Todd Harris (L) and Daniel Bensen (Tyra)

RA Cap­i­tal aims to take pre­clin­i­cal biotech to Nas­daq as Tyra files S-1 dur­ing sum­mer lull

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The sum­mer has brought a rel­a­tive breather to the IPO mar­ket af­ter sev­er­al months of boom­ing funds, but the biotech sec­tor saw a new fil­ing last Fri­day in Tyra Bio­sciences.

Based out of Carls­bad, CA, Tyra pen­ciled in a $100 mil­lion ask ahead of the week­end, com­ing less than five months af­ter it com­plet­ed a $106 mil­lion Se­ries B. Tyra’s ul­ti­mate raise may prove greater than the ini­tial es­ti­mate as it’s raised near­ly $160 mil­lion over­all, but the biotech has yet to get any of its ex­per­i­men­tal drugs in­to hu­man test­ing, with the lead pro­gram for blad­der can­cer ex­pect­ed to see an IND fil­ing in mid-2022.

RA Cap­i­tal Man­age­ment and Box­er Cap­i­tal have been there every step of the way for Tyra, and each will take home a nice IPO prize by virtue of own­ing a near­ly 20% stake pre-of­fer­ing. Al­ta Part­ners and Canaan have al­so con­tributed re­peat­ed­ly, lead­ing to 13% and 14.6% stakes, re­spec­tive­ly.

Tyra’s stat­ed goals all deal with en­sur­ing can­cer pa­tients can con­tin­ue tar­get­ed treat­ment should their tu­mors mu­tate or see their ther­a­pies stop work­ing. The biotech has de­vel­oped a plat­form it calls SNAP, which in­volves shoot­ing X-ray beams to dis­cov­er the three-di­men­sion­al struc­ture of a par­tic­u­lar pro­tein.

It’s not a new ap­proach, but Tyra is hop­ing to dif­fer­en­ti­ate it­self with a team that re­peat­ed­ly looks over the mod­els sev­er­al times per week, get­ting as close to an atom-by-atom per­spec­tive of its can­di­dates’ bind­ing process as it can. The pipeline as a whole will be tar­get­ed at the fi­brob­last growth fac­tor re­cep­tor, or FGFR, fam­i­ly, with the lead pro­gram start­ing off at FGFR3.

Known as TYRA-300, the can­di­date is be­ing stud­ied in mus­cle in­va­sive blad­der can­cer and sol­id tu­mors. The MIBC field has on­ly seen one FDA-ap­proved FGFR3 in­hibitor, and Tyra is aim­ing to po­si­tion it­self as a sec­ond-gen­er­a­tion play­er by de­sign­ing TYRA-300 to avoid the phe­nom­e­non of “gate­keep­er mu­ta­tions” that it says have lim­it­ed the ef­fi­ca­cy of that drug, J&J’s Balver­sa.

Funds from the IPO will go to­ward launch­ing a Phase I/II clin­i­cal tri­al for this pro­gram and tak­ing it through the Phase I por­tion, though it’s un­clear when the study will be­gin — and how much Tyra will spend — giv­en the IND is like­ly about a year away. The biotech al­so out­lined fund­ing plans for two oth­er pro­grams in the S-1: an FGFR2 in­hibitor and a sep­a­rate FGFR3 pro­gram for achon­dropla­sia.

Two founders and mem­bers of Tyra’s C-suite will be adding to their per­son­al bank ac­counts as well. CEO Todd Har­ris gets a 7.2% stake ahead of the IPO, while COO Daniel Bensen has a 2.7% piece of the pie.

Though the groundswell of biotech IPOs has slowed down in Au­gust, 2021 is still on pace to eclipse 2020’s record year. More than 80 com­pa­nies have com­bined to raise near­ly $13 bil­lion, in the first sev­en and a half months of the year, per the End­points News’ tal­ly. Last year, 91 biotechs raised $16.5 bil­lion in IPOs, ac­cord­ing to Nas­daq fig­ures.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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