Last update 01 Nov 2024
DNP-60502
Last update 01 Nov 2024
Overview
Basic Info
Drug Type Unknown |
Synonyms Research programme: AMPK activators - Sumitomo Pharma, DNP-60502 |
Target |
Mechanism AMPK agonists(AMP activated protein kinase agonists) |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Inactive Organization |
Drug Highest PhasePendingPreclinical |
First Approval Date- |
Regulation- |
Related
100 Clinical Results associated with DNP-60502
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100 Translational Medicine associated with DNP-60502
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100 Patents (Medical) associated with DNP-60502
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6
News (Medical) associated with DNP-6050221 Dec 2022
First approved PARP inhibitor to demonstrate clinically meaningful benefits in combination with a new hormonal agent
Lynparza in combination with abiraterone extended median radiographic progression-free survival benefit beyond two years in this setting
LONDON, UK I December 21, 2022 I
AstraZeneca and MSD’s
Lynparza
(olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the European Union for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men for whom chemotherapy is not clinically indicated.
This approval by the European Commission was based on results from the
PROpel Phase III trial
and follows the positive
recommendation
in the EU by the Committee for Medicinal Products for Human Use in November 2022.
In the trial,
Lynparza
in combination with abiraterone and prednisone or prednisolone, reduced the risk of disease progression or death by 34% versus abiraterone and prednisone or prednisolone (based on a hazard ratio [HR] of 0.66; 95% confidence interval [CI] 0.54-0.81; p<0.0001). Median radiographic progression-free survival (rPFS) was 24.8 months for
Lynparza
plus abiraterone versus 16.6 months for abiraterone alone. Furthermore, a planned rPFS analysis by blinded independent central review (BICR) showed
Lynparza
plus abiraterone had a median rPFS of 27.6 months compared to 16.4 months with abiraterone alone, extending median rPFS by almost one year.
Updated results from a second planned analysis presented at ESMO 2022 showed a favourable trend towards improved overall survival with
Lynparza
plus abiraterone versus abiraterone alone (based on HR of 0.83; 95% CI 0.66-1.03; p=0.11), however, the difference did not reach statistical significance at the time of this data cut-off (analysis at 40% data maturity).
Prostate cancer is the most common cancer in men in Europe, with an estimated 473,000 patients diagnosed and 108,000 deaths in 2020.
1,2
Overall survival for patients with mCRPC is approximately three years in clinical trial settings, and even shorter in the real-world.
3
Approximately half of patients with mCRPC may receive only one line of active treatment, with diminishing benefit of subsequent therapies.
4-9
Noel Clarke, Urological Surgeon and Professor of Urological Oncology at Manchester’s Christie/Salford Royal Hospitals and Manchester University, a senior investigator of the PROpel trial, said: “The results of the PROpel Phase III trial of olaparib in combination with abiraterone as a first-line treatment show that this therapeutic combination can provide significant clinical benefit to patients with metastatic castration-resistant prostate cancer. Patients with this condition in the EU will now, for the first time, have the opportunity to benefit from this new treatment combination.”
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Many patients with metastatic castration-resistant prostate cancer are only able to receive one line of active therapy, as the disease can progress quickly.
Lynparza
in combination with abiraterone has been shown to reduce the risk of disease progression by 34% versus the standard of care treatment in the PROpel trial. Moreover, the combination of
Lynparza
with abiraterone as a first-line treatment expands the use of Lynparza to a broader group of metastatic castration-resistant prostate cancer patients than those treated with
Lynparza
alone in the second-line setting in the PROfound trial. Today’s approval marks a significant advance toward addressing the unmet need of patients with metastatic castration-resistant prostate cancer in the EU.”
Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, MSD Research Laboratories, said: “MSD is committed to developing new treatment options for patients with metastatic castration-resistant prostate cancer, a complex disease that urgently needs more therapies. This approval by the European Commission marks another step towards delivering on that commitment and we look forward to extending the benefits of
Lynparza
to more patients with metastatic castration-resistant prostate cancer in the EU.”
