As­traZeneca joins Mer­ck, Bris­tol-My­ers in Chi­na's check­point race as reg­u­la­tors OK first PD-L1

As­traZeneca has made a stride to­ward re­al­iz­ing its am­bi­tions in Chi­na as reg­u­la­tors green­light Imfinzi as a treat­ment for non-small cell lung can­cer.

In par­tic­u­lar, the PD-L1 agent is fill­ing a void for im­munother­a­pies in Stage III un­re­sectable case, the com­pa­ny said, where the can­cer has not spread to the rest of the body. It is to be used, with cu­ra­tive in­tent, in pa­tients whose can­cer hasn’t pro­gressed fol­low­ing con­cur­rent plat­inum-based chemother­a­py and ra­di­a­tion ther­a­py.

Dave Fredrick­son

“This ap­proval il­lus­trates our long-stand­ing com­mit­ment to im­prov­ing health out­comes in Chi­na, where more than one-third of the world’s lung can­cer di­ag­noses and deaths oc­cur,” said Dave Fredrick­son, who heads As­traZeneca’s on­col­o­gy busi­ness unit, in a state­ment.

Imfinz’s ap­proval al­so marks the en­try of a PD-L1 in­hibitor to the coun­try, where PD-1 drugs have been pil­ing up. Bris­tol-My­ers Squibb scored the first-ever Chi­nese ap­proval for a check­point in­hibitor in June 2018, with Op­di­vo in­di­cat­ed for sec­ond-line treat­ment of NSCLC, and Mer­ck has been rack­ing up OKs for dif­fer­ent reg­i­mens in­volv­ing Keytru­da.

Then there are the do­mes­tic ri­vals, whose drugs are cur­rent­ly lim­it­ed to lym­phoma or melanoma but al­so have plans for a lu­cra­tive lung can­cer mar­ket. And they are ea­ger to com­pete on price.

Leon Wang

For As­traZeneca, this is just more rea­son to roll up its sleeves and get to ne­go­ti­at­ing with pay­ers. Its head of Chi­na, Leon Wang, has pre­vi­ous­ly told Bloomberg that he sees new treat­ments con­tribut­ing to 60% of all its Chi­na rev­enue with­in five years. To il­lus­trate that dri­ve, Wang of­fered the ex­am­ple of its first-gen EGFR-tar­get­ing lung can­cer Ires­sa, in which they won the drug sup­ply con­tract in by slash­ing the price more than 70%.

Quick ap­provals for third-gen EGFR TKI Tagris­so (which is now on the Na­tion­al Re­im­burse­ment Drug List), as well as the PARP in­hibitor Lyn­parza, helped — and now it’s time for Imfinzi to shine. No­tably, Roche’s PD-L1 Tecen­triq — which gained FDA ap­proval ear­li­er than Imfinzi — is not yet avail­able in Chi­na.

In the Phase III PA­CIF­IC tri­al, Imfinzi cut the risk of death by 32% and pro­longed pro­gres­sion-free sur­vival by 11.2 months ver­sus place­bo (me­di­an PFS 16.8 vs 5.6 months), when paired with chemo or ra­di­a­tion ther­a­py. At the three-year mark, 57% of pa­tients on the Imfinzi arm are still alive com­pared to 43.5% on place­bo, ac­cord­ing to a post hoc analy­sis pre­sent­ed at AS­CO.

Imfinzi sales have gone over the $1 bil­lion mark in the first three quar­ters of the year, grow­ing 182% com­pared to the same pe­ri­od last year.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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CEO Stephen Yoder (Pieris)

Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Artist rendering of the Assembly Square site in Somerville, MA (BioMed Realty)

Bio­Med Re­al­ty snaps up in­no­va­tion cam­pus site with­in earshot of pricey and bustling Boston biotech hub

On the short list of the premier biotech hubs in the world, the Boston area has transformed into a home for innovation — and ridiculously high rent. Now, a real estate firm is seeking tenants for a major site in neighboring Somerville with more than enough elbow room.

Snapped up by BioMed Realty, the land — which consists of an existing 162,000 square-foot office building and a 7.5 acre site — will serve as an “innovation space” for a variety of research, technology and life science tenants, the real estate company said in a press release. Financial terms weren’t disclosed.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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