Susan Molineaux, Calithera CEO (via Lightstone Ventures)

Still reel­ing from PhII fail­ure, Calithera beefs up its on­col­o­gy port­fo­lio with a lit­tle help from Take­da

Calithera start­ed the year by ax­ing a third of its staff af­ter a mon­u­men­tal Phase II flop in re­nal cell car­ci­no­ma. And while CEO Su­san Mo­lin­eaux has re­fused to give up on the pro­gram, she’s go­ing to need an as­sist if she wants to close the year on a high­er note.

That’s where Take­da comes in.

For two up­front pay­ments of $10 mil­lion and $35 mil­lion, tiered roy­al­ties and an undis­closed amount in biobucks, Take­da is fork­ing over two Phase II-ready can­cer pro­grams to Calithera — one of which tar­gets KEAP1/NRF2 mu­ta­tions, the same ones Calithera is now pur­su­ing with its once-failed glu­t­a­m­i­nase in­hibitor tela­gle­na­s­tat.

“We have learned a great deal about the un­met med­ical need of pa­tients with KEAP1/NRF2 mu­ta­tions, as well as how to iden­ti­fy and re­cruit these pa­tients, dur­ing the con­duct of our KEAP­SAKE tri­al eval­u­at­ing tela­gle­na­s­tat,” Mo­lin­eaux said in a state­ment. “This com­ple­men­tary ap­proach in KEAP1/NRF2-mu­tant squa­mous NSCLC demon­strates our com­mit­ment to these pa­tients and the path­way.”

The first new can­di­date in Calithera’s bas­ket is Take­da’s dual TORC 1/2 in­hibitor sapanis­ert­ib. It’s de­signed to tar­get a key sur­vival mech­a­nism in KEAP1/NRF2-mu­tat­ed tu­mor cells, which are found in a con­sid­er­able amount of pa­tients with sol­id tu­mors, ac­cord­ing to the com­pa­nies. If all goes ac­cord­ing to plan, the pro­gram is head­ing in­to a Phase II tri­al ear­ly next year as a monother­a­py in pa­tients with squa­mous NSCLC har­bor­ing a NRF2 mu­ta­tion, with a read­out com­ing in the next 12 to 18 months.

The South San Fran­cis­co-based biotech is al­so get­ting mi­vavo­tinib, an SYK in­hibitor that’s al­so ex­pect­ed to en­ter Phase II next year for pa­tients with dif­fuse large B-cell lym­phoma with and with­out MyD88 and CD79 mu­ta­tions. Calithera al­so sees po­ten­tial for stud­ies in non-Hodgkin’s lym­phoma and blood can­cer.

That makes five clin­i­cal pro­grams now in Calithera’s pipeline, ac­cord­ing to the com­pa­ny’s web­site.

Calithera is still reel­ing from its Phase II fail­ure in re­nal cell car­ci­no­ma, the re­sults of which were read out back in Jan­u­ary. Adding tela­gle­na­s­tat to Ex­elix­is’ Cabome­tyx failed to im­prove pro­gres­sion-free sur­vival, in­ves­ti­ga­tors con­clud­ed. In fact, pa­tients on Cabome­tyx and place­bo lived slight­ly longer — a PFS of 9.3 months com­pared to 9.2 months for those treat­ed with tela­gle­na­s­tat and Cabome­tyx, which doesn’t mean much con­sid­er­ing the haz­ard ra­tio of 0.94 was far off sta­tis­ti­cal sig­nif­i­cance (p=0.65).

The com­pa­ny’s stock $CALA is still trad­ing at less than half of what it was last De­cem­ber. Shares were up 1% in pre­mar­ket trad­ing on Tues­day, go­ing for $2.03 apiece.

While that was the end of the road for tela­gle­na­s­tat’s Phase II study in re­nal cell car­ci­no­ma, Mo­lin­eaux is push­ing for­ward with an­oth­er Phase II study in KEAP1/NRF2 mu­tant NSCLC pa­tients, dubbed KEAP­SAKE, which dosed the first pa­tients last sum­mer.

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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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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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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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.

Craig Thompson, Cerevance CEO

UP­DAT­ED: Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

For the first time since discontinuing its late-stage Alzheimer’s program, Merck has found promise on the path forward in the memory-robbing disease.

After a Phase III flop of its drug verubecestat, the New Jersey Big Pharma axed the study in early 2018. More than four years later, the company is ready to sign up for another pact to test the waters of the befuddling disease.

This time, there’s $1.1 billion in biobucks on the line and a target that its partner says no other biopharma is looking at en route to finding the next treatment for Alzheimer’s, a neuroscience field that has hit hurdle after hurdle for decades.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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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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