The safety and tolerability of
Lynparza
in combination with abiraterone in PROpel was in line with that observed in prior clinical trials and the known profiles of the individual medicines. There was no increase in the rate of discontinuation of abiraterone in patients treated with
Lynparza
in combination with abiraterone and no detrimental effect on health-related quality of life versus those treated with abiraterone alone (Functional Assessment of Cancer Therapy-Prostate questionnaire).
In
August
, supplemental New Drug Application (sNDA) for
Lynparza
in combination with abiraterone and prednisone or prednisolone was accepted and granted Priority Review in the US for the treatment of adult patients with mCRPC. The Prescription Drug User Fee Act (PDUFA) date is
anticipated
during the first quarter of 2023.
Lynparza
is approved in the US based on results from the
PROfound Phase III trial
as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone; and in the EU, Japan, and China for patients with BRCA-mutated mCRPC who have progressed following prior therapy that included a new hormonal agent.
Financial considerations
Following this approval for
Lynparza
in the EU, AstraZeneca will receive a regulatory milestone payment from MSD of $105m, anticipated to be booked as Collaboration Revenue by the Company during the fourth quarter of 2022.
Notes
Metastatic castration-resistant prostate cancer
Metastatic prostate cancer is associated with a significant mortality rate.
10
Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.
11
In patients with mCRPC, their prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones.
12
Approximately 10-20% of men with advanced prostate cancer will develop castration-resistant prostate cancer (CRPC) within five years, and at least 84% of these men will have metastases at the time of CRPC diagnosis.
12
Of patients with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years.
12
Despite the advances in mCRPC treatment in the past decade with taxane and new hormonal agent (NHA) treatment, there is high unmet need in this population.
12,13,14,15
PROpel
PROpel is a randomised, double-blind, multi-centre Phase III trial testing the efficacy, safety, and tolerability of
Lynparza
versus placebo when given in addition to abiraterone, as well as prednisone or prednisolone, in men with mCRPC who had not received prior chemotherapy or NHAs in the mCRPC setting.
The primary endpoint is rPFS and secondary endpoints include overall survival, time to secondary progression or death, and time to first subsequent therapy.
In the PROpel Phase III trial,
Lynparza
is combined with abiraterone, an NHA which targets the androgen receptor (AR) pathway. AR signalling engages a transcriptional programme that is critical for tumour cell growth & survival in prostate cancer.
16,17
Preclinical models have identified interactions between PARP signalling and the AR pathway which support the observation of a combined anti-tumour effect of
Lynparza
and NHAs, like abiraterone, in both HRR deficient and HRR proficient prostate cancer.
18-20
The PARP1 protein has been reported to be required for the transcriptional activity of androgen receptors; therefore, inhibiting PARP with
Lynparza
may impair the expression of androgen receptor target genes and enhance the activity of NHAs.
16,19,21
Additionally, it is thought that abiraterone may alter/inhibit the transcription of some HRR genes which may induce HRR deficient phenotype, which may increase sensitivity to PARP inhibition.
18,20,22,23
For more information about the trial please visit
ClinicalTrials.gov
.
Lynparza
Lynparza
(olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in HRR, such as those with mutations in BRCA1 and/or BRCA2, or those where deficiency is induced by other agents (such as NHAs).
Inhibition of PARP with
Lynparza
leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.
Lynparza
is currently approved in a number of countries across multiple tumour types including maintenance treatment of platinum-sensitive relapsed ovarian cancer and as both monotherapy and in combination with bevacizumab for the 1st-line maintenance treatment of BRCA-mutated (BRCAm) and homologous recombination repair deficient (HRD)-positive advanced ovarian cancer, respectively; for gBRCAm, HER2-negative metastatic breast cancer (in the EU and Japan this includes locally advanced breast cancer); for gBRCAm, HER2-negative high-risk early breast cancer (in Japan this includes all BRCAm HER2-negative high-risk early breast cancer); for gBRCAm metastatic pancreatic cancer; and HRR gene-mutated metastatic castration-resistant prostate cancer (BRCAm only in the EU and Japan). In China,
Lynparza
is approved for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer as well as a 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
Lynparza,
which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 75,000 patients worldwide.
