Roche pulls a tu­mor mi­cro-en­vi­ron­ment drug out of the freez­er, hands it to a UK up­start

Two years af­ter pulling it from clin­i­cal de­vel­op­ment, Roche has hand­ed con­trol of a sol­id tu­mor can­cer drug to a tiny Ox­ford Uni­ver­si­ty spin­out.

For an undis­closed fee, Celleron Ther­a­peu­tics ac­quired the drug, an an­ti-CSF1R an­ti­body that’s de­signed to mod­u­late the tu­mor mi­cro-en­vi­ron­ment — an in­creas­ing­ly pop­u­lar ap­proach among can­cer drug de­vel­op­ers. Celleron says it will now put the drug in­to tri­als for pa­tients with tenosyn­ovial gi­ant cell tu­mors, a rare dis­ease where se­ries of be­nign tu­mors be­gin to grow around the joints and ten­dons. It’s caused by cells over-pro­duc­ing CSF1R.

The deal ap­pears to be a straight biotech-re­pur­pos­ing-off-the-Phar­ma-shelf deal. Al­though Roche launched 4 dif­fer­ent tri­als for the drug — one of which is still tech­ni­cal­ly on-go­ing — the Swiss phar­ma re­tired the drug as part of a broad pipeline sweep back in Oc­to­ber of 2018. It was a “busi­ness de­ci­sion,” the com­pa­ny wrote on one with­drawn study’s page on clin­i­cal­tri­, stip­u­lat­ing there were “no safe­ty or ef­fi­ca­cy con­cerns.”

In fact, the an­ti­body had looked promis­ing in the on­ly ef­fi­ca­cy re­sults that ever sur­faced. In a Phase I study pub­lished in The Lancet On­col­o­gy, 24 out of 28 pa­tients re­spond­ed to the drug, and two of them had a com­plete re­sponse.

Celleron will now have a chance to test whether those re­sults can bear out in larg­er tri­als. The com­pa­ny says it’s “built a pro­pri­etary plat­form around epi­ge­net­ic con­trol and im­mune mod­u­la­tion,” but most of their clin­i­cal ef­forts so far have fo­cused on an in-li­censed drug from As­traZeneca that in­hibits hi­s­tone deacety­lase, a class of en­zymes that change one of the types of epi­ge­net­ic mark­ers on DNA. They’ve put it in­to Phase I and Phase II tri­als in the UK and in Chi­na in dif­fer­ent com­bi­na­tions and dif­fer­ent can­cers, in­clud­ing T-cell lym­phomas and HCC.

Still, Celleron has its own as­sets, in­clud­ing a se­ries of pre­clin­i­cal as­sets that tar­get hi­s­tones. They al­so have CXD201, a mol­e­cule that in­hibits topoi­so­merase, one of the en­zymes that winds and un­winds DNA. And they say they use bio­mark­er da­ta to match the best drugs to the best pa­tients.

The com­pa­ny has nev­er an­nounced how much cap­i­tal they’ve raised, but they said in 2017 they raised fund­ing from a South Ko­re­an con­sor­tium.

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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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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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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Ramy Farid, Schrödinger CEO (Schrödinger)

Bris­tol My­ers fronts new Schrödinger al­liance with $55M up­front, ex­pand­ing pre­ci­sion on­col­o­gy pro­file

Bristol Myers Squibb has a new R&D partner, one to which they’re paying a pretty penny to use their discovery platform.

The pharma company is doling out $55 million upfront to Schrödinger $SDGR to work on up to five small molecules, with the potential for $2.7 billion in milestone payments. Schrödinger’s initial targets include HIF-2 alpha and SOS1/KRAS for a type of kidney cancer and KRAS-driven cancers, respectively.

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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