On May 22, 2024 The University of Birmingham and Orphelia Pharma, a pharmaceutical company dedicated to the development and marketing of orphan paediatric medicines, reported the extension of their collaboration to leverage patient-level data of the BEACON refractory or relapsed neuroblastoma trial to support the marketing authorisation of KIZFIZO (Press release, ORPHELIA Pharma, MAY 22, 2024, View Source;utm_medium=rss&utm_campaign=orphelia-pharma-and-university-of-birmingham-strengthen-their-collaboration-to-support-the-registration-of-kizfizo [SID1234643536]).

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Neuroblastoma is a rare type of cancer usually diagnosed in children under 2 years of age, and for which age-specific therapeutic options are needed.

KIZFIZO (temozolomide oral suspension, 40 mg/ml) is the first ready-to-use oral liquid paediatric formulation of temozolomide developed for use in the treatment of relapsed or refractory high-risk neuroblastoma, which carries a very poor prognosis.

The BEACON trial (NCT02308527) was a hypothesis-generating phase II trial that served to identify active regimens in relapsed or refractory neuroblastoma, some of which are now being further investigated. The trial recruited paediatric patients between 2013 and 2021 and involved the University of Birmingham as the sponsor, the European expert groups SIOPEN (International Society of Paediatric Oncology European Neuroblastoma) and ITCC (Innovative therapies for children with cancer).

KIZFIZO was not available in time for the BEACON trial but Orphelia Pharma and the University of Birmingham are collaborating to assess the clinical benefit and the safety of temozolomide-based regimens in relapsed or refractory high-risk neuroblastoma patients. Overall, anonymised data from the BEACON trial are being used to support the registration dossier of KIZFIZO, according to a data sharing agreement drawn up by University of Birmingham Enterprise.

BEACON-2 is the follow-on trial that will test bevacizumab and dinutuximab beta in combination with the backbone chemotherapy temozolomide and irinotecan. As part of its ongoing commitment to child cancer, Orphelia Pharma has also agreed to support the new BEACON-2 trial, also sponsored by University of Birmingham, by making KIZFIZO available as a child-friendly temozolomide option, in addition to the standard form of temozolomide, where participating investigators can have access to this medicine upon regulatory approval of its use as part of the BEACON-2 trial.

Jeremy Bastid, Chief Development Officer at Orphelia Pharma, commented: "The support of the University of Birmingham has been invaluable to us. The BEACON data has already demonstrated a clear clinical benefit and an improved overall survival over historical controls."

Dr Lucas Moreno, Head of Paediatric Haematology and Oncology at Vall d’Hebron University Hospital, Barcelona, Spain and Chief Investigator for BEACON said: "We are delighted that the data generated could not only delineate the best treatment options for those patients, but also support the registration of a new paediatric formulation of temozolomide, which is much sought-after for our younger patients."

Professor Amos Burke, Director of the Cancer Research Clinical Trials Unit concluded: "A liquid formulation of temozolomide is welcomed for younger patients and the use of data from the standard capsule formulation of temozolomide used in BEACON to support registration for a new liquid formulation demonstrates the importance of the collaborative use of results from this practice-changing trial."

On May 22, 2024 NUCLIDIUM and Guerbet (GBT) reported a strategic partnership to advance NUCLIDIUM’s diagnostic and therapeutic copper-based radiopharmaceuticals (Press release, NUCLIDIUM, MAY 22, 2024, View Source [SID1234643534]). This partnership will provide NUCLIDIUM access to Guerbet’s knowledge and extensive network in diagnostic imaging, manufacturing, and clinical trials, aiding the progression of NUCLIDIUM’s theranostic candidates towards commercialization. Guerbet has made a strategic, non-exclusive investment in NUCLIDIUM as part of the agreement. As part of the agreement, François Nicolas, Senior Vice President of R&D at Guerbet, will join NUCLIDIUM’s Board of Directors as an observer. No further details of the agreement have been disclosed.

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"Guerbet is a global leading expert in diagnostic imaging with a longstanding record in developing, manufacturing, and globally distributing medical imaging solutions. This collaboration emphasizes the value of our innovative copper-based theranostic pipeline, which aims to provide cancer patients with comprehensive solutions from the precise diagnosis to effective treatments. Our goal is to accelerate the clinical development of our unique product candidates and we look forward to gaining valuable strategic insights from François and the Guerbet team," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM.