Lynparza
has a broad clinical trial development programme, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types.
Lynparza
is the foundation of AstraZeneca's industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.
The AstraZeneca and MSD strategic oncology collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise
Lynparza
, the world’s first PARP inhibitor, and
Koselugo
(selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types.
Working together, the companies will develop
Lynparza
and
Koselugo
and other potential new medicines as monotherapies and as combinations. The companies will also develop
Lynparza
and
Koselugo
in combination with their respective PD-L1 and PD-1 medicines independently.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit
astrazeneca.com
and follow the Company on Twitter @
AstraZeneca
.
References
1. Rawla, P. The Epidemiology of Prostate Cancer.
World J Oncol
. 2019;10(2):63-89.
2. IARC GloboCan. Prostate Cancer Factsheet. 2020. Available at
https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf
. Accessed December 2022.
3. Ng K,
et al
. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Advances and Treatment Strategies in the First-Line Setting.
Oncol Ther
. 2020;8:209–230.
4. George DJ,
et al
. Treatment Patterns and Outcomes in Patients with Metastatic Castration-Resistant Prostate Cancer in a Real-World Clinical Practice Setting in the United States.
Clin Genitourin Cancer
. 2020;18:284-294.
5. de Bono J,
et al
. Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for ≥24 weeks in Europe.
Eur Urol
. 2018;74(1):37-45
6. Hussein M,
et al
. Prostate-Specific Antigen Progression Predicts Overall Survival in Patients with Metastatic Prostate Cancer: Data from Southwest Oncology Group Trials 9346 (Intergroup Study 0162) and 9916.
J Clin Oncol
. 2009;27(15):2450.
7. de Wit, R,
et al
. Real-World Evidence of Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Cabazitaxel: Comparison with the Randomized Clinical Study CARD.
Prostate Cancer Prostatic Dis
. 2022;2660.
8. Ryan C,
et al
. Abiraterone Acetate Plus Prednisone Versus Placebo Plus Prednisone in Chemotherapy-Naive Men with Metastatic Castration-Resistant Prostate Cancer (COU-AA-302): Final Overall Survival Analysis of a Randomised, Double-Blind, Placebo-Controlled Phase 3 Study.
Lancet Oncol
. 2015 Feb;16(2):152-60.
9. Miller K,
et al
. The Phase 3 COU-AA-302 Study of Abiraterone Acetate Plus Prednisone in Men with Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: Stratified Analysis Based on Pain, Prostate-Specific Antigen, and Gleason Score.
Eur Urol
. 2018;74(1):17-23.
10. Chowdhury S,
et al
. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry.
Target Oncol
. 2020;15(3):301-315.
11. Cancer.Net. Treatment of metastatic castration-resistant prostate cancer. Available at
www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/treatment-metastatic-castration-resistant-prostate-cancer.
Accessed: December 2022.
12. Kirby M,
et al.
Characterising the Castration-Resistant Prostate Cancer Population: Systematic Review.
Int J of Clin Pract
. 2021;65(11):1180-1192.
13. UroToday. What is Changing in Advanced Prostate Cancer? Available at
https://www.urotoday.com/journal/everyday-urology-oncology-insights/articles/122176-what-is-changing-in-advanced-prostate-cancer.html
. Accessed December 2022.
14. Liu J,
et al
. Second-Line Hormonal Therapy for the Management of Metastatic Castration-Resistant Prostate Cancer: a Real-World Data Study Using a Claims Database.
Sci Rep
. 2020;10(1):4240.
15. UroToday. Beyond First-line Treatment of Metastatic Castrate-resistant Prostate Cancer. Available at
https://www.urotoday.com/library-resources/mcrpc-treatment/114592-beyond-first-line-treatment-of-metastatic-castrate-resistant-prostate-cancer.html
. Accessed December 2022
16. Schiewer MJ,
et al.
Dual roles of PARP-1 promote cancer growth and progression.
Cancer Discov.
2012;2(12):1134-1149.
