Months af­ter burst­ing in­to the bis­pe­cif­ic scene out of nowhere, Janux fol­lows the Mer­ck hype to an IPO

Hot off of a $1 bil­lion deal with Mer­ck signed in De­cem­ber, Janux Ther­a­peu­tics has been on a tear with vir­tu­al­ly back-to-back fi­nanc­ing rounds. Now, it’s ready for Wall Street.

Janux filed an IPO with the SEC Wednes­day with a $100 mil­lion pro­posed of­fer­ing, though that num­ber has be­come a place­hold­er for biotechs in the last 16 months who of­ten go on to raise much more.

David Camp­bell

De­cem­ber’s deal left Janux el­i­gi­ble for up to $500.5 mil­lion in up­front and mile­stone pay­ments ear­marked for each of two tar­gets se­lect­ed by Mer­ck. Talks of the deal had start­ed in per­son the Jan­u­ary be­fore the pan­dem­ic, and fi­nal­ized as the Janux pro­grams evolved, CEO David Camp­bell told End­points News in an in­ter­view.

But ac­cord­ing to its S-1, Mer­ck paid just $8 mil­lion up­front in con­nec­tion to the first tar­get, and will pay an­oth­er $8 mil­lion up­on the se­lec­tion of the sec­ond. Janux will re­ceive mile­stone pay­ments of $142.5 mil­lion for each of the tar­gets that suc­cess­ful­ly reach reg­u­la­tion, and the re­main­ing po­ten­tial $350 mil­lion will de­pend on sales of the li­censed prod­uct.

Janux com­plet­ed a $56 mil­lion Se­ries A in March, then in late April, the com­pa­ny an­nounced a $125 mil­lion crossover round led by RA Cap­i­tal, a Boston VC be­hind sev­er­al pre-IPO fi­nanc­ings. It’s a com­pa­ny that’s flour­ished since the Mer­ck deal, de­spite not en­ter­ing the clin­ic yet. Pre­vi­ous­ly, that would hold com­pa­nies back from go­ing pub­lic, but not as of late.

The small San Diego biotech was found­ed in 2017 on a T cell en­gager plat­form called TRAC­Tr, which promis­es to pro­duce drugs that al­ter their phar­ma­co­ki­net­ics de­pend­ing on the con­text. Up­on ac­ti­va­tion in a tu­mor, its can­di­dates are con­vert­ed from their orig­i­nal form — which can re­main in the blood­stream for over 100 hours — to a T cell en­gager that on­ly cir­cu­lates for less than an hour.

TCEs bridge a tu­mor cell and a T cell to redi­rect T cells to elim­i­nate tu­mors, and are pop­u­lar be­cause the po­ten­tial to of­fer them as read­i­ly avail­able, off-the-shelf drugs avoids the man­u­fac­tur­ing process typ­i­cal­ly as­so­ci­at­ed with CAR T-cell ther­a­pies, which can be lengthy.

In its S-1 fil­ing, the com­pa­ny said that TRAC­Tr can­di­dates test­ed in pri­mates have shown the po­ten­tial to sig­nif­i­cant­ly re­duce the risk of tox­ic cy­tokine re­lease syn­drome re­sponse and im­prove half-life with week­ly dos­ing in hu­mans.

The com­pa­ny ex­pects to sub­mit at least 2 INDs by 2022’s end, ini­tial­ly seek­ing ap­proval for lat­er lines of ther­a­py in pa­tients with can­cer. Its 2 lead can­di­dates tar­get­ing TROP2 and PS­MA were “on the cusp” of en­ter­ing IND stud­ies in Q1 back in De­cem­ber, Cam­bell said, though it ap­pears to have missed that boat.

Janux is jump­ing in a field that’s gained sub­stan­tial heat since Am­gen first ush­ered Blin­cy­to to an ap­proval in 2014 for the treat­ment of lym­phoblas­tic leukemia. So­te­ria Bio­ther­a­peu­tics with back­ing from Roche re­cent­ly re­ceived Se­ries A fund­ing to ad­vance its bis­pe­cif­ic T cell en­gagers with an “on-off” switch that founders think can avoid some safe­ty flags. Take­da bought Mav­er­ick in a $525 mil­lion deal in March af­ter get­ting to know its T cell en­gager tech through a pact.

The S-1 fil­ing al­so re­vealed that Janux has li­censed a cell line from WuXi Bi­o­log­ics in April for $150,000. That deal could land WuXi as much as $15 mil­lion.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

When John Maher treated the first head and neck cancer patient at Guy’s Hospital in London with his pan-ErbB CAR-T back in 2015, he was among a small club of researchers convinced they had an answer to the challenges that had kept those engineered T cells — wildly successful in hematological cancers — either too dangerous or out of reach for patients with solid tumors.

The field has blossomed since then, with a proliferation of technologies that promise to address any number of challenges identified as unique to solid tumors. And Maher himself has rethought his approach and come up with a new CAR-T platform to generate the next slate of candidates.