Take­da-part­nered Evox signs up to $1.2B pact with Lil­ly; New liq­uid biop­sy com­pa­ny launch­es with $12M Se­ries A

Ox­ford spin­out Evox — one of a hand­ful of play­ers that are us­ing tiny ex­o­somes to de­liv­er a ther­a­peu­tic pay­load where need­ed, in­clud­ing to the brain — is ac­ing the deal­mak­ing game with big phar­ma. Just months af­ter se­cur­ing $44 mil­lion up­front in an up to $882 mil­lion deal with Take­da, the com­pa­ny has inked a pact with Eli Lil­ly fo­cused on drugs to treat neu­ro­log­i­cal dis­or­ders.

This deal is lighter up­front, and heav­ier on mile­stones: $20 mil­lion cash up-front, re­search fund­ing over three years, as well as a $10 mil­lion in­vest­ment from Lil­ly in ex­change for a con­vert­ible bond. Mile­stone pay­ments add up to a meaty $1.2 bil­lion for Evox, in ad­di­tion to po­ten­tial roy­al­ties.

→ A lit­tle over a month af­ter Thrive un­veiled its first ‘re­al-world’ da­ta and Grail raised a gar­gan­tu­an $390 mil­lion round, Cas­din Cap­i­tal, NFX Cap­i­tal and The Mark Foun­da­tion for Can­cer Re­search are get­ting in on the liq­uid biop­sy game. They’ve backed C2i Ge­nomics with a $12 mil­lion to sup­port their plat­form for mon­i­tor­ing can­cer re­cur­rence and treat­ment re­sponse. The founders de­tailed their tech­nol­o­gy in Na­ture Med­i­cine on June 1.

→ Al­most a year af­ter land­ing ac­cel­er­at­ed ap­proval for their sick­le cell drug Oxbry­ta, Glob­al Blood Ther­a­peu­tics is ask­ing the FDA to okay the drug for kids ages 4 to 11. Cur­rent­ly ap­proved for pa­tients 12 and up, Oxbry­ta is one of the first ap­proved drugs de­signed to treat the un­der­ly­ing pathol­o­gy be­hind sick­le cell.

→ Mi­cro­bio­me-based ther­a­peu­tics com­pa­ny Mi­cro­bi­ot­i­ca is ty­ing up with Can­cer Re­search UK and Cam­bridge Uni­ver­si­ty Hos­pi­tals NHS Foun­da­tion Trust to fi­nal­ly put the ques­tion to bed: which con­sor­tium of bac­te­ria play a piv­otal role in steer­ing re­spons­es in can­cer pa­tients to check­point in­hibitors?

Pre­vi­ous stud­ies have shown that the gut mi­cro­bio­me plays a key, causative role in de­ter­min­ing which pa­tients re­spond to these med­i­cines, but sci­en­tists have not quite honed in on a con­sis­tent gut bac­te­r­i­al sig­na­ture as­so­ci­at­ed with treat­ment re­sponse or re­sis­tance. Mi­cro­bi­ot­i­ca, us­ing its ge­nom­ic pro­fil­ing tech­nol­o­gy, has found a sig­na­ture in a large num­ber of melanoma pa­tients — and now with this new col­lab­o­ra­tion will look for sig­na­tures in dif­fer­ent can­cers and across a range of im­munother­a­pies. Even­tu­al­ly, chief Mike Ro­manos told End­points News, the in­for­ma­tion will be used to de­vel­op mi­cro­bio­me-based ther­a­peu­tics to help pa­tients who are non-re­spon­ders be­come re­spon­ders.

Neu­ro­crine Bio­sciences has post­ed pos­i­tive bio­mark­er for its Phase II drug for con­gen­i­tal adren­al hy­per­pla­sia, a de­vel­op­ment-stunt­ing dis­ease. The open-la­bel study on the drug, called crinecer­font, found “mean­ing­ful re­duc­tions in all three key dis­ease hor­mone mark­ers” in adult pa­tients. A reg­is­tra­tional study is planned for next year.

AX­O­NIS Ther­a­peu­tics — fo­cused on the treat­ment of spinal cord in­jury and paral­y­sis — has closed the first part of a $4 mil­lion fi­nanc­ing round. The Cam­bridge, Mass­a­chu­setts-based com­pa­ny plans to use the funds to­wards the pre­clin­i­cal de­vel­op­ment of their neu­ro­mod­u­lat­ing KCC2 ther­a­py. The round was led by AX­O­NIS board mem­ber Ker­ry Mur­phy. The sec­ond tranche of fund­ing will be pro­vid­ed af­ter suc­cess­ful de­liv­ery of proof-of-con­cept da­ta — ex­pect­ed in ap­prox­i­mate­ly one year.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.