Helsinn Healthcare SA signs exclusive license agreement with Juniper Biologics Pte. Ltd. for LEDAGA® (chlormethine) in Australia, Asia and the Middle East*

On September 1, 2022 Helsinn Group ("Helsinn"), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, and Juniper Biologics Pte Ltd, a science-led healthcare company focused on researching, developing and commercializing novel therapies, reported the signing of an exclusive distribution license and supply agreement to register, distribute, promote, market and sell LEDAGA (chlormethine gel) in Australia, Southeast Asia and the Middle East* as a topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma ("MF-CTCL") in adults (Press release, Juniper Biologics, SEP 1, 2022, View Source [SID1234618864]).

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Giorgio Calderari, Helsinn CEO commented: "I am pleased to announce this agreement with Juniper today which further widens the geographic distribution of LEDAGAmaking this treatment option available to even more patients suffering from MF-CTCL. Juniper is an excellent partner for Helsinn and I’m looking forward to working with them to deliver on our mission to improve the lives of people with cancer all over the world."

Raman Singh, CEO of Juniper Biologics stated: "This latest deal is testament of the shared purpose and strong partnership between Juniper Biologics and the Helsinn Group. The licensing of LEDAGA marks a key milestone in our mission to help improve the treatment for patients suffering from the burden of MF-CTCL. With LEDAGA, we will not only be adding to our growing portfolio of oncology medicines, we will more importantly be providing cancer patients with access to this important treatment option."

Chlormethine gel 0.016%, also known as mechlorethamine gel, is approved in multiple countries, including the EU and US, and is marketed under the trade names LEDAGA and VALCHLOR. The authorized use for each country varies based on the design of the registrational trial and the individual health authority requirements. For more details, please refer to the approved product information for each respective jurisdiction.

*The full list of countries covered by the license agreement includes: Australia, Afghanistan, Armenia, Azerbaijan, Bangladesh, Bhutan, Brunei, Cambodia, Georgia, India, Indonesia, Iraq, Kazakhstan, Kyrgyzstan, Laos, Malaysia, Mongolia, Myanmar, Nepal, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Tajikistan, Turkmenistan, Uzbekistan and Vietnam.

About Mycosis Fungoides

Mycosis fungoides (MF) accounts for almost 50% of all primary cutaneous lymphomas, a form of non-Hodgkin’s lymphoma. The cause of MF remains unknown and there are no curative treatments. MF has an indolent clinical course, slowly progressing from patches to thicker plaques and eventually to tumours over years or decades. Signs include rash, patch and plaques with severe itch. MF typically affects older adults (median age at diagnosis: 55-60 years) with male predominance.

About LEDAGA

LEDAGA gel is an alkylating drug indicated for the topical treatment of MF-CTCL in adult patients. LEDAGA is a gel which is applied topically once a day. The drug has been approved by the European Commission (for the treatment of MF-CTCL in adult patients). Since June 2019, LEDAGA is commercialized in more than 30 countries including Europe, Canada, Latin America.

GSK to highlight the latest advances in cancer research from across its portfolio and pipeline at ESMO

On September 1, 2022 GSK plc (LSE/NYSE: GSK) reported that it will present new findings from across its diverse oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 (9-13 September), including presentations on Zejula (niraparib) and Jemperli (dostarlimab), as well as early-stage research in immuno-oncology and real-world evidence assessing treatment patterns and outcomes (Press release, GlaxoSmithKline, SEP 1, 2022, View Source [SID1234618863]). The research being presented will further demonstrate the potential of GSK’s approved therapies and commitment to exploring new approaches that target key pathways and maximise anti-tumour activity.

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Hesham Abdullah, SVP, Global Head of Oncology Development, GSK said: "The long-term data we are presenting at ESMO (Free ESMO Whitepaper) further our understanding of the role of Zejula and Jemperli to treat certain ovarian and endometrial cancers, highlighting our commitment to gynaecological cancers, and will provide the oncology community with deeper insights to inform treatment decisions and help optimise outcomes for patients. We look forward to presenting research that continues to explore the full potential of our approved and investigational therapies, as we seek to improve outcomes for more patients."

