San Fran biotech gets an­oth­er blow to lead drug; Swiss biotech rais­es $49 mil­lion in Se­ries A — with help from big ven­ture

In the wake of Calithera Bio­sciences ax­ing a third of its work­force in Jan­u­ary over a failed Phase II tri­al with lead drug tela­gle­na­s­tat in pa­tients with re­nal cell car­ci­no­ma, they just got slammed with the sec­ond half of a dou­ble wham­my.

The South San Fran­cis­co biotech an­nounced this morn­ing that it is ter­mi­nat­ing an­oth­er Phase II tri­al in­volv­ing the drug — this tri­al had the drug plus stan­dard-of-care chemo be­ing used in pa­tients with NSCLC with ei­ther KEAP1 or NFR2 mu­ta­tions.

The KEAP­SAKE clin­i­cal tri­al was canned be­cause there was no ob­serv­able clin­i­cal ben­e­fit, ac­cord­ing to an in­ter­im analy­sis.

While Calithera CEO Su­san Mo­lin­eaux was dis­ap­point­ed in the out­come of the tri­al, she main­tained that the KEAP­SAKE tri­al was a well-run study.

“We al­so want to ex­press our sin­cere grat­i­tude to the pa­tients who par­tic­i­pat­ed in the tri­al and their fam­i­lies, as well as the physi­cians who served as in­ves­ti­ga­tors for the tri­al and their site staff,” said Mo­lin­eaux in a pre­pared state­ment. “We re­main com­mit­ted to pa­tients with dif­fi­cult-to-treat can­cers and will con­tin­ue to ad­vance our in­ves­ti­ga­tion­al tar­get­ed ther­a­pies for bio­mark­er-spe­cif­ic pa­tient pop­u­la­tions.”

The ran­dom­ized, place­bo-con­trolled, dou­ble-blind study had 40 pa­tients ran­dom­ized — and avail­able ef­fi­ca­cy da­ta led to the con­clu­sion that there was a very low prob­a­bil­i­ty for the study to achieve a pos­i­tive re­sult. While the biotech has no plans to con­tin­ue the de­vel­op­ment of tela­gle­na­s­tat at this time, the firm es­ti­mates the cost sav­ings re­sult­ing from end­ing the tri­al will be $10-15 mil­lion.

Swiss biotech rais­es $49M Se­ries A — co-led by 5AM, Roche and Sofinno­va Part­ners

Swiss biotech Gly­co­Era AG an­nounced this morn­ing that the com­pa­ny closed a $49 mil­lion Se­ries A round.

The round, co-led by 5AM Ven­tures, Roche Ven­ture Fund and Sofinno­va Part­ners, raised funds to ex­pand the com­pa­ny and its plat­form tech­nol­o­gy in de­vel­op­ing as­sets for sev­er­al dis­ease in­di­ca­tions, ac­cord­ing to a com­pa­ny state­ment.

But as part of the round, Gly­co­Era is bring­ing on a few new mem­bers to its board of di­rec­tors: Mi­ra Chau­rushiya of 5AM, Monique Schiers­ing from Roche’s Ven­ture Fund and Graziano Seghezzi with Sofinno­va Part­ners. They will join Gly­co­Era’s co-founders, Veron­i­ca Gam­bil­lara Fon­ck and Amir Farid­moay­er, as well as In­nospark Ven­tures ad­vi­sor Ganesh Kaun­dinya on the board.

“Back­ing teams is a core part of the Sofinno­va strat­e­gy, so we are de­light­ed to be work­ing, once again, with a group of vet­er­ans who were in­stru­men­tal in the suc­cess of an­oth­er Sofinno­va port­fo­lio com­pa­ny, Gly­co­V­axyn,” Seghezzi said in a pre­pared state­ment. “We have enor­mous con­fi­dence in Gly­co­Era’s po­ten­tial to car­ry its ground­break­ing tech­nol­o­gy for­ward in­to mul­ti­ple ther­a­peu­tic ar­eas.”

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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BioCryst re­sumes en­roll­ment for im­mune dis­eases drug; Ea­gle buys stake in res­pi­ra­to­ry dis­ease biotech

In April, the FDA hit BioCryst with a partial hold, leading the biotech to pause enrollment on three of its rare disease clinical trials and sending its shares down 30%.

Last week, BioCryst said the partial clinical hold had been resolved and that it would resume enrolling its clinical trials for its drug, dubbed BCX9930, but with new protocols at a lower 400 mg dose.

BioCryst’s drug is a factor D inhibitor, which was being tested in an array of immune diseases. The biotech is running two pivotal trials for paroxysmal nocturnal hemoglobinuria, as well as a third trial looking at a set of three diseases — C3 glomerulopathy, IgA nephropathy and primary membranous nephropathy.

Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.