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Submitted URL: https://endpts.com/aa/8886IKY1YRG99CPK/
Effective URL: https://endpts.com/kura-oncology-drops-multiple-clinical-programs-for-jj-discovered-tipifarnib/
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Troy Wilson, Kura Oncology CEO
February 24, 2023 11:01 AM EST
R&D


KU­RA ON­COL­O­GY DROPS MUL­TI­PLE CLIN­I­CAL PRO­GRAMS FOR J&J-DIS­COV­ERED
TIP­I­FARNIB


PAUL SCHLOESSER

ASSOCIATE EDITOR

Ku­ra On­col­o­gy is ax­ing all but one clin­i­cal de­vel­op­ment pro­gram
in­volv­ing an old Janssen can­di­date.

Ac­cord­ing to an SEC fil­ing on Thurs­day, Ku­ra has dropped mul­ti­ple
pro­grams for tip­i­farnib, a far­ne­syl­trans­ferase in­hibitor (FTI) that
tar­gets a pro­tein called HRAS. The drug was orig­i­nal­ly dis­cov­ered by J&J,
which hand­ed it off to se­r­i­al biotech ex­ec­u­tive Troy Wil­son, who spun
out the drug in­to Ku­ra On­col­o­gy as its lead can­di­date in a 2015 deal.

Ku­ra flash­es pos­i­tive HRAS da­ta on once-failed J&J drug

One of the de­vel­op­ment pro­grams had been ex­am­in­ing tip­i­farnib as a
monother­a­py in HRAS-mu­tant head and neck squa­mous cell car­ci­no­ma
(HN­SCC). But af­ter “sig­nif­i­cant fea­si­bil­i­ty chal­lenges” caused the
tri­al to stop more en­roll­ment, which Ku­ra an­nounced in its Q3 earn­ings
last No­vem­ber, the pro­gram is now done.

“In an on­go­ing ef­fort to pri­or­i­tize those pro­grams with the high­est
po­ten­tial to cre­ate val­ue for pa­tients, health care providers and
share­hold­ers, we have de­cid­ed to close AIM-HN and dis­con­tin­ue fur­ther
de­vel­op­ment of tip­i­farnib as a monother­a­py, de­spite com­pelling
clin­i­cal da­ta,” the fil­ing read.

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Ku­ra then an­nounced it would be prun­ing tip­i­farnib in com­bi­na­tion with
os­imer­tinib, an EGFR-tar­get­ing can­cer drug mar­ket­ed by As­traZeneca as
Tagris­so. The com­bo was be­ing ex­am­ined in a Phase I tri­al in
EGFR-mu­tat­ed NSCLC, which start­ed back in No­vem­ber.

How­ev­er, that tri­al is now stopped.

“As part of our on­go­ing pri­or­i­ti­za­tion ef­forts, we have de­cid­ed to
close our KUR­RENT-LUNG tri­al and dis­con­tin­ue fur­ther de­vel­op­ment of
tip­i­farnib in com­bi­na­tion with os­imer­tinib, de­spite com­pelling
pre­clin­i­cal da­ta,” ac­cord­ing to SEC docs.

In the mean­time, one of the two pro­grams in­volv­ing tip­i­farnib and
No­var­tis’ alpelis­ib, mar­ket­ed as Piqray, re­mains in ef­fect. A 2021
col­lab­o­ra­tion be­tween Ku­ra and the phar­ma gi­ant was test­ing the
com­boed drugs in pa­tients with HN­SCC with tu­mors with ei­ther HRAS
over­ex­pres­sion — which tip­i­farnib tar­gets — and/or PIK3CA mu­ta­tion,
which is what Piqray goes af­ter.

While the pair start­ed a Phase I/II open-la­bel tri­al lat­er that year
test­ing the com­bi­na­tion, Ku­ra said that af­ter see­ing en­cour­ag­ing
clin­i­cal ac­tiv­i­ty, it is now pri­or­i­tiz­ing de­ter­min­ing the op­ti­mal
ac­tive dose for pa­tients in the PIK3CA co­hort. As such, the com­pa­nies are
end­ing en­roll­ment in the HRAS co­hort.

CEO Troy Wil­son told End­points News via email that “We are pri­or­i­tiz­ing
our pro­grams with the high­est po­ten­tial to cre­ate val­ue for pa­tients,
physi­cians and share­hold­ers,” adding that the com­pa­ny is work­ing on
iden­ti­fy­ing an op­ti­mal dose and sched­ule for the top­i­farnib and
alpelis­ib com­bi­na­tion in HN­SCC.




