengths – be that novel assets, knowledge, or resources – we can ensure breakthrough innovation reaches patients in need, faster. Partnering to Deliver on a Long-Term View to R&D Innovation Issei Tsukamoto Head of Business Development As Astellas’ Head of Business Development, Issei Tsukamoto oversees research and development (R&D) collaborations, licensing agreements, merger and acquisitions, venture investments and alliance management. Issei knows that, in the race to bring meaningful treatments to patients, selectivity and patience are key. “With so much potential scientific innovation, knowing what biology, modalities or technologies to pursue, when, and importantly, how, is critical,” he shared. Astellas takes a long-term strategic view to R&D, focusing efforts in four priority areas with potential to redefine expectations for patients: immuno-oncology, genetic regulation, targeted protein degradation, and blindness and regeneration. “Rather than being lured by what’s on trend or affordable, we prioritize deals that are a strong strategic fit. In other words, deals with ambitious partners who share our vision, complement our areas of expertise, and enhance our potential in our specialty areas of R&D.” Issei Tsukamoto Head of Business Development As Astellas’ Head of Business Development, Issei Tsukamoto oversees research and development (R&D) collaborations, licensing agreements, merger and acquisitions, venture investments and alliance management. Issei knows that, in the race to bring meaningful treatments to patients, selectivity and patience are key. “With so much potential scientific innovation, knowing what biology, modalities or technologies to pursue, when, and importantly, how, is critical,” he shared. Astellas takes a long-term strategic view to R&D, focusing efforts in four priority areas with potential to redefine expectations for patients: immuno-oncology, genetic regulation, targeted protein degradation, and blindness and regeneration. “Rather than being lured by what’s on trend or affordable, we prioritize deals that are a strong strategic fit. In other words, deals with ambitious partners who share our vision, complement our areas of expertise, and enhance our potential in our specialty areas of R&D.” A Dynamic, Creative Approach to Partnership There is no ‘one-size-fits-all,’ particularly when it concerns complex novel modalities: new challenges require flexible and creative solutions. “More than ever, flexible deal structures are needed to navigate uncharted fields of scientific innovation. We explore bespoke deal types, combining arrangements, terms, and timelines in unprecedented ways to best meet the needs of each partnership,” he reflects. “We try not to limit ourselves, which gives us the freedom to think outside the box.” Astellas’ collaboration with Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company, is a perfect example of this approach. What originally began as a strategic investment to support the advancement of Poseida’s pipeline of differentiated cell and gene therapies with the capacity to potentially cure certain cancers and rare diseases, expanded into a research collaboration and license agreement to combine the innovative cell therapy platforms from each organization. “When we partnered with Poseida, rather than focusing on a single program or indication, we explored a range of collaboration arrangements to ensure we were in the best position to advance potential cutting-edge cancer treatments for patients,” Issei said. Building the Right Environment for Success, Early Truly maximizing the potential of a partnership requires thinking beyond the signing of the deal. A shared environment where innovation thrives is essential, and establishing this requires deep trust, transparency, and constant communication throughout scientific dialogue as well as alliance management. Astellas’ collaboration with Sutro Biopharma, a clinical-stage company focused on oncology, to develop novel immunostimulatory antibody-drug conjugates, or iADCs, demonstrates the value of this approach. The partnership, which builds on Astellas’ existing expertise with antibody-drug conjugates, created an opportunity for both companies – together – to advance new, precision-based iADCs for patients who do not respond to currently available immunotherapies. Through building a trust-based relationship, aligning on a clear ‘north star,’ and communicating openly, the two companies were able to accelerate a promising program in this novel cancer modality faster than if working alone. “Ensuring teams can hit the ground running is key to successes like this,” Issei explained. “Traditionally, alliance managers come in at the tail-end of the negotiation process, but, at Astellas, our team is involved far earlier to understand the spirit of the deal, why certain decisions were made and to start building relationships. The result is that both teams are primed to accelerate innovation for patients, as a cohesive group.” Partnering for the Future Building these strong relationships is particularly important, as partners must navigate uncertainties, whether risks or unexpected opportunities, together. This demands resilience, agility, and tenacity. As a specialty pharmaceutical organization, Astellas is well suited to this. A combination of global scale and capabilities, with flexible, nimble ways of working mean we can act quickly on collaborative opportunities that will be pipeline drivers today and in the future. “These are thrilling times with scientific breakthroughs happening across all corners of healthcare. If we can better combine these by evolving how we partner, thinking creatively, and building deep, trust-based relationships, the future of R&D holds endless potential to transform the lives of patients,” concluded Issei. Our enduring commitment to R&D innovation mirrors that of our people. If you are a like-minded, ambitious innovator and believe that together we could deliver transformative therapies to patients, sooner, get in touch from the following link banner. Partnering We are actively seeking collaboration opportunities with external partners. Related Links

