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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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