Boehringer Ingelheim buys CD38 drug; Merck bets on machine learning in antibody design
CD38 may be best known as a target for cancer therapies — notably J&J’s Darzalex and Sanofi’s Sarclisa. But Boehringer Ingelheim believes it has potential in immunological and fibrotic diseases, too.
The German pharma giant is acquiring a preclinical CD38 program from Ribon Therapeutics, paying an undisclosed upfront and promising future milestones.
Unlike the approved CD38 drugs, which are both antibodies, Ribon developed a small molecule inhibitor, which it believes carries the extra advantage of blocking intracellular CD38 activity.
Ribon has attracted backing from a slate of VC as well as pharma investors thanks to its platform elucidating the family of NAD+-utilizing enzymes. Its own lead programs target PARP7 and PARP14 to treat oncology and inflammatory diseases.
Machine learning in antibody design lands BigHat a deal with Merck
Merck is buying into BigHat’s antibody design platform in a deal that can lead to three drug discovery programs.
San Mateo-based BigHat set out to pair wet lab capabilities for synthesizing, expressing, purifying and characterizing molecules with machine learning technologies to engineer antibodies with “more complex functions and better biophysical properties.” It’s also in a research collaboration with Amgen to optimize and improve upon one of Amgen’s antibodies.
“This agreement with Merck brings us a major step closer to our goal of 3-5 deep collaborations with leading biopharmas to complement our internal therapeutic pipeline,” said Elizabeth Schwarzbach, BigHat’s chief business officer.
She added that Merck and BigHat have already started working on the first program.
Aldeyra files NDA for dry eye drug
It took perhaps longer than expected, but Aldeyra has finally filed its drug for dry eye disease with the FDA.
Administered as an eye drop, reproxalap would be the first marketed reactive aldehyde species) modulator if it’s approved, according to Aldeyra. The NDA submission carries data from five clinical trials, the company added, which measured efficacy on a variety of metrics, including the ocular dryness symptom score, ocular redness, Schirmer test (a test of tear production), and Schirmer test ≥10 mm responder analysis.
“The NDA submission for reproxalap is, to our knowledge, the most comprehensive regulatory package ever for a dry eye disease drug candidate,” president and CEO Todd Brady said in a statement. “With data suggesting activity within minutes of administration, reproxalap could provide an important treatment option for the millions of dry eye patients who generally regard currently available therapies as inadequate.”
Aldeyra ran into a setback back in late 2021 when reproxalap missed the primary endpoint in a Phase III trial, but it charged ahead with another late-stage trial with an amended endpoint — and the drug proved a success. Subsequent data, including from a crossover study, were also positive.