17. Schiewer MJ & Knudsen KE. AMPed Up To Treat Prostate Cancer: Novel AMPK Activators Emerge for Cancer Therapy.
EMBO Mol Med
. 2014;6(4):439-441.
18. Li L,
et al.
Androgen Receptor Inhibitor–Induced “BRCAness” and PARP Inhibition are Synthetically Lethal for Castration-Resistant Prostate Cancer.
Sci Signal
. 2017; 10(480):eaam7479.
19. Polkinghorn WR,
et al.
Androgen Receptor Signaling Regulates DNA Repair in Prostate Cancers.
Cancer Discov.
2013;3(11):1245-1253.
20. Asim M,
et al
. Synthetic Lethality Between Androgen Receptor Signalling and the PARP Pathway in Prostate Cancer.
Nat Commun
. 2017;8(1):374.
21. Ju B-G,
et al
. A Topoisomerase IIbeta-Mediated dsDNA Break Required for Regulated Transcription.
Science
. 2006;312(5781):1798-1802.
22. Goodwin JF,
et al
. A Hormone-DNA Repair Circuit Governs the Response to Genotoxic Insult.
Cancer Discov
. 2013;3(11):1254-1271.
23. Tarish FL,
et al
. Castration Radiosensitizes Prostate Cancer Tissue by Impairing DNA Double-Strand Break Repair.
Sci Transl Med
. 2015;7(312):312re11.
SOURCE:
AstraZeneca
Phase 3Drug ApprovalClinical ResultPriority Review
28 Oct 2022
→
According to an SEC filing
,
Aurinia
’s EVP of research
Robert Huizinga
and CMO
Neil Solomons
are both walking away by Halloween, and while no explanations are given, details of their severance packages were provided. Huizinga had spent the last nine years at Aurinia after the
Isotechnika
merger: first as VP, clinical affairs, then as EVP, corporate development before his latest promotion in 2020. Solomons co-founded Aurinia a decade ago and used to be VP of R&D with
Vifor Pharma
. The
Peter Greenleaf
-led Aurinia
just launched its “Get Uncomfortable” ad campaign
, urging lupus nephritis patients to schedule checkups with their doctor.
→
CRISPR Therapeutics
COO
Lawrence Klein
will not return
next year “to pursue external opportunities,” but he’ll stay until this year draws to a close. Klein was originally appointed VP, strategy in February 2016, eventually receiving promotions to CBO in 2019 and COO a year later. The search begins for a replacement as CRISPR and
Vertex
make their case to the FDA
for
exa-cel
, a once-and-done treatment for sickle cell disease and transfusion-dependent beta-thalassemia, after getting lapped by
bluebird bio
with
Zynteglo
.
→ Pairing up with
Eli Lilly
on AMPK activators a couple of weeks ago
in a deal that almost reaches the $500 million mark
,
Nimbus Therapeutics
has poached
Nathalie Franchimont
from
Biogen
, naming her CMO. Franchimont had recently led the multiple sclerosis and immunology development unit and she held a cornucopia of other positions in her 10 years with Biogen, which is pinning its Alzheimer’s hopes on
lecanemab
after the
Aduhelm
debacle. At
Amgen
, she worked in medical affairs and clinical development, specifically with the bone drug
denosumab
(now marketed as
Xgeva
and
Prolia
).
→
Serge Stankovic
is set to retire
as president of
Acadia Pharmaceuticals
at the end of the year. A former clinical development exec with
Teva
and
Alkermes
, Stankovic was named head of R&D at Acadia in 2015 and president in 2018, helping guide the San Diego biotech to its only approved drug in April 2016. The FDA gave the OK to
Nuplazid
for Parkinson’s disease psychosis, but Acadia’s been shooting bricks lately in other indications,
with CRLs
in
back-to-back years
for dementia- and Alzheimer’s-related psychosis. Upon his retirement, Stankovic will move into a part-time advisory role.
→
Arturo Molina
’s time is winding down as CMO of antibody-drug conjugate developer
Sutro Biopharma
, and Peer Review will keep its eyes peeled for his next destination
after he leaves on Nov. 4
. Sutro CEO
Bill Newell
will stand in for him until a permanent successor is found. Molina was VP of oncology scientific innovation at
J&J
’s California Innovation Center before he joined Sutro,
which struck an ADC deal with
Astellas
for $90 million upfront in late June.
