A roundup of bio/pharmaceutical partnering news from Gilead Sciences/MacroGenics, Pfizer/Anokion, CSL Seqirus/US government, and Amgen/Evotec/Toronto Innovation Acceleration Partners.

* Gilead, MacroGenics In $1.7-Bn Deal for Bispecific Antibodies
* Pfizer Takes $35-M Equity Stake in Bio/Pharma Company Anokion
* CSL Seqirus, US Gov’t in $30-M Pact for Influenza Vaccine Mfg
* Amgen Joins Canadian Drug-Development Consortium

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Gilead, MacroGenics In $1.7-Bn Deal for Bispecific Antibodies
Gilead Sciences and MacroGenics, a Rockville, Maryland-based bio/pharmaceutical company, developing monoclonal antibody-based therapeutics for treating cancer. have entered an exclusive option and collaboration agreement for developing select biospecific antibodies in a $1.7-billion deal ($60 million upfront and $1.7 billion in target nomination, option fees, and milestone payments).

The deal involves MacroGenics’ MGD024, a bispecific antibody in Phase I development for treating certain blood cancers, including acute myeloid leukemia and myelodysplastic syndromes. Under the deal, Gilead is granted an exclusive option to license the drug. The deal also involves two additional bispecific antibody research programs.

Under the agreement, Gilead will pay MacroGenics an upfront payment of $60 million and MacroGenics will be eligible to receive up to $1.7 billion in target nomination, option fees, and development, regulatory and commercial milestones. MacroGenics will also be eligible to receive tiered, double-digit royalties on worldwide net sales of MGD024 and a flat royalty on worldwide net sales of products under the other two research programs. MacroGenics will be responsible for the ongoing Phase I study for MGD024 during which Gilead may elect to exercise its option to license the program at predefined decision points.

Source: Gilead Sciences

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Pfizer Takes $35-M Equity Stake in Bio/Pharma Company Anokion
Pfizer has made a $35-million equity investment in Anokion, a Cambridge, Massachusetts-based clinical-stage bio/pharmaceutical company focused on treating autoimmune diseases.

Pfizer made the investment as part of its Breakthrough Growth Initiative, a $500-million investment fund established by Pfizer in 2020 focused on making non-controlling equity investments in clinical-stage public companies, with a primary focus on companies with small- to medium-sized market capitalizations across a range of therapeutic categories in line with Pfizer’s core therapeutic areas: internal medicine, inflammation & immunology, oncology, rare disease, vaccines and hospital.

The funding will used in part to support continued clinical development of KAN-101, Anokion’s lead candidate for treating celiac disease. KAN-101 has been granted fast-track designation by the US Food and Drug Administration for this indication.

Source: Anokion

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CSL Seqirus, US Gov’t in $30-M Pact for Influenza Vaccine
CSL Seqirus, a influenza vaccine company and subsidiary of CSL Limited, a Melbourne, Australia-based bio/pharmaceutical company, has been awarded a $30.1-million contract by the US government to manufacture and clinically assess a cell-based, adjuvanted influenza vaccine candidate.

Under the agreement, CSL Seqirus will deliver an H5N8 A/Astrakhan influenza virus vaccine candidate and will then sponsor a subsequent Phase II clinical trial to evaluate the candidate with CSL Seqirus’ proprietary adjuvant,MF59. MF59 has been successfully combined with other influenza strains to boost immune response and improve manufacturing output. The Phase II trial is anticipated to begin in the second quarter of 2023.

The agreement is with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services.

The Phase II trial will assess the safety and immunogenicity of this vaccine. Additionally, the study will examine homologous and heterologous boosting after six months, as well as the use of heterologous priming pairs (H5N8 A/Astrakhan and H5N6 A/Guangdong).

CSL Seqirus will manufacture the vaccine at the company’s Holly Springs, North Carolina, facility, which was built in partnership with BARDA, to manufacture the required bulk vaccine. The H5N8 vaccine will then be filled into pre-filled syringes to support the Phase II clinical study.

Source: CSL Seqirus

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Amgen Joins Canadian Drug-Development Consortium
Evotec, a Hamburg, Germany-based drug-discovery and development company, and Toronto Innovation Acceleration Partners (TIAP), a not-for-profit organization formed by Toronto’s universities and research institutes, have expanded LAB150, their partnership to expand academic research into market-ready products, to include Amgen as a strategic partner. The expansion goes along with a combined investment of $14 million to expedite LAB150 programs toward the formation of new companies.

The expanded agreement builds upon existing partnerships between Evotec, TIAP, and Amgen to support the development of therapeutics by TIAP’s member base and draws upon Evotec’s drug-discovery platforms. Amgen will provide financial support for chosen LAB150 projects, along with mentorship from their drug discovery and development teams. In addition, Amgen Ventures will evaluate LAB150-derived companies for venture investment.

Source: Evotec