François Nicolas, Senior Vice President of R&D Guerbet added: "NUCLIDIUM leads in pioneering a new generation of targeted radiotheranostics that could vastly extend patient benefits. Targeted radiopharmaceuticals represent a significant advancement in cancer treatment, yet face supply limitations and production challenges. NUCLIDIUM’s copper-based strategy presents a promising approach to address these issues, enhancing patient access and improving disease staging and treatment. This aligns with Guerbet’s growth strategy to broaden our core business areas. I am excited to support Leila and her team in demonstrating the clinical value of its platform."

NUCLIDIUM is advancing a unique pipeline of targeted copper-based radiopharmaceuticals leveraging isotopes 61Cu and 67Cu. Its innovative platform facilitates a seamless transition from diagnostic to therapeutic applications by merely exchanging the isotopes on the same tumor-targeting molecule. The company will apply its easy-to-produce manufacturing process to enhance product availability and address major challenges in radiotheranostic medicine to develop precise and effective theranostics for multiple solid tumor types including prostate, colorectal, gastric, breast and pancreatic cancers as well as neuroendocrine tumors. The partnership with Guerbet is a critical pillar in NUCLIDIUM’s strategy to establish valuable collaborations to advance its proprietary pipeline and ensure reliable supply chains for its copper-based radiopharmaceuticals.

On May 22, 2024 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that members of management will present at the following upcoming investor conferences (Press release, Mersana Therapeutics, MAY 22, 2024, View Source [SID1234643531]):

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TD Cowen 5th Annual Oncology Innovation Summit
Format: Fireside chat
Date/Time: Wednesday, May 29, 2024, at 9:00 a.m. Eastern Time

Goldman Sachs 45th Annual Global Healthcare Conference
Format: Fireside chat
Date/Time: Wednesday, June 12, 2024, at 8:00 a.m. Eastern Time
Live webcasts of these events will be available on the Investors & Media section of Mersana’s website at www.mersana.com. Archived replays will be available for approximately 90 days following the events.

On May 22, 2024 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that G1’s Chief Medical Officer Dr. Raj Malik and Chief Commercial Officer Andrew Perry will participate in a fireside chat at TD Cowen’s 5th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper), on Wednesday, May 29, at 8:30AM EDT (Press release, G1 Therapeutics, MAY 22, 2024, View Source [SID1234643530]).

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The webcast of the event will be accessible on the Events & Presentations page of View Source

On May 22, 2024 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across multiple types of cancer from its oncology portfolio and pipeline during the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (#ASCO24), which is taking place virtually and in-person in Chicago, Illinois from May 31 to June 4 (Press release, Eisai, MAY 22, 2024, View Source [SID1234643529]).

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Notable data includes an oral presentation on biomarker analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial (NCT02811861(New Window)), which evaluated lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA) versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (Abstract #4504). An analysis of patterns of disease progression and subsequent therapy from this trial will also be presented in a poster presentation (Abstract #4524).

"At Eisai, we let the science drive us to new approaches that accelerate progress in oncology, while also remaining grounded in our human health care concept that reinforces our commitment to prioritize the needs of patients and families impacted by a cancer diagnosis," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "With this in mind, we look forward to sharing research that provides further insight into the role of lenvatinib plus pembrolizumab as a first-line standard of care option in advanced renal cell carcinoma, as well as research that explores various modalities in our pipeline for the potential treatment of advanced diseases with the goal of improving patients’ lives."

Other key research of note from Eisai’s pipeline include an oral presentation of Phase 3 data from the JBCRG-M06/EMERALD study in Japan evaluating trastuzumab and pertuzumab in combination with Eisai’s eribulin mesylate or a taxane in patients with HER2-positive, locally advanced or metastatic breast cancer (NCT03264547(New Window); Abstract #1007). Additional pipeline research to be presented in poster sessions include an overview of a Phase 2 study of BB-1701, an antibody drug conjugate targeting HER2, in previously treated patients with HER2-positive or HER2-low unresectable or metastatic breast cancer (NCT06188559(New Window); Abstract #TPS1122), findings from a Phase 1b trial of tasurgratinib (development code: E7090) with or without endocrine therapies for patients with ER-positive, HER2−negative recurrent/metastatic breast cancer after receiving a CDK4/6 inhibitor (NCT04572295(New Window); Abstract #3103), as well as the dose-expansion part of a Phase 1b global study of E7386 in combination with lenvatinib in patients with hepatocellular carcinoma and other solid tumors including endometrial cancer (NCT04008797(New Window); Abstract #TPS3169).

