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.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Sanjiv Patel, Relay CEO

Re­lay reaps $400M IPO wind­fall af­ter draw­ing the cur­tain on mo­tion-based drug de­sign pipeline

A red-hot venture market back in 2018 propelled Relay Therapeutics to a whopping $400 million crossover round. And now, the biotech is riding on a red-hot IPO market to a public debut that brought in the same exact amount.

The $400 million raise breaks down to 20 million shares sold at $20 each — above even the amended proposed range of $16 to $18.

It’s also double what Relay had penciled in with the initial S-1 filing, in yet another illustration that those figures are often nothing more than a placeholder these days.

Source: Shutterstock

Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

BioAt­la rakes in $72.5M Se­ries D, ad­vanc­ing re­search for pH-de­tect­ing can­cer treat­ments

A little over a year after agreeing to a worldwide collaboration with hefty Chinese biotech BeiGene worth up to $270 million, BioAtla is ready for another haul.

The San Diego-based biotech pulled in a $72.5 million haul for their Series D financing, which the company announced Wednesday. Funds will go toward their four main clinical programs developing cancer treatments, two of which are currently in Phase II, BioAtla president and former Celgene COO Scott Smith said.

Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

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

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Covid-19 roundup: Vac­cine by end of 2020? Ken Fra­zier warns hype do­ing 'grave dis­ser­vice'

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

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Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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