AUTHOR


PAUL SCHLOESSER

ASSOCIATE EDITOR

pschloesser@endpointsnews.com
Paul Schloesser on LinkedIn
A registered nurse at the Altoona Center for Clinical Research in Duncansville,
PA begins the process of preparing refrigerated doses of Pfizer's Lyme disease
vaccine (Gary M. Baranec/AP Images)
February 23, 2023 10:47 AM ESTUpdated 11:02 AM
R&D
Pharma


PFIZ­ER CUTS CRO UNI­CORN FROM LY­ME VAC­CINE TRI­AL IN DIS­PUTE OVER CON­DUCT


DREW ARMSTRONG

EXECUTIVE EDITOR


KYLE LAHUCIK

ASSOCIATE EDITOR

Pfizer is ending its work with research contractor Care Access on an
18,000-patient Lyme disease vaccine trial, according to an internal email
reviewed by Endpoints News, widening the breach that has emerged between the
drug giant and the richly-valued research startup in recent days.

Last week, Pfizer said it was removing thousands of patients recruited by Care
Access from the Phase III work, citing issues with how Care Access had conducted
its part of the trial. At the time, it was unclear whether any collaboration
between the companies on the Lyme research would continue and if Care Access
would recruit new patients.


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Rocket Pharma's R&D headquarters in Cranbury, NJ, illuminated for rare disease
awareness
February 24, 2023 10:59 AM EST
Pharma
Marketing


ROCK­ET PHAR­MA RE-UPS RARE DIS­EASE AWARE­NESS WITH EM­PIRE STATE BUILD­ING
LIGHT-UP


BETH SNYDER BULIK

SENIOR EDITOR

Rocket Pharma began asking landmark owners join its monumental light-up —
changing nighttime illumination colors on buildings and notable destinations —
to shine a spotlight on rare disease awareness in 2019. That year, the Empire
State Building, which is home to Rocket’s corporate offices in New York, was lit
in the rare disease official spectrum of colors of blue, purple, pink and green
on Rare Disease Day, Feb. 28.


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Juan Andres, Moderna president, strategic partnerships and enterprise expansion
February 24, 2023 10:53 AM ESTUpdated 11:16 AM
People
Manufacturing


READY FOR RE­TIRE­MENT, JUAN AN­DRES IS WAV­ING GOOD­BYE TO MOD­ER­NA IN MAY


TYLER PATCHEN

NEWS REPORTER

One of Moderna’s talents behind its rapid manufacturing ramp-up during the
Covid-19 pandemic will retire.

Juan Andres, the company’s president of strategic partnerships and enterprise
expansion, will depart Moderna in May, CEO Stéphane Bancel said during the
company’s fourth-quarter earnings call Thursday.

Andres joined the biotech in 2017, initially heading up Moderna’s manufacturing
operations before becoming chief technical operations and quality officer in
2020. Bancel said Andres did a “historic job” with his team in 2020 and 2021 to
scale Moderna’s vaccine manufacturing during a pandemic.

Read More
ENDPOINTS CAREERS


HEMOLYTIC ANEMIA SALES SPECIALIST, RARE GENETIC DISEASES

AGIOS PHARMACEUTICALS

REMOTE

view job offer post your job now
Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)
February 24, 2023 07:23 AM ESTUpdated 09:32 AM
R&D


NO­VAR­TIS RE­TREAT FROM NASH TAKES DOWN $80M AL­LIANCE WITH PLI­ANT
THER­A­PEU­TICS


AMBER TONG

SENIOR EDITOR

Back in 2019, Novartis committed $80 million to collaborate with Pliant
Therapeutics on a preclinical candidate to treat liver fibrosis associated with
nonalcoholic steatohepatitis, or NASH. Within two years, Pliant completed a
Phase I study of the drug and handed it over to the pharma partner.

But Novartis is now giving the drug back.

Novartis told Pliant that the move “part of its new strategy focusing on a
limited number of therapeutic areas, to divest clinical NASH assets and, as a
result, to discontinue the development of PLN-1474,” according to a Feb. 17 SEC
filing from Pliant.


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February 24, 2023 07:00 AM EST
Deals
R&D


NEK­TAR’S LAT­EST PHII FLOP THREAT­ENS TO UN­RAV­EL $400M-PLUS DEAL WITH ELI
LIL­LY


AMBER TONG

SENIOR EDITOR

Eli Lilly is slamming the Phase III door for the lead program out of its
six-year-old pact with Nektar Therapeutics, after their partnered autoimmune
drug failed to beat the current standard of care in lupus.

The Phase II trial involving patients with moderately-to-severely active
systemic lupus erythematosus was the first mid-stage study among a few to read
out. Nektar said it is “discussing next steps” with Lilly about the other trials
planned as part of their deal, for which Lilly paid $150 million in cash back in
2017 and promised $250 million worth of milestones, on top of funding a big
chunk of Phase II development.

Read More

February 24, 2023 10:20 AM EST
FDA+


FULL FDA HOLD DE­RAILS CLIN­I­CAL STUDY OF FUL­CRUM DRUG IN A NO GOOD, VERY BAD
WEEK FOR SICK­LE CELL R&D


JOHN CARROLL

EDITOR & FOUNDER

The roller-coaster ride of highs and lows at Cambridge, MA-based Fulcrum
Therapeutics just took a sickening plunge.

