On July 10, 2025 IGI Therapeutics SA, a wholly owned subsidiary of New York-based Ichnos Glenmark Innovation, Inc. (IGI), and AbbVie (NYSE: ABBV) reported an exclusive licensing agreement for IGI’s lead investigational asset, ISB 2001, developed using IGI’s proprietary BEAT protein platform, for oncology and autoimmune diseases (Press release, Ichnos Sciences, JUL 10, 2025, View Source;utm_medium=rss&utm_campaign=ichnos-glenmark-innovation-igi-and-abbvie-announce-exclusive-global-licensing-agreement-for-isb-2001-a-first-in-class-cd38xbcmaxcd3-trispecific-antibody [SID1234654323]).

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"Multispecifics including trispecific antibodies represent a new frontier in immuno-oncology with the potential to deliver deeper, more durable responses by engaging multiple targets simultaneously," said Roopal Thakkar, M.D., Executive Vice-President, Research and Development and Chief Scientific Officer, AbbVie. "This partnership with IGI reflects our unwavering commitment to advancing novel therapies for patients with multiple myeloma, a disease where significant unmet need remains despite recent progress."

"ISB 2001 exemplifies the potential of our BEAT protein platform to generate effective multispecificsTM that may overcome resistance and improve outcomes in hard-to-treat cancers," said Cyril Konto, M.D., President and CEO of IGI. "This agreement marks a defining milestone in IGI’s scientific journey and reflects our team’s deep commitment to delivering meaningful therapies for patients. Our partnership with AbbVie accelerates ISB 2001’s path to patients and sharpens our focus on advancing the next generation of BEAT-enabled assets in oncology."

Under the terms of the agreement, AbbVie will receive exclusive rights to develop, manufacture, and commercialize ISB 2001 across North America, Europe, Japan, and Greater China. Subject to regulatory clearance, IGI will receive an upfront payment of $700 million and is eligible to receive up to $1.225 billion in development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales.

About ISB 2001
ISB 2001 is a first-in-class trispecific T-cell engager that targets BCMA and CD38 on myeloma cells and CD3 on T cells currently in Phase 1 for relapsed/refractory multiple myeloma. Developed using IGI’s proprietary BEAT protein platform, ISB 2001 was engineered with two distinct binders against myeloma-associated antigens to enhance avidity, even at low target expression levels, while aiming to improve safety over first-generation bispecific antibodies. Recently presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting as a Rapid Oral Presentation (Abstract #7514), data from 35 patients demonstrated a sustained overall response rate (ORR) of 79% and a high complete/stringent complete response (CR/sCR) rate of 30% at active doses ≥ 50 µg/kg in a heavily pretreated population of relapsed/refractory myeloma patients, with a favorable safety profile.

U.S. Food & Drug Administration granted ISB 2001 Orphan Drug Designation in July 2023 and Fast Track Designation for the treatment of relapsed/refractory myeloma patients in May 2025.

About the BEAT Multispecific Platform
IGI’s proprietary BEAT platform goes beyond traditional bispecific antibody approaches, addressing key engineering bottlenecks that have historically limited large-scale bispecific production. By leveraging a proprietary common light chain library and TCR interface-based heavy chain pairing, BEAT enables the development of next-generation immune cell engagers with strong therapeutic potential in oncology. Unlike many engineered formats, BEAT mirrors the architecture of natural antibodies utilizing both light and heavy chains to enhance stability and function. Key attributes of the BEAT platform include its multispecific versatility, enabling the design of antibodies that engage diverse immune cell types such as T cells, myeloid cells, and NK cells against multiple antigens. The platform also features optimized engineering through high-fidelity heavy chain pairing with a common light chain, allowing for precise Fc modulation and access to a broad structural design space. Additionally, BEAT supports robust manufacturability, producing correctly assembled multispecific antibodies with favorable stability, extended half-lives, low immunogenicity and high titer yields through standardized process development and manufacturing operations.

On July 10, 2025 NUCLIDIUM, a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, reported the successful closing of its Series B financing round, raising CHF 79 million (EUR 84 million) (Press release, NUCLIDIUM, JUL 10, 2025, View Source [SID1234654324]). The round was led by Kurma Growth Opportunities Fund, Angelini Ventures, Wellington Partners, and Neva SGR (Intesa Sanpaolo Group), with participation from DeepTech & Climate Fonds (DTCF), Bayern Kapital, Vives Partners, Eurazeo, NRW.BANK and HighLight Capital, as well as existing investors. The proceeds will be used to advance the clinical development of NUCLIDIUM’s Copper-61/Copper-67 (61Cu/67Cu) theranostic pipeline across multiple oncology indications. In parallel, the company will expand its production and manufacturing capabilities through a global production network.