The annual meeting of the American Society of Clinical Oncology drew more than 30,000 attendees to San Diego, and more who participated in the conference virtually, all of them looking to see and hear the latest developments in blood cancers and hematological disorders. Multiple myeloma is always a big topic of discussion at the annual ASH meeting, and developments this year include clinical data supporting the use of certain therapies in even earlier lines of treatment. On the cell therapy front, there is an ongoing effort to improve the manufacturability of these treatments. Data were presented demonstrating shorter “vein-to-vein times,” the time from when cells are harvested to when therapeutic cells are infused into the patient. And in sickle cell disease, encouraging early data were presented showing promise for a gene-editing therapy that could offer patients a one-time treatment. We couldn’t catch everything at what is one of the biggest medical meetings of the year. Here’s a recap of some highlights from the ASH 2024 meeting: 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 Movement in Multiple Myeloma —GSK reported Phase 3 data that support bringing the multiple myeloma drug Blenrep back to the market. The latest results show a Blenrep drug regimen, as a second-line of treatment, helped patients live longer compared against a drug regimen that includes the blockbuster Johnson & Johnson drug Darzalex. These results at ASH follow a Phase 3 data readout earlier this year showing Blenrep beat a drug combination that includes the Bristol Myers Squibb cancer drug Pomalyst. Blenrep won accelerated approval in 2020. GSK withdrew Blenrep from the market after it failed a confirmatory Phase 3 study. But that test evaluated the drug as a monotherapy and as a fifth line of treatment. The Phase 3 studies that are part of regulatory submissions currently under review tested the drug in combination with other multiple myeloma therapies and as an earlier line of treatment. GSK’s plans for the drug include a study underway that could support expanding the drug’s use to first-line multiple myeloma treatment, where its competition will include Darzalex. —Speaking of Darzalex, Johnson & Johnson reported data for an injectable formulation of the drug, Darzalex Faspro, as a treatment for smoldering multiple myeloma, which is an asymptomatic precursor to this type of blood cancer. In smoldering multiple myeloma, patients have high levels of abnormal plasma cells and elevated levels of monoclonal protein in the blood. presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions In a Phase 3 test that enrolled 390 participants, J&J’s Darzalex Faspro significantly delayed high-risk smoldering multiple myeloma from progressing to active disease. The drug also extended overall survival compared to active monitoring, which is the current standard of care. Darzalex Faspro currently has nine approvals in multiple myeloma. Last month, the company submitted applications in the U.S. and Europe seeking to add smoldering multiple myeloma to the product’s list of approved indications. —Arcellx’s BCMA-targeting cell therapy, anito-cel, posted Phase 2 results in multiple myeloma that analysts say are comparable to Carvykti from partners Legend Biotech and Johnson & Johnson. It’s the safety results that reinforce their view of the Arcellx cell therapy as potentially best in class. Carvykti’s trials showed some cases of delayed neurological toxicities, including parkinsonism, a movement disorder. Arcellx is engineered to offer better safety and the results so far show no signs of parkinsonism. Analysts say Arcellx also has advantages through its partnership with Gilead Sciences, which has a global cell therapy manufacturing infrastructure and experience commercializing such products. —J&J and Legend added to the body of evidence showing that Carvykti is helping multiple myeloma patients live longer compared to standard therapies. The Phase 3 study, which tested the cell therapy in patients who had received one to three prior lines of therapy, showed that after a median 33.6 months of follow-up, Carvykti led to significantly increased rates of rates of minimal residual disease negativity, a marker of survival outcomes for multiple myeloma patients. A Look at Leukemia & Lymphoma Drugs —Kura Oncology reported more detailed data for ziftomenib, a drug candidate now partnered with Kyowa Kirin. The small molecule menin inhibitor is being developed to treat leukemias driven by certain genetic mutations. Results from the Phase 1 dose-escalation study showed a 100% complete response rate in those with NPM1 mutations. In patients whose disease harbored KMT2A mutations, the complete response rate was 83%. The companies said the drug was safe and well tolerated in combination with standard of care therapies. Last month, Kyowa Kirin paid $330 million to begin the alliance on ziftomenib. If the drug reaches the market, it will compete against Revuforj, a Syndax Pharmaceuticals menin inhibitor that won FDA approval in November. —Eli Lilly drug Jaypirca landed accelerated FDA approval last year as a treatment for advanced cases of mantle cell lymphoma following at least two prior lines of therapy. At the ASH conference, Lilly reported Phase 3 data that could support full approval for the drug, a small molecule inhibitor of a protein called BTK. Results show Jaypirca reduced the risk of disease progression or death by 46% compared to standard