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)

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline swoop in­to Nas­daq on the wings of Jim Mom­tazee's SPAC with a $7B-plus Roivant de­but ready to do some deals

Seven years after founding Roivant Sciences as an upstart contender in the world of biotech creation, Vivek Ramaswamy and his recently anointed CEO Matt Gline are gliding into Nasdaq on the gilded wings of a cash-heavy SPAC.

In a carefully crafted SPAC pact aimed at wedding new investors at Montes Archimedes Acquisition Corp. with a syndicate of investors coming back to re-up for the next round of company building, they’ve assembled a fresh $611 million in financing for Roivant — $411 million held in trust from the investors in MAAC with a fresh $200 million from the syndicate.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.