Greg Miller, Transition Bio CEO

The tar­get is the sys­tem: Con­den­sates biotech as­pires to ‘rewrite the rule­book’ on drug dis­cov­ery

An­oth­er biotech has burst in­to the buzzy but still bud­ding field of bio­mol­e­c­u­lar con­den­sates with $50 mil­lion in Se­ries A fund­ing.

Tran­si­tion Bio, based in both Cam­bridge, UK, and Cam­bridge, MA, is look­ing to bring con­den­sate drug dis­cov­ery, a field that orig­i­nat­ed in neu­ro­science, to can­cer. Co-found­ed by two bio­physics pro­fes­sors — David Weitz of Har­vard and Tuo­mas Knowles of the Uni­ver­si­ty of Cam­bridge — the 18-month-old biotech is build­ing a ma­chine learn­ing plat­form that maps out con­den­sates in what Knowles de­scribed as a “phase di­a­gram.”

First ob­served in worm cells in 2009, con­den­sates are tran­sient droplets that help or­ga­nize the in­sides of cells, “bring­ing to­geth­er what needs to be to­geth­er,” Knowles said. But un­like or­ganelles, which sep­a­rate out a cell’s con­tents with phys­i­cal bar­ri­ers, con­den­sates act like liq­uids, con­dens­ing (hence the name) and dis­solv­ing to bring pro­teins to­geth­er or set them apart.

Tuo­mas Knowles

“Typ­i­cal­ly a healthy con­den­sate would be formed in a high­ly re­versible man­ner, such that when it’s no longer re­quired it can dis­solve and not clog up any of the oth­er cel­lu­lar ma­chin­ery,” Knowles said.

How­ev­er, dis­ease-re­lat­ed con­den­sates can mal­func­tion in a num­ber of ways. In some cas­es, they may gel to­geth­er so they’re no longer liq­uid and dis­solv­able, Knowles said. In oth­ers, con­den­sates may bring to­geth­er the wrong com­bi­na­tion of mol­e­cules or ap­pear where they don’t in healthy cells.

Us­ing its plat­form, Tran­si­tion Bio plans on map­ping out the many dif­fer­ent con­di­tions that lead to con­den­sate for­ma­tion and func­tion in cells. By do­ing so, the biotech hopes it can use ma­chine learn­ing to fig­ure out how to reg­u­late con­den­sates.

“Ar­guably, much of what we know about what makes a drug-like mol­e­cule is based on drug­ging sin­gle pro­teins,” Knowles said, “so those rules are like­ly to look very dif­fer­ent once we start to drug these very high­ly mul­ti­mer­ic and dy­nam­ic sys­tems.

“So we re­al­ly have to — in some sense — rewrite and re­dis­cov­er the rule book,” Knowles added.

There are a hand­ful of oth­er con­den­sate biotechs out there, in­clud­ing Dew­point Ther­a­peu­tics and Nereid, found­ed by the bio­physi­cists that penned the ini­tial worm study. In Feb­ru­ary, Dew­point, which has part­ner­ships with Bay­er and Mer­ck, raised an­oth­er $150 mil­lion hop­ing to get in­to the clin­ic by the end of next year.

For Tran­si­tion Bio, the next step will be to gen­er­ate in vi­vo val­i­da­tion for their con­den­sate sys­tem tar­gets, CEO Greg Miller said.

The Se­ries A round was led by North­pond Ven­tures and in­clud­ed Tai­ho Ven­tures, Bris­tol My­ers Squibb, Mag­net­ic Ven­tures, and Life­force Cap­i­tal, which led Tran­si­tion Bio’s seed round.

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.

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.

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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.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

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.

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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.

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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.

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.

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