Tolododekin Alfa

iStock, wildpixel Delivering therapeutics directly to tumors, as in the case of Replimune’s recently approved Tudriqev and Amgen’s Imlygic, holds advantages, especially when cancer is caught early, but challenges remain before the method becomes a mainstay in treatment. Replimune’s hard-fought approval last month for the melanoma immunotherapy Tudriqev— only the second-ever nod for an oncolytic virus delivered directly into the tumor—could signal the arrival of locally potent therapies that could change the nature of early-stage treatment. Century-old successes like Bacillus Calmette-Guérin (BCG) delivered into the bladder through a catheter to target cancer have given way to more recent advances, such as Amgen’s Imlygic (T-Vec), an oncolytic virus injected directly into unresectable melanoma lesions that in 2015 became the first FDA-approved therapy in its class. Despite the promise of locally delivered treatments, sales of Imlygic so far have not risen to the level that would make the class a particular boon for drugmakers. The oncolytic virus brought in modest sales that the pharma did not report separately in 2025. Treatments like Replimune’s Tudriqev could turn the tide, however if sales estimates by BMO Capital Markets of $1.3 billion annually in 2035 pan out. A small but dedicated group of biopharma leaders is hoping for exactly that. They argue for earlier treatment to kickstart the immune system at a point when the tumor is more vulnerable—something they say locally delivered treatments are uniquely suited to do. Approvals Third time’s the charm for Replimune as melanoma drug earns FDA greenlight Replimune’s immunotherapy for advanced melanoma faced a perilous regulatory road with two previous rejections, but the drug—to be marketed as Tudriqev—prevailed with strong support from oncologists and a 10-3 advisory committee vote in its favor. August 6, 2026 · 3 min read · Heather McKenzie Read more “Intraoperative immunotherapy specifically leverages the standard of care for solid tumors—surgery—reimagining it from a physical intervention only to a therapeutic intervention as well,” said Michael Goldberg, CEO of Surge Therapeutics, whose intraoperative breast cancer immunotherapy will enter Phase 3 this year. “Today, a surgeon resects the tumor, closes up the patient and sends them home. There is a hugely missed opportunity here . . . given that recurrence and metastasis account for 90% of cancer-related death.” Pharma giant Johnson & Johnson in 2022 built a new department around the concept, incorporating its expertise in both cancer therapeutics and medical devices to develop cutting-edge treatments and partner with others in the field. “The idea of mechanically putting a drug into a tumor has major advantages over the current standard of care,” Avi Spira, global head of interventional oncology at J&J, told BioSpace in an interview. “In the last 20 years, we’re finding cancers earlier and earlier, and as we go earlier in disease, local delivery becomes even more important.” Reducing doses to improve safety The balance between toxicity and efficacy in cancer treatment is tricky, and local delivery may help certain therapies walk that line more effectively, said Howard Kaufman, CEO at Ankyra Therapeutics. “Are you going to kill the patient before you kill the cancer? That’s the problem you have to solve, but if you administer a drug locally, you can get an effective response with a lower dose because you’re getting more of the drug where it needs to be,” Kaufman told BioSpace . Ankyra’s lead candidate, a J&J-partnered asset called ANK-101 in Phase 1 trials, delivers a dose of the cytokine IL-12 directly to solid tumors. When given systemically, therapies targeting IL-12 have failed in early clinical trials due to severe, life-threatening toxicities from excessive inflammation. But Ankyra’s platform includes an inert aluminum hydroxide scaffold that keeps 99% of the drug inside the tumor, allowing concentrations as much as four times higher than previous IL-12 targeting attempts with fewer safety issues, Kaufman said. And the idea of local delivery isn’t limited to immunotherapies. The lead asset in J&J’s interventional oncology portfolio is a nanoparticle radioenhancer now in late-stage development in partnership with Nanobiotix. Injected directly into a tumor prior to radiation therapy, the metal core of the nanoparticle supercharges radiation, potentially allowing for reduced levels overall. The treatment has been marketed in Europe for locally advanced soft tissue sarcomas as Hensify since 2019. “We envision a future where we may be able to lower the dose of radiation and have the same efficacy,” Spira said. The long commercial and regulatory road The commercial landscape for intratumoral therapies is still largely unexplored but addressing patients earlier in their diagnosis could open the door to a wider market. Imlygic is approved for use on tumors that cannot be removed surgically, limiting its use in earlier-stage disease, but Kaufman sees an opportunity for new treatments to