→ As biotech stocks were going subterranean,
it dawned on
Sagimet Biosciences
that an IPO wasn’t prudent for them in March. This week there’s a new sheriff in town at the NASH-centered biotech, with
Dave Happel
taking over for
George Kemble
as chief executive. Since 2020, Happel had been president and CEO of
Cognoa
, and in an earlier role, he was EVP of commercial development and strategy for
Horizon
. With Happel in place, Kemble is sliding into the role of executive chairman, succeeding
Westlake Village BioPartners
managing director
Beth Seidenberg
.
→ It didn’t take long for ex-
Biotheryx
chief
Robert Williamson
to find his next gig,
landing at T cell-focused
Triumvira Immunologics
as president and CBO. Williamson was at the controls for Biotheryx when the protein degradation squad
garnered a $92 million Series E round
in May 2021, and as we told you, he
then became chief business and financial officer
at
OncoMyx
in March. Triumvira says
it’s constructing a new cell therapy manufacturing facility
in South San Francisco for its lead program,
TAC01-HER2
, that should open by next year.
→ Let’s Twist again:
Patrick Finn
has been promoted to
president and COO of DNA synthesis heavyweight
Twist Bioscience
, which
inked a $710 million antibody discovery deal
with
Boehringer Ingelheim
last year. Finn signed on as Twist’s SVP, commercial operations in February 2015 and was elevated to chief commercial officer in 2019. He’s also been VP of sales and marketing for
Enzymatics
, now known as
Qiagen
.
→
Positions are getting filled
left and right at antibody radiation-conjugate (ARC) player
Actinium
:
Jenny Hsieh
(chief strategy officer) was head of corporate strategy and operations with
Immunomedics
as it was being sold to
Gilead
for $21 billion. In March, the large pharma handed out pink slips
to 114 staffers that worked out of Immunomedics’ old HQ
in Morris Plains, NJ;
Sunitha Lakshminarayanan
(head of CMC and product development) previously took on the role of executive director, cell therapy process engineering at
Bristol Myers Squibb
;
Stephen Dressel
(VP, strategic finance and analysis) had a 10-year career at
Regeneron
and just spent a year and a half with
Dewpoint Therapeutics
as senior director, financial planning & analysis;
Peter Baker
(director, drug substance/drug products operations) helped manufacture
Lutathera
and
Pluvicto
as head of production at
Novartis
’
Advanced Accelerator Applications
; and
Micah Riskin
(director, product steward, manufacturing sciences & technology) has Bristol Myers ties and recently led process development and MSAT for
Imvax
.
But wait, there’s more
: Actinium has plucked
Akash Nahar
(VP, clinical development) from
Merck
, where he served as global product development lead for hematology;
Elaina Haeuber
(VP, head of clinical operations) is a veteran of
Syneos Health
who had been VP of operations at
WCG
until May; finally,
Madhuri Vusirikala
(VP, clinical development, bone marrow transplant and cellular therapy) and
Patrik Brodin
(VP, head of radiation sciences) round out the hiring bonanza.
→
Cameron Durrant
will be on the lookout for another COO and CFO as
Tim Morris
decamps from both posts at
Humanigen
and becomes finance chief
at
Opthea
, a retinal disease biotech that will be all set financially for the time being
with $170 million in funding
through
Carlyle
and
Abingworth
’s
Launch Therapeutics
and an additional $90 million private placement. The ex-CFO of
Iovance
and
AcelRx
just took another board seat at
Aquestive Therapeutics
over the summer.
→ As they build a plan around WHIM syndrome drug
mavorixafor
,
X4 Pharmaceuticals
has recruited
Mark Baldry
as chief commercial officer. A former commercial exec at
Shire
, Biogen and
Amicus
, Baldry has held this same post at
Wave Life Sciences
and
Freeline Therapeutics
. The highs haven’t outweighed the lows this year at X4,
scoring a $55 million PIPE
but
cutting 20% of its staff
and pruning the pipeline.
