A small Cal­i­for­nia biotech is back with more cash and a new big name VC to work with.

Car­mot Ther­a­peu­tics re­port­ed a Se­ries D fi­nanc­ing worth $160 mil­lion Tues­day morn­ing, which the biotech said will be used to push for­ward and com­plete clin­i­cal stud­ies and ad­vance pre-clin­i­cal pro­grams.

Ex­ist­ing backer Col­umn Group led the fi­nanc­ing and was joined by a “sig­nif­i­cant in­vest­ment” from new in­vestor RA Cap­i­tal Man­age­ment, who will hold a board ob­serv­er seat at the com­pa­ny. Ad­di­tion­al fun­ders in­clude Deep Track Cap­i­tal, Wil­lett Ad­vi­sors, Hori­zons Ven­tures and “oth­er in­sti­tu­tion­al in­vestors.”

As part of the fi­nanc­ing, Phase I and II clin­i­cal stud­ies will be done on some of the biotech’s lead can­di­dates, in­clud­ing a dual mod­u­la­tor of GLP-1 and GIP in­cretin re­cep­tors, a GLP-1/GIP mod­u­la­tor, and an oral small mol­e­cule GLP-1 re­cep­tor ag­o­nist.

Car­mot did not im­me­di­ate­ly re­spond to a re­quest for com­ment from End­points News.

The biotech’s plat­form, in short, is called “Chemo­type Evo­lu­tion” — and CBO James Wat­son told End­points at the last fi­nanc­ing round that the plat­form al­lows the com­pa­ny to bet­ter op­ti­mize its can­di­dates for the dis­eases it’s look­ing to treat.

This is the newest round of fi­nanc­ing for the biotech, which has sev­er­al can­di­dates for di­a­betes and obe­si­ty in its pipeline — plus a can­di­date in on­col­o­gy. Two years ago, Car­mot se­cured $47 mil­lion in a Se­ries C to progress its lead can­di­date, CT-868 and tar­get GLP-1 and GIP, through Phase II clin­i­cal tri­als. Am­gen had al­so par­tic­i­pat­ed in the deal.

Car­mot and Am­gen had been part­ners since 2014, with the for­mer us­ing its plat­form to find KRAS-tar­get­ing ther­a­peu­tics. And as of last June, Car­mot has been re­ceiv­ing roy­al­ty pay­ments for its ef­forts in find­ing nov­el bind­ing sites and co­va­lent in­hibitors of KRASG12, which Am­gen then used to de­vel­op Lumakras, ap­proved by the FDA last year.

“We are de­light­ed to se­cure fund­ing from a pre-em­i­nent group of in­vestors that will ad­vance our clin­i­cal pro­grams for the treat­ment of di­a­betes and obe­si­ty,” Car­mot co-founder and CEO Stig Hansen said in a state­ment.

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

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The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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