Zealand Pharma and Novo Nordisk linked resources to commercialize Zegalogue for severe hypoglycemia. For that and more from a busy week across the globe, see inside.
Zealand Pharma and Novo Nordisk linked resources to commercialize Zegalogue for severe hypoglycemia, Osivax presented data from its lead vaccine programs and Clover Biopharmaceuticals announced positive data for its universal COVID-19 booster.
Zealand Pharma Partners with Novo Nordisk to Commercialize Zegalogue
Denmark’s Zealand Pharma forged a global licensing and development agreement with Novo Nordisk to commercialize Zegalogue (dasiglucagon) for injection. The FDA has approved Zegalogue for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged six and above.
Under the agreement, Zealand will be responsible for certain planned development, regulatory and manufacturing activities to support approval outside the United States.
Under terms of the partnership, Zealand will receive an upfront payment of DKK 25 million (about $3.35 million). It is eligible to receive up to an additional DKK 220 million (about $30 million) based on the achievement of certain milestones plus sales-based milestones and tiered royalties ranging from high single-digit to low double-digit percentages.
Adam Steensberg, CEO of Zealand, said the agreement is an important step in the company’s strategy to build commercial partnerships that will bring meaningful treatments to patients across the globe.
“Although modern diabetes therapy has significantly reduced the occurrence of very low blood sugar levels, or hypoglycemia, for people with diabetes it remains feared and potentially serious,” Camilla Sylvest, executive vice president at Novo Nordisk, said in a statement.
Elsewhere around the globe:
Osivax – In France, Osivax presented data for its lead programs. OVX836, a broad-spectrum influenza vaccine and OVX033, a broad-spectrum coronavirus vaccine, at the Universal Influenza Vaccines (UIV) 2022 event in the U.K. Presentations included data from a Phase IIa dose optimization study that showed OVX836 was well-tolerated at all dosing levels. The vaccine provided protective efficacy in reducing PCR-confirmed influenza-like illnesses by 78%.
AC Immune SA – The Michael J. Fox Foundation for Parkinson’s Research awarded the Swiss company a new grant to continue the development of its Morphomer-based alpha-synuclein (a-syn) positron emission tomography (PET) tracer, ACI-12589. If successful, AC Immune’s a-syn PET tracer program could deliver the world’s first imaging agent capable of accurately detecting and monitoring the progression of Parkinson’s disease. AC Immune has been supported by the foundation for the past seven years.
Abivax – Also based in France, Abivax secured €49.2 million (about $49.2 million) in financing. The news funds will primarily be used to complete the Phase III study of obefazimod for the treatment of ulcerative colitis. The first patient is expected to be enrolled sometime this month. TCGX led the financing. Other participating firms include Venrock Healthcare Capital Partners, Deep Track Capital, Sofinnova Partners, Invus and Truffle Capital.
Chiesi Global Rare Diseases – The German business unit of Chiesi Farmaceutici S.p.A. presented data from multiple programs focused on lysosomal storage diseases at the Society for the Study of Inborn Errors of Metabolism Annual Symposium. The presentations included five abstracts with data from a clinical development program evaluating pegunigalsidase alfa (PRX-102), an investigational enzyme replacement therapy (ERT) for the treatment of Fabry disease. The company is also presenting two abstracts dedicated to Alpha Mannosidosis, including updates from Europe’s first patient registry for this ultra-rare disease.
IRLAB Therapeutics – Sweden’s IRLAB announced that partner Ipsen initiated clinical studies with mesdopetam. Ipsen plans to begin three clinical pharmacology studies in healthy volunteers, including a pharmacokinetic, a drug-to-drug interaction and a mass balance study. These three studies are expected to be completed between the third quarter of 2022 and the first quarter of 2023. The studies are standard clinical pharmacokinetic programs running parallel to the Phase IIb mesdopetam study currently being conducted by IRLAB. Top-line results are anticipated around the end of the year.
Clover Biopharmaceuticals – Based in China, Clover announced positive data from its Phase III COVID-19 vaccine study assessing SCB-2019 as a universal booster. SCB-2019 was administered as a heterologous third dose to participants who had already received two doses of an inactivated vaccine. Preliminary data showed the candidate elicited “superior levels of neutralizing antibodies” against the original strain of SARS-CoV-2 and Omicron subvariants BA.1 and BA.2 when compared to a third dose of inactivated vaccine.
Affimed NV – Germany’s Affimed shared a poster presentation including Phase I data from patients with locally advanced or metastatic treatment-refractory EGFR-positive solid tumors treated with AFM24 monotherapy. The results represent a significant milestone for the company’s development program, Affimed stated. AFM24 was administered in doses up to 720 mg intravenously once weekly until disease progression, intolerable toxicity, patient withdrawal, or termination at the investigator’s discretion. Tumor types included mainly colorectal and non-small cell lung cancer, the company noted in its announcement. The results will be presented at ESMO.
Evaxion AS – Denmark-based Evaxion, in collaboration with UMass Chan Medical School, received a grant from the NIH for the development of a gonorrhea lead vaccine candidate. Evaxion’s AI platform, EDEN, was used to identify novel, highly efficacious B-cell antigens to be included in the vaccine. In preclinical studies, the vaccine candidate demonstrated protection against infection.
Lonza – Switzerland’s Lonza and U.K.-based Touchlight forged a collaboration to build on advances in genetic medicine. Through the partnership, Lonza will have the ability to integrate an additional, differentiated source of DNA for its customers developing mRNA therapeutics and vaccines, the company noted. Touchlight will be able to widen channels through which customers can gain access to its novel doggybone DNA (dbDNA) technology, it stated.
SynAffix BV – Based in The Netherlands, Synaffix BV and Emergence Therapeutics announced a licensing agreement valued at up to $360 million. Under terms of the deal, Emergence gains access to Synafix’s proprietary antibody-drug conjugate (ADC) technologies comprising GlycoConnect, HydraSpace and SYNtecan E linker-payload. Emergence will be responsible for the research, development, manufacturing and commercialization of the ADCs. Synaffix will be accountable for manufacturing components that are specifically related to its proprietary technologies.
