Bay Area start­up Rain Ther­a­peu­tics nabs $18M Se­ries A to tar­get lung can­cer niche

A biotech laser fo­cused on a sub­type of non-small cell lung can­cer has raised $18.4 mil­lion from San Fran­cis­co’s Biotech­nol­o­gy Val­ue Fund and oth­er in­vestors.

The Se­ries A cash will see Fre­mont, CA-based Rain Ther­a­peu­tics through a Phase II study for its lead drug, tar­lox­o­tinib, in pa­tients with EGFR and ErbB Ex­on 20 in­ser­tion mu­tat­ed NSCLC, sched­uled to be­gin in 2019. Per­cep­tive Ad­vi­sors, Auck­land UniS­er­vices Lim­it­ed’s In­ven­tors Fund and oth­er pri­vate in­vestors al­so chipped in for the round, adding a large sum to the $1 mil­lion Rain banked late last year.

EGFRs (epi­der­mal growth fac­tor re­cep­tors) have been part of the game plan for block­buster drugs like As­traZeneca’s Tagris­so and Roche’s Tecen­triq, but the team at Rain be­lieves there is yet an un­met niche with­in the niche that their drug could ad­dress.

Robert Doe­bele

“Tar­get­ing wild­type EGFR, or wild­type EGFR-like tu­mors has al­ways been very chal­leng­ing with con­ven­tion­al small mol­e­cule in­hibitors be­cause of the abun­dance of EGFR in healthy tis­sues,” said co-founder Robert Doe­bele in a state­ment. “Pa­tients with Ex­on 20 lung can­cer show an ad­dic­tion to EGFR, how­ev­er the re­sem­blance of EGFR Ex­on 20 to EGFR wild­type sug­gests most con­ven­tion­al strate­gies will be lim­it­ed by tox­i­c­i­ty. With its nov­el mech­a­nism of ac­tion, Tar­lox has the po­ten­tial to ad­dress this in­her­ent, un­met chal­lenge in Ex­on 20 pa­tients.”

Rain es­ti­mates that 6,500 pa­tients in the US are di­ag­nosed an­nu­al­ly with EGFR and oth­er HER-fam­i­ly Ex­on 20 in­ser­tion mu­ta­tions in NSCLC. Some an­i­mal mod­el work has been done at the Uni­ver­si­ty of Col­orado — where Doe­bele works as an as­so­ciate pro­fes­sor of med­i­cine and di­rects an on­col­o­gy re­search ini­tia­tive — show­ing tu­mor re­gres­sion. The de­vel­op­ment and com­mer­cial­iza­tion rights for the drug it­self, though, was li­censed from the Uni­ver­si­ty of Auck­land in New Zealand.

Avan­ish Vel­lan­ki

Avan­ish Vel­lan­ki, the oth­er founder, runs the com­pa­ny as CEO. A for­mer in­vest­ment banker, his most re­cent biotech stint was a CBO role at Ap­tose Bio­sciences.

Gor­jan Hrus­tanovic of the Biotech­nol­o­gy Val­ue Fund will join Rain’s board of di­rec­tors.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.