Pfiz­er's in­vest­ment fund is mak­ing waves in VC — in­clud­ing a $25M bet on IBD play­er Vedan­ta Bio­sciences

Pfiz­er has a gut feel­ing about Vedan­ta Bio­sciences.

On Tues­day, the Cam­bridge, Mass­a­chu­setts-based mi­cro­bio­me up­start be­came the fourth biotech to re­ceive an in­vest­ment from the Pfiz­er Break­through Growth Ini­tia­tive (PG­BI), bag­ging $25 mil­lion to send its in­flam­ma­to­ry bow­el dis­ease can­di­date to Phase II.

Since its launch in June, the PG­BI has in­vest­ed $120 mil­lion in small- to medi­um-sized biotechs span­ning sev­er­al key fo­cus ar­eas: in­ter­nal med­i­cine, in­flam­ma­tion and im­munol­o­gy, on­col­o­gy, rare dis­ease, vac­cines and hos­pi­tal. So far, Ho­mol­o­gy Med­i­cines has the largest stake, with $60 mil­lion to ad­vance its phenylke­tonuria (PKU) pro­gram.

In­spired by the abil­i­ty of fe­cal trans­plants to re­boot the bal­ance of healthy mi­crobes in the gut, Vedan­ta is work­ing on tai­lored pack­ages of bac­te­r­i­al strains de­signed to spur spe­cif­ic ther­a­peu­tic re­spons­es. The com­pa­ny says Pfiz­er’s in­vest­ment will fund a Phase II tri­al for its live bio­ther­a­peu­tic to treat IBD — dubbed VE202 — which is ex­pect­ed to launch this year.

VE202 is pro­duced from pure, clon­al bac­te­r­i­al cell banks, by­pass­ing the need for di­rect sourc­ing of fe­cal donor ma­te­r­i­al. Topline Phase I da­ta showed VE202 was gen­er­al­ly safe and well-tol­er­at­ed, and “demon­strat­ed durable and dose-de­pen­dent col­o­niza­tion,” Vedan­ta said.

“We be­lieve Vedan­ta’s ap­proach to mod­u­lat­ing the mi­cro­bio­me may hold promise for peo­ple liv­ing with IBD, and we are ex­cit­ed for its po­ten­tial as this im­por­tant study moves for­ward,” Michael Vin­cent, se­nior VP and CSO of Pfiz­er’s in­flam­ma­tion and im­munol­o­gy re­search unit, said in a state­ment.

Vin­cent is join­ing Vedan­ta’s sci­en­tif­ic ad­vi­so­ry board, and Pfiz­er holds rights to first ne­go­ti­a­tion on VE202. Mer­ck and Ab­b­Vie vet Jef­frey Sil­ber is lead­ing Vedan­ta’s ef­forts as CMO af­ter join­ing the com­pa­ny back in Sep­tem­ber.

Ho­mol­o­gy and Vedan­ta aren’t the on­ly two Mass­a­chu­setts-based biotechs to ben­e­fit from the PG­BI. Cam­bridge-head­quar­tered Tril­li­um Ther­a­peu­tics al­so snagged a $25 mil­lion in­vest­ment for its CD47 pro­gram. ES­SA Phar­ma, lo­cat­ed in Van­cou­ver, British Co­lum­bia, re­ceived a $10 mil­lion in­vest­ment for its work in the prostate can­cer space.

“Now, more than ever, our pa­tients need us, work­ing to­geth­er, to turn great sci­en­tif­ic ideas in­to in­no­v­a­tive new med­i­cines,” Pfiz­er said in a state­ment in June.

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.

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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.

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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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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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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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.

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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.