Weeks after using some upbeat results to set the stage for a $125 million raise
— no easy feat in this market — the Fulcrum team got hit with a full clinical
hold on one of their top drugs. And the news ripped up a chunk of market value
that sent shares $FULC tumbling more than 50% Friday morning.


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daily — and it's free.

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Paul Stoffels, Galapagos CEO (Andrew Harnik/AP Images)
February 24, 2023 10:02 AM EST
R&D


GALA­PA­GOS GOES 0-FOR-3 ON IN­FLAM­MA­TION PRO­GRAM AS IT CUTS AN EAR­LY-STAGE
CAN­DI­DATE


LEI LEI WU

NEWS REPORTER

Galapagos has cut anti-inflammatory drug candidate GLPG4399 following the
completion of an early-stage healthy volunteer trial, according to its 2022
annual report released Thursday afternoon.

GLPG4399 was a SIK3 inhibitor, one in a line of such salt-inducible kinase (SIK)
inhibitors that Galapagos has been trying to develop for inflammatory diseases
like rheumatoid arthritis and ulcerative colitis. Originally, the biotech had
been planning to move the drug forward in a study with rheumatoid arthritis
patients in the middle of this year, but now it’s halting the program and going
back to search for new SIK inhibitors.

Read More
ENDPOINTS CAREERS


HEMOLYTIC ANEMIA SALES SPECIALIST, RARE GENETIC DISEASES

AGIOS PHARMACEUTICALS

REMOTE

view job offer post your job now
February 24, 2023 09:41 AM EST
People
Startups
Cell/Gene Tx


GENE THER­A­PY START­UP LO­CAN­ABIO LAYS OFF STAFF, NAR­ROWS FO­CUS ON DUCHENNE


KYLE LAHUCIK

ASSOCIATE EDITOR

Biotech startup Locanabio has laid off 30% of its workforce, portending a
limited scope going forward for the gene therapy developer, backed with more
than $150 million since its 2019 unveiling.

Out of UC San Diego scientist Gene Yeo and bankrolled by a who’s who of biotech
investors, Locanabio’s initial ambitions included various neurodegenerative,
neuromuscular and retinal diseases. The focus now is on Duchenne muscular
dystrophy, specifically targeting exon 51, CFO Kat Lange told Endpoints News in
an email.


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February 23, 2023 08:57 AM ESTUpdated 4 hours ago
Editor's note


WHO ARE THE YOUNG BIO­PHAR­MA LEAD­ERS MAK­ING THEIR MARK IN THE IN­DUS­TRY?
NOM­I­NATE THEM FOR END­POINTS' SPE­CIAL RE­PORT


PAUL SCHLOESSER

ASSOCIATE EDITOR

Starting today, Endpoints News will begin accepting nominations for our annual
“20 Under 40” list.

Since 2020, Endpoints has profiled the biotech talent of tomorrow — the
scientists, leaders, financiers and thinkers who are already making an impact
with the potential to make an even bigger one in their long careers ahead.

You can make a nomination via our form here. If you’re nominating on behalf of a
company, please limit your suggestions to two people per organization.

Read More


KU­RA ON­COL­O­GY DROPS MUL­TI­PLE CLIN­I­CAL PRO­GRAMS FOR J&J-DIS­COV­ERED
TIP­I­FARNIB


PFIZ­ER CUTS CRO UNI­CORN FROM LY­ME VAC­CINE TRI­AL IN DIS­PUTE OVER CON­DUCT


ROCK­ET PHAR­MA RE-UPS RARE DIS­EASE AWARE­NESS WITH EM­PIRE STATE BUILD­ING
LIGHT-UP


READY FOR RE­TIRE­MENT, JUAN AN­DRES IS WAV­ING GOOD­BYE TO MOD­ER­NA IN MAY


NO­VAR­TIS RE­TREAT FROM NASH TAKES DOWN $80M AL­LIANCE WITH PLI­ANT
THER­A­PEU­TICS


NEK­TAR’S LAT­EST PHII FLOP THREAT­ENS TO UN­RAV­EL $400M-PLUS DEAL WITH ELI
LIL­LY


FULL FDA HOLD DE­RAILS CLIN­I­CAL STUDY OF FUL­CRUM DRUG IN A NO GOOD, VERY BAD
WEEK FOR SICK­LE CELL R&D


GALA­PA­GOS GOES 0-FOR-3 ON IN­FLAM­MA­TION PRO­GRAM AS IT CUTS AN EAR­LY-STAGE
CAN­DI­DATE


GENE THER­A­PY START­UP LO­CAN­ABIO LAYS OFF STAFF, NAR­ROWS FO­CUS ON DUCHENNE


WHO ARE THE YOUNG BIO­PHAR­MA LEAD­ERS MAK­ING THEIR MARK IN THE IN­DUS­TRY?
NOM­I­NATE THEM FOR END­POINTS' SPE­CIAL RE­PORT

Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas




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