Transforming the lives of patients with gynaecologic malignancies

A long-term, ad-hoc analysis from the phase III PRIMA (ENGOT-OV26/GOG-3012) study evaluating niraparib as a maintenance monotherapy in patients with first-line ovarian cancer following a response to platinum-based chemotherapy (presentation #530P) will reinforce the role of this poly (ADP-ribose) polymerase (PARP) inhibitor for this difficult-to-treat cancer.

Long-term data in mismatch repair-deficient solid tumours

Updated results from the GARNET trial will further demonstrate the potential of dostarlimab, a programmed cell death receptor-1 (PD-1) blocking antibody, in the treatment of advanced solid tumours. This includes a longer-term analysis from cohorts A1 and F of the study, evaluating overall survival (OS) and progression-free survival (PFS) in certain patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours (presentation #549P), showcasing our commitment across tumour types.

Understanding real-world outcomes to advance patient care

GSK will also present a real-world analysis of patients with dMMR/microsatellite instability-high (MSI-H) endometrial cancer who received early access to dostarlimab via the temporary authorisation for use (ATU) programme in France, highlighting the need for patient access to new treatment regimens (presentation #553P).

Findings also will be presented from primary and secondary research demonstrating the variation in perspectives of regulators, payors, oncologists, and patients on non-OS or surrogate endpoints, and potential strategies to bridge gaps in value attribution (presentation #1317MO).

Full list of GSK’s presentations at ESMO (Free ESMO Whitepaper):

Zejula

Abstract Name

Presenter

Presentation Details

PRIMA/ENGOT-OV26/GOG-3012 study: updated long-term PFS and safety

A. González-Martín

#530P

Phase 1b study of elimusertib (ATRi; BAY 1895344) in combination with niraparib (PARPi) in patients with advanced solid tumors

T. Yap

#494TiP

Jemperli

Abstract Name

Presenter

Presentation Details

Efficacy of dostarlimab in endometrial cancer (EC) by molecular subtype: a post hoc analysis of the GARNET study

A. Oaknin

#547P

Progression-free survival (PFS) and overall survival (OS) in advanced/recurrent (AR) mismatch repair deficient/microsatellite instability–high or proficient/stable (dMMR/MSI-H or MMRp/MSS) endometrial cancer (EC) treated with dostarlimab in the GARNET study

A. Tinker

#548P

Progression-free survival (PFS) and overall survival (OS) in patients (pts) with mismatch repair deficient (dMMR) solid tumors treated with dostarlimab in the GARNET study

T. Andre

#549P

Real-world data on dostarlimab in post-platinum mismatch repair deficient (dMMR)/ microsatellite instability high (MSI-H) advanced/recurrent (A/R) endometrial cancer: descriptive analysis of the French cohort Temporary Authorization of Use (ATU)

M. Rodrigues

#553P

Pipeline

Abstract Name

Presenter

Presentation Details

METEOR-1: A phase 1 study of the safety and efficacy of the protein arginine methyltransferase 5 (PRMT5) inhibitor GSK3326595 in advanced solid tumors

S. Postel-Vinay

#456MO

Phase 2 study of anti-TIGIT GSK4428859A (GSK’859A)/EOS-448 + anti-CD96 GSK6097608 (GSK’608) + anti–PD-1 dostarlimab in non-small cell lung cancer (NSCLC)

D. Spigel

#1189TiP

Real-world outcomes

Abstract Name

Presenter

Presentation Details

Non-OS endpoints in oncology: strategies to bridge the gap in value attribution by regulators, payors, oncologists, and patients

