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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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