A Foresite-incubated biotech that debuted just eight months ago closed a new mega financing round on Thursday, and with it comes a company rebranding.
Esker Therapeutics will now call itself Alumis following the completion of a $200 million Series B, the biotech announced Thursday. The funds are expected to go toward Alumis’ pipeline, including its lead program ESK-001, a TYK2 inhibitor targeting the pan-JAK pathway that the company has touted as potentially safer than current JAK inhibitors.
‘The funding really serves for us to advance the program into the clinic, and then we have also a pipeline building behind it,’ CEO Martin Babler told Endpoints News in an interview. ‘And we want to also make sure that we can take full advantage of our data analytics platform to really explore additional targets and additional indications.’
The lead compound is being evaluated in psoriasis, and a Phase I safety and tolerability study was expected to read out by the end of 2021. Though the company hasn’t put out a press release with the data yet, Babler said Alumis is ‘extremely pleased’ with the molecule.
‘The features that we see is really that we have a great PK profile, and that we have good selectivity,’ he said. ‘We’re on track to really understand how this molecule stacks up against others in the field.’
Former CEO and founder June Lee had previously said she expected the program to serve as a proof-of-concept for the rest of Alumis’ platform. By aiming to identify certain genetic targets, Lee noted she wanted to serve patients she felt had been in the ‘come-one-come-all’ immunology market. ESK-001 will have plenty of competition as the JAK field has seen much crowding in recent years. Though Lee said Alumis’ molecule sprouted from the same class as Bristol Myers Squibb’s deucravacitinib, that drug beat out Amgen’s Otezla in a pivotal head-to-head psoriasis trial last year, and the FDA has set a PDUFA date for September.
‘Fundamentally, TYK2 is a member of the class of the JAK inhibitors, but it has really a differentiated profile,’ Babler said. ‘And one of the things about this molecule, it’s one of several allosteric TYK2 inhibitors that are in development. And those inhibitors really don’t have a lot of JAK pharmacology. And so we don’t really see at least so far from from the leading molecule in this class, which is the BMS molecule, and our own and others, the same pharmacology that you see with JAK inhibitors.’
Outside this molecule, the company is aiming to develop other candidates in the immunology space, with Babler saying in a release Thursday the company may look to acquire other assets in addition to building out its pipeline.
The JAK space has been shaken in recent months by repeated safety issues, following a post-marketing study for Pfizer’s Xeljanz that elevated the concerns in early 2021. Despite the renewed scrutiny, the FDA has waved through new JAK inhibitors recently, approving Xeljanz and AbbVie’s Rinvoq for new indications last month.
But the drugs came with expanded warnings and a key label change, saying they can only be taken after a patient has failed on one or more TNF blockers such as Humira. The shift came after regulators flagged the risk of cardiovascular events in patients older than 50 with boxed warnings on Xeljanz, Rinvoq and Eli Lilly’s Olumiant.
‘While we have a lead asset, this is also about building an entire pipeline behind it,’ Babler said. ‘And so we are actively working on several other programs that we will disclose at the appropriate time.’
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)
It’s big days for biology.
The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.
But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.
Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.
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As the FDA is looking to reduce drug shortages further by collecting more data on the volume of drugs and APIs manufactured worldwide, companies like Pfizer, Thermo Fisher, Viatris and industry groups are pushing back on new guidance that seeks to establish how that data should be collected and submitted to the agency.
The technical conformance guide, released last October, spells out the requirements under Section 3112(e) of the CARES Act, which was signed into law in March 2020 and added a new section to the FD&C Act.
Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)
Bursting at the seams and executing plans for swift expansion to support its manufacturing work for the mRNA vaccine out of Pfizer/BioNTech, Indianapolis-based Exelead has now been scooped up in a $780 million cash buyout deal.
Germany’s Merck KGaA, which bought out another mRNA manufacturer, AmpTec, early last year, has been beefing up its ops around lipids, which, in mRNA vaccines, play a key role in turning human cells into a mini—vaccine factories?
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Jay Bradner, NIBR president (Jeff Rumans)
Alnylam was a few years ahead in the small interfering RNA (siRNA) space when Novartis jumped on the bandwagon in early 2020, licensing the company’s cholesterol-lowering drug Leqvio through its buyout of The Medicines Company. Less than a month after securing an approval, the pharma giant wants more where that came from.
Novartis is joining forces with Alnylam once again for the discovery and development of a regenerative siRNA-based therapy to treat end-stage liver disease, the companies announced on Thursday.
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Sosei Heptares is teaming up with a big-name partner: Alphabet’s Verily.
No financials were disclosed, but the pair will aim to use Verily’s immune profiling and Sosei Heptares’ GPCR drug design capabilities to develop a variety of new therapeutics. The collaboration will focus on GPCR drugs in the immunology, gastroenterology and immuno-oncology spaces, as well as other disorders with immunoprotective or immunopathogenic mechanisms, the companies said.
After showcasing clinical data at #ASH21 for a sickle cell disease candidate, Sanofi has decided to throw in the towel on its 8-year partnership with collaborator Sangamo — and return its rights to the candidate.
The gene editing biotech announced the ‘transition’ this morning, several days after Sanofi told Sangamo that the biotech was backing out of the deal. The Paris-based pharma giant will be returning its rights and obligations on SAR445136, a zinc finger nuclease gene-edited cell therapy back to Sangamo by the end of June.
Jo Varshney, VeriSIM Life CEO
VeriSIM Life has been working on creating a biosimulation platform since its founding in 2017 — and after more than four years and a pre-seed and seed round, the California software firm now has a Series A under its belt.
The $15 million round, led by Morpheus Ventures and supported by new investors Debiopharm Innovation Fund and Colorcon Ventures, includes existing investors OCA Ventures, Intel Capital, Serra Ventures and Susa Ventures. The round will fund VeriSIM Life for the next 2 to 2½ years.
Chris Perkin, Altasciences via Youtube
Altasciences CEO Chris Perkin has gone through several acquisitions in his 45-year career. And if there’s one thing he learned, it’s how not to go through an acquisition.
His company put that knowledge to use on Tuesday when it announced that it had acquired competitor Sinclair research, a preclinical contract research organization in Missouri. With the pickup, Altasciences gains 80 animal rooms, and full-service IND and NDA-enabling toxicology and safety pharmacology services.
https://endpts.com/foresites-immunology-play-gets-a-200m-megaround-for-tyk2-program-rebranding-as-alumis/
