Deep­en­ing US foot­print, As­traZeneca-part­nered French biotech In­nate shoots for $100M IPO

Fresh off of a 20th birth­day cel­e­bra­tion, French biotech In­nate Phar­ma filed for a US IPO worth up to $100 mil­lion. They de­tailed in their fil­ings a strat­e­gy to roll cash in­to pre­clin­i­cal work, ad­vanc­ing the tri­als for two drugs tar­get­ing blood can­cer and sol­id tu­mors and fur­ther test­ing the check­point in­hibitor mon­al­izum­ab, while al­so build­ing a com­mer­cial in­fra­struc­ture to mar­ket and cap­i­tal­ize on their trade­mark leukemia drug Lu­mox­i­ti.

Jen­nifer But­ler

The im­muno-on­col­o­gy biotech ac­quired its first big drug last year as it li­censed Lu­mox­i­ti from As­traZeneca. It’s the first FDA-ap­proved drug for hairy cell leukemia in 20 years. But, as they write in their F-1, al­though the com­pa­ny will be ful­ly re­spon­si­ble for mar­ket­ing the drug by 2020, they “cur­rent­ly have no sales, mar­ket­ing or com­mer­cial prod­uct dis­tri­b­u­tion or­ga­ni­za­tion and have no ex­pe­ri­ence in mar­ket­ing or man­ag­ing the man­u­fac­tur­ing of prod­ucts.”

Long­time As­traZeneca ex­ec Jen­nifer But­ler is now the head of In­nate’s US op­er­a­tions.

The com­pa­ny brought in €93 mil­lion last year (around $100 mil­lion), and €59 mil­lion in the first half of 2019 (about $65 mil­lion). They have re­ceived $550 mil­lion over the last 10 years in up­front pay­ments, mile­stone pay­ments and eq­ui­ty in­vest­ments through part­ner­ships with As­traZeneca and Sanofi and oth­ers, and they es­ti­mate they’re el­i­gi­ble for up to $5.5 bil­lion in var­i­ous pay­ments from such col­lab­o­ra­tions.

The three largest stock­hold­ers are No­vo Nordisk, Med­Im­mune (which is owned by As­traZeneca) and Bpifrance Par­tic­i­pa­tions, with co-founder Hervé Brail­ly hold­ing a 2.1% slice. No­vo ac­quired its 13.9% stake in ex­change for a new im­muno-on­col­o­gy tar­get af­ter a vaunt­ed In­nate leukemia ther­a­py flunked a Phase II tri­al. The biotech is cur­rent­ly list­ed on Eu­ronext Paris.

As of June 30, they had $220 mil­lion in cash, cash equiv­a­lents, short term in­vest­ments and non-cur­rent fi­nan­cial as­sets.

The com­pa­ny is work­ing on three class­es of prod­ucts: broad-spec­trum im­mune check­point in­hibitors, tu­mor anti­gen tar­get­ing, and sup­pres­sive fac­tors of the TME.

They are cur­rent­ly test­ing mon­al­izum­ab, their lead drug, in col­lab­o­ra­tion with As­traZeneca for sol­id tu­mors, in­clud­ing SC­CHN (head and neck) and CRC (col­orec­tal). They part­nered out that drug as part of the same deal that li­censed Lu­mox­i­ti to them, with As­traZeneca ex­er­cis­ing its $100 mil­lion for an op­tion on the drug, with an­oth­er $100 mil­lion pay­out at the first Phase III de­vel­op­ment and $825 mil­lion in po­ten­tial mile­stone mon­ey.

Pre­lim­i­nary da­ta from the lat­est 40-per­son ex­pan­sion to a Phase II tri­al showed a 27.5% re­sponse rate and one com­plete re­sponse. Fol­low-up da­ta are com­ing with­in the year.

As­traZeneca al­so agreed to fun­nel $20 mil­lion in­to four pre­clin­i­cal pro­grams, each po­ten­tial­ly worth $355 mil­lion, and pur­chased their 9.8% stake in In­nate for $72 mil­lion. In­nate paid $50 mil­lion for Lu­mox­i­ti.

This year, they al­so gained FDA fast-track sta­tus for the an­ti­body IPH4102 for treat­ment-re­sis­tant Sézary syn­drome, an ag­gres­sive form of lym­phoma, in ad­di­tion to or­phan drug des­ig­na­tions in the US and Eu­rope.

Lu­mox­i­ti was ap­proved un­der pri­or­i­ty re­view af­ter a Phase III tri­al demon­strat­ed a 75% re­sponse rate, with 30% of pa­tients re­spond­ing com­plete­ly. But there were less than 100 pa­tients and the drug was no­table among the half of all FDA-ap­proved treat­ments that were stamped based on a sin­gle tri­al in 2018.

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.

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

Al­ny­lam gets the green light 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.

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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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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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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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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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.