Bio­Th­eryX col­lects $92M in Se­ries E round; WuXi Bi­o­log­ics ups its stake in an emerg­ing ADC play­er

Bio­Th­eryX is con­tin­u­ing to rake in in­vestor cap­i­tal, net­ting a fresh $92 mil­lion Se­ries E round on Thurs­day.

The San Diego-based com­pa­ny not­ed it will fund at least two spe­cif­ic pro­grams in its an­nounce­ment: BTX-A51 and BTX-1188. The for­mer, Bio­Th­eryX’s lead can­di­date, is a mul­ti-ki­nase in­hibitor look­ing at p53 pro­tein mod­u­la­tion in acute myeloid leukemia, myelodys­plas­tic syn­drome and sol­id tu­mors. BTX-A51 is cur­rent­ly in a Phase I tri­al for r/r AML.

BTX-1188, mean­while, is what the com­pa­ny calls a PHM-based PRO­TAC and mono­va­lent de­grad­er. It’s in the IND-en­abling phase, with goals for hema­to­log­i­cal ma­lig­nan­cies and sol­id tu­mors.

“With this fi­nanc­ing, we are well po­si­tioned to ex­e­cute our plans to bring our first mol­e­c­u­lar glue pro­gram BTX-1188 in­to the clin­ic by the end of 2021, ex­pand our plat­form of mol­e­c­u­lar glues, PRO­TACs and mono­va­lent de­graders and progress our lead pro­gram BTX-A51 through Phase I,” CEO Robert Williamson said in a state­ment.

Far­al­lon Cap­i­tal Man­age­ment led the round, and Bio­Th­eryX saw oth­er par­tic­i­pa­tion from Avid­i­ty Part­ners, Deep Track Cap­i­tal, Janus Hen­der­son, Lu­mi­ra, Point72, Rock Springs Cap­i­tal, Sur­vey­or Cap­i­tal, Tekla Cap­i­tal Man­age­ment, Alexan­dria Ven­ture In­vestors and ex­ist­ing in­vestors. — Max Gel­man

WuXi Bi­o­log­ics ups its stake in an emerg­ing ADC play­er

Less than a year and a half af­ter launch­ing, Du­al­i­ty Bi­o­log­ics is al­ready back at the ven­ture well, this time pulling up a hefty $90 mil­lion Se­ries B round.

The start­up says it’s work­ing on a next-gen ADC plat­form, and has al­ready raised more than $120 mil­lion to date. WuXi Bi­o­log­ics, which con­tributed to the Se­ries A, upped its stake this time around.

“ADC has emerged as an ex­cit­ing ther­a­peu­tic modal­i­ty which at­tracts in­creas­ing in­vest­ment from phar­ma­ceu­ti­cals and ven­tures,” WuXi CEO Chris Chen said in a state­ment.

Du­al­i­ty­Bio, as it’s al­so called, is fo­cused on de­vel­op­ing AD­Cs and bis­pe­cif­ic an­ti­bod­ies for on­col­o­gy and au­toim­mune dis­eases. It says it has sev­er­al pre­clin­i­cal can­di­dates in the works.

The Se­ries B round was led by Lil­ly Asia Ven­tures, with a hand from YU­NION Health­care Fund, Hua­gai Cap­i­tal, NRL Cap­i­tal, Green Pine Cap­i­tal Part­ners, and Oriza Hold­ings.

“With­in just over one year, Du­al­i­ty­Bio has not on­ly es­tab­lished a world-class team with deep in­dus­try in­sights and ex­cel­lent ex­e­cu­tion ca­pa­bil­i­ties, but al­so forged a glob­al­ly com­pet­i­tive drug de­vel­op­ment plat­form with a very strong pipeline,” said Yi Shi, found­ing man­ag­ing part­ner of LAV. — Nicole De­Feud­is 

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.

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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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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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

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.

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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.