Core Insights - IGI Therapeutics SA and AbbVie Inc. have entered into an exclusive licensing agreement for IGI's investigational asset ISB 2001, aimed at oncology and autoimmune diseases [1][2] - AbbVie will have exclusive rights to develop, manufacture, and commercialize ISB 2001 in North America, Europe, Japan, and Greater China [2] Financial Terms - IGI will receive an upfront payment of $700 million and is eligible for up to $1.225 billion in milestone payments, along with tiered, double-digit royalties on net sales [3] - The total potential financial benefit for IGI from this agreement could reach $1.925 billion [3] Product Details - ISB 2001 is a first-in-class trispecific T-cell engager targeting BCMA and CD38 on myeloma cells and CD3 on T cells, currently in Phase 1 for relapsed/refractory multiple myeloma [3] - Recent data from a study presented at the 2025 ASCO Annual Meeting showed a sustained overall response rate (ORR) of 79% and a complete/stringent complete response (CR/sCR) rate of 30% in heavily pretreated relapsed/refractory myeloma patients [4] Regulatory Status - The U.S. FDA granted ISB 2001 Orphan Drug Designation in July 2023 and Fast Track Designation for relapsed/refractory myeloma patients in May 2025 [5] Market Context - Other companies in the industry are also pursuing significant partnerships, such as AstraZeneca's reported talks with Summit Therapeutics for a $15 billion deal and BioNTech's agreement with Bristol Myers Squibb involving $1.5 billion upfront [5][6] - AbbVie’s stock price increased by 2.63% to $195.63 following the announcement [7]

Core Viewpoint - IGI Therapeutics and AbbVie have entered into an exclusive licensing agreement for ISB 2001, a novel trispecific T-cell engager targeting multiple myeloma, which is currently in Phase 1 clinical trials [1][2]. Company Overview - IGI Therapeutics is a clinical-stage biotechnology company focused on developing innovative biologics in oncology, utilizing its proprietary BEAT® technology platform to create first-in-class multispecific therapies [7]. - AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines across various therapeutic areas, including oncology [8]. Product Details - ISB 2001 is designed to target BCMA and CD38 on myeloma cells and CD3 on T cells, aiming to improve safety and efficacy compared to first-generation bispecific antibodies [3]. - The drug has shown a sustained overall response rate (ORR) of 79% and a complete/stringent complete response (CR/sCR) rate of 30% in a heavily pretreated patient population [3]. Licensing Agreement - Under the agreement, AbbVie will have exclusive rights to develop, manufacture, and commercialize ISB 2001 in North America, Europe, Japan, and Greater China [2]. - IGI will receive an upfront payment of $700 million and could earn up to $1.225 billion in milestone payments, along with tiered, double-digit royalties on net sales [2]. Regulatory Designations - ISB 2001 received Orphan Drug Designation from the U.S. FDA in July 2023 and Fast Track Designation for treating relapsed/refractory myeloma patients in May 2025 [4]. BEAT® Platform - The BEAT® platform enables the development of next-generation immune cell engagers with enhanced stability and function, addressing limitations of traditional bispecific antibody production [5]. - Key features include multispecific versatility, optimized engineering for precise modulation, and robust manufacturability [5].

Key Takeaways Opdivo led BMY's Q1 sales at $2.26B, driven by strong demand across multiple cancer indications. EC and FDA approvals expand Opdivo's use in NSCLC, HCC, and colorectal cancer treatment regimens. BMY trades at 7.37x forward earnings amid generic threats and lagging shares, down 13.9% year to date.Bristol Myers’ (BMY) growth portfolio primarily comprises Opdivo, Orencia, Yervoy, Reblozyl, Opdualag, Abecma, Zeposia, Breyanzi, Camzyos, Sotyku, Krazati and others.Among these, immuno-oncology drug ...

COMBINING TO CURE ® Forward-Looking Statements/Safe Harbor Arcus is at the forefront of designing combination therapies, with best-in-class potential, in the relentless pursuit of cures for cancer. Forward Looking Statements Safe Harbor: This presentation contains forward-looking statements about Arcus Biosciences, Inc. ("we," "Arcus" or the "Company") made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements regarding events or results to occur in t ...

Plinabulin's Mechanism and Preclinical Evidence - Plinabulin is a unique tubulin binder with a distinct binding site compared to other tubulin-binding agents[16, 21] - Preclinical studies show that Plinabulin, combined with radiation and anti-PD-1, activates dendritic cells (DCs), stimulates T-cell proliferation, and achieves abscopal effects[17, 24] - Plinabulin induces DC maturation, especially when administered after irradiation (IR), and Plinabulin-treated DCs stimulate T cell proliferation, enhanced by combining with IR[25] Clinical Efficacy and Immune Activation - In a Phase 1 study, the Plinabulin triple combination (with radiation and PD-1/PD-L1 inhibitors) led to an 80% disease control rate (DCR) in 10 IO-refractory patients[18, 32] - Durable responses were observed in 2 Hodgkin lymphoma patients who progressed after 12 or 16 prior lines of therapy[33] - Responding patients exhibited early immune activation with DC maturation and proinflammatory monocytes in the peripheral blood across six different cancer types[19, 35] Summary and Future Directions - Plinabulin demonstrates induction of DC maturation and re-sensitization to anti-PD(L)1 in IO-refractory tumors[37] - The impressive overall results, showing a high 80% disease control rate in ICI-refractory and heavily pre-treated patients, warrant further clinical studies of Plinabulin/IO combinations in IO-refractory settings[37, 38]

Key Takeaways MRK is focused on Winrevair's growth as Keytruda, its top revenue driver, faces patent expiration in 2028. Winrevair showed significant efficacy in PAH phase III trials, leading to early study stoppages. The FDA granted priority review to MRK's sBLA to update Winrevair's label, with a decision due on Oct. 25.Merck’s (MRK) blockbuster PD-L1 inhibitor, Keytruda, approved for several types of cancer indications, is the company's biggest revenue driver. The drug alone accounts for around 50% of ...

Data show confirmed ORR of 83% (10/12) at doses selected for ongoing expansion study Median follow-up of 9.0 months as of the updated data cutoff Responses observed in patients with low PD-L1 and/or CLDN18.2 expression Company to host investor event on Tuesday, July 8th ROCKVILLE, Md., July 02, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced the pres ...

Genitourinary Tumor Study Ongoing with Active Screening and EnrollmentMILAN and NEW YORK, July 01, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology, today announced that a total of 38 patients were enrolled in newly diagnosed glioblastoma multiforme (TEM-GBM) study, with 25 patients receiving Temferon. Two patients have been enrolled in the TEM-LT long-term follow-up study, surviving three years from the time of 1st surgery. One of these long-term survivors has not exper ...

Monotherapy efficacy and safety profile provided backbone for clinical development strategy in 1L combination with nivolumab plus chemotherapy ROCKVILLE, MD, June 30, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced publication of the first-in-human monotherapy data for givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, in Clinical Cancer Research ...

71% objective response rate (ORR) (12/17) per RECIST v1.1, with a favorable safety profile 83% ORR (10/12) in patients across doses selected for ongoing dose expansion study Responses observed in patients with low PD-L1 and/or CLDN18.2 expression Updated results to be presented at ESMO GI on July 2nd Company to host investor event on July 8th ROCKVILLE, Md., June 26, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on the development of precision i ...