treatments. Treatment with the Lilly drug also prolonged the time to the next treatment or death by a median 23.9 months. Lilly said the safety profile of Jaypirca in Phase 3 was consistent with the Phase 1/2 test used to support the drug’s accelerated approval. —In a pre-planned analysis of a Phase 2 clinical trial in diffuse large B-cell lymphoma, Merck’s experimental drug zilovertamab vedotin led to a 97.2% complete response rate. What kept the study from achieving the 100% mark was discontinuation of two participants by physician decision, one patient each in the middle- and high-dose cohorts. All participants in the low-dose group showed a complete response. Based on the clinical trial results for the drug candidate, an antibody drug conjugate (ADC), Merck has selected the low dose to advance to Phase 3 testing. The results so far are encouraging for this therapy and others developed to seek out ROR1, a novel target currently unaddressed by any approved drugs. Other companies developing ROR1-targeting ADCs include Ipsen, which licensed its candidate from Sutro Biopharma earlier this year, and CStone Pharmaceuticals. Sickle Cell Disease Developments —Last month, Beam Therapeutics teased encouraging early clinical results for six patients dosed with BEAM-101, a gene-editing therapy for sickle cell disease. Updated data at ASH put some figures to the results as of an Oct. 28 data cutoff. Results showed these patients achieved fetal hemoglobin levels exceeding 60% and a reduction in sickle-shaped hemoglobin below 40% at month 1. Those levels were sustained to the last time point available, indicating that the effects of the one-time treatment are durable so far. The therapy’s safety profile was consistent with that of busulfan, the conditioning therapy that is used to prepare a patient to receive BEAM-101. As previously reported, there was one fatality from respiratory failure, which investigators attributed to busulfan. In all six patients dosed, there have been no serious adverse events attributed to BEAM 101. —Novo Nordisk presented Phase 2 data for etavopivat showing the once-daily oral drug led to a reduction in vaso-occlusive crises, a complication of sickle cell disease. The one-year, proof-of-concept study also showed an increase in hemoglobin levels. With these results, Novo Nordisk said it has selected the dose to test in a Phase 3 clinical trial. Etavopivat came to Novo Nordisk from the $1.1 billion acquisition of Forma Therapeutics in 2022. Catching Up on Cell Therapies —The cancer target GPRC5D is currently addressed by only one FDA-approved drug, the Johnson & Johnson bispecific antibody Talvey, a treatment for multiple myeloma. Bristol Myers Squibb aims to be the first to drug GPRC5D with a cell therapy. At the ASH meeting, BMS presented Phase 1 data showing its candidate, arlocabtagene autoleucel (arlo-cel), led to durable responses that deepened over time. Bristol says these results support arlo-cel as a potential first-in-class treatment for relapsed or refractory multiple myeloma in heavily pretreated patients. A Phase 2 test of the cell therapy is ongoing. —Galapagos’s non-Hodgkin lymphoma cell therapy candidate GLPG5101 posted additional Phase 1/2 results showing encouraging efficacy and safety. The company also pointed out that the vein-to-vein time was a median seven days. By comparison, the multi-step manufacturing process for currently available cell therapies can take a month or more. Galapagos’s process leverages Cocoon, a point-of-care manufacturing system from contract manufacturing giant Lonza. —Orca Bio posted data for Orca-T, an allogeneic T-cell immunotherapy in testing as a treatment for three types of blood cancer: acute myeloid leukemia, acute lymphoblastic leukemia, and high-risk myelodysplastic syndrome. Results from a three-year follow-up analysis from Phase 1b showed an overall survival rate of 86% for the study drug compared to 67% in a non-randomized historical group that received an allogeneic stem cell transplant. Orca-T is comprised of highly purified immune cells from donors. In the Phase 1b test, Orca Bio said this allogeneic therapy was manufactured reliably with vein-to-vein time of 72 hours or less across the U.S. An ongoing Phase 3 test comparing Orca-T to conventional allogeneic stem cell transplants is expected to report preliminary data in the first half of 2025. A Recap in Rare Blood Disease —Sanofi revealed details of its Phase 3 test of rilzabrutinib in persistent or chronic immune thrombocytopenia, a rare immune disorder leading to low platelet levels. Results show the small molecule BTK inhibitor led to platelet response in 65% of patients in the study drug arm compared to 33% of those who received a placebo. Furthermore, a durable platelet response was observed in 23% of patients who received rilzabrutinib versus zero in the placebo group. The drug, which came from the $3.7 billion acquisition of Principia Biopharma in 2020, is currently under regulatory review in the U.S. and Europe. —Standard of care for the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH) includes two blockbuster AstraZeneca drugs, Soliris and Ultomiris, though Apellis Pharmaceuticals and Novartis are trying to take market share with their FDA-approved therapies. Regeneron Pharmaceuticals aims to compete with those complement inhibitors with a drug combination: the approved antibody pozelimab (brand name Veopoz) and the experimental RNA-interference therapy cemdisiran. A Phase 3 test is underway testing the combination against Soliris. At ASH, Regeneron reported data from an exploratory cohort testing the two drugs against Ultomiris. Results showed the Regeneron drug combo helped patients achieve and maintain greater control over their disease compared to Ultomiris. Public domain image by Flickr user SciTechTrend