Terry Connolly, K36 Therapeutics CEO

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

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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Lorenz Mayr, Vector BioPharma CEO (PhoreMost)

Up­dat­ed: 'Close to the mid­dle': Ver­sant launch­es Vec­tor with 'gut­less ade­n­ovirus' de­liv­ery method

Most of the gene therapy world centers around viral vectors, but a few biotechs have sprung up in recent years to try and avoid the safety issues that can come with adeno-associated viruses.

A new biotech has emerged to straddle somewhere “close to the middle,” in the words of Alex Mayweg, Versant managing director and board member of the incubator’s latest startup, Vector BioPharma.

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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