→ There’s a batch of new execs at
Anokion
, while the Swiss autoimmune biotech
also says
that
Stephan Kontos
will relinquish his CSO duties to chair the scientific advisory board.
Alison Long
(CMO) once led clinical R&D at
Spark
and had been the medical chief with now-defunct
Kaleido BioSciences
;
Glenn Booma
(chief strategy officer) is a
Genzyme
alum who had worked as a life sciences consultant for the past nine years; and
Stephanie Haller
(SVP, clinical operations) only needs to replace three letters on her business card after parting ways with
Alexion
, where she was senior director, clinical operations, therapeutic area lead, nephrology. Additionally, Anokion promoted
Kristie Grebe
from VP, clinical & translational development to SVP, immunology & translational medicine.
Pfizer
invested $35 million
into Anokion’s celiac disease therapy
KAN-101
last week.
→ The glycoproteomics specialists at
InterVenn Biosciences
have promoted
Erwin Estigarribia
to president and COO. Estigarribia brought plenty of diagnostics experience before coming to InterVenn in 2019, with stints as an operations exec at
CardioDx
and
Applied Proteomics
— and further back, he had a series of leadership roles with
Chiron
, Novartis and
Geron
.
→ We have all sorts of other CMO appointments to discuss, and
Edward Kim
is first up
at Swedish mental illness and addiction disorder biotech
Orexo
. Kim steps away from
Biohaven
, where he was head of medical affairs, and he’s a Novartis neuro alum who has further Big Pharma connections as the former schizophrenia therapeutic area leader at J&J’s
Janssen
.
→
PaxMedica
’s
modest IPO
may have been under the radar a couple months ago, but the New York biotech
has added some gravitas to the staff
with Big Pharma alum
Stefan Schwabe
as CMO. Schwabe spent more than a decade in neuro roles at J&J, Novartis and
Sanofi
, and since 2012 he had been CMO and EVP of R&D at
Supernus
, getting out of Dodge not long after the FDA
threw cold water on the latest pitch
for its Parkinson’s drug
SPN-830
earlier this month. PaxMedica is advancing its lead asset
PAX-101
(
intravenous suramin
) in autism spectrum disorder, with a preclinical study of the drug in the works for Fragile X-associated tremor/ataxia syndrome (FXTAS).
→
Mark Deeg
has been named
medical chief at
Enveda Biosciences
, a Boulder, CO startup that chalked up the cash
with a $51 million Series A
in June 2021. Deeg was once the chief medical and safety officer for Eli Lilly’s
Chorus
in his 10 years with the Indianapolis pharma, and the ex-
Regulus
CMO recently oversaw global clinical development at
Cullgen
. Elsewhere, Deeg earned a promotion to VP of R&D at
Pear Therapeutics
before taking the Cullgen job last year.
→ As Rob Thomson shed the interim label this season and is now bound for the World Series as manager of the Philadelphia Phillies, will we say the same someday
for interim CMO
Richard Graydon
’s job status at Seattle breast cancer biotech
Atossa Therapeutics
? Graydon worked on such drugs as
Carvykti
(
cilta-cel
) and
Imbruvica
as the senior director of clinical development for Janssen, and he has served as director of clinical development at
Daiichi Sankyo
.
→
Jens Würthner
has jumped on board
as CMO of Amsterdam’s
Scenic Biotech
, which allied with
Roche
two years ago in a development deal involving genetic modifiers
and raised $31 million in March
. Würthner’s Big Pharma background includes stops at
AstraZeneca
,
GSK
and as a clinical program leader at Novartis before pivoting to
ADC Therapeutics
in 2016. He had led global clinical development at ADC since January 2020.
→ To close this CMO loop, antimicrobial developer
Adaptive Phage Therapeutics
has tapped
Edward Fang
for the position. Fang has held this post before at
Adenium Biotech
and US-China outfit
MicuRx Pharmaceuticals
. In April, Adaptive Phage topped off the cash tank from its Series B from May 2021
to bring the total to $61 million
, and the following month it began the Phase I/II trial for its diabetic foot osteomyelitis treatment.