A. Fameli

#1317MO

Frequency and impact of retreatment in relapsed refractory multiple myeloma (RRMM): Real-world survey conducted in 5 European countries (United Kingdom, France, Germany, Italy, Spain)

A. Bailey

#642P

Treatment patterns, outcomes, and physician decision-making in multiple myeloma: a real-world European study

A. Ribbands

#644P

Full list of investigator-sponsored studies and supported collaborative studies at ESMO (Free ESMO Whitepaper):

Zejula

Abstract Name

Presenter

Presentation Details

NIRVANA-1: A multicentre randomized study comparing carboplatin-paclitaxel (CP) followed by niraparib (nira) to CP–bevacizumab (bev) followed by nira-bev in patients with FIGO Stage III ovarian high-grade epithelial cancer and no residual disease after upfront surgery

G. Freyer

#615TiP

Lete-cel

Abstract Name

Presenter

Presentation Details

Prevalence and clinical characteristics of metastatic synovial sarcoma (mSS) patients with tumours expressing NY-ESO-1 antigen (NY+) and who are HLA-A*02:01, *02:05 or *02:06 allele positive (HLA+): Cohort study from the French Sarcoma Group

A. Dufresne

#1503P

About ovarian cancer

Ovarian cancer is the 8th most common cancer in women worldwide.[1]Despite high response rates to platinum-based chemotherapy in the front-line setting, approximately 85% of patients will experience disease recurrence.[2] Once the disease recurs, it is rarely curable, with decreasing time intervals to each subsequent recurrence.

About endometrial cancer

Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. It is the most common gynaecologic cancer in the US and second most common gynaecologic cancer globally.[3] Approximately 15-20% of women with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.[4]

About multiple myeloma

Multiple myeloma is the third most common form of blood cancer in the US.[5] An estimated 35,000 Americans are diagnosed with the disease annually and nearly half (13,000 people) will die from it.[6] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[7]

About dostarlimab

Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.[8]In addition to GARNET, dostarlimab is being investigated in other registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers.

Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: dostarlimab (GSK4057190), a PD-1 antagonist; cobolimab (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of each of these assets under the Agreement.

Important Information for JEMPERLI in the EU

Indication

JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability‑high (MSI‑H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum‑containing regimen.

Refer to the JEMPERLI Prescribing Information for a full list of adverse events and the complete important safety information in the EU.

About niraparib

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies.

Important Information for ZEJULA in the EU

Indication

ZEJULA is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Refer to the ZEJULA Prescribing Information for a full list of adverse events and the complete important safety information in the EU.

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, tumour cell targeting therapies and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.

Official opening of Axcynsis Therapeutics’ office and research facility in Singapore

On September 1, 2022 Singapore-based biotech start-up, Axcynsis Therapeutics, reported that achieves its important milestone three months after its fund-raising announcement (Press release, Axcynsis Therapeutics, SEP 1, 2022, View Source [SID1234618862]). Located at Singapore’s biotech hub, The Science Park 2, Axcynsis opens its first office and research facility spanning approximately 4000 square feet.

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"Our Biology, Chemistry and Bioconjugation laboratories, furnished with state-of-the-art equipment for Antibody-X conjugate discovery, will lay the foundation for Axcynsis’ innovation to further strengthen our discovery platforms." said Dr. Zou Bin, founder and CEO of Axcynsis Therapeutics.

Following this opening, Axcynsis Therapeutics looks to further expand the growing team to work towards its mission in developing the next generation Antibody-X conjugates.

BCI Pharma will present a poster to the XXVII EFMC International Symposium on Medicinal Chemistry

On September 1, 2022 BCI Pharma reported that it will attend the XXVII EFMC International Symposium on Medicinal Chemistry in Nice from September 4-8, 2022 and present its promising research program targeting tumor-associated macrophages (Press release, BCI Pharma, SEP 1, 2022, View Source [SID1234618860]). Mode of action and efficacy data of our preclinical candidate will be discussed.

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