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NUCLIDIUM’s differentiated platform links tumor-targeting molecules with copper isotopes – Copper-61 for diagnostics and Copper-67 for therapeutics – to address current limitations in radiotheranostics, such as suboptimal clinical efficacy and complex manufacturing. Diagnostic results from initial clinical trials in these indications show superior lesion detection and higher tumor-to-background ratios compared with clinically approved tracers. Initial data were recently presented at SNMMI 2025 by Dr. Gary Ulaner, MD, PhD highlighting a favorable safety profile and potentially improved imaging performance of 61Cu-NuriPro compared to current PET imaging standards, suggesting strong clinical promise and broader potential for 61Cu/67Cu theranostic pairing. Early therapeutic data from the two lead compounds, NuriPro and TraceNET, show strong tumor-to-background ratios in metastatic prostate cancer and neuroendocrine tumors including breast cancer.

"NUCLIDIUM is entering the next clinical phases with its lead compounds to diagnose and treat metastatic prostate, neuroendocrine tumors and breast cancer," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM. "Our copper-based radiotheranostics are developed for seamless use in hospital workflows, care delivery and waste management, making these therapies more accessible worldwide. Our groundbreaking next generation copper theranostic platform also allows us to rapidly develop new targets across a wider range of cancers, particularly those highly relevant to women’s health."

With this financing, NUCLIDIUM will continue expanding its worldwide production and manufacturing network for diagnostics and therapeutics, growing its international team, and strengthening strategic collaborations with hospitals and academic centers, initially across Europe and North America.

In conjunction with the financing round, Daniel Parera, MD, Partner at Kurma Partners, Regina Hodits, PhD, Managing Director at Angelini Ventures, and Liliana Nordbakk, Partner Life Sciences at Neva SGR, will join NUCLIDIUM’s Board of Directors.

"This significant Series B financing reflects the confidence of our investors in NUCLIDIUM’s vision and the transformative potential for the diagnostic and therapeutic industry in oncology and nuclear medicine," said Tony Rosenberg, Chairman of the NUCLIDIUM Board. "With this backing, we are positioned to accelerate clinical development, broaden patient access globally, and reinforce our commitment to innovation in precision oncology. I am delighted to welcome our new Board and advisory members, whose deep expertise will further strengthen NUCLIDIUM’s leadership in radiopharmaceuticals."

"NUCLIDIUM’s platform stands out in a rapidly evolving field and will change how radiotheranostic care is delivered. This investment reflects our strong conviction in the future of precision medicine and our belief in NUCLIDIUM’s potential to scale as a next-generation company — an ambition shared across a strong European syndicate," added Daniel Parera, MD, Partner at Kurma Partners, Regina Hodits, PhD, Managing Director at Angelini Ventures, and Liliana Nordbakk, Partner Life Sciences at Neva SGR for all participating investors.

The Series B financing transaction was advised by VISCHER AG, and Walder Wyss, Switzerland as legal counsels.

On July 10, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported patient recruitment has been completed in Stage 1 of a clinical trial of the Company’s PDS01ADC therapeutic administered systemically in combination with floxuridine (FUDR) administered by hepatic artery infusion pump (HAIP) for patients with metastatic colorectal cancer (NCT05286814), led by the National Cancer Institute (NCI), a component of the National Institutes of Health (NIH) (Press release, PDS Biotechnology, JUL 10, 2025, View Source [SID1234654325]). The study met the pre-set RECIST v1.1 criteria for expansion into Stage 2 of the study.

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The trial is an open label, single center, non-randomized Phase 2 study with three cohorts: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer. It is led by Dr. Jonathan Hernandez, Chief of the Surgical Oncology Section, Surgical Oncology Program, Center for Cancer Research, at the NCI. A Simon two-stage trial design is being used for each cohort. For the colorectal cancer cohort, if at least 6 of 9 participants experienced an objective response by RECIST v1.1 criteria, the cohort would continue to enroll up to a total of 22 participants. This milestone has been achieved for the colorectal cancer cohort, and enrollment has progressed to Stage 2. The cholangiocarcinoma and adrenocortical cancer cohorts continue to enroll in Stage 1. The study is being performed under the Company’s collaborative research and development agreement with the NCI.

PDS01ADC is a fused antibody drug conjugate composed of two Interleukin-12 (IL-12) heterodimers, each fused to the NHS76 antibody, which binds to both single- and double-stranded DNA (dsDNA), and therefore targets regions of tumor necrosis where DNA has become exposed.

"Colorectal cancer is among the most deadly and difficult to treat cancers. In 2020, it was estimated that more than 930,000 deaths were due to colorectal cancer worldwide according to the World Health Organization, and more effective treatments are desperately needed" said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "This novel investigational approach to the targeting and use of IL-12 results in little, or no systemic exposure to IL-12, and may allow patients to reap the benefits of cytokine therapy without the typical treatment-limiting toxicities. We are delighted that the NCI has achieved this milestone and anticipate completion of patient recruitment for the metastatic colorectal cancer cohort of the study by the fourth quarter of 2025."