→ Ex-
Antios
chief
Greg Mayes
is shoring up his leadership
at Toronto psychedelics player
Reunion Neuroscience
with
Edward Smith
as CFO and
Aviva Asnis-Alibozek
as VP, medical affairs. Smith has held a string of CFO posts at
Lava Therapeutics
,
Marinus Pharmaceuticals
and
PolyMedix
, and he’s a board member at
Benitec Biopharma
. A one-time medical affairs director at AstraZeneca, Asnis-Alibozek was EVP of medical affairs during her six years at
TRM Oncology
.
→
Travis May
’s healthcare information upstart
Datavant
— a relative in the
Vivek Ramaswamy
family of “vants” — has crunched the numbers
and selected
Marla Kessler
as chief marketing officer. The Pfizer marketing vet followed up her 13 years at
IQVIA
with a recent yearlong stay at
Aetion
as chief customer officer.
→
Things can only get Better
: J&J alum
Diane Gomez-Thinnes
has joined
San Francisco-based
Better Therapeutics
as chief commercial officer. Last year, Gomez-Thinnes finished her 17-year tenure at J&J as the worldwide president of its medtech
Mentor
, and from there she became the president of US operations for
Galderma
.
→
Kleanthis Xanthopoulos
’ cell therapy crew at
Shoreline Biosciences
has welcomed
Charles Calderaro III
as chief technical officer. Calderaro knows his way around the space from his days at
Kite
, where he was in charge of CAR-T manufacturing as global head of technical operations. After several leadership positions in a 14-year period at
Genentech
, Calderaro moved on to
BioMarin
as SVP, global manufacturing from 2016-19.
→ CRO
Sannova Analytical
has saddled up
Jason Apter
as CEO and
Stephen Unger
as CFO. This isn’t Apter’s first time running things in the CEO seat, having called the shots previously as CEO at
Johnson Matthey’s
health division. Apter also has experience under his belt from
Millipore Sigma
and
Sigma-Aldrich
. Meanwhile, Unger hops aboard after a stint as CFO at
Quotient
and
Circulogene
Theranostics
.
→
Genuv
has named
Jenny Choih
president of its new Cambridge, MA-based subsidiary Genuv US. Choih joined Genuv in 2016, most recently serving as director of development. Earlier in her career, Choih was a consultant at
McKinsey
.
→
Intellia
CEO
John Leonard
is joining the likes of
Sean Parker
and
John Connolly
on the board of directors at
3T Biosciences
, a TCR startup that pulled together a $40 million Series A led by chairman
Sean Harper
and the folks at Westlake Village BioPartners. The
Abbott
and
AbbVie
alum is also a board member at IQVIA.
→ As
Redonda Miller
exits from the board of directors at
Invivyd
,
Christine Lindenboom
will step in
during a time of tumult
marked by last week’s layoffs and executive departures
after
Tillman Gerngross
bailed as CEO in February. An Amgen and Pfizer vet, Lindenboom is
Alnylam
’s SVP of investor relations & corporate communications.
→ Fred Hutch’s
Tom Lynch
has sewn up a spot
on the board of directors at
Flagship
’s
Foghorn Therapeutics
. Lynch’s appointment comes after the FDA threw down the stop sticks
with a full clinical hold
on Foghorn’s blood cancer drug
FHD-286
in August. A partial hold
was handed out
a few months before.
→
Expansion Therapeutics
has elected
Raymond Kelleher
to the board of directors at a time when drugging RNA continues to attract interest. Kelleher, a faculty member at Massachusetts General Hospital and Harvard Medical School, is managing director of
Cormorant Asset Management
.
→
Ubiquigent
has announced that
the company’s CSO
Sheelagh Frame
has joined its board of directors. Frame began her career at Ubiquigent in 2018 as head of biology before being promoted to her current position last year. Prior to this role, Frame was with
Cyclacel
and
Onyx
Pharmaceuticals
.
