Start-Ups & SMEs
The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.
On the back of a stellar showing in Phase III, apitegromab is going to be filed in the US and Europe in the coming weeks for spinal muscular atrophy and CEO Jay Backstrom believes it will be a $2bn blockbuster.
Acquired in August 2021 by Bayer, the San Diego-based biotech has used its autonomous operating model to make a purchase of its own, taking control of its functional genomics partner Tavros.
The Swiss-headquartered, NASDAQ-listed group has posted a Phase II win for OCS-05 in acute optic neuritis, which opens up its potential in additional, and much larger, neuro-ophthalmic indications, CEO Riad Sherif tells Scrip.
Following promising Phase II data presented at ASH on the company's allogenic leukemia-derived dendritic cell vaccine, Mendus has secured support from the FDA and the EMA for pivotal studies starting later this year.
Neumora, one of two firms testing kappa opioid receptor antagonism in depression, failed its first of three Phase III studies. The company’s share price crashed sharply.
The new year is only a couple of days old but the Anglo-Irish biotech has agreed a sale to Hookipa that will create a US-listed entity around HB-700, which targets multiple KRAS mutations in lung, colorectal and pancreatic cancers, and Poolbeg's Phase II-ready drug which is designed to prevent cancer immunotherapy-induced cytokine release syndrome.
Certa and OccuRx both came out of Fibrotech and are now joining forces to advance asengeprast as a potential therapy for scleroderma and focal segmental glomerulosclerosis.
Deal Snapshot: December is just over a week old but the UK giant has packed a lot in, signing collaborations with likes of Duality Biologics (cancer) and Muna Therapeutics (neurodegeneration). Now it is targeting fibrotic diseases and osteoarthritis after inking a deal with Relation Therapeutics.
The Dutch group has assembled an impressive syndicate which is betting that the first-in-class monoclonal antibody CIT-013 could be a transformative treatment for rheumatoid arthritis and hidradenitis suppurativa.
Verona Pharma is rising high with the newly-launched chronic obstructive pulmonary disease drug Ohtuvayre but its development would have been severely compromised if it had not been for government benefits, non-executive chair David Ebsworth tells Scrip.
The company’s CD40 agonist mitazalimab has impressed in Phase II trials as a potential treatment for pancreatic cancer but with no partner in place yet and a lack of funds, Alligator has to cut 70% of its staff to keep going.
Emerging Company Profile: Resalis will soon start human trials of an oligonucleotide targeting a microRNA that is overexpressed in obese mice, but much remains to be proven in humans.
While most drug development in the multiple sclerosis space has focused just on relapse prevention, Immunic’s dual-acting therapy vidofludimus calcium also offers a novel approach for neurodegeneration, its CEO Daniel Vitt tells Scrip.
The Norwegian biotech is losing a big pharma partner and up to half of its staff, but remains confident about the prospects for its personalized cancer vaccine programs.
Among the major topics at the conference this week will be the impact on global biopharma of the upcoming Trump administration, frenetic activity in the obesity field, and hopes of increased funding for UK biotech companies.
Medixci’s Nick Williams told attendees at BIO-Europe that it was a shame that promising biotechs head to the NASDAQ as soon as possible. He and called for a change in culture from investors and for them to back the continent’s start-ups with proper funding.
Emerging Company Profile: Volastra is testing two KIF18A inhibitors in early clinical trials in ovarian cancer, backed by investors like Polaris Partners and ARCH Ventures.
It is chasing Summit and other companies in the PD1/VEGF field, but Ottimo’s CEO David Epstein believes it has a unique drug design – plus a clear plan for a big pharma buyout
The deal, potentially worth more than $1.3bn, includes Modifi’s MGMT-targeting technology, which it hopes can provide a biomarker-based approach for glioblastoma multiforme.