An eventful four-day week!

After a rainy bank holiday weekend, the four-day week was jam-packed with action for the Optimum team, as our client Calliditas recommended shareholders accept a $1 billion+ takeover offer. 

Calliditas receives public offer by Asahi Kasei Corporation 

Asahi Kasei Corporation announced on Tuesday a public cash offer to acquire all shares and American Depositary Receipts in Calliditas Therapeutics AB. The total value of the Offer corresponds to SEK 11,164 million (just over $1 billion). 

The Board of Directors of Calliditas unanimously recommended that the shareholders and holders of American Depositary Shares accept the public tender offer. 

Calliditas’ Kinpeygo gets regulatory green light in Europe  

Calliditas on Thursday announced  that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of full marketing authorisation for Kinpeygo (budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). 

Kinpeygo, which was granted conditional marketing authorisation in the EU on 15 July 2022, was the first ever approved treatment for IgAN in the EU and UK. The full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study population. Kinpeygo is marketed in in the EU and UK exclusively by Calliditas’ commercial partner, STADA Arzneimittel AG. The CHMP’s opinion will be passed to the European Commission for a final decision that is anticipated in August 2024. 

Resolution Therapeutics to Participate in the Jefferies Global Healthcare Conference and  Upcoming Scientific Presentations at EASL Congress 2024 

Don’t miss your chance to meet Amir Hefni, CEO of Resolution Therapeutics Limited, who will participate in meetings with investors at the Jefferies Global Healthcare Conference in New York on Tuesday on June 4, 2024. 

Resolution is a clinical-stage biopharmaceutical company pioneering engineered autologous macrophage cell therapies to transform the treatment of inflammatory organ diseases. Investors are encouraged to contact their Jefferies representative to schedule a meeting. 

On Wednesday, Resolution also announced two abstracts have been accepted as poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, which is being held in Milan, Italy between June 5-8, 2024. 

The first is a late-breaking abstract showcasing extended follow-up data from the MATCH Phase 2 trial.  The second abstract highlights new data on Resolution’s discovery platform to differentiate, engineer and cryopreserve macrophages for therapeutic use in patients with end-stage liver disease (ESLD). 

Adcendo ApS Announces Extension of Series A Financing to EUR 98M to Further Bolster its First-in-Class ADC Pipeline 

Denmark’s Adcendo ApS, a biotech company focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of cancers with a high unmet medical need, on Wednesday announced the successful completion of a second Series A extension financing, raising a total of 98M EUR to further bolster its first-in-class ADC pipeline. 

This additional 16M EUR financing was led by Dawn Biopharma, a platform controlled by KKR, with participation from existing investors Novo Holdings, Ysios Capital, RA Capital Management, HealthCap, Gilde Healthcare and Pontifax Venture Capital. As part of the investment, Iyona Rajkomar, Managing Partner at Dawn Biopharma, will join the Adcendo Board of Directors. 

Study on Treatment of Wilson Disease in Japan Published in Japanese Journal of Gastroenterology and Hepatology by Vivet Therapeutics 

Vivet Therapeutics, a clinical stage biotech company developing novel and long-lasting gene therapies for rare inherited liver metabolic disorders, on Thursday announced the publication of a peer reviewed paper titled ‘Treatment of Wilson Disease in Japan: An Insurance Claims Database Study’ in the Japanese Journal of Gastroenterology and Hepatology. Wilson disease (WD) is a hereditary, progressive, severely debilitating disease principally affecting the liver and the central nervous system. 

The study underscores the unmet medical need for new therapies for Wilson Disease. Vivet’s lead program, VTX-801, is currently undergoing clinical evaluation and is a potential disease-modifying treatment for patients with WD. 

Vesper Bio announces completion of single ascending dose stage in trial of its lead candidate VES001, a potentially disease-modifying treatment for fronto-temporal dementia 

Vesper Bio ApS, a clinical stage biotech and world leader in sortilin receptor biology, on Thursday announced completion of the single ascending dose stage of its first-in-human trial of VES001 in healthy volunteers. 

VES001 is the first oral, brain penetrant, small molecule sortilin inhibitor designed as a potentially disease-modifying treatment for the neuro-cognitive disorder fronto-temporal dementia (FTD(GRN)). Data returned from this study (NCT06226064) demonstrate the safety and tolerability of VES001 across the full range of doses tested and show it has excellent pharmacokinetics and distribution to relevant parts of the brain. The data predict a once or twice daily efficacious dose. 

FTD is the most common form of dementia in people under 60 but is often misdiagnosed as Alzheimer’s Disease. 

22nd episode of the Optimum Perspectives Podcast looks at AI in drug development 

The Optimum Perspectives Podcast is going from strength to strength and is now on its 22nd episode. Listen to the latest discussion with Jeremy Skillington, CEO of Poolbeg Pharma, and Tushar Pandey, CEO and founder of SimBioSys, about the growing importance of Artificial Intelligence (AI) in drug development. Hit the subscribe button to catch the episodes as we publish them! 

Who’s on the move this month? 

Check out the latest moves in the life sciences sector with our monthly round-up of new funds and the biggest job changes, including analysts, bankers, and healthcare journalists. 

That’s all folks! We hope you are enjoying Optimum’s weekly round-ups; subscribe today so you never miss an edition.