→
TC Biopharm
has finished setting up
its scientific advisory board, which now consists of:
Blythe Sather
(VP and head of research at
Tune
Therapeutics
),
Erin Adams
(professor at the University of Chicago),
Chris Bond
(experience from
Genentech
,
OncoMed
,
Juno
,
Celgene
and
Kite
),
Isabelle Riviere
(director of the cell therapy and cell engineering laboratory at Memorial Sloan Kettering Cancer Center),
Daniel Olive
(researcher at the Cancer Research Center of Institut Paoli-Calmettes), and
Uma Lakshmipathy
(head of patheon translation services and cell therapy R&D pharma services group at
Thermo
Fisher
).
→
Trinity Biotech
is adding a fresh face to its board of directors as two others hit the exit.
Tom Lindsay
joins as non-executive director, having served previously as president of
Alere’s
(now a part of
Abbott
) business in Africa and currently serves as a board member at
Genedrive
. At the same time, directors
Seon Kyu Jeon
and
Michael Sung Soo Kim
are heading out the door.
Illustration: Kim Ryu for Endpoints News
CollaborateAntibodyCell TherapyADCAcquisition
12 Oct 2022
Courtesy of Michael Vi/Getty Images
Nimbus Therapeutics scored a $496 million payday through a collaboration and licensing deal with pharma giant Eli Lilly for potential therapeutics for metabolic diseases, the companies announced Tuesday.
The two companies will collaborate on the development of novel targeted therapies designed to activate a specific isoform of AMPK for the potential treatment of metabolic diseases. AMPK (AMP-activated protein kinase) is considered a high-value target in this indication due to its role in glucose, lipid metabolism, and inflammation.
In partnership with Eli Lilly, Nimbus will identify isoform-selective, small molecule activators of AMPK heterotrimers.
On its website, Nimbus noted that activating AMPK in the liver, skeletal muscle, kidney, and other tissues has a “profound impact in metabolic disease models.” Nimbus first announced it was delving into AMPK two years ago. The company noted that AMPK is a heterotrimer comprised of α, β and γ subunits, and there are two known isoforms of β.
When Nimbus unveiled its intentions to explore this approach to treating disease, Nimbus said its drug development expertise provided it with a new understanding of the AMPK subunit.
These understandings enabled it to identify activators that are selective for β2 subtype of the AMPK protein, and Nimbus believes it can improve glucose and lipid homeostasis while mitigating safety concerns.
While its programs remain preclinical, Eli Lilly is intrigued enough to initiate collaboration in this space. Ruth Gimeno, senior vice president of diabetes research and clinical investigation at Eli Lilly, said therapies that target AMPK can address a critical need in the metabolic disease space.
Targeting metabolic-induced diseases, such as obesity-related diseases, diabetes or nonalcoholic steatohepatitis with AMPK activation has had some challenges. Nimbus Therapeutics believes it has overcome these issues.
With its computational drug discovery engine, the company is uniquely positioned to develop isoform-selective small molecule AMPK activators applicable in a broad range of metabolic diseases, a space where Eli Lilly is well versed.
Peter Tummino, Nimbus Therapeutics’ chief scientific officer, noted the company has established a successful track record in developing highly-selective small molecules against hard-to-interrogate targets.
“Nimbus has established a successful track record in developing and progressing highly-selective small molecules to the clinic against hard-to-interrogate targets, which is a demonstration of the power of our computational and structural approach to drug discovery,” Tummino said in a statement.
For Nimbus, the partnership comes about a month after the company received a $125 million investment from Pfizer Ventures, the investment arm of the pharma giant. At the time, Nimbus Chief Executive Officer Jeb Keiper told BioSpace the investment will support the development of its TYK2 inhibitor, which is in Phase IIb studies for plaque psoriasis.
A portion of the funds will also be used to assess the TYK2 asset in inflammatory bowel disease and lupus, two indications where significant inhibition of TYK2 can be critical.
Under the terms of the agreement, Nimbus is eligible to receive up to $496 million, which will cover research expenses and developmental milestones. The company will also be eligible for potential royalties on commercial sales.
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Diabetes Mellitus | Preclinical | JP | - | |
| Metabolic Syndrome | Preclinical | JP | - |
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
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