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. These abstracts will be made available via the ASCO (Free ASCO Whitepaper) website on Thursday, May 23, 2024 at 4:00 PM Central Daylight Time (CDT).

　

Cancer Type Study/Compound Abstract Title Abstract Type & Details
Lenvatinib Plus Pembrolizumab
Genitourinary Cancer CLEAR Biomarker analyses in patients with advanced renal cell carcinoma (aRCC) from the phase 3 CLEAR trial
Oral Abstract Session
Abstract #4504
June 3, 2024
9:00 AM CDT

Genitourinary Cancer CLEAR Lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in advanced renal cell carcinoma (aRCC): Patterns of progression and subsequent therapy in the CLEAR trial
Poster Session
Abstract #4524
June 2, 2024
9:00 AM CDT

Melanoma LEAP-004 Lenvatinib (len) plus pembrolizumab (pembro) in patients with advanced melanoma that progressed on anti-PD-(L)1 therapy: Over 4 years of follow-up from the phase 2 LEAP-004 study
Poster Session
Abstract #9559
June 1, 2024
1:30 PM CDT

Lenvatinib

Differentiated Thyroid Cancer

Real-World Evidence Patients with radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) with BRAF V600E and/or K601E Mutation Status – A real-world view of effectiveness of lenvatinib monotherapy
Poster Session
Abstract #6098
June 2, 2024
9:00 AM CDT

Gastrointestinal Cancer REFLECT ctDNA analysis of patients (pts) with unresectable hepatocellular carcinoma (uHCC) treated with lenvatinib (LEN) or sorafenib (SOR) as 1L therapy
Poster Session
Abstract #4094
June 1, 2024
1:30 PM CDT

Eribulin
Breast Cancer JBCRG-M06/ EMERALD Trastuzumab and pertuzumab in combination with eribulin mesylate or a taxane as first-line chemotherapeutic treatment for HER2-positive, locally advanced or metastatic breast cancer: results of a multicenter, randomized, non-inferiority phase 3 trial in Japan (JBCRG-M06/EMERALD)
Oral Abstract Session
Abstract #1007
June 1, 2024
5:00 PM CDT

Pipeline
Breast Cancer BB-1701 An open-label, multicenter, phase 2 study to evaluate the safety and efficacy of BB-1701, a novel antibody drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2), in previously treated patients with HER2-positive (HER2+) or HER2-low unresectable or metastatic breast cancer (BC)
Poster Session
Abstract #TPS1122
June 2, 2024
9:00 AM CDT

tasurgratinib Phase Ib trial of tasurgratinib (E7090) with or without endocrine therapies for patients (pts) with ER+, HER2− recurrent/metastatic breast cancer (BC) after receiving a CDK4/6 inhibitor
Poster Session
Abstract #3103
June 1, 2024
9:00 AM CDT

H3B-6545 H3B-6545 in women with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (-) breast cancer (BC)
Rapid Oral Session
Abstract #1015
June 3, 2024
11:30 AM CDT

H3B-6545 H3B-6545 + palbociclib in patients (pts) with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (-) breast cancer (BC)
Poster Session
Abstract #1051
June 2, 2024
9:00 AM CDT

Solid tumors E7386 Dose-expansion part of a phase 1b global study of E7386 in combination with lenvatinib (LEN) in patients (pts) with hepatocellular carcinoma (HCC) and other solid tumors including endometrial cancer (EC)
Poster Session
Abstract #TPS3169
June 1, 2024
9:00 AM CDT

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with Merck’s anti-PD-1 therapy pembrolizumab. Eisai and Merck are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across more than multiple clinical trials.

In May 2023, Eisai entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd. (Headquarters: Zhejiang Province, China, "BlissBio"), for BB-1701, a HER2-targeting antibody drug conjugate (ADC), with option rights for a strategic collaboration. Eisai and BlissBio are currently investigating BB-1701 in a Phase 2 clinical trial in Japan and the United States for breast cancer and a Phase 1/2 clinical trial in the United States and China for HER2-expressing solid tumors.