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.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.