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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.