National Cancer Institute

Plus, news about Abilita Therapeutics, Orion, Novartis, XGEN Venture, Palleon, Henlius, TigaTx, HERVolution Therapeutics and Krystal Biotech: Gilead now owns 30% of Assembly Biosciences: The drugmaker made a $20.1 million equity investment in Assembly Bio, in addition to awarding $10 million in funding. The companies began working together in late 2023. Assembly Bio expects to share data for its experimental hepatitis D treatment in the first half of next year. Its stock $ASMB jumped 16% on Thursday morning. — Jaimy Lee NGM Bio licenses out drug: KdT Ventures, an Austin, TX-based venture firm, will dole out up to $608 million in upfront payments and biobucks for NGM313, which had been studied in MASH patients. KdT, which recently raised a new fund , set up a new company to house the drug, which will be tested in a Phase 2 trial next year for an undisclosed, non-metabolic indication. NGM was taken private earlier this year and then raised a $122 million funding round in July. — Kyle LaHucik Abilita’s antibody deal: The San Diego biotech inked a licensing and research collaboration with Orion in oncology and pain for up to $785 million. — Kyle LaHucik Novartis closes two MorphoSys sites: The MorphoSys facilities are located in the US and Germany, and the closures come after the drugmaker bought the German biotech for $2.9 billion in February. The factories are expected to shutter by the end of 2025 and will “impact” 330 employees, a Novartis spokesperson told Endpoints News . R&D programs at the two sites will be integrated into Novartis, the company added. — Anna Brown Milan VC closes fund: XGEN Venture closed its life sciences fund at €180 million. Earlier this year, it said it had targeted €200 million . — Kyle LaHucik Palleon, Henlius team up: The Boston-area biotech will work with Shanghai-based Henlius Biotech on glycan editing for autoimmune diseases. Henlius gets the exclusive license to Palleon’s E-602 in China in exchange for paying up to $95.3 million. — Kyle LaHucik TigaTx bags $35.5M to develop cancer treatment: The Boston-based biotech plans to use the cash to take its lead asset, TIGA-001, into the clinic. The company was awarded up to $33.5 million by the Advanced Research Projects Agency for Health as well as a $2 million grant from the National Cancer Institute. — Ayisha Sharma Dark genome biotech raises $11.7M in Series A: HERVolution Therapeutics expects to use the funds to advance its lead candidate, IPT-001, into human studies in 2025. The preclinical immune therapy asset targets a human endogenous retrovirus and is in development for both pancreatic and prostate cancer. The fundraise was led by the Serum Institute of India. — Ayisha Sharma Pittsburgh drugmaker shares early lung cancer data: In a Phase 1/2 study, Krystal Biotech’s inhaled candidate, called KB707, produced a 27% objective response rate and a 73% disease control rate in patients with advanced non-small cell lung cancer. The company has added two cohorts to the trial evaluating the drug in combination with a PD-1 or a PD-1 plus chemotherapy. — Ayisha Sharma

Karmanos is the first in the world with access to this innovative treatment that uses radiofrequencies to target and shrink cancerous tumors DETROIT, Dec. 18, 2024 /PRNewswire/ -- The Barbara Ann Karmanos Cancer Institute, the largest provider of cancer care and research in Michigan and part of McLaren Health Care, announced today that the new TheraBionic P1 device, an FDA-approved, at-home treatment, is now available to treat advanced liver cancer. Karmanos Cancer Center is the first institution worldwide to prescribe this treatment. Continue Reading Physicians at the Barbara Ann Karmanos Cancer Institute are the first in the world to prescribe the new FDA-approved, handheld TheraBionic P1 device for treating hepatocellular carcinoma (advanced liver cancer) in the convenience of the patient's home. The TheraBionic P1 device is a novel, handheld, portable device that produces low levels of 27.12 MHz radiofrequency electromagnetic fields, which are amplitude-modulated at tumor-specific frequencies. The device is coupled with a spoon-shaped antenna placed on the patient's tongue during treatment administered in three one-hour sessions daily, delivering low levels of