Steve Hurly, Lava CEO

La­va breaks pro­longed si­lence with an $83M Se­ries C and two I/O pro­grams set for the clin­ic

La­va de­buted in May of 2018 with $18.9 mil­lion, a plat­form built around some­thing called gam­ma delta cells and a plan, ap­par­ent­ly, of say­ing noth­ing else for the next two years. They nev­er an­nounced a pro­gram and they did not is­sue an­oth­er press re­lease for the next 20 months.

In May, though, the Dutch-Amer­i­can biotech an­nounced a part­ner­ship on can­cer bis­pecifics with J&J. And to­day, CEO Steve Hurly is ready to talk about what they’ve been work­ing on for the last two years in Utrecht and Philadel­phia – as well as the $83 mil­lion they raised from No­vo, Sanofi and oth­ers to bring that work in­to the clin­ic next year.

“There was not a lot of PR, and I think the goal was to get the ini­tial prod­ucts cho­sen, get them run­ning to the clin­ic, get the team built out be­fore we spent too much time kind of fo­cused on out­ward news­flow,” Hurly told End­points News. He was hired, he said, to take the com­pa­ny from a “qui­et re­search group” spun off a uni­ver­si­ty in Utrecht to a biotech with a US foot­print and clin­i­cal pro­grams.

La­va tries to use a pop­u­la­tion of im­mune cells called gam­ma delta T cells to at­tack can­cer. It was a rel­a­tive­ly nascent field when Ver­sant first backed the com­pa­ny in 2018, but a slew of up­starts have since joined, in­clud­ing Gam­ma Delta, Adap­tate, and Re­gen­eron-backed Adicet Bio. In what CSO Charles Al­bright billed as “a ma­jor ex­pan­sion” Ed­i­tas last year ex­pand­ed their long-run­ning col­lab­o­ra­tion with Bris­tol My­ers Squibb sub­sidiary  Juno Ther­a­peu­tics to cov­er  Gam­ma Delta.

These cells can of­fer ben­e­fits over the tra­di­tion­al al­pha-be­ta T cells used in CAR-T treat­ments and oth­er im­muno-on­col­o­gy ap­proach­es. They have as­pects of the in­nate im­mune sys­tem, with a built-in abil­i­ty to seek and hunt out can­cer­ous cells. “This is a high­ly cy­to­tox­ic cell ther­a­py,” Hurly said.

La­va’s ap­proach in­volves build­ing bis­pe­cif­ic an­ti­bod­ies that grab a re­cep­tor on gam­ma-delta T cells and link it with a par­tic­u­lar pro­tein on the tu­mor. The idea is that, like with oth­er T cell bis­pecifics in de­vel­op­ment, it will on­ly ac­ti­vate the cells in the vicin­i­ty of the can­cer. That ac­ti­va­tion, though, then trig­gers a cas­cade of ef­fects and in­flam­ma­to­ry sig­nals that ac­ti­vate both oth­er gam­ma delta T cells and in­nate im­mune cells in the vicin­i­ty to at­tack the tu­mor.

Fi­nal­ly, Hurly said, be­cause gam­ma delta T cells can func­tion sim­i­lar to anti­gen-pre­sent­ing cells – the couri­er-like im­mune mes­sen­gers that break off and fer­ry for­eign pro­teins to the T and B cells that will then mem­o­rize and at­tack them if seen again – their ther­a­pies can help in­duce im­mune mem­o­ry of the can­cer, should it ap­pear again.

Ben­jamin Wino­grad

The ap­proach al­so al­lows them to tar­get anti­gens that oth­er tech­nolo­gies have not been able to hit, Hurly said. Their lead pro­gram, which they out­lined in a Na­ture Can­cer pa­per this week, goes af­ter CD1D, a pro­tein in­volved in the im­mune sys­tem and over-ex­pressed in some B cell ma­lig­nan­cies. They plan to start a Phase I/II study in the first quar­ter of next year, and lat­er move in­to sol­id tu­mors.  A sec­ond pro­gram, fo­cused on sol­id tu­mors but with an undis­closed tar­get, is slat­ed to en­ter the clin­ic in Q3.

Hurly ac­knowl­edged the com­pa­ny has been qui­et and that even their web­site is a “work in progress” soon to be re­placed, but they’ve spent the last year ramp­ing up a sec­ond base in Philadel­phia, es­tab­lish­ing GMP man­u­fac­tur­ing, and land­ing Cel­gene vet Ben­jamin Wino­grad as CMO. They al­so land­ed No­bel Prize win­ner Jim Al­li­son as a board mem­ber.

He ex­pects the next two years will be far loud­er ones for the com­pa­ny, but al­so for the gam­ma delta T cell field as a whole, which could dif­fer­en­ti­ate it­self over oth­er T cell ap­proach­es.

“You’re go­ing to start turn­ing over the cards,” he said.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Silviu Itescu, Mesoblast CEO

Mesoblast sends in im­proved po­ten­cy as­say, look­ing to re­sub­mit to FDA on acute graft-ver­sus-host dis­ease drug

In 2020, the FDA rejected Mesoblast’s remestemcel-L, or Ryoncil, its lead candidate for pediatric acute graft-versus-host disease (aGVHD) that didn’t respond to steroids. The FDA raised a number of concerns, first objecting to Mesoblast’s single arm, open-label trial, though regulators struggled to describe how a randomized trial would work, since pediatricians and parents were reluctant to put children with aGVHD in a placebo arm.

Johnny Stilou, Scandion Oncology acting CEO

Scan­dion's shares fall af­ter on­col­o­gy biotech re­ports PhII fail

Danish biotech Scandion Oncology posted some Phase II results on Friday, and investors were none too pleased.

The biotech reported topline results from the second part of an ongoing Phase II trial called CORIST. The study was investigating Scandion’s lead candidate SCO-101 in 25 patients as a combination treatment with FOLFIRI chemotherapy in metastatic colorectal cancer. And so far, the study did not meet the biotech’s primary endpoint: tumor reduction of at least 30%.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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