Michael Kamdar, Molecular Assemblies CEO

With a new method to syn­the­size DNA, San Diego's Mol­e­c­u­lar As­sem­blies notch­es $24M Se­ries A

A San Diego biotech is tak­ing a clos­er look at the way syn­thet­ic DNA is en­gi­neered, aim­ing to po­ten­tial­ly re­vamp the decades-old process and serve as a part­ner to com­pa­nies with­out the re­sources to cre­ate the DNA them­selves.

And now they have sig­nif­i­cant in­vestor back­ing to do so. Mol­e­c­u­lar As­sem­blies closed an over­sub­scribed Se­ries A on Thurs­day morn­ing, lock­ing down $24 mil­lion in the round to ad­vance their syn­thet­ic bi­ol­o­gy plat­form.

The big idea here start­ed more than 30 years ago, when Mol­e­c­u­lar As­sem­blies’ co-founder J. William Ef­cav­itch helped com­mer­cial­ize the first method of syn­the­siz­ing DNA through a chem­i­cal-based method at an­oth­er com­pa­ny. Though it en­abled growth in bio­phar­ma, the method uti­lized ma­te­ri­als that caused waste is­sues and dam­aged the DNA even as it pro­duced the nu­cleotides.

Not on­ly is this process cum­ber­some and ex­pen­sive, it’s still the pri­ma­ry way in which com­pa­nies cre­ate DNA for ther­a­peu­tic pur­pos­es, CEO Michael Kam­dar told End­points News. Where Mol­e­c­u­lar As­sem­blies, found­ed in 2013, hopes to step in is with a new tech­nique to syn­the­size DNA strands while cut­ting down on costs and the tox­ic waste.

Their goal is to es­sen­tial­ly cre­ate DNA in the same way the body makes it, and re­searchers have de­vel­oped a two-step, aque­ous ap­proach. It can de­liv­er high­ly-pure, se­quence-spe­cif­ic DNA on de­mand, Kam­dar said, and do so with­out a tem­plate.

It can scale to longer DNA se­quences, some­thing Kam­dar said he be­lieves can be a “game-chang­er” in the are­na. Where­as the old method can be lim­it­ed to short­er DNA strands of about 70 to 75 nu­cleotides and more nar­row ap­pli­ca­tions, Mol­e­c­u­lar As­sem­blies says their process can cre­ate strands of 150 nu­cleotides or longer.

Ul­ti­mate­ly, the com­pa­ny as­pires to get to a point where their cus­tomers are ask­ing for DNA strands that are as long as genes — 1,500 nu­cleotides.

“We’re go­ing to be the ink in all the print­ers,” Kam­dar told End­points. “If a ther­a­peu­tic or biotech­nol­o­gy com­pa­ny needs DNA to ad­vance their ef­forts in CRISPR, or ad­vance their ef­forts in CAR-T, or ad­vance their ef­forts in vac­cines, we can be the ink in that ap­proach. And then what they de­vel­op be­comes the fin­ished prod­uct that you see go­ing to pa­tients.”

There are a host of ap­pli­ca­tions for these types of long DNA, rang­ing from ther­a­peu­tics and agri­cul­ture to da­ta stor­age, Kam­dar said. Right now, though, the com­pa­ny is fo­cus­ing on its work with part­ners. Last year, Mol­e­c­u­lar As­sem­blies signed on­to a deal with Codex­is, cou­pling their syn­thet­ic DNA tech­nol­o­gy with Codex­is’ pro­tein en­gi­neer­ing ca­pa­bil­i­ties. That deal has served as a sort of proof-of-con­cept, Kam­dar said, il­lus­trat­ing that the tech works to pro­duce pure, long DNA strands.

Thurs­day’s fi­nanc­ing al­so comes about a month af­ter Mol­e­c­u­lar As­sem­blies signed on to a DARPA project for DNA- and RNA-based vac­cines and ther­a­pies. Led by GE re­search, the ini­tia­tive aims to cre­ate a mo­bile, on-de­mand plat­form that can be de­ployed to re­gions ex­posed to dis­ease. Mod­er­na is al­so in­volved in the pro­gram, the gov­ern­ment says.

Next up is work­ing to­ward more part­ner­ships with biotechs, and Kam­dar says they in­tend to forge some new al­liances over the next 12 to 18 months. The com­pa­ny has seen in­ter­est from those fo­cused on gene ther­a­py, but Mol­e­c­u­lar As­sem­blies is look­ing at sev­er­al po­ten­tial ap­pli­ca­tions.

In­vestors in­volved in the raise in­clud­ed Ag­i­lent Tech­nolo­gies, iS­e­lect Fund, Codex­is, Alexan­dria Ven­ture In­vest­ments, and Arg­onau­tic Ven­tures. In ad­di­tion, LYFE Cap­i­tal joined the syn­di­cate.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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