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.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Alex Leech, Alchemab CEO (SV Health Investors)

Alchemab bags fresh round of in­vestor for tar­get-ag­nos­tic an­ti­body de­vel­op­ment for Hunt­ing­ton's, Covid-19

With a “target-agnostic” approach to antibody development, the UK’s Alchemab has used lessons learned from patients with resistance to certain diseases to chase after conditions as far apart as Huntington’s and Covid-19. Now, investors are jumping on board the concept with an $86 million Series A.

The proceeds will go toward advancing the company’s target-agnostic drug discovery program, a release said. That approach looks at the antibody repertoires of patients who show resistance to typically destructive diseases regardless of genetic disposition.

Craig Parker, Surrozen CEO

The world of Wnt heads to Nas­daq as Sur­rozen an­nounces a $212M SPAC deal

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another day, another SPAC merger in the world of biotech.

Less than 24 hours after Tango Therapeutics announced its own leap to Nasdaq through the blank check route, Surrozen has decided to take a similar step. The Wnt pathway-focused biotech is reverse-merging with Consonance Capital Management’s SPAC in a $212 million deal, which includes $92 million from the shell company and $120 million in PIPE financing.