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.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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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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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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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Le­vo Ther­a­peu­tics miss­es pri­ma­ry end­point in PhI­II tri­al of Prad­er-Willi drug — the lat­est set­back in a dis­as­ter-prone field

Marking yet another setback in the Prader-Willi Syndrome field, Levo Therapeutics failed to hit its primary endpoint in a Phase III study of intranasal carbetocin. But the biotech is now shifting its focus to the secondary endpoints in an effort to pluck victory out of the jaws of defeat.

The disorder, characterized by a false sense of starvation, is caused by the absence or deletion of a father’s chromosome 15. Illinois-based Levo’s potential therapy involves a selective oxytocin-receptor agonist.

Leonard Schleifer (AP Images)

Re­gen­eron adds more pos­i­tive PhI­II da­ta for its NGF pro­gram — but safe­ty is still a big con­cern

Two years after fasinumab hit its first late-stage bar, Regeneron is standing by its “high-risk, high reward” bet on the NGF antibody. But while new Phase III data solidified the potential reward, the risk is still threatening to blow it all up.

Regeneron execs and analysts alike now have their eyes set on a rival drug from Pfizer and Eli Lilly, whose fate at the FDA will likely set the scene for the class.

Pfiz­er's Lor­bre­na bests Xalko­ri in PhI­II read­out — is it a po­ten­tial suc­ces­sor?

Pfizer has long pinned hopes on lorlatinib as being a successor to Xalkori for ALK-positive non-small cell lung cancer, and the pharma released data Wednesday indicating that may eventually be the case.

Lorlatinib, now marketed as Lorbrena, met its primary endpoint in a Phase III trial by showing a significantly improved progression-free survival as compared to Xalkori in patients who had previously not received any treatment for their illness. Lorbrena had already been approved as a second-line treatment for ALK-positive metastatic NSCLC back in 2018.

Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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