make a difference here as well. Lung cancer Summit, BioNTech, more headline WCLC with next-gen lung cancer drugs BioNTech, Summit Therapeutics, GSK and Roche have made a splash at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer. September 14, 2026 · 4 min read · Gabrielle Masson Read more “When I have my CEO hat on and think about investors, they look at something like the commercial benefit of [Imlygic], for example, but that’s a poor example because the reality is, if we can use these drugs earlier, the market share is actually much greater,” Kaufman said. Jakob Dupont, executive partner at VC firm Sofinnova Investments, noted that the overall risk pro this class remains challenging. In addition to the largely untested commercial waters, he pointed to Replimune’s battle for FDA approval as a cautionary tale. “There’s a lot of risk, whether it’s therapeutic risk, developmental risk, regulatory risk for some of these to move forward,” Dupont told BioSpace . Once a therapy makes it to market, there’s still the obstacle of delivery, Spira said. “The coordinated, multidisciplinary care that you need to get this fully adopted was a challenge,” he said. “That limited the commercial potential and, quite honestly, the clinical impact of what was being developed.” Despite the barriers, Spira said the path forward for intratumoral therapies is becoming clearer. “This is a field that is evolving very rapidly, and what’s happened historically isn’t as relevant because of the advances we’re making,” he explained. “I see in the next five years a real tipping point where you’re going to notice a lot more activity both in clinical development and clinical care.” .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to ClinicaSpace! 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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious diseases, announced two poster presentations will be featured at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 to June 2 in Chicago. The presentations highlight ongoing Phase 1 clinical trials of tolododekin alfa, a novel IL-12 anchored immunotherapy, including a trial-in-progress poster describing its evaluation in combination with an anti-PD-1/PD-L1 antibody in people with advanced non-small cell lung cancer (NSCLC), as well as baseline quality-of-life data from a separate Phase 1 trial of tolododekin alfa in people with advanced or metastatic solid tumors. These presentations underscore Ankyra’s commitment to advancing anchored immunotherapy as a practical platform design that retains high-dose therapeutics, like IL-12, at the tumor site to deliver enhanced efficacy with lower systemic toxicity. Presentation details: Title: A Phase 1b, Two-Arm Study of Tolododekin Alfa (ANK-101) in Combination with an Anti-PD-1/PD-L1 Antibody in Participants with Advanced Non-Small Cell Lung Cancer (NSCLC) Type: Poster Session Session: Developmental Therapeutics – Immunotherapy Abstract: #TPS2678 Poster: #461b Date / time : Saturday, May 30, 2026; 1:30 – 4:30 pm CDT; Hall A Lead author: Thomas Marron, MD, PhD, Division of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine, Mount Sinai, New York Title: Quality-of-Life in Cancer Patients Treated with Anchored Interleukin-12 (IL-12) Immunotherapy: Results from a First-in-Human Phase 1 Trial of Tolododekin Alfa (ANK-101) Type: Poster Session Session: Developmental Therapeutics – Immunotherapy Abstract: #2593 Poster: #383 Date / time : Saturday, May 30, 2026; 1:30 – 4:30 pm CDT; Hall A Lead author: Jong Chul Park, MD, Mass General Brigham, Harvard Medical School, Boston About tolodoken alfa Tolododekin alfa is an investigational, first-in-class interleukin-12 (IL-12)-anchored immunotherapy. IL-12 is a highly potent proinflammatory cytokine, but its therapeutic use has been limited by toxicity. With Ankyra’s anchoring technology, tolododekin alfa has been shown to deliver and retain high doses of IL-12 in the tumor microenvironment. Early results from an ongoing Phase 1 study show durable retention within tumors, encouraging clinical activity, and a favorable safety profile, with no dose-limiting toxicities across multiple difficult-to-treat solid tumor types. Ankyra is also evaluating tolododekin alfa for the treatment of non-small cell lung cancer and cutaneous squamous cell carcinoma. About Ankyra Therapeutics Ankyra Therapeutics is a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious immune-mediated diseases. Powered by its novel anchoring platform, Ankyra engineers therapies that unlock the full therapeutic potential of immune-modulating drugs once limited by toxicity. Anchored immunotherapies are designed to stay precisely at the disease site, allowing higher doses for greater therapeutic impact while limiting systemic exposure. Ankyra is advancing a robust pipeline of first-in-class therapies and strategic collaborations to shape the next generation of immunotherapy. For more information, please visit . Contacts For Investor and Media Inquiries: Howard L. Kaufman, MD President and CEO, Ankyra Therapeutics, Inc. info@ankyratx.com