radiofrequency electromagnetic fields throughout the patient's body. The electromagnetic fields block the growth of tumor cells without affecting healthy tissue. The P1 device was FDA-approved in September 2023 for the treatment of advanced hepatocellular carcinoma (HCC), the most common type of liver cancer. Patients 18 years of age or older who have failed first- and second-line therapy are eligible for this treatment. The TheraBionic P1 device is the first FDA-approved systemic therapy using radiofrequency electromagnetic fields to treat cancer. "This new treatment offers additional hope, extended life, and minimal side effects to patients with incurable cancer," said Boris Pasche, M.D., Ph.D., FACP, president and CEO of Karmanos and co-inventor of the TheraBionic P1 device. "Having this treatment finally come to market makes a meaningful difference in how we treat this disease and help our patients continue their lives." Dr. Pasche is a renowned medical oncologist specializing in treating gastrointestinal malignancies and hereditary cancer. His research focuses on cancer susceptibility and new therapies. With the TheraBionic P1 device, liver cancer frequencies are recognized by receptors on the liver cancer cells, transforming these frequency signals into growth arrest, making them solely effective in treating liver cancer. However, these same frequencies would not work for breast cancer tumors, and the reverse is also true. The radiofrequency levels delivered during treatment are lower than those generated by cellular phones when held close to the body. HCC accounts for approximately 90% of all liver cancers, with average survival rates between 6 and 20 months. Patients with advanced hepatocellular carcinoma who fail first- and second-line therapies often have severely impaired liver function, with many patients needing to enter hospice care, so additional treatment options were previously limited or nonexistent. Multiple studies over two decades have shown using the TheraBionic P1 device resulted in tumor shrinkage, blocked new cancer cell growth, and increased overall survival rates. According to TheraBionic, Inc., patients undergoing treatment in these studies did not experience debilitating side effects associated with other cancer-fighting therapies, including loss of appetite, diarrhea, and irritation of the palms and soles. A Patient and Caregiver's Experience Robert Perrier's case highlights the benefits of TheraBionic P1 therapy in treating HCC. Diagnosed in January 2011, he experienced recurrence after surgery and subsequent failed treatments. Perrier began using the P1 device in September 2011 alongside oral chemotherapy, which his physician discontinued two years later due to side effects. From then until he died in 2017, he only received treatments from the P1 device, living nearly six years post-diagnosis. He passed away from kidney failure after declining dialysis following complications from a hip fracture. His wife attributes her husband's additional years to using the device. "…the TheraBionic device has provided my husband several additional years of life," said Eveline Perrier. "I hope that other patients will be able to benefit from the device in the future." "I often think about my patients in the past who would have benefited in having more time with their loved ones if this device was available, which is why I am excited we can prescribe it to patients," said Anthony Shields, M.D., Ph.D., medical oncologist and member of the Gastrointestinal and Neuroendocrine Oncology Multidisciplinary Team (MDT) at Karmanos. "As oncologists who treat gastrointestinal cancers, we often face some of the most incurable diseases. Our team is excited to be able to offer our patients another option in the fight, which is why patients come to Karmanos." Learn More About the P1 Device Advanced HCC patients and their caregivers may learn more about the P1 device and schedule a second opinion with a medical oncologist on the Karmanos Gastrointestinal and Neuroendocrine Oncology MDT by visiting karmanos.org/therabionic or calling 1-800-KARMANOS. Prescribing physicians are Wasif Saif, M.D., MBBS, medical oncologist and co-leader of the Gastrointestinal and Neuroendocrine Oncology MDT, Najeeb Al Hallak, M.D., MS, medical oncologist and