Each year, more than 150,000 new cases of colorectal cancer are diagnosed in the U.S. Approximately 20% of these cases are already metastatic at the time of diagnosis, and an additional 25% of patients with initially localized disease will eventually progress to metastatic disease (Biller LH, 2021;325;(7):669-685). According to the American Cancer Society, colorectal cancer is the second leading cause of cancer-related deaths in the U.S.

On July 10, 2025 Epitopea, a transatlantic cancer immunotherapeutics company developing accessible, off-the-shelf RNA-based immunotherapies, reported the formation of its dedicated clinical team and the expansion of its research team. These developments represent a significant milestone in the company’s ongoing progress in advancing its RNA-based immunotherapies, known as CryptiVaxTM, into clinical trials.

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Siri Brinchmann-Hansen Torhaug, Head of Oncology Development, and Gertrud Koefoed Rasmussen, Head of Development Operations, will both join Epitopea’s Executive leadership team. They report into Dr. Klaus Edvardsen, who has served as Epitopea’s Chief Medical Officer (CMO) since February 2025, and oversees the strategic direction of clinical trials and regulatory affairs.

Epitopea’s research team in Cambridge has been extended to include translational immunology capabilities with the appointment of Dr. Theres Oakes as Director of Translational Sciences and Dr. Lisa Smith as Director of Research (UK). Both report into Dr. Jon Moore, Co-founder and Chief Scientific Officer (CSO) of Epitopea, and will work in close collaboration with the clinical team to ensure the seamless integration of research and clinical strategies.

Siri Brinchmann-Hansen Torhaug is a highly accomplished, board-certified, oncology specialist with extensive experience in clinical strategy and development. Siri has worked in various senior leadership roles, including as Chief Medical Officer at Nykode Therapeutics, where she was instrumental in developing clinical strategies for oncology and autoimmune disease therapies. She brings a wealth of experience from working across both early-phase translational research and late-stage clinical trials. At Epitopea, Siri will focus on clinical strategy and development, ensuring that the company’s pipeline moves forward with precision and efficacy.

"It’s a pleasure to join Epitopea’s Executive and clinical leadership team," said Siri Brinchmann-Hansen Torhaug, Head of Oncology Development. "With my background in oncology clinical trials, I am excited to contribute to the company’s innovative work in cancer immunotherapy. I look forward to working alongside Klaus and Gertrud to advance Epitopea’s promising pipeline, with the aim of improving patient outcomes in oncology."

Gertrud Koefoed Rasmussen brings over 20 years of experience in clinical operations across multiple therapeutic areas, including oncology and rare diseases. Most recently, Gertrud held the position of VP and Head of Development Operations at Nykode Therapeutics, where she built and expanded the clinical operations department and led clinical trials across all phases of development. She has extensive experience in vendor management, regulatory compliance, and process optimization. At Epitopea, Gertrud will lead clinical trial management and regulatory compliance, ensuring that trials are conducted efficiently and in accordance with regulatory guidelines.

"Joining Epitopea is an exciting opportunity to leverage my expertise in clinical operations and contribute to the development of innovative therapies," said Gertrud Koefoed Rasmussen, Head of Development Operations. "I look forward to collaborating with the team to manage and execute clinical trials that will bring groundbreaking cancer immunotherapies to patients with significant unmet medical needs."

Dr. Klaus Edvardsen, CMO of Epitopea, commented, "It is an honor to lead the formation of this clinical team, and I am thrilled to work with Gertrud and Siri, who both bring invaluable experience and expertise to Epitopea. Their leadership will be crucial as we move forward with our clinical trials and work to bring our transformative cancer immunotherapies to the clinic."

As part of the research team appointments, Dr. Theres Oakes brings extensive expertise in antigen-directed immuno-oncology through her academic training and prior role at Achilles Therapeutics. Dr. Lisa Smith brings considerable experience in drug discovery and oncology from her previous roles at Kudos Therapeutics, Mission Therapeutics and Benevolent AI.

Dr. Jon Moore, CSO and Co-Founder of Epitopea commented, "We are harnessing the talents of our existing research team and recent joiners to build world-class cancer immunotherapeutics. To this end, we welcome Lisa to accelerate these efforts. Furthermore, with the translational sciences team we are building around Theres, we will have the capability to assess the performance of our immunotherapeutics in patients with unrivalled precision. It has been a real privilege to be able to build such a strong biology group, and I am very excited to see what impact we can make on the treatment of these devastating diseases."

(Press release, Epitopea, JUL 10, 2025, View Source [SID1234661167])

On July 10, 2025 Purple Biotech presented its corporate presentation (Presentation, Purple Biotech, JUL 10, 2025, View Source [SID1234654326]).

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