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.
自2017年被发现以来，Janux Ther'a'peu'tics一直保持着相当低的价格，但去年年底Mer'ck为其T细胞检测仪投入了超过10亿美元的承诺中的千里石，这让Janux Ther'a'peu'tics突然出现。现在，不到三个月后，这家小型生物技术公司已经获得了第一轮由一些项目后盾领导的原始基金。
Janux公司在为INDs准备第一批项目的同时，在周三上午投入了5600万美元的资金，杰伊·利希特的Aval on Ventures加入了新的Investors或Bimed和RA Capital Man的力量，为该公司提供资金。“Janux”公司在周三上午投入了5600万美元的资金，“JayLichter”Aval on Ventures“JayLichter”Aval on Ventures“JayLichter”Aval on Ventures“。Janux公司将用这笔钱购买其T细胞计数仪，以获得PSMA和TROP2，这两种仪器预计将在2022年第一和第二季度投入使用。
坎普·贝尔说，这三个因素，即改进的PHARMACOKINET、低毒性和更好的毒性再租赁，是Janux与其他T细胞免疫平台相区别的地方。这是正确的不仅是它的PSMA和TROP2 program，但oth-er可以di日期毛皮在管道中像一个EGFR engager。
Caribou Biosciences首席执行官雷切尔·豪尔维茨说，周三上午，Caribou Biosciences完成了1.15亿美元的C轮融资，使他们的融资总额达到1.57亿美元左右。