Gastrointestinal and Neuroendocrine Oncology MDT, and Dr. Shields. About Liver Cancer According to the American Cancer Society (ACS), liver cancer diagnoses have been on the rise since 1980, with liver cancer incidence rates tripling and deaths from liver cancer doubling. ACS estimated that in 2024, more than 41,000 people in the U.S. were diagnosed with liver cancer, and nearly 30,000 patients have passed away from the disease. Liver Cancer Treatment at Karmanos At Karmanos, liver cancer is treated by the Gastrointestinal and Neuroendocrine Oncology MDT, which includes surgical, medical, and radiation oncologists; interventional radiologists; pathologists; specialized nurse practitioners; dietitians; social workers; and genetic counselors. The team focuses entirely on treating gastrointestinal cancers and shares its collective expertise. Each patient receives a carefully constructed treatment plan designed to achieve the best possible outcome. About the Barbara Ann Karmanos Cancer Institute Karmanos Cancer Institute is a leader in transformative cancer care, research and education through courage, commitment and compassion. The Karmanos vision is a world free of cancer. As part of McLaren Health Care, Karmanos is the largest provider of cancer care and research in Michigan. For more than 75 years, the administrative and research headquarters, along with the premier specialty cancer hospital, have been located in downtown Detroit. With 16 network sites, Karmanos delivers world-renowned care and access to clinical trials throughout Michigan and northern Ohio. The National Cancer Institute recognizes Karmanos as one of the best cancer centers in the nation with a comprehensive cancer center designation. Its academic partnership with the Wayne State University School of Medicine provides the framework for cancer research and education – defining new standards of care and improving survivorship. For more information, call 1-800-KARMANOS (800-527-6266) or visit . Follow Karmanos on Facebook, Twitter, LinkedIn and YouTube. SOURCE Karmanos Cancer Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TigaTx will use the ARPA-H and NIH funding to progress its lead program, TIGA-001, an IgA anti-EGFR neutrophil engager, into the clinic and generate clinical proof-of-concept data for its engineered IgA platformTigaTx will also apply the ARPA-H funding to expand its engineered IgA platform to other oncology indications, as well as infectious diseases, for which it aims to develop secretory, dimeric IgA as a new therapeutic class Company will collaborate with world-renowned investigators from Weill Cornell Medicine, Yale University and Hadassah Hebrew University Medical Center on ARPA-H-funded work BOSTON, Dec. 18, 2024 (GLOBE NEWSWIRE) -- TigaTx, Inc., a biotechnology company developing a therapeutic platform technology of engineered Immunoglobulin A (IgA) monoclonal antibodies to address a broad range of diseases, announced today that the Advanced Research Projects Agency for Health (ARPA-H) has awarded TigaTx up to $33.5 million in funding. Separately, TigaTx was awarded a two-year, $2 million Direct to Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the U.S. National Institutes of Health under award number R44CA291266. Many immune cell types, such as T cells, NK cells, and macrophages, are currently engaged by anti-cancer therapies, resulting in successful outcomes for cancer patients. However, neutrophils, the first line of defense in infection and inflammation, are the most abundant immune cells in human circulation and have not yet been harnessed by cancer therapies. Beyond their abundance, neutrophils possess other ideal characteristics as anti-cancer effector cells. They are innate killer cells, and they cross talk with other cells of the innate and adaptive immune system, thereby, further propagating the anti-tumor cascade. TigaTx’s novel, proprietary platform technology leverages engineered monomeric IgA to bind to and potently activate neutrophils, unleashing their powerful anti-tumor killing ability to treat cancer. TigaTx’s technology yields IgA molecules that have drug-like properties and overcomes historical challenges associated with manufacturing IgA. The ARPA-H and SBIR funding will allow TigaTx to advance its lead