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.

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

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Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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Covid-19 roundup: Bris­tol My­ers sus­pends clin­i­cal tri­als, grounds field team; Vir ush­ers an­ti­body can­di­dates to hu­man test­ing

The global nature of the Covid-19 pandemic is manifesting more profoundly every day. With Spain’s death toll now surpassing China’s and India on full lockdown, the number of confirmed cases around the world has exceeded 436,000 while recoveries edged close to 112,000.

While the outbreak derails R&D at another pharma giant, several drugmakers have some encouraging updates on both experimental and repurposed molecules. Philanthropic campaigns in anticipation of the economic fallout continue. An Australian biotech is taking extreme measures to hunker down. There’s also an alternative epidemiology model emerging out of the UK, stirring up more discussion regarding the true extent of the infections in the country.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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