Cy­to­ki­net­ics nabs Chi­nese part­ner, up to $450M as CV be­comes com­pa­ny fo­cus

Cy­to­ki­net­ics’ ALS pro­grams may have seen bet­ter days, but its car­dio­vas­cu­lar di­vi­sion has at­tract­ed well-backed part­ners, in­clud­ing Am­gen and Roy­al­ty Phar­ma, who, in 2017 paid $90 mil­lion in ex­change for a 4.5% roy­al­ty on their lead heart drug.

Now a Chi­nese drug­mak­er and a ma­jor in­vestor are sign­ing on­to their sec­ond car­dio­vas­cu­lar can­di­date, an ex­per­i­men­tal drug known as CK-274 and de­signed to treat hy­per­trophic car­diomy­opathies — ge­net­ic con­di­tions that cause heart mus­cles to be­come ab­nor­mal­ly and po­ten­tial­ly dan­ger­ous­ly thick. Ji Xing Phar­ma­ceu­ti­cals will pay Cy­to­ki­net­ics $25 mil­lion up­front for the rights to com­mer­cial­ize the drug in Chi­na and cer­tain neigh­bor­ing re­gions, along with $200 mil­lion in po­ten­tial mile­stones.

Along­side the sale of Chi­nese rights, Cy­to­ki­net­ics has en­tered a mul­ti-faceted arrange­ment with RTW In­vest­ments to raise up to $225 mil­lion to sup­port the drug’s de­vel­op­ment.

Robert Blum

“These deals af­ford us the op­por­tu­ni­ty to di­al up de­vel­op­ment of CK-274 in mul­ti­ple in­di­ca­tions and across a wider span of ge­o­gra­phies,” CEO Robert Blum said in a state­ment.

First, RTW will make $45 mil­lion avail­able to Cy­to­ki­net­ics if they reach cer­tain mile­stones for ob­struc­tive hy­per­trophic car­diomy­opathies (oHCM) in ex­change for 2% of fu­ture roy­al­ties. An­oth­er $45 mil­lion is avail­able for mile­stones in non-ob­struc­tive hy­per­trophic car­diomy­opathies (nHCM) in ex­change for an­oth­er 2% of roy­al­ties.

Sec­ond, RTW will pay $85 mil­lion up­front, due by Oc­to­ber, in ex­change for an undis­closed per­cent­age of roy­al­ties.

Third, RTW will pay around $50 mil­lion for 2 mil­lion shares of Cy­to­ki­net­ics, at $25 per share.

The new tranche of cash con­tin­ues Cy­to­ki­net­ics piv­ot to fo­cus on car­dio­vas­cu­lar dis­ease, and re­flects a con­tin­ued strat­e­gy to raise mon­ey by sell­ing rights and roy­al­ties, as op­posed to pub­lic of­fer­ings.

Al­though the South San Fran­cis­co biotech has had a heart dis­ease pro­gram since its ear­ly days, its ALS pro­gram cap­tured much of the at­ten­tion for years. In 2013, Astel­las signed on to it for up to $490 mil­lion. But in 2017, they scrapped their lead ALS drug af­ter it failed to beat place­bo in a 700-per­son tri­al, and last year, an­oth­er ALS drug failed an­oth­er mid-stage tri­al.

The lead car­dio­vas­cu­lar drug is ome­cam­tiv mecar­bil, which Cy­to­ki­net­ics has co-de­vel­oped with Am­gen since 2006 and which is now in a Phase III tri­al. CK-274 is now in a Phase II tri­al that’s due to read­out next year.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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My­ovant lands a fresh $200M loan as FDA mar­ket­ing de­ci­sion looms; Amarin goes it alone in Eu­rope

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.

Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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Ver­sant de­buts Ridge­line's start­up #4, armed with $30M and al­ter­na­tive TCR cell ther­a­pies for sol­id tu­mors

For all the iterations and advances in TCR therapies for cancer, any experimental treatments involving T cell receptors share one trait: By definition, they only recognize antigens presented as peptides on the major histocompatibility complex (MHC) on cells.

Versant reckons it’s time to expand the arsenal. With $30 million in initial funding, its Ridgeline Discovery Engine in Switzerland has been working on a non-peptidic approach that it says has tumor-agnostic potential, especially in solid tumors. They’ve named it Matterhorn, after a Swiss mountain as they did with the three other companies that have emerged from the Basel-based incubator.

CF Foun­da­tion, Long­wood team on new in­cu­ba­tor for com­pa­nies with cut­ting-edge CF treat­ments

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.

Deep tech, round 2: DCVC Bio bags $350M fund to chase the tip of the life sci­ence spear

It took one trip from San Francisco to Vancouver for Kiersten Stead and her DCVC Bio crew to feel confident about throwing their weight — and cash — behind AbCellera.

CEO Carl Hansen’s academic background and the potential of the platform, which combined machine vision and robotics with microfluidics, were promising. But the site visit sealed the Series A deal, where DCVC was the lead and only investor.