Todd Harris and Daniel Bensen. Tyra

RA Cap­i­tal, Canaan help in­fuse $50M in­to Al­ta-in­cu­bat­ed biotech bat­tling ac­quired re­sis­tance to TKIs

Since Gleevec was ap­proved in 2001, over 40 oth­er ty­ro­sine ki­nase in­hibitors have come on­to the mar­ket to treat var­i­ous types of can­cer. But with the pro­lif­er­a­tion of the class al­so came a surge of ac­quired re­sis­tance, where pa­tients’ tu­mors mu­tate around the drug tar­get and stop re­spond­ing to the ther­a­pies.

Tyra Bio, a Carls­bad, CA-based biotech “pur­pose built” to ad­dress that prob­lem, has just raised $50 mil­lion from Al­ta Part­ners, RA Cap­i­tal Man­age­ment, Box­er Cap­i­tal of Tavi­s­tock Group, and Canaan.

“It’s not en­tire­ly clear what type of ac­quired re­sis­tance might emerge re­al­ly un­til you get these drugs in­to pa­tients,” co-founder and CEO Todd Har­ris told End­points News. “In some in­stances, the first gen­er­a­tion drugs couldn’t have en­tire­ly pre­dict­ed what might come along.”

Bob More

But with some class­es of TKIs now in their third gen­er­a­tion, there is an in­creas­ing amount of clin­i­cal ev­i­dence and bet­ter tools to crunch them for in­sights in­to the pre­cise mu­ta­tions — in­sights that Tyra would take right back to the start of drug dis­cov­ery and de­vel­op­ment. In the long run, the goal is for their drugs to not just be de­ployed when re­sis­tance emerges but to move to the front­line set­ting with the hope of a longer du­ra­tion of re­sponse.

Har­ris added that the strat­e­gy has shown some promise in ALK and EGFR, but re­mained tight-lipped about the ex­act tar­gets they are start­ing with, though it’s a safe bet they would first go af­ter the most well-known ones.

Daniel Bensen, COO and co-founder, will be steer­ing a small team along­side CSO Ronald Swan­son, CFO Es­ther van den Boom, and Robert Hud­kins, VP of chem­istry, as well as Jane Ar­bole­da, as­so­ciate di­rec­tor of cell bi­ol­o­gy, to bring their first can­di­dates to the clin­ic. An army of biotechs are in the game, many fo­cus­ing on par­tic­u­lar nich­es with­in the vast TKI space. Tyra will be look­ing to out­pace some of them.

Ja­son Sheltzer of Cold Spring Har­bor Lab­o­ra­to­ry, William Hahn of Dana Far­ber, and Jef­frey Hager, for­mer­ly of Ideaya Bio, have come on board as sci­en­tif­ic ad­vi­sors.

“Our strength is re­al­ly in a nim­ble and high­ly ex­pe­ri­enced drug dis­cov­ery and drug de­vel­op­ment team,” Har­ris said, lever­ag­ing tried and true tech­nolo­gies such as struc­tured-based drug de­sign, and patch­ing in self-built pre­clin­i­cal mod­els when­ev­er nec­es­sary.

Har­ris al­so co-found­ed what even­tu­al­ly be­came Si­en­na Bio­phar­ma, a skin drug de­vel­op­er that count­ed Arch Ven­tures and Part­ner Fund Man­age­ment as back­ers but nev­er­the­less was forced to file for Chap­ter 11 af­ter a bruis­ing tri­al fail­ure. The en­tre­pre­neur­ial les­son he learned: Fi­nance your com­pa­ny for the ups and downs along the biotech road.

Al­ta Part­ners, which in­cu­bat­ed Tyra, is ready for the long haul. The in­clu­sion of crossover firm RA Cap­i­tal al­so gives Har­ris more con­fi­dence that this one will stick. Each in­vestor in the Se­ries A is send­ing a rep­re­sen­ta­tive to the board: Bob More of Al­ta Part­ners, Jake Sim­son of RA Cap­i­tal, Sid Sub­ra­mo­ny of Box­er Cap­i­tal and Ni­na Kjell­son of Canaan. Mi­rati CMO Isan Chen and for­mer Gates foun­da­tion ex­ec Gilla Ka­plan are the oth­er two di­rec­tors.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

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When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

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First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

Mallinck­rodt, once the na­tion’s largest oxy­codone pro­duc­er, an­nounces ten­ta­tive $1.6B set­tle­ment

Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy.

The tentative deal would settle hundreds of lawsuits from state and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.