Mark Alles. Celgene

Mark Alles be­gins his post-Cel­gene ca­reer on the board of a US-Chi­na biotech led by a for­mer col­league

An­ten­gene had Cel­gene writ­ten all over its brand. Its founder and CEO, Jay Mei, was the big biotech’s ex­ec­u­tive di­rec­tor of clin­i­cal de­vel­op­ment in hema­tol­ogy/on­col­o­gy for eight years be­fore launch­ing his own start­up in Chi­na with his for­mer em­ploy­er as a part­ner and in­vestor. Cel­gene chipped in­to An­ten­gene’s $120 mil­lion round last year, and just days ago, it al­so wooed Cel­gene’s Chi­na gen­er­al man­ag­er to be its chief busi­ness of­fi­cer.

You can add one more promi­nent il­lus­tra­tion to the list. In one of his first moves since sell­ing Cel­gene to Bris­tol-My­ers Squibb for $74 bil­lion, for­mer CEO Mark Alles is join­ing An­ten­gene’s board of di­rec­tors.

“Mark brings out­stand­ing gov­er­nance and com­mer­cial ex­pe­ri­ence that will help pro­mote our de­vel­op­ment and com­mer­cial strat­e­gy in Chi­na, the Asia Pa­cif­ic re­gions and the rest of the world,” Mei said in a state­ment.

While he was still work­ing for the New Jer­sey biotech, Mei had ac­com­pa­nied Alles on a trip to Bei­jing to meet with John Oyler re­gard­ing an as­set swap deal that would see BeiGene mar­ket­ing some of Cel­gene’s can­cer drugs in Chi­na, in ex­change for a made-in-Chi­na PD-1 (which they even­tu­al­ly dropped). In fact, he re­calls the ex­act date they met: May 14, 2016.

Jay Mei (End­points/Pharm­Cube)

Click on the im­age to see the full-sized ver­sion

That part­ner­ship ce­ment­ed BeiGene’s sta­tus as a pi­o­neer­ing US-Chi­na biotech act­ing as a bridge be­tween Amer­i­can in­no­va­tion and the vast Chi­nese mar­ket, con­tribut­ing their share of R&D work along the way. Mei counts An­ten­gene, based in Shang­hai and Philadel­phia, as a mem­ber of this camp — con­sist­ing of hy­brids that work like a multi­na­tion­al drug­mak­er but un­der­stand the do­mes­tic mar­ket deeply.

“In fact I of­ten say Chi­na is a coun­try with three worlds,” he told re­porters at the End­points-Pharm­Cube BI­IS con­fer­ence in late 2018. “[Shang­hai] is in the heart of the first world; you dri­ve an hour or two and it might be the sec­ond world; dri­ve three to four hours and you ar­rive at the third world. Chi­na is very com­plex.”

But the coun­try has gone a long way in em­brac­ing emerg­ing biotechs from over­seas — speed­ing up reg­u­la­to­ry process­es and ap­provals dras­ti­cal­ly — as well as nur­tur­ing its own.

“Ten years ago when I first came to Chi­na to in­tro­duce Cel­gene’s prod­ucts, the ex­perts had heard of our drugs be­cause they’d been to ASH and AS­CO,” Mei re­called. “But no­body had heard of the com­pa­ny.”

Thanks in part to Alles’ busi­ness de­vel­op­ment strate­gies, that is no longer the case. And the in­dus­try vet, who’s al­so tak­en a board role at Sy­ros, said he’s now ex­cit­ed to bring all that ex­pe­ri­ence to An­ten­gene now that it’s ever clos­er to com­mer­cial­iza­tion.

The first an­tic­i­pat­ed launch would be of se­linex­or, or ATG-010, a con­tro­ver­sial mul­ti­ple myelo­ma drug li­censed from Karyopharm. Al­so work­ing to­ward that goal is new CBO John Chin, who spent 15 years with Cel­gene and was cred­it­ed for man­ag­ing the Revlim­id fran­chise.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Philipp Spycher

Promis­ing bet­ter link­er tech to ADC field, Araris has 'very, very am­bi­tious' plans for the clin­ic

A couple months after raising CHF 2.5 million ($2.76 million) in initial seed funding, one-year-old Araris Biotech is topping off the round with another CHF 12.7 million ($14 million).

The Paul Scherrer Institute and ETH Zurich spinout now has CHF 15.2 million to work with, and CEO Philipp Spycher has big plans. He hopes to bring one of the company’s antibody-drug conjugates (ADC) to the clinic by late 2022 or early 2023. “It’s very, very ambitious, but we are very optimistic that we actually can make it,” he said.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for Hunt­ing­ton's

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.

Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.