Soros, Gates back medtech's move into a 'social enterprise'; Aging anti-rejection drug earns fresh approval
George Soros and Bill Gates are teaming up to buy out a British diagnostics company.
The pair and their foundations will spend about $41 million to transform Mologic into a “Social Enterprise” aimed at expanding access to state-of-the-art medical technology, the company announced Monday. Launched in 2003, Mologic comes from the father-and-son team of Mark and Paul Davis, the latter of whom helped create one of the first at-home pregnancy tests.
“Mologic’s transition into a social enterprise is a deliberate, logical and natural step for a company focused on delivering affordable diagnostics and biotechnology to places that have been left underserved by the relentless pursuit of profiteering,” Mark Davis, who also serves as CEO, said in a statement. — Max Gelman
Anti-rejection drug gets FDA OK for lung transplants
An anti-rejection drug previously used to prevent organ rejection in patients with liver, kidney and heart transplants has been approved by the FDA for lung transplant patients as well on Friday.
Prograf was approved for use in combination with other immunosuppressant drugs. The approval marks the first and only for a drug to prevent rejection of a lung transplant.
Approval was granted based on a non-interventional, fit-for-purpose study using real-world data. Data were collected on all US lung transplants, and data from randomized controlled trials of Prograf in other settings provided confirmatory evidence, the FDA said.
“A dramatic improvement in outcomes was observed among lung transplant patients receiving Prograf as part of their immunosuppression medications compared to the well-documented natural history of a transplanted drug with no or minimal immunosuppressive therapy,” the press release from the FDA said. — Josh Sullivan
AstraZeneca pneumonia candidate targeted in licensing deal
Aridis Pharmaceuticals will exclusively license AstraZeneca’s late-stage pneumonia antibody candidate suvratoxumab.
Suvratoxumab, which recently finished a Phase II trial, will complement Aridis’ own Phase III pneumonia program for AR-301. Both candidates target the S. aureus strain.
As part of the deal, AstraZeneca will become a shareholder in Aridis and will retain future “first-to-negotiate” rights for licensing the program.
In that Phase II test, suvratoxumab reduced the relative risk of pneumonia by 32% in 196 patients with a 47% reduction in the over-65 population. The drug was also associated with a substantial reduction in duration of care needed at the ICU and hospital. — Kyle Blankenship
Rational design for protein degradation? Austrian deep learning startup takes a stab
For all the promises of PROTACs and molecular glues as a class, there remains lots of room for improvement on how individual protein degraders are discovered.
That’s according to Christopher Trummer, a former bioinformatics consultant who noticed, while doing contract research for a variety of biopharma companies, that there was really no rational approach to designing molecules that can grab targets and tag them for disposal. Identifying the right ones was always a trial and error affair.
“Typically if you do some brute force methods, high throughput screening — even if you partner with [what are considered] the cheapest CROs, right — you would end up in at least half a million or a million for screening, in the PROTAC area, maybe 2,000, 3,000 compounds, something like that,” he said. “So it is very very costly.”
Together with his friend Jakob Hohenberger, who has a background in tech, Trummer began exploring a solution steeped in deep learning. The result was Celeris Therapeutics, whose Celeris One software promises to predict protein-protein interactions and docking specifically for applications in targeted protein interactions.
It was enough to draw inquiries from Big Pharma and biotech companies, Trummer said, one of which has already agreed to a partnership.
The team of 15 is currently based in Austria. While Celeris plans to keep a presence here — and grow even bigger by building a wet lab later this year — Trummer, the CEO, plans to move to Silicon Valley soon to be closer to investors as well as scientists and potential partners.
True to its European roots, though, Celeris has kept its funding modest. After APEX Medical brought their pre-seed funding to €1.6 million ($1.89 million), the biotech is targeting €5 million for the seed round.
“We genuinely believe that these machine learning based simulations will streamline the way early stage drug development is performed and eventually will benefit all over the world,” Gordon Euller, general partner at APEX, wrote in an email.
The goal, ultimately, is to operate like the cash-rich AI player Exscientia, which is lending its technology to clients but also pursuing in-house discovery and development. — Amber Tong
Opioid alternative starts PhII trial in bunionectomy and abdominoplasty surgery
Vertex has kicked off a Phase II proof-of-concept study in acute pain after bunionectomy surgery, the company announced Monday. It will start a Phase II study of pain following abdominoplasty surgery in the coming weeks.
The randomized, double-blinded, placebo-controlled studies will evaluate its selective NaV1.8 inhibitor VX-548, and include a hydrocodone bitartrate/acetaminophen reference arm. The small molecule has shown to reduce neuropathic pain and musculoskeletal pain in previous clinical trials. If Vertex hits on VX-548, it could provide a potent, non-addictive alternative to opioids.
“NaV1.8 is a genetically and pharmacologically validated target and we are excited about the potential for VX-548 as a new class of effective pain treatments without the limitations of current therapies, including the addictive potential of opioids,” EVP Carmen Bozic said in a press release.
Results from the study are expected by Q1 of 2022. — Josh Sullivan
French biotech PEP-Therapy expands Series A round
A few months after closing its $3.4 million Series A round, Paris-based PEP-Therapy has investors reaching a little deeper into their wallets.
PEP-Therapy has reeled in another $3 million in a Series A expansion, bringing its total haul to $6.4 million. The company’s working on what it calls Cell Penetrating & Interfering Peptide (CP&IP) technology, designed to penetrate cells and specifically block relevant intracellular protein-protein interactions. Its lead candidate PEP-010 is currently in a Phase Ia/b trial for advanced solid tumors.
“We are delighted to have completed this financing round via an attractive balance of dilutive and non-dilutive funds from new high quality and diversified investors who will bring expertise and new insights to support our development,” CEO Antoine Prestat said in a statement. — Nicole DeFeudis