On December 19, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported they have entered into a license agreement allowing Astellas to leverage Sangamo’s novel proprietary neurotropic adeno-associated virus (AAV) capsid, STAC-BBB, which has demonstrated potent blood-brain barrier penetration and neuronal transduction in nonhuman primates (Press release, Astellas, DEC 19, 2024, View Source [SID1234649211]). The agreement grants Astellas a worldwide exclusive license to utilize the STAC-BBB capsid for one target, with the right to add up to four additional targets after paying additional licensed target fees to deliver their intravenously administered genomic medicines to treat certain neurological diseases.

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Sandy Macrae, Chief Executive Officer, Sangamo
"We strongly believe in the potential of STAC-BBB, our industry-leading, intravenously delivered AAV capsid, to overcome the challenges associated with delivering therapies to the central nervous system. This agreement underscores the continued industry interest in our STAC-BBB capsid and reinforces our ongoing commitment to partnering with collaborators who understand its unique potential. We are delighted to license STAC-BBB to Astellas to advance potential treatments for neurological diseases with significant unmet medical needs."

Adam Pearson, Chief Strategy Officer, Astellas
"Delivering treatments to the brain and central nervous system remains a highly complex challenge in the field of gene therapy. We believe that technologies such as Sangamo’s STAC-BBB capsid could prove critical in helping us deliver effective transformational treatments to patients suffering from serious genetic neurological conditions. We continue to build a world-class gene therapy pipeline and end-to-end discovery, development, manufacturing, and commercial capabilities. This agreement is another example of our commitment to delivering meaningful therapies for patients with genetic diseases."

Under the terms of the agreement, Sangamo is responsible for completing a technology transfer related to the STAC-BBB capsid. Astellas is responsible for all research, preclinical and clinical development, regulatory interactions, manufacturing, and global commercialization of the resulting gene therapy products. Sangamo will receive a $20 million upfront license fee from Astellas and is eligible to earn up to $1.3 billion in additional licensed target fees and milestone payments across the five potential neurology disease targets, as well as tiered mid-to-high single digit royalties on potential net sales of such products, subject to certain specified reductions.

On December 19, 2024 Artios Pharma Limited ("Artios"), a clinical-stage biotech company led by pioneers of DNA damage response ("DDR") drug development, reported that it will present at the 43rd Annual J.P. Morgan Healthcare Conference taking place in San Francisco from January 13 to 16, 2025 (Press release, Artios Pharma, DEC 19, 2024, View Source [SID1234649210]).

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Artios Pharma to Present at the 43rd Annual J.P. Morgan

Niall Martin, PhD, Artios’ Chief Executive Officer, will present the company’s strategic vision for 2025 and beyond on January 16 at 08:00 am PST (11:00 am EST / 04:00 pm UTC) in the Elizabethan C room at The Westin St. Francis, 335 Powell Street, San Francisco.

On December 19, 2024 AFYX Therapeutics A/S, a pioneering Danish biopharmaceutical company specializing in reversed innovation and the repurposing of established pharmaceutical substances, reported it has successfully raised DKK 25 million in its latest funding round (Press release, AFYX Therapeutics, DEC 19, 2024, View Source [SID1234649209]). This milestone will support the company’s efforts to advance its product pipeline, scale operations, and expand its footprint across the European Union and other global markets.

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The funding round was led by existing investors and employees and highlights the robust internal and external trust in AFYX’s mission and strategic direction. The new funds will accelerate the development of the company’s leading products, including its clobetasol patch for oral lichen planus and esketamine therapy for cluster headaches. Additionally, the capital will fuel AFYX’s commercial expansion into new markets, organizational growth, and broader international partnerships.

"We are thrilled to have secured this significant investment, which will enable us to advance our mission of developing transformative biopharmaceutical solutions," said Dr. Claus Møller San Pedro, CEO and co-founder of AFYX Therapeutics. "The continued trust from our investors reflects their confidence in our team and vision. With their ongoing support, we’re well-positioned to address critical unmet medical needs and deliver groundbreaking therapies that improve patient outcomes."

Since its formation in January 2024, through the merger of three highly experienced pharmaceutical innovators, AFYX Therapeutics has made remarkable progress. Over its first year, the company has accelerated its research and development activities, expanded its commercial reach, and secured new international distribution partnerships, paving the way for sustained growth and innovation.

On December 19, 2024 Vivesto AB, an oncology-focused development company, reported that positive results were obtained from preclinical studies with combination treatments within the company’s Cantrixil program, supporting continued development in hematological cancer (Press release, Vivesto, DEC 19, 2024, View Source [SID1234649208]). Vivesto also announced that a new patent application covering the treatment of hematological cancer with Cantrixil was filed, with the aim to strengthen the IP position.

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The drug candidate Cantrixil has been evaluated in further combination treatments with other anti-cancer drugs generating new in vitro data in hematological cancer cell lines. The results demonstrate clear positive effects of Cantrixil in combination with other anti-cancer drugs. The positive results confirm previous preclinical efficacy results and support continued development in hematological cancer. New results from hematological cancer models are expected to be presented throughout 2025.

"Hematological cancer is one of Vivesto’s priority focus areas, and we are pleased to report successful results from yet another preclinical study supporting the further development of the Cantrixil program. We believe that Cantrixil can play a key role in the treatment of hematological cancer and look forward to reporting new data from additional ongoing studies early next year that will be of great importance as the program is developed towards clinical phase," said Erik Kinnman, CEO of Vivesto. "Vivesto also filed a new patent application for the treatment of hematological cancer with Cantrixil as a robust patent portfolio is fundamental for value creation in clinical development, and eventually, commercialization of the product."

Cantrixil has previously shown strong cytotoxic effects at low doses in cell lines derived from patients with hematological cancer. The recently generated data provides important input to the dosing selection and treatment regime in upcoming preclinical and clinical studies.

On December 18, 2024 TigaTx, Inc., a biotechnology company developing a therapeutic platform technology of engineered Immunoglobulin A (IgA) monoclonal antibodies to address a broad range of diseases, reported that the Advanced Research Projects Agency for Health (ARPA-H) has awarded TigaTx up to $33.5 million in funding (Press release, TigaTx, DEC 18, 2024, View Source [SID1234654374]). 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.

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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 Medicine

Jedd 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 Center

Daniel 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 Institute

Esen 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.