Weeks af­ter rais­ing $40M, Cel­gene-part­nered In­hi­brx lays ground­work for near­ly $75M pub­lic de­but

Cel­gene-part­nered biotech In­hi­brx has had a busy 2019 so far. The La Jol­la, Cal­i­for­nia-based com­pa­ny kicked off an ear­ly-stage on­col­o­gy study, part­nered with blue­bird bio, signed a pact with Italy’s Chiesi Group and se­cured a $40 mil­lion ven­ture cap­i­tal in­jec­tion. On Mon­day, it laid the ground­work for a rough­ly $75 mil­lion IPO.

In­hi­brx is de­vel­op­ing a pletho­ra of bi­o­log­ics — it has three on­col­o­gy pro­grams in hu­man clin­i­cal tri­als, a rare dis­ease pro­gram, for which it ex­pects to ini­ti­ate a hu­man study in the third quar­ter of 2019, as well as two pre­clin­i­cal drugs.

Its lead ex­per­i­men­tal drug tar­gets death re­cep­tor 5, or DR5, and is de­signed to treat mul­ti­ple tu­mor types, in­clud­ing dif­fi­cult-to-treat gas­troin­testi­nal tu­mors and mesothe­lioma both as a monother­a­py and in com­bi­na­tion with chemother­a­py. It is cur­rent­ly be­ing in­ves­ti­gat­ed in an ear­ly stage tri­al in pa­tients with sol­id tu­mors in­clud­ing sar­co­mas, and the read­out of that study is ex­pect­ed in the sec­ond half of this year.

Glob­al rights to In­hi­brx’s drug, IN­BRX-103, tar­get­ing CD47 — which pro­tects tu­mor cells from be­ing en­gulfed by macrophages — have been li­censed to Cel­gene $CELG. Mean­while, it has en­tered in­to an op­tion agree­ment with Chiesi for de­vel­op­ment and com­mer­cial­iza­tion rights out­side of North Amer­i­ca for IN­BRX-101 — which is be­ing de­vel­oped for the rare res­pi­ra­to­ry dis­ease Al­pha-1 an­tit­rypsin (AAT) de­fi­cien­cy.

Now, In­hi­brx is look­ing to list on the Nas­daq un­der the sym­bol “$IN­BX” and raise $74.75 mil­lion in the IPO. In a sep­a­rate pri­vate place­ment con­cur­rent with the of­fer­ing, Chiesi is buy­ing $10 mil­lion worth of In­hi­brx shares, ac­cord­ing to In­hi­brx’s fil­ing.

Last month, In­hi­brx raised $40 mil­lion from Viking Glob­al In­vestors — al­to­geth­er the com­pa­ny has so far raised $205 mil­lion since its in­cep­tion. Oth­er in­vestors in the biotech in­clude RA Cap­i­tal, Lil­ly Asia Ven­tures, Ar­row­Mark Part­ners, WuXi Bi­o­log­ics and Alexan­dria.

Im­age: Fer­gu­son Pape Bald­win Ar­chi­tects (FP­BA)

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Center” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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