Atlas, F-Prime launch K36 Therapeutics to advance oncology molecule for elusive epigenetic target

Terry Connolly, K36 Therapeutics CEO

Af­ter be­ing in stealth for near­ly 11 months, a new biotech has made it­self known, com­plete with an in­flux of cash from some big-name in­vestors.

K36 Ther­a­peu­tics, an on­col­o­gy biotech out of Cam­bridge, MA, emerged from stealth this morn­ing — an­nounc­ing a long-fin­ished $30M Se­ries A co-led by F-Prime Cap­i­tal, At­las Ven­ture and glob­al in­vest­ment firm Eight Roads Ven­tures.

K36 CEO Ter­ry Con­nol­ly told End­points News that the se­ries was ac­tu­al­ly closed back in Feb­ru­ary — and is now just be­ing an­nounced. Con­nol­ly said that he ex­pects the fund­ing to get K36 through proof-of-con­cept stud­ies and hope­ful­ly push the can­di­date to the IND phase, which the biotech plans to file by the end of June next year.

If more fund­ing is need­ed, K36 will have those dis­cus­sions at that time — but in the mean­time, $30 mil­lion is enough, ac­cord­ing to Con­nol­ly.

With on­ly 5 em­ploy­ees, K36 on­ly has one drug it’s fo­cus­ing on: KTX-1001, which the com­pa­ny in-li­censed from No­var­tis. That drug tar­gets the hi­s­tone methyl­trans­ferase (HMT) MM­SET, look­ing at pa­tients with mul­ti­ple myelo­ma.

Con­nol­ly told End­points that he was em­ploy­ee No. 1 in mid-Feb­ru­ary.

He said what drew him to K36 was the tar­get. Con­nol­ly knew MM­SET from his time at Cel­gene, where he spent eight years be­fore mov­ing on to Drag­on­fly Ther­a­peu­tics and then to K36. Cel­gene was known for its mul­ti­ple myelo­ma drugs Rem­i­cade and Po­m­a­lyst, and al­so worked close­ly with the biotech Epizyme on a se­ries of methyl­trans­ferase in­hibitors.

‘And it’s re­al­ly just one of those holy grail tar­gets for mul­ti­ple myelo­ma, where peo­ple have been try­ing to drug it for a cou­ple of decades and no one has been suc­cess­ful,’ Con­nol­ly said in an in­ter­view. ‘So when I learned that there was a mol­e­cule that was avail­able for li­cens­ing, and this com­pa­ny was go­ing to in-li­cense the mol­e­cule and be the first to take a se­lect MM­SET in­hibitor in­to the clin­ic, I want­ed to be a part of that.’

The com­pa­ny’s cur­rent end goal is get­ting an IND sub­mit­ted. Af­ter that point, K36 will start look­ing at oth­er pro­grams, but not be­fore, Con­nol­ly said.

Along­side leav­ing stealth and an­nounc­ing its raise, K36 al­so an­nounced a new ad­di­tion to its board: Lori Kunkel, a for­mer act­ing CMO at Loxo On­col­o­gy and cur­rent­ly a mem­ber of the board of di­rec­tors at Nurix.

The drug is the newest can­di­date in a long line of drugs with epi­ge­net­ic tar­gets — and while some have worked, many of the drugs have not had as much ef­fi­ca­cy as hoped. It is in the same class of drugs as Epizyme’s tazeme­to­stat, a methyl­trans­ferase in­hibitor which got ap­proved for its sec­ond in­di­ca­tion last year in fol­lic­u­lar lym­phoma.

The US House of Representatives voted almost unanimously on Wednesday evening (423-3) to pass a bill that will provide $500 million over five years to certain small drugmakers to cover the costs of R&D and to expand access to patients not eligible for clinical trials for potential amyotrophic lateral sclerosis drugs.

Rare neurodegenerative diseases, like ALS, have been historically very difficult to treat and to develop treatments for. But this bipartisan bill, introduced by Rep. Mike Quigley (D-IL) and dozens of cosponsors, will provide $100 million for each of fiscal years 2022 through 2026 to help HHS award grants to facilitate the development and access to ALS drugs intended to prevent, diagnose, mitigate, treat, or cure the disease.

