With new $106M crossover round, Tenaya preps heart fail­ure pro­grams for the clin­ic — and maybe an IPO

Less than a year and a half since pulling in its last round of fund­ing, Tenaya Ther­a­peu­tics is back with a crossover round that could set it up for an IPO down the road.

Pri­vate and pub­lic in­vestors have now jumped aboard the Tenaya train to the tune of a $106 mil­lion Se­ries C, the com­pa­ny an­nounced Mon­day morn­ing, with the hopes of ad­vanc­ing its lead gene ther­a­py pro­gram for heart fail­ure in­to the clin­ic. Tenaya al­so aims to fund its oth­er heart fail­ure plat­forms, hav­ing made much progress in cel­lu­lar re­gen­er­a­tion and pre­ci­sion med­i­cine as well, CEO Faraz Ali told End­points News.

Faraz Ali

“For us it’s not about op­por­tunis­ti­cal­ly try­ing to catch an IPO win­dow,” Ali said, “but feel­ing that our sci­ence has ar­rived at a point on mul­ti­ple fronts that we have a rea­son to be­lieve that each of these plat­forms can de­liv­er prod­ucts that could be mean­ing­ful in hu­mans.”

Ali added that Tenaya hasn’t made any con­crete plans for an IPO just yet, but they’re “ab­solute­ly think­ing about” go­ing pub­lic, giv­en the mar­ket con­di­tions that have led to a biotech boom over the last 12 months.

The South San Fran­cis­co-based com­pa­ny got start­ed way back in De­cem­ber 2016 with a $50 mil­lion Se­ries A look at how fresh sources of re­gen­er­a­tive cells could po­ten­tial­ly re­pair a dam­aged heart. It had been an area that pre­vi­ous­ly drove a va­ri­ety of large­ly un­suc­cess­ful re­search ef­forts aimed at help­ing pa­tients who have suf­fered from heart at­tacks and strokes.

But Tenaya has grown to about 80 staffers over the last sev­er­al years and built out its three dif­fer­ent plat­forms. Aside from the gene ther­a­py pro­grams, Tenaya is work­ing on a sin­gle AAV vec­tor-based cell ther­a­py and a small mol­e­cule treat­ment for dif­fer­ent heart fail­ure pop­u­la­tions.

In Oc­to­ber 2019, Ali led a $92 mil­lion Se­ries B, and Tenaya hadn’t yet dis­closed many of its tar­gets. Now, how­ev­er, they’re ready to dish on the de­tails. Their lead can­di­date is tar­get­ing ge­net­ic hy­per­trophic car­diomy­opa­thy due to mu­ta­tions in the MYBPC3 gene, with an AAV gene ther­a­py, in both adults and chil­dren.

The dis­ease it­self has a broad range of symp­toms, with some adults ex­pe­ri­enc­ing no symp­toms for years while oth­ers can die with­in a few weeks of be­ing born. It es­sen­tial­ly caus­es sick­en­ing of the heart ven­tri­cles, Ali said, caus­ing re­duc­tions in ejec­tion frac­tion. There’s cur­rent­ly no tar­get­ed ther­a­py for the dis­ease, and Tenaya is aim­ing to be the first to de­liv­er a healthy copy of the gene.

They’re con­sid­er­ing an IV in­fu­sion for­mu­la­tion or a pos­si­ble de­liv­ery clos­er to the heart. To ac­com­plish this and low­er man­u­fac­tur­ing costs, Tenaya has al­so in­vest­ed in its own catheters.

Be­yond that, the com­pa­ny is re­search­ing an­oth­er gene ther­a­py in­volv­ing DWORF, a mi­cro-pep­tide act­ing on the SER­CA path­way. There’s al­so a pro­gram fo­cused on car­diac re­gen­er­a­tion, us­ing a sin­gle AAV vec­tor to de­liv­er com­bi­na­tions of mul­ti­ple genes that dri­ve in vi­vo re­pro­gram­ming of car­diac fi­brob­lasts to cre­ate new heart mus­cle cells, as well as a small mol­e­cule go­ing af­ter a still-un­named tar­get to treat ge­net­ic di­lat­ed car­diomy­opa­thy.

And as Tenaya pre­pares to po­ten­tial­ly go pub­lic, they’re look­ing at a tra­di­tion­al IPO rather than a SPAC, which has al­so seen sky­rock­et­ing amounts of cap­i­tal re­cent­ly.

“The heart fail­ure field had re­al­ly fall­en out of fa­vor for a pe­ri­od of time,” Ali said. “Tra­di­tion­al small mol­e­cule pro­grams against some of the usu­al tar­gets … had sort of pe­tered out, and there were sev­er­al fail­ures in large out­come stud­ies. So some­thing had to change.”

Mon­day’s round was led by RTW In­vest­ments, and new in­vestors RA Cap­i­tal, Fi­deli­ty Man­age­ment & Re­search Com­pa­ny and funds and ac­counts ad­vised by T. Rowe Price. Tenaya saw ad­di­tion­al par­tic­i­pa­tion from all ex­ist­ing in­vestors in­clud­ing The Col­umn Group, Cas­din Cap­i­tal, GV and oth­ers.

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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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.

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.

Carl Hansen, AbCellera CEO

Look­ing for the next mR­NA break­through, Mod­er­na taps Ab­Cellera in mys­te­ri­ous an­ti­body dis­cov­ery deal

Moderna’s success with its Covid-19 vaccine has busted the dam open on a range of potential mRNA therapeutics — and now the biotech is pushing to keep the cutting edge in-house. A new partnership with standout antibody discovery outfit AbCellera could help keep the ball in the competition’s court.

Moderna will partner with antibody player AbCellera on up to six undisclosed targets for a range of mRNA-encoded drugs harvested from AbCellera’s bustling discovery platform, the companies said Wednesday.

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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