Rahul Singhvi, Resilience CEO

Re­silience nets an­oth­er deal, this time with bil­lion­aire’s can­cer re­search cen­ter

Re­silience is hav­ing a fun week. Fresh off a $625 mil­lion Se­ries D and the launch of a joint ven­ture with MD An­der­son, the bio­man­u­fac­tur­er Re­silience has inked an­oth­er part­ner­ship with an in­flu­en­tial can­cer cen­ter.

Sean Park­er

Bil­lion­aire Nap­ster founder Sean Park­er’s Park­er In­sti­tute for Can­cer Im­munother­a­py (PI­CI) and Re­silience on Wednes­day cracked open a five-year strate­gic al­liance to de­vel­op and man­u­fac­ture can­cer ther­a­pies gen­er­at­ed from PI­CI’s net­work of im­munother­a­py re­search cen­ters.

The deal aims for PI­CI and Re­silience to bring nov­el cell and gene ther­a­pies to mar­ket through the cre­ation and in­cu­ba­tion of new com­pa­nies with a com­mit­ment of up to $50 mil­lion in fund­ing. The deal will lever­age tech­nolo­gies from across the PI­CI Net­work and have di­rect ac­cess to Re­silience’s bio­man­u­fac­tur­ing ca­pac­i­ty and ca­pa­bil­i­ties.

“This strate­gic al­liance is rep­re­sen­ta­tive of the trans­for­ma­tive growth un­der­way at PI­CI as we take our vi­sion to the next lev­el with new com­pa­ny in­vest­ments and in­cu­ba­tion,” Park­er said in a state­ment.

The agree­ment will see Re­silience al­so col­lab­o­rat­ing with PI­CI in­ves­ti­ga­tors on chal­lenges re­lat­ed to bio­man­u­fac­tur­ing and nov­el treat­ment modal­i­ties. Re­silience will al­so serve as PI­CI’s first val­ued man­u­fac­tur­ing part­ner for com­plex modal­i­ties. It will al­so work with PI­CI-af­fil­i­at­ed part­ners.

Re­silience and PI­CI will es­tab­lish a joint steer­ing com­mit­tee to ap­prove in­vest­ments and new com­pa­ny op­por­tu­ni­ties, mon­i­tor and track the progress of al­liance port­fo­lio com­pa­nies, and iden­ti­fy chal­lenge fo­cus ar­eas, among oth­er du­ties.

This is not PI­CI’s first for­ay in­to forg­ing deals as it has pre­vi­ous­ly worked with biotechs like Xyphos Bio­sciences to de­vel­op a CAR-T ther­a­py. The or­ga­ni­za­tion has a slew of part­ner­ships and deals with com­pa­nies, uni­ver­si­ties and re­search or­ga­ni­za­tions since its found­ing in 2016.

Re­silience in the mean­time is rid­ing high on its new round of in­vest­ment to fur­ther its mis­sion of be­com­ing the “Fox­conn” of biotech, which was in­tend­ed to be used to build out more deals, po­ten­tial ac­qui­si­tions and R&D ex­pan­sion.

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.

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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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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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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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.

‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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