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.

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.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

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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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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