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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.