Astel­las forges a $390M deal to buy a biotech fo­cused on Ronald Evans’ ‘ex­er­cise-in-a-pill’ tech

Ron Evans

For years now, Salk’s Ron Evans — a cel­e­brat­ed se­r­i­al en­tre­pre­neur in sci­en­tif­ic cir­cles — has been con­cen­trat­ing on the po­ten­tial of a new path­way for turn­ing your av­er­age couch pota­to ro­dent in­to Mighty Mouse — with­out ex­er­cise. And now Astel­las has stepped in to buy the Cam­bridge, MA-based biotech that was one of the ear­ly en­thu­si­asts for this tech­nol­o­gy and its po­ten­tial ap­pli­ca­tion in Duchenne mus­cu­lar dy­s­tro­phy.

Al­ready a part­ner and eq­ui­ty in­vestor in Mi­to­bridge, Astel­las is pay­ing $165.5 mil­lion more in cash — added to about $60 mil­lion in eq­ui­ty it al­ready owns — to ac­quire the mi­to­chon­dria en­er­gy spe­cial­ists, along with an­oth­er $225 mil­lion in mile­stones.

The deal fol­lows an op­tion deal with Mi­to­bridge that dates back to 2013. The oth­er ma­jor share­hold­ers in Mi­to­bridge are MPM Cap­i­tal and Long­wood Founders Fund. Mi­to­bridge will now be­come a sub­sidiary of Astel­las.

Astel­las’ in­ter­est has been kept as Mi­to­bridge pur­sued its ear­ly-stage work on MA-211, now in Phase I.

A cou­ple of years ago the biotech in-li­censed pre­clin­i­cal tech de­vel­oped by Evans on PPARδ, a path­way he feels could trig­ger the health ben­e­fits of a rig­or­ous ex­er­cise regime, with­out the ac­tu­al ex­er­cise. Evans re­cent­ly com­plet­ed his pre­clin­i­cal work, say­ing he had per­fect­ed the ap­proach in mice.

Evans iden­ti­fied the drug as GW1516, a ver­sion of which has been cir­cu­lat­ing as a sup­ple­ment among ath­letes look­ing for an il­lic­it boost in per­for­mance. GSK had the drug and dropped it more than a decade ago af­ter se­ri­ous side ef­fects, in­clud­ing can­cer, ap­peared in the mice it was used on.

That path­way — if prop­er­ly used and de­vel­oped with­out the tox­i­c­i­ty — could have pro­found im­pli­ca­tions in DMD, a crip­pling dis­ease that leaves boys in wheel chairs at an ear­ly age, be­fore slow­ly killing them. Sarep­ta ob­tained a con­tro­ver­sial ap­proval for its drug for Duchenne, but the field is con­sid­ered wide open for any biotech that could pro­vide more sub­stan­tial ben­e­fits.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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