program, TIGA-001, an IgA anti-EGFR neutrophil engager, into the clinic to generate clinical proof-of-concept data for the engineered IgA platform. While anti-EGFR IgGs and tyrosine kinase inhibitors are approved for colon, lung, and head and neck cancers, less than 25% of patients respond, and even for those patients who do respond, their cancer will typically recur. TIGA-001’s distinct neutrophil activation-targeted mechanism of action has the potential to benefit patients with resistance or intolerance to approved anti-EGFR therapies. In parallel, the ARPA-H award will enable TigaTx to expand its engineered IgA platform to treat infectious diseases. With increasing emergence of antibiotic-resistant strains of bacteria and persistent and emergent viral threats, TigaTx will develop secretory, dimeric IgA as a new therapeutic class for infectious diseases. "We're thrilled to announce this funding from ARPA-H and NIH, which provides important external validation of the breakthrough potential of our IgA monoclonal antibody platform and its first-in-class therapeutic applications,” said Anne Altmeyer, Ph.D., President and CEO of TigaTx. “This funding will allow us to validate our platform by generating clinical proof-of-concept data for our lead oncology program, TIGA-001. The funding will also enable us to expand our IgA platform technology to other high-unmet-need indications both in oncology and infectious diseases." Howard Stern, M.D., Ph.D., Chief Scientific Officer of TigaTx, commented, “Engineered IgA neutrophil engagers have the potential to revolutionize the treatment of cancer by harnessing neutrophils’ innate killing power. Further expanding our IgA platform to dimeric IgA opens a new frontier to address the growing threat of communicable diseases.” Under the ARPA-H funding, TigaTx will collaborate with several prestigious academic institutions and world-renowned oncology and immunology researchers to further characterize engineered IgA’s mechanism of action and develop additional proof-of-concept in cutting-edge preclinical models. Collaborating institutions include: Weill Cornell Medicine Taha Merghoub, Ph.D., Deputy Director of the Sandra and Edward Meyer Cancer Center; Margaret and Herman Sokol Professor of Oncology Research; Professor of Pharmacology and Professor of Immunology Research in Medicine; Co-Director of the Ludwig Collaborative and Swim Across America Laboratory; Co-Director of the Parker Institute for Cancer Immunotherapy at Weill Cornell MedicineJedd D. Wolchok, M.D., Ph.D., FAACR, FASCO, Meyer Director of the Sandra and Edward Meyer Cancer Center; Professor of Medicine; Co-Director of the Ludwig Collaborative and Swim Across America Laboratory; Director of the Parker Institute for Cancer Immunotherapy at Weill Cornell Medicine; Oncologist at New York Presbyterian/Weill Cornell Medical CenterDaniel Hirschhorn, Ph.D., Assistant Professor of Research in Pharmacology Yale School of Medicine Richard Flavell, Ph.D., FRS, Sterling Professor of Immunobiology; Investigator, Howard Hughes Medical InstituteEsen Sefik, Ph.D., Assistant Professor, Immunobiology; Howard Hughes Medical Institute Fellow Hadassah Hebrew University Medical Center (Jerusalem, Israel) Zvi Fridlender, M.D. M.Sc, Head, Department of Internal Medicine D, Head Laboratory of Lung Cancer Research The content of this release is solely the responsibility of the authors and does not necessarily represent the official views of the Advanced Research Projects Agency for Health (ARPA-H) or the National Institutes of Health. About TigaTx TigaTx is a biotechnology company developing engineered monomeric IgA neutrophil engagers to unleash the tumor killing power of neutrophils for cancer and engineered dimeric IgA for infectious diseases. The company's cutting-edge approach in engineered therapeutic IgA is based on pioneering work by Professor Jeanette Leusen conducted at the Utrecht Medical Center (Utrecht, The Netherlands), and has broad applicability across many different diseases. Based in Boston, MA, TigaTx is developing a pipeline of therapies to treat different cancer types and infectious diseases. For more information, visit https://www.tigatx.com. Contact:Liz MeloneMedializ@melonecomm.com Anne AltmeyerChief Executive OfficerTigaTx, Inc.aaltmeyer@tigatx.com