Rick Klaus­ner Lyell

→ Lyell chief Rick Klaus­ner con­tin­ues to build up his net­work of com­pa­nies beaver­ing away at new cell ther­a­pies. The Glax­o­SmithK­line part­ner led a $45 mil­lion E round for Eu­re­ka Ther­a­peu­tics, which is work­ing with en­gi­neered T cells on sol­id tu­mors. Klaus­ner, a for­mer di­rec­tor of the Na­tion­al Can­cer In­sti­tute, al­so found­ed Juno and Grail. The fund­ing comes with a strate­gic re­search col­lab­o­ra­tion be­tween Eu­re­ka and Lyell.

→ Shares of Blue­print Med­i­cines $BPMC bounced high­er Tues­day morn­ing af­ter the Cam­bridge, MA-based biotech re­port­ed that their mid-stage study for avapri­tinib in pa­tients with in­do­lent sys­temic mas­to­cy­to­sis of­fered pos­i­tive da­ta. Blue­print says that at 16 weeks they record­ed a sig­nif­i­cant de­cline of 30% in pa­tients’ to­tal symp­tom score. An­drew Berens at SVB Leerink not­ed: “While we be­lieve Ay­vak­it in iSM pro­vides an­oth­er val­ue dri­ver for BPMC shares, we ac­knowl­edge the fun­da­men­tal val­u­a­tion dis­con­nec­tion from cur­rent BPMC shares amid mar­ket tur­moil.”

→ Wel­comed to the Hong Kong Stock Ex­change with open arms, In­no­Care has bagged $288 mil­lion in its IPO, Reuters re­port­ed. The biotech — which has of­fices across Bei­jing, Shang­hai, Nan­jing, Guangzhou, Prince­ton and Boston — has priced its float at the top of the range (HK$8.95), mark­ing the first ma­jor IPO to pro­ceed in Hong Kong since the stock mar­ket re­opened af­ter the Lu­nar New Year hol­i­day amid coro­n­avirus fears. Most of the new cash will go to­ward its lead drug, a BTK in­hibitor dubbed ore­labru­ti­nib; the rest will fund de­vel­op­ment of oth­er can­cer and au­toim­mune drugs.

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.”

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.

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.

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.

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.

The past two months have been tough for Bristol Myers Squibb and its checkpoint inhibitor Opdivo after setbacks in lung and brain cancers. But in the battle against Merck’s Keytruda, any success matters — and now Bristol could be looking at a quick approval for Opdivo in an unmatched indication.

The FDA will launch a speedy review of a combination of Bristol Myers Squibb’s Opdivo and chemotherapy to treat first-line patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, the drugmaker said Wednesday. The agency set an action date of May 25 for the application.