Janux Ther­a­peu­tics had kept a rel­a­tive­ly low pro­file since be­ing found­ed back in 2017 but burst on­to the scene late last year when Mer­ck plunked down more than $1 bil­lion in promised mile­stones for its T cell en­gagers. Now, less than three months lat­er, the small biotech has clinched its first round of pri­vate fund­ing led by some promi­nent back­ers. As it pre­pares its first pro­grams for INDs, Janux com­plet­ed a $56 mil­lion Se­ries A on Wednes­day morn­ing, with Jay Lichter’s Aval­on Ven­tures join­ing forces with new in­vestors Or­biMed and RA Cap­i­tal Man­age­ment to fund the com­pa­ny. Janux will use the cash to pri­mar­i­ly ad­vance its T cell en­gagers tar­get­ing PS­MA and TROP2, which are ex­pect­ed to hit the clin­ic in the first and sec­ond quar­ters of 2022, re­spec­tive­ly. CEO David Camp­bell told End­points News that the Mer­ck deal, on top of the da­ta that had al­ready im­pressed a num­ber of in­vestors, helped get Wednes­day’s fi­nanc­ing across the fin­ish line. All the buzz has cen­tered around Janux’s T cell en­gager plat­form called TRAC­Tr, which the com­pa­ny says can de­vel­op drugs that al­ter their phar­ma­co­ki­net­ics de­pend­ing on the con­text. Up­on ac­ti­va­tion in a tu­mor, its can­di­dates are con­vert­ed from their orig­i­nal form — which can re­main in the blood­stream for over 100 hours — to a T cell en­gager that on­ly cir­cu­lates for less than an hour. Janux al­so says any T cell en­gager that es­capes from the tu­mor mi­croen­vi­ron­ment is quick­ly elim­i­nat­ed, fur­ther tamp­ing down tox­i­c­i­ty lev­els and pre­vent­ing buildup in healthy tis­sue. And the com­pa­ny al­so has mon­key da­ta that show in­hi­bi­tion of cy­tokine re­lease at greater than 200-fold high­er dos­es, and greater than 2,000-fold high­er plas­ma lev­els, than ear­li­er gen­er­a­tion T cell en­gagers. These three fac­tors, im­proved phar­ma­co­ki­net­ics, low­er tox­i­c­i­ty and bet­ter pre­ven­tion of cy­tokine re­lease, are where Janux is hop­ing to dif­fer­en­ti­ate it­self from oth­er T cell en­gager plat­forms, Camp­bell said. That’s true not just for its PS­MA and TROP2 pro­grams, but the oth­er can­di­dates fur­ther down the pipeline like an EGFR en­gager. Janux plans to pur­sue prostate can­cer with the PS­MA pro­gram, with Camp­bell say­ing their pre­clin­i­cal da­ta have shown a “clear” path for­ward in the in­di­ca­tion. Re­searchers are go­ing to start eval­u­at­ing the can­di­date as a monother­a­py in lat­er lines of the dis­ease, but in the fu­ture may look to ex­pand the tar­get pa­tient pop­u­la­tion by com­bin­ing the pro­gram with check­point in­hibitors. “We’re go­ing to come in with a once-week­ly dose drug that we ex­pect, based up­on the pre­clin­i­cal da­ta that we’ve gen­er­at­ed, will be able to cir­cum­vent the cy­tokine re­lease syn­drome that has im­pact­ed many of the pro­grams in this par­tic­u­lar space,” Camp­bell said. The TROP2 can­di­date is like­ly to go af­ter triple neg­a­tive breast can­cer and non-small cell lung can­cer. TROP2 is the same tar­get for the Gilead/Im­munomedics drug Trodelvy, whose ap­proval in triple neg­a­tive breast can­cer this past April has helped Janux val­i­date the tar­get as a vi­able ap­proach, Camp­bell said. Camp­bell said Janux is plan­ning to off­set this can­di­date’s first clin­i­cal tri­al by a quar­ter sim­ply be­cause the com­pa­ny is still build­ing out its small staff from 10 em­ploy­ees to about 35 to 40. Wednes­day’s fund­ing will help them ac­com­plish that goal as well, en­sur­ing both pro­grams can hit the ground run­ning when their first hu­man tri­als even­tu­al­ly launch next year. Ex­ist­ing in­vestors Bregua and Cor­re­la­tion Ven­tures al­so con­tributed to the Se­ries A. In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders? Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday. The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights. Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates. CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means. Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society. One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies. The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.” They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management. GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan. The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday. A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement. The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance. Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one. Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms. There is no shortage of biotechs pursuing off-the-shelf CAR-Ts, a so-called Holy Grail in oncology R&D. Now, less than a month after teaming up with AbbVie, a California player launched by CRISPR pioneer Jennifer Doudna has returned to the venture well, scooping up a big crossover round to help it along. Caribou Biosciences took the wraps off a $115 million Series C on Wednesday morning, bringing their total raise to around $157 million, CEO Rachel Haurwitz said. Soticlestat made it. Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.