The fight against drug-re­sis­tant bac­te­ria march­es for­ward as Adap­tive Phage earns $40M+ Se­ries B

A com­pa­ny work­ing to­ward the field of bac­te­rio­phages, de­vel­op­ing ther­a­pies that use bac­te­ria-killing virus­es, just pulled in a sig­nif­i­cant amount of new cap­i­tal.

Adap­tive Phage Ther­a­peu­tics closed a $40.75 mil­lion Se­ries B, the Gaithers­burg, MD-based biotech an­nounced Tues­day morn­ing. The fi­nanc­ing was led by Deer­field Man­age­ment with par­tic­i­pa­tion from the Mayo Clin­ic, which had been a pre­vi­ous in­vestor.

Bac­te­rio­phages had long been an emp­ty area of re­search in the US, but the field has gar­nered more in­ter­est re­cent­ly as an­tibi­ot­ic-re­sis­tant bac­te­ria con­tin­ue to grow in promi­nence. Some of the ear­li­est sci­en­tists to the­o­rize about their use have thought that find­ing the right phages can lead to bet­ter treat­ments for in­fec­tions and ill­ness­es.

The mol­e­cules are virus­es, and work the same way hu­man-in­fect­ing virus­es do — by en­ter­ing host cells and repli­cat­ing. But in this case the host cells are bac­te­ria. The ul­ti­mate goal of bac­te­rio­phage ther­a­py is to use phages to en­ter bac­te­r­i­al cells and cause them to burst, there­by cur­ing pa­tients.

It’s long proved a dif­fi­cult task, name­ly due to the lack of re­search and fund­ing which is fail­ing to help prove these the­o­ries. Many of the pa­tients who have re­ceived ex­per­i­men­tal bac­te­rio­phage ther­a­pies have al­so been ex­treme­ly sick, with the treat­ments used as last-re­sort op­tions.

Fur­ther­more, there’s the need to iden­ti­fy specif­i­cal­ly which bac­te­r­i­al strain is in­fect­ing pa­tients, and match­ing the right bac­te­rio­phage to the pathogen. Mis­match­ing the two not on­ly won’t help the sick pa­tients, but might end up caus­ing fur­ther harm as well.

For Adap­tive Phage, the funds will go to­ward the ther­a­pies that come out of its pro­pri­etary plat­form. The com­pa­ny is de­vel­op­ing a bank of phages, say­ing it’s col­lect­ed hun­dreds of dif­fer­ent virus­es so far that pro­vide broad cov­er­age against six high-pri­or­i­ty, drug-re­sis­tant bac­te­ria.

Adap­tive Phage’s two lead pro­grams are to treat pros­thet­ic joint in­fec­tion and di­a­bet­ic foot os­teomyelitis, and they al­so plan to use some funds to ad­vance a sus­cep­ti­bil­i­ty test to more quick­ly iden­ti­fy po­ten­tial phage ther­a­pies. The com­pa­ny’s tech­nol­o­gy was orig­i­nal­ly de­vel­oped by the Pen­ta­gon’s biode­fense pro­gram, and Adap­tive Phage ac­quired it in 2017.

Deer­field is no stranger to this area ei­ther, as it bought out Melin­ta in March 2020 af­ter the an­tibi­otics com­pa­ny filed for Chap­ter 11 bank­rupt­cy. The deal turned over con­trol to Deer­field in ex­change for the $140 mil­lion of se­nior debt it holds in the com­pa­ny.

So­cial: Greg Mer­ril, Adap­tive Phage Ther­a­peu­tics CEO (Adap­tive Phage)

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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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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