berahyaluronidase alfa (ALT-B4) / Alteogen, Biogen - LARVOL DELTA

Alteogen Enters into a License Agreement with Biogen for Development and Commercialization of Hybrozyme-Based Subcutaneous Biologics (PRNewswire) - "Under the terms of the agreement, Biogen will obtain exclusive rights to develop and commercialize SC formulations for two biologic products using Alteogen's ALT-B4 (berahyaluronidase alfa)...Alteogen will receive an upfront payment of US$20 million and is eligible to receive an additional US$10 million upon initiation of development of the second product. In addition, Alteogen is eligible to receive up to US$549 million in development, regulatory, and sales milestone payments for the two products combined....Under the agreement, Biogen also holds an option to develop a third product."

Licensing / partnership • Oncology

Study Evaluating Safety & Tolerability of Migaldendranib With/Without Berahyaluronidase Alfa-pmph in Healthy Volunteers (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Ashvattha Therapeutics, Inc.

New P1 trial

Alteogen Announces Exclusive License Agreement with Tesaro, a Subsidiary of GSK, for the Development of a Subcutaneous Formulation of Dostarlimab Enabled by Hybrozyme Technology (The Manila Times) - "Alteogen will receive an upfront payment of US$20 million and is eligible to receive milestone payments up to US$265 million upon achievement of specified development, regulatory and sales milestones. Additionally, Alteogen will be entitled to receive royalties on the sales of the commercialized product. Alteogen will be responsible for clinical and commercial supply of ALT-B4 to Tesaro."

Licensing / partnership • Oncology

Alteogen Expects Multiple Tech Exports by Year-end (Business Korea) - "Alteogen recorded consolidated revenue of 49 billion won, operating profit of 26.7 billion won, and net profit of 22 billion won in the third quarter of this year...'As Keytruda SC launches in earnest simultaneously in the United States and Europe, there appears to be no risk of profit decrease with the operating profit margin falling below 50% as we continue to stably receive royalties in the next quarter and next year.'...Revenue through ALT-B4 is also expected to increase...'ALT-B4’s patent duration extends until 2039 (expected to reach early 2042 when all extension conditions including PTA and PTE are applied)'...""

Commercial • Breast Cancer • Cervical Cancer • Gastric Cancer • Melanoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

AstraZeneca enters license agreement with Alteogen for subcutaneous formulations of multiple oncology assets (AstraZeneca Press Release) - "AstraZeneca and Alteogen Inc. have entered into an exclusive license agreement for ALT-B4, a novel hyaluronidase utilising Hybrozyme platform technology. Under the terms of the agreement, AstraZeneca will acquire worldwide rights to use ALT-B4 to develop and commercialise subcutaneous formulations of several oncology assets. Alteogen will be responsible for clinical and commercial supply of ALT-B4 to AstraZeneca."

Licensing / partnership • Oncology

Alteogen, Subcutaneous Injection ADC Patent Application… “Safe and Better Therapeutic Effect” [Google translation] (News1 Korea) - "Alteogen...announced on the 2nd that it has filed a domestic priority application for a subcutaneous injection (SC) formulation of an antibody drug conjugate (ADC)...Alteogen has been focusing on the possibility of developing a SC formulation ADC by incorporating its platform technology, ‘ALT-B4’, to overcome the limitations of existing ADC treatments....'This patent can strengthen the competitiveness of our own pipeline, 'ALT-P7,' which targets the HER2 receptor.'"

Patent • Breast Cancer • Oncology • Solid Tumor