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Genmab could soon join the growing list of companies targeting the antibody drug conjugate (ADC) market, with the announcement that it has agreed to acquire ProfoundBio for $1.8bn.

The deal is expected to close in the first half of this year. As per the acquisition agreement, Danish drugmaker Genmab will gain access to ProfoundBio’s ADC technology platform along with three clinical assets.

Genmab placed a particular spotlight on Rina-S (rinatabart sesutecan) – ProfoundBio’s ADC currently in a Phase I/II trial (NCT05721222) for the treatment of ovarian cancer. Rina-S, a topoisomerase1-based conjugate, targets folate receptor-alpha – a protein that is overexpressed in ovarian cancer.

This deal could put Genmab in direct competition with AbbVie, whose folate receptor-alpha antibody Elahere (mirvetuximab soravtansine-gynx) – gained in a $10.1bn acquisition of ImmunoGen – won an accelerated approval for treating ovarian cancer in a certain setting back in 2022. The drug gained full approval in January this year.

Novo Nordisk has agreed to acquire Germany-based Cardior Pharmaceuticals for up to €1bn ($1.1bn) to expand its cardiovascular pipeline. The deal is expected to close in Q2 2024.

Cardior’s lead candidate is a Phase II heart failure candidate, CDR132L. The therapy is an antisense oligonucleotide, which selectively blocks abnormal levels of the microRNA molecule, miR-132. miR-132 plays a part in cardiac processes, as it is overexpressed in patients with heart failure.

CDR132L is being evaluated in a placebo-controlled Phase II trial (NCT05350969) in 280 patients with left-sided heart failure following myocardial infarction. Novo plans to expand CDR132L’s indication and investigate the therapy in a Phase II trial in chronic heart failure patients with cardiac hypertrophy.

The company has invested in expanding its cardiovascular portfolio through multiple deals in recent months. In February, Novo signed a $1.46bn deal with US-based biotech Neomorph to discover and develop multiple ‘molecular glue’ protein degraders for cardiometabolic disorders and rare diseases.

Moderna has announced the halt of its project to build a messenger ribonucleic acid (mRNA) manufacturing facility in Kenya, citing a significant decrease in the Covid-19 vaccine demand across the region.

In March 2023, the company finalised an agreement with the government of the Republic of Kenya to establish a manufacturing unit that can produce 500 million vaccine doses annually. The latest decision aligns with the company’s ongoing assessment of future vaccine requirements in the region. The planned facility’s viability is currently under threat as Africa’s need for Covid-19 vaccines has diminished since the height of the pandemic.

Moderna has not secured any vaccine orders for African nations since 2022. The cancellation of existing orders has led to losses and write-downs exceeding $1bn for the company. Despite these financial setbacks, Moderna is equipped to guarantee equitable access to its Covid-19 vaccine, intending to fulfil the emerging needs of African countries through its extensive global production network.

Sanofi has moved its natural killer (NK) cell engager candidate SAR443579/IPH6101 to a Phase II trial evaluating the drug’s use in treating a range of blood cancers.

The drugmaker dosed the first patient in the Phase II part of the Phase I/II trial (NCT05086315), according to a 15 April 2024, press release by research partner Innate Pharma.

The trial will investigate the therapy’s safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity in various haematological malignancies. The non-randomised trial is estimated to enrol 126 patients with diseases including relapsed or refractory acute myeloid leukaemia, B-cell acute lymphoblastic leukaemia and high risk-myelodysplasia, amongst others.

Innate and Sanofi initially entered a research collaboration and license agreement in 2016. Sanofi licensed two NK cell engager programmes, including SAR443579/IPH6101, from Innate in a €400m ($437.5m) milestone payment structured deal.

The US Food and Drug Administration (FDA) has rejected Regeneron Pharmaceutical’s approval application for odronextamab in two forms of lymphoma, amid concerns about the enrolment status of the ongoing confirmatory trials.

The FDA has been clamping down on requirements for accelerated approvals in oncology. An advisory committee met late last year to discuss ensuring clinical benefit via delayed confirmatory trials whilst maintaining timely access to promising treatments. According to a 25 March press release, the FDA issued complete response letters (CRLs) highlighting the need for more data from the confirmatory trials. However, Regeneron specified that the CRLs did not identify any approvability issues about odronextamab’s efficacy, safety, trial design, labelling, or manufacturing.

The New York-based biotech was pursuing accelerated approval for odronextamab to treat patients with relapsed/refractory (r/r) follicular lymphoma and in r/rdiffuse large B-cell lymphoma who have not responded to two or more lines of systemic therapy.