From left to right: Carol Brown, Elizabeth Jaffee, and Mitchel Berger

Can­cer Moon­shot moves for­ward with new 'Cancer Cab­i­net' and goals to re­duce can­cer

Pres­i­dent Joe Biden’s re­vival of the Can­cer Moon­shot ini­tia­tive now in­cludes a new Can­cer Cab­i­net, with some big ideas to make the goals of the Moon­shot fea­si­ble.

The White House’s so-called Can­cer Cab­i­net — a new en­ti­ty cre­at­ed when Biden re-ig­nit­ed the Can­cer Moon­shot in Feb­ru­ary 2022 — an­nounced spe­cif­ic “pri­or­i­ty ini­tia­tives” ear­li­er this week as part of the ini­tia­tive’s stat­ed goal of try­ing to cut can­cer fa­tal­i­ty by half in 25 years. The Cab­i­net, ac­cord­ing to the White House, in­cludes mul­ti­ple fed­er­al agen­cies, in­clud­ing the NCI, FDA, CDC, and NIH — and the re­cent­ly-added De­part­ments of La­bor and Com­merce, NASA and the White House Gen­der Pol­i­cy Coun­cil.

Orig­i­nal­ly start­ed in 2016, the moon­shot ini­tia­tive was born af­ter then-Vice Pres­i­dent Biden un­der the Oba­ma ad­min­is­tra­tion lost his son Beau to brain can­cer.

The Can­cer Cab­i­net out­lined the fol­low­ing pri­or­i­ty ac­tions, a White House state­ment said:

  • im­prov­ing ac­cess to can­cer screen­ings, cit­ing that Amer­i­cans missed al­most 10 mil­lion can­cer screen­ings com­pared to pre­vi­ous years be­cause of the Covid-19 pan­dem­ic,
  • ad­dress­ing en­vi­ron­men­tal and tox­ic ex­po­sures, as the White House point­ed out that cer­tain en­vi­ron­men­tal fac­tors can play a role in cer­tain types of can­cer,
  • de­creas­ing the im­pact of pre­ventable can­cers through dif­fer­ent op­tions such as the HPV vac­cine and he­pati­tis C an­tivi­rals, and to
  • “sup­port” the R&D pipeline for de­vel­op­ment and in­volve more pop­u­la­tions in clin­i­cal re­search.

Be­yond that, the USP­TO al­so an­nounced that it was ex­tend­ing its fast-track pro­gram for can­cer prod­ucts, which was first im­ple­ment­ed in June 2016 as part of the Can­cer Moon­shot. Ac­cord­ing to the White House, patent ap­pli­ca­tions re­lat­ed to can­cer im­munother­a­py are giv­en an ac­cel­er­at­ed re­view, cut­ting the re­view time in half.

On top of those goals from the Can­cer Cab­i­net, the White House al­so an­nounced Wednes­day that it is ap­point­ing three doc­tors on­to the ad­vi­so­ry Pres­i­dent’s Can­cer Pan­el: Eliz­a­beth Jaf­fee, Mitchel Berg­er and Car­ol Brown. Mem­bers are ap­point­ed to serve three-year terms.

Jaf­fee, a deputy di­rec­tor at Johns Hop­kins’ can­cer cen­ter, is a pre­vi­ous AACR pres­i­dent and will serve as the Pan­el’s chair. Mitchel Berg­er, on top of be­ing the di­rec­tor of the Brain Tu­mor Cen­ter, is al­so di­rec­tor of the Cen­ter for Neu­ro­log­i­cal In­jury and Re­pair. Car­ol Brown is a gy­ne­co­log­ic on­col­o­gist at Sloan Ket­ter­ing.

And as part of the now-re­vi­tal­ized Can­cer Moon­shot, the CDC re­cent­ly cut a $215 mil­lion check as part of a 5-year, $1.1 bil­lion grant to fund the first year of three na­tion­al pro­grams es­tab­lished in the 1990s to im­prove can­cer pre­ven­tion, de­tec­tion, di­ag­no­sis and con­trol in all 50 states, plus 18 trib­al or­ga­ni­za­tions and five ter­ri­to­ries.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.