Fol­low­ing the flow of the biotech in­dus­try, La­va heads to Nas­daq with a gam­ma delta T cell promise

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Join­ing in on the great IPO erup­tion of the last 12 months, La­va Ther­a­peu­tics is flow­ing to Nas­daq.

With a fo­cus on im­muno-on­col­o­gy, the Dutch-Amer­i­can biotech priced late Wednes­day night in prepa­ra­tion for a Thurs­day de­but, of­fer­ing shares ini­tial­ly at $15 apiece. They man­aged to just eclipse the nine-fig­ure mark, ex­pect­ing an es­ti­mat­ed raise of $100.5 mil­lion once the of­fer­ing clos­es ear­ly next week.

La­va plans to use the tick­er $LVTX once its shares hit the mar­ket.

Biotech IPOs keep chug­ging along as the quar­ter comes to a close. This fol­lows a record 2020 when the in­dus­try saw 91 pub­lic de­buts with a col­lec­tive $16.5 bil­lion raised, ac­cord­ing to Nas­daq. So far through 2021, biotech’s col­lec­tive raise is near­ing $4 bil­lion, a fig­ure slight­ly off last year’s pace, per the End­points News tal­ly.

And af­ter a brief slow down at the end of Feb­ru­ary, the mar­ket start­ed heat­ing back up again last week when four biotechs priced, mark­ing the sec­ond-busiest week of 2021. That ti­tle, how­ev­er, still be­longs to the first cal­en­dar week of Feb­ru­ary, when 10 com­pa­nies went pub­lic.

The com­pa­ny’s sci­en­tif­ic ap­proach in­volves build­ing bis­pe­cif­ic an­ti­bod­ies that grab a re­cep­tor on gam­ma delta T cells and link it with a par­tic­u­lar pro­tein on the tu­mor, with the goal of the drug on­ly ac­ti­vat­ing while in the vicin­i­ty of the can­cer. La­va al­so says its ther­a­pies can help in­duce im­mune mem­o­ry of the can­cer, should it ap­pear again, due to gam­ma delta T cells’ sim­i­lar­i­ty to anti­gen-pre­sent­ing cells.

La­va’s pric­ing Wednes­day night comes af­ter a rel­a­tive­ly busy 2020. The biotech de­buted back in May 2018 with a mod­est $18.9 mil­lion to re­search what was then a nascent field: gam­ma delta T cells. La­va built its re­search on the sci­en­tif­ic dis­cov­er­ies of CSO Hans van der Vli­et, an on­col­o­gist at VU Uni­ver­si­ty Med­ical Cen­ter and Can­cer Cen­ter Am­s­ter­dam.

They stayed al­most en­tire­ly un­der the radar — not is­su­ing an­oth­er press re­lease for over a year and a half — un­til an­nounc­ing a can­cer bis­pecifics part­ner­ship with J&J’s Janssen last May. A few months lat­er, they re­turned to the ven­ture well with $83 mil­lion in Se­ries C fi­nanc­ing and two pro­grams ready for the clin­ic.

With­in their F-1, La­va spills the beans on how it plans to spend its cash as a pub­lic com­pa­ny. Though they’re rais­ing on­ly $100.5 mil­lion, La­va out­lines a $135 mil­lion busi­ness plan by in­clud­ing a por­tion of its cur­rent cash stand­ing. Al­most all of that, or $125 mil­lion, will go to­ward its two lead pro­grams: $85 mil­lion for LA­VA-051 in CLL, MM and AML, and $40 mil­lion for LA­VA 206×207 in mCR­PC.

An­oth­er $10 mil­lion is pen­ciled in for pre­clin­i­cal can­di­dates in hema­to­log­ic ma­lig­nan­cies and sol­id tu­mors.

LA­VA-051, tar­get­ing CD1D, is ex­pect­ed to be­gin a Phase I/IIa clin­i­cal tri­al in re­lapsed and/or re­frac­to­ry mul­ti­ple myelo­ma and CLL in the first half of 2021. LA­VA 206×207, mean­while, is look­ing to launch a Phase I/IIa tri­al in metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer in the sec­ond half of 2021.

If all goes well, the pro­ceeds from the IPO raise will give La­va enough cash to com­plete those two stud­ies, as well as pre­pare two oth­er pro­grams to en­ter the clin­ic.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

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Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.