Look­ing to solve the sol­id tu­mor puz­zle box, Caris­ma aims to take 'CAR-M' ground­break­er in­to ear­ly-stage tri­al

In an ef­fort to crack the code of hard-to-treat sol­id tu­mors, bio­phar­ma has tried nu­mer­ous path­ways to ef­fec­tive­ly tar­get those mass­es with­out dam­ag­ing healthy tis­sues. Philly’s Caris­ma Ther­a­peu­tics thinks it has a win­ner with its macrophage cell-based “CAR-M” can­di­dates, and now it’s tak­ing a new flush of in­vestor cash to try one in the clin­ic.

Steven Kel­ly

Caris­ma has scored a $47 mil­lion Se­ries B round to take its lead can­di­date, an­ti-HER2 CAR-M tu­mor fight­er CT-0508, in­to a Phase I tri­al as well as ad­vanc­ing the rest of its pre­clin­i­cal macrophage pipeline. Caris­ma has keyed in on the use of tar­get­ed macrophage cells and vec­tors to pen­e­trate the en­vi­ron­ment of sol­id can­cer tu­mors with­out hurt­ing health tis­sues — a puz­zle in the sol­id tu­mor field.

CT-0508’s ear­ly-stage study will turn out the first hu­man da­ta for a CAR-M ther­a­py based on those macrophage cells, Caris­ma said. CEO Steven Kel­ly told End­points News his com­pa­ny could of­fer an ef­fec­tive and safer way to tar­get tu­mors and “warm them up” for the im­mune sys­tem to at­tack.

“There are a num­ber of char­ac­ter­is­tics about macrophages that would lend them­selves to­wards ap­pli­ca­tions of sol­id tu­mors and oth­er in­di­ca­tions, but what we’re fo­cused on is sol­id tu­mors,” Kel­ly said. “Macrophages are pref­er­en­tial­ly re­cruit­ed in­to a tu­mor mi­croen­vi­ron­ment, and lym­pho­cytes like the CAR-T ap­proach­es are ac­tive­ly ex­clud­ed. So we think that we have an ad­van­tage by over­com­ing traf­fick­ing lim­i­ta­tions to sol­id tu­mors.”

This has been the stick­ing point for the in­dus­try: ther­a­peu­tics that can in­vade the walls which sur­round can­cer­ous tu­mors with­out dam­ag­ing oth­er­wise healthy cells.

Kel­ly is con­fi­dent that Caris­ma’s tech­nol­o­gy will ul­ti­mate­ly de­ci­pher how to do just that.

“Once it starts eat­ing (the can­cer­ous tu­mor cells), the macrophages will start pro­duc­ing cy­tokines that ef­fec­tive­ly warm up that en­vi­ron­ment and con­vert an im­muno­log­i­cal­ly cold tu­mor in­to a warm or hot tu­mor and re­cruit in oth­er cells, like T cells for ex­am­ple. So that last el­e­ment is re­al­ly unique to macrophages due to the anti­gen pre­sen­ta­tion ca­pa­bil­i­ty,” he said. “They en­gage in cells di­rect­ly, they warm up the tu­mor mi­croen­vi­ron­ment, and they gen­er­ate a true adap­tive im­mune re­sponse. That’s how we think of our­selves and how we’re dif­fer­en­ti­at­ed in the cell ther­a­py space.”

Kel­ly said it was a bit pre­ma­ture to know when Caris­ma would be­gin pub­lic read­outs of the da­ta sur­round­ing its macrophage ther­a­peu­tics, but he hoped they would be able to do so by the mid­dle of this year.

The to­tal cap­i­tal Caris­ma has raised since its Se­ries A fi­nanc­ing in 2018 now to­tals rough­ly $109 mil­lion, and is a key step in mov­ing the com­pa­ny from “ef­fec­tive­ly a dis­cov­ery-stage com­pa­ny to a clin­i­cal-stage com­pa­ny,” Kel­ly said.

“A lot of ef­fort has gone in­to build­ing this com­pa­ny. We had to tran­si­tion from a bench project at (the Uni­ver­si­ty of) Penn, we had to demon­strate all the things nec­es­sary to get an IND de­clared — (so) safe­ty and ef­fi­ca­cy — we had to de­vel­op a GMP man­u­fac­tur­ing process,” Kel­ly said. “All those were ef­fec­tive­ly de­vel­oped to FDA sat­is­fac­tion, and we’re mov­ing in­to the clin­ic now.”

In­vestors in the Se­ries B fi­nanc­ing are led by Sym­bio­sis II, with sub­se­quent in­vest­ment from So­las­ta Ven­tures and Liv­zon Phar­ma­ceu­ti­cal Group. Ad­di­tion­al­ly, Caris­ma said, ex­ist­ing in­vestors Ab­b­Vie Ven­tures, Health­Cap, Welling­ton Part­ners, IP Group, TPG Biotech, Agent Cap­i­tal, and MRL Ven­tures Fund con­tributed to the new round of fund­ing.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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David Southwell (L) and Christoph Westphal

Har­vard spin­out kicks off 2021 with a crossover round and sights set on the clin­ic

Several months after striking an alliance with Novartis, TCR therapy-focused TScan Therapeutics has reeled in a crossover round that should hold it over for the next two years as it eyes a public debut.

The Christoph Westphal portfolio company had been arranging the crossover for the last few months, CEO David Southwell said. Just before Christmas, they nailed down what he called a “really blue-chip” syndicate of four new investors, including BlackRock, RA Capital Management and two undisclosed funds. They closed on the $100 million Series C just over a week ago, and waited until Monday morning to announce it.

Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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