Vipin Suri, Catamaran Bio CSO

Cata­ma­ran Bio sails in­to the CAR-NK wa­ters with a $42M launch round

Cata­ma­ran Bio’s found­ing mem­bers de­cid­ed to jump in­to the CAR-NK game last De­cem­ber over drinks at a trendy bar in Boston.

They were sit­ting around a ta­ble, dis­cussing an MD An­der­son study which pro­vid­ed some of the first clin­i­cal proof that nat­ur­al killer (NK) cells can be reengi­neered to at­tack tu­mors, much like CAR-T ther­a­pies. It was a “long and live­ly” dis­cus­sion, COO Mark Boshar re­calls. And by the time it was over, they had a start­ing point to launch a com­pa­ny.

“The ‘ide­al’ cell ther­a­py ap­proach would come from a holis­tic ap­proach — not a sin­gle linch­pin tech­nol­o­gy — in or­der to make progress be­yond the lim­i­ta­tions of ear­ly gen­er­a­tion prod­ucts,” Boshar wrote in a state­ment.

On Mon­day, Cata­ma­ran Bio emerged from stealth with $42 mil­lion in Se­ries A and seed fund­ing to de­vel­op what Boshar called the “holy grail” of cell ther­a­pies: off-the-shelf CAR-NK drugs made with donor cells to treat sol­id tu­mors.

Cata­ma­ran’s ther­a­pies will do two key things: at­tack sol­id tu­mor cells and the tu­mor mi­croen­vi­ron­ment, which sur­rounds the cells like a force field, CSO Vipin Suri told End­points News. In the hopes of get­ting around the cell ther­a­py man­u­fac­tur­ing bot­tle­neck, the biotech is us­ing a non-vi­ral trans­po­son sys­tem to de­liv­er the ge­net­ic pay­loads, rather than vi­ral vec­tors.

Un­like CAR-T treat­ments — which re­quire the long and cost­ly process of draw­ing a pa­tient’s own cells, treat­ing them and rein­ject­ing them — CAR-NK ther­a­pies can be made with donor cells. That’s be­cause donor T cells would like­ly trig­ger graft-ver­sus-host dis­ease, while for­eign NK cells don’t. The end goal is a cell ther­a­py that doesn’t look like a trip to the hos­pi­tal, Suri said.

“The idea is very much to have an off-the-shelf ther­a­py such that … when a physi­cian de­ter­mines that a pa­tient can ben­e­fit from cell ther­a­py, it is avail­able to be ad­min­is­tered as a ther­a­py right then, or short­ly there­after,” he told End­points News. 

Cata­ma­ran cur­rent­ly has two pro­grams, dubbed the TAIL­WIND Plat­form, which Suri ex­pects to en­ter the clin­ic in the next few years. De­vel­op­ment will be fund­ed by the Se­ries A, which was led by Sofinno­va Part­ners and Light­stone Ven­tures, with help from found­ing in­vestor SV Health In­vestors, as well as Take­da Ven­tures and Astel­las Ven­ture Man­age­ment.

The CAR-NK field is abound with new play­ers, led by MD An­der­son and Take­da, who said they’re look­ing to ini­ti­ate a piv­otal tri­al next year. Then there’s J&J-backed Fate Ther­a­peu­tics, which was cleared for its first CAR-NK clin­i­cal tri­al in Sep­tem­ber; Nkar­ta re­cent­ly dosed the first par­tic­i­pant in a clin­i­cal tri­al, and says a sec­ond IND is com­ing in Q1 of 2021; and ONK Ther­a­peu­tics, which said in Oc­to­ber that it’s about two years out from an IND.

“All these com­pa­nies have great teams, but we re­al­ly be­lieve that the team that Kevin (Po­jasek), Mark and Vipin put to­geth­er is a tru­ly dif­fer­en­ti­at­ed com­pa­ny,” SV Health man­ag­ing part­ner Houman Ashrafi­an told End­points

Houman Ashrafi­an

The team of sci­en­tif­ic founders in­cludes George Wash­ing­ton Uni­ver­si­ty pro­fes­sor Cather­ine Bol­lard, who’s di­rec­tor of the Cen­ter for Can­cer Im­munol­o­gy Re­search at the Chil­dren’s Na­tion­al Re­search In­sti­tute, and Uni­ver­si­ty of Min­neso­ta as­sis­tant pro­fes­sor Bran­den Mo­ri­ar­i­ty, who holds patents in key ar­eas, in­clud­ing for tech­nolo­gies us­ing DNA trans­po­son sys­tems. There’s al­so CMO Chris Car­pen­ter, who pre­vi­ous­ly served as CMO of Ru­bius Ther­a­peu­tics af­ter spend­ing time at GSK and Mer­ck, and se­nior VP of re­search Ce­leste Richard­son, who hails from Ob­sid­i­an Ther­a­peu­tics and No­var­tis.

“Cata­ma­ran to us sym­bol­izes the jour­ney. Our jour­ney is to broad­en the reach of cell ther­a­py for pa­tients in more in­di­ca­tions,” Suri said.

This sto­ry has been up­dat­ed to clar­i­fy that Nkar­ta has re­cent­ly dosed the first pa­tient in its clin­i­cal tri­al.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.