Beth Seidenberg and Sean Harper, Westlake Village

Sean Harp­er and Beth Sei­den­berg add $500M to their new VC, bet­ting on the LA biotech ecosys­tem

When Ar­se­nal Bio launched last year, the head­line name was Nap­ster bil­lion­aire Sean Park­er, who, af­ter fund­ing an im­munother­a­py in­sti­tute, de­cid­ed to back a bold bet on cell ther­a­py 2.0.

The first in­vestor named on the press re­lease for Ar­se­nal’s $85 mil­lion launch, though, wasn’t Park­er; it was West­lake Vil­lage Biopart­ners, an LA-based VC firm found­ed just the year pri­or by long­time Am­gen R&D chief Sean Harp­er and the long­time life sci­ences chief at the leg­endary Sil­i­con Val­ley firm Klein­er Perkins, Beth Sei­den­berg.

Ar­se­nal marked West­lake’s first pub­lic in­vest­ment, and while 8 of the 11 com­pa­nies they’ve backed re­main un­der wraps, the duo has al­ready raised a new fund — two, ac­tu­al­ly. One fund, worth $430 mil­lion, will con­tin­ue their orig­i­nal goal, al­low­ing them to back about a dozen ear­ly-stage star­tups. An­oth­er, worth $70 mil­lion, will let the firm join Se­ries B and oth­er mid-rounds for the com­pa­nies they helped launch.

The new funds bring West­lake to $820 mil­lion in cap­i­tal in the two-plus years since their launch. They had al­ways in­tend­ed to raise the sec­ond fund. The third, they said, arose out of some strong sug­ges­tions they re­ceived as they were fundrais­ing.

“Our lim­it­ed part­ners were look­ing at my re­turns for my [Klein­er Perkins] biotech com­pa­nies and said, ‘Beth, do you know how much mon­ey you left on the ta­ble?'” Sei­den­berg told End­points News.

So far, the com­pa­nies they’ve an­nounced have fo­cused on high pro­file cell ther­a­py ef­forts. In ad­di­tion to Ar­se­nal, they al­so backed TMu­ni­ty, a Carl June-found­ed ef­fort to use CRISPR to en­gi­neer CAR-Ts. And they in­vest­ed in Kyver­na Ther­a­peu­tics, a Gilead-part­nered biotech, to use cell ther­a­py for au­to-im­mune and neu­rode­gen­er­a­tive con­di­tions.

Harp­er, though, says that amounts to a sam­pling er­ror, as most of the com­pa­nies they’ve backed re­main in stealth mode.

“We have cell-based ther­a­pies, gene ther­a­pies, small mol­e­cules and an­ti­bod­ies,” he told End­points. “We’re pret­ty ag­nos­tic in the modal­i­ty and we’re pret­ty op­por­tunis­tic and broad in the dis­ease ar­eas we’re work­ing in.”

The duo said they look for one of three things to build a biotech around, bring­ing to each first­hand tech­ni­cal knowl­edge of ear­ly drug de­vel­op­ment: A proven col­lec­tion of drug dis­cov­ery vet­er­ans, to whom they can pro­vide mon­ey and lab space and let them do their thing; a promis­ing tech­nol­o­gy com­ing out of the uni­ver­si­ty lev­el; or shelved drugs in oth­er com­pa­nies that they can of­fer a fo­cused de­vel­op­ment.

The fund’s lat­est com­pa­ny, al­so an­nounced Tues­day, amounts to a heavy bet on the first mod­el.

Known as Ace­lyrin, the com­pa­ny so far con­sists on­ly of Shao-Lee Lin and Bob Carey, the for­mer R&D chief and CBO of Hori­zon Ther­a­peu­tics, re­spec­tive­ly.  The plan, they say, is to part­ner and li­cense as­sets in im­munol­o­gy, but they haven’t dis­closed what as­sets or in­tel­lec­tu­al prop­er­ty they have — or even if they have li­censed any in­tel­lec­tu­al prop­er­ty. They al­so haven’t dis­closed the size of the Se­ries A, if they have lab space, or if they have any oth­er em­ploy­ees.

Harp­er notes, though, that the duo has suc­ceed­ed be­fore, build­ing Hori­zon’s pipeline, in­clud­ing a hand­ful of ap­proved im­munol­o­gy drugs. And Lin says they can of­fer fu­ture part­ners unique acu­men and ex­pe­ri­ence.

“There’s a lot of fund­ing out there,” she told End­points. “The gap we be­lieve we fill, is that in ad­di­tion to the ac­cess to cap­i­tal, we be­lieve we bring ex­per­tise to the ta­ble. We have track records of build­ing mul­ti-bil­lion dol­lar ther­a­peu­tics.”

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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Chi­nese biotech Ever­est signs $550M+ li­cens­ing deal for BTK in­hibitors on heels of Covid-19 pact

Everest Medicines is on a roll with two licensing deals in one week.

The Shanghai-based biotech has paid Sinovent and SinoMab $12 million upfront for the rights to a BTK inhibitor for renal diseases, the company announced Thursday. The deal comes just days after Everest came away with rights to a Covid-19 vaccine in China, Taiwan, Singapore, Thailand and Indonesia.

Everest will pay Sinovent and SinoMab up to $549 million in milestone payments and royalties. The agreement includes tech transfer of Sinovent and SinoMab’s manufacturing process for the candidate, named XNW1011.