Mathai Mammen, J&J EVP of pharmaceuticals, R&D (Rob Tannenbaum)

The new J&J has a fresh corporate face to show the public — several in fact.

As the healthcare conglomerate follows a now familiar pharma path in separating itself into an innovation-focused R&D-based group from its less appealing consumer side, it’s promoting some key individuals to the executive committee that steers the company.

Those fresh faces include Mathai Mammen, the global head of R&D who joins the inner circle as executive vice president of pharmaceuticals, R&D. External innovation chief Bill Hait becomes executive vice president, chief external innovation, medical safety and global public health officer. Jim Swanson, until today simply the chief information officer, adds the EVP part to his title in moving onto the committee. And Vanessa Broadhurst, company group chairman, global commercial strategy organization, has been appointed EVP, global corporate affairs.

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Adam Margolin, NextVivo CEO

When conducting preclinical tests in drug development, researchers have for years used different kinds of animal models, from mice to nonhuman primates. But what if the need for such models became obsolete?

It’s one of many questions hoping to be answered by the biotech NextVivo, which emerged from stealth Thursday morning with a small $7.9 million seed round. With prominent Silicon Valley VC Khosla Ventures as the lead, it’s clear NextVivo has, at the very least, tickled the minds of big-name investors.

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Please signup to continue — it’s fast and free. This article is sponsored by Catalent and produced by Endpoints Studio. Each year, we aim to highlight 20 extraordinary women who are leaving their mark on drug R&D — and this year’s group was no exception.

Our list, while by no means exhaustive, includes scientists, CEOs, researchers and professors who are supercharging the discovery and development of new therapies worldwide. Our team of writers spent time with each honoree (with a few exceptions), learning their stories and sketching profiles, which you’ll find in our special report.

For the second time, we brought the celebration to a live virtual audience, featuring an award presentation followed by a panel on what it takes to break the glass ceiling in biopharma with Kojin Therapeutics CEO Luba Greenwood, AskBio CEO Sheila Mikhail, and Silverback Therapeutics CEO Laura Shawver. Our panelists had a lively discussion on how the industry’s culture has changed, how to handle sexual harassment, the progress we’ve made and the challenges that still hold women back today.

We applaud each of our honorees for scaling the heights of biopharma R&D. You got to meet most of them via brief recordings we played during our live event. Below, you’ll find bonus videos offering a longer glimpse into those interviews. And if you didn’t get a chance to tune in to our main event live, you can replay the entire show.

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Members of the public disembark a train at King Cross Station in London, on the day that extra measures are put in place to fight the spread of the Omicron variant of Covid-19. Since Nov. 30, it’s been mandatory for people in England to wear face coverings in shops and on public transport. (Ben Cawthra/Sipa USA/Sipa via AP Images)

Like hundreds of other virologists and epidemiologists, Benjamin tenOever’s Thanksgiving weekend was interrupted with emails about an emergency Omicron meeting.

But when he logged onto a WHO conference call 9 a.m. Monday morning, officials had a surprisingly upbeat spin on the little-understood variant that had already prompted leaders around the world, fearful the strain could evade vaccines, to close their borders to broad swaths of Southern Africa.

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Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Shane Schaffer, Cingulate CEO

A few months after filing its S-1, Cingulate finally joined the biotech IPO crowd yesterday — but it wasn’t greeted with quite the same fanfare that other life science companies saw earlier this year.

The Kansas-based biotech, focused on creating longer-acting ADHD meds, priced 4.2 million shares at $6 apiece, raising a meager $25 million. That price was the low end of an already revised range of $6 to $8.

Stephen Hahn (AP Photo/Alex Brandon, File)

Since leaving the FDA’s top post last January, Steve Hahn has been busy, jumping between multiple industry positions thanks to Flagship Pioneering, and most recently taking the helm at a startup focused on the detection of early cancer with a simple blood test.

Hahn’s new company, known as Harbinger Health, will receive $50 million from Flagship to use a proprietary platform combining AI and machine learning to potentially create an entirely new paradigm for cancer diagnosis, enabling early therapeutic interventions or prevention. Hahn’s prior work as chief medical executive of the University of Texas MD Anderson Cancer Center will likely inform his new role, where he’s serving as a Flagship CEO-partner as well as CEO of Harbinger.

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