On May 22, 2024 Valerio Therapeutics S.A. (Euronext Growth Paris: ALVIO), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) and driver oncogenes, reported the completion of dosing for the first cohort of subjects in its Phase 1/2 trial of lead candidate, VIO-01, a pan-DDR decoy for the treatment of solid tumors (Press release, Valerio Therapeutics, MAY 22, 2024, View Source [SID1234643563]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

VIO-01 is the next-generation DNA decoy generated from Valerio Therapeutics’ proprietary PlatON platform. An optimized product with modifications for increased half-life, plasma stability and tumor targeting, VIO-01 is a potent pan-DDR trapper capable of abrogating multiple DNA damage pathways including homologous recombination and non-homologous end joining. The pan trapping nature of VIO-01 allows for treatment of a wide range of potential solid tumor indications rather than restrictions to BRCA1/2 mutations or HRD positivity as with other DNA damage inhibitors.

The Clinical Review Committee (CRC) is composed of Valerio Therapeutics Medical and Safety teams as well as Principal Investigators convened to review all available and relevant safety information from the first cohort of 3 patients. No clinically significant adverse events or serious adverse events were reported and no MTD was declared, allowing the Clinical Review Committee to unanimously agree to escalate to the second dose cohort.

The VIO-01-101 Phase 1b portion of the trial aims to determine to recommended phase 2 dose and/or pharmacologically active dose in patients with selected solid tumors including, HRD+ Ovarian cancer, BRCA1/2 mutant Breast Cancer, HRR mutated prostate cancer, and solid tumors with HRR mutations. The dose escalation to clinically relevant exposures and safety expansion is expected to continue through 2024.

Dr. Shefali Agarwal, Chairwoman of the Board of Directors and CEO, stated:

"The result of this meeting represents one of the key milestones in the development of VIO-01 and the PlatON platform. This is an import step on our way to becoming a leader in the development of innovative drugs with unique mechanisms of action. We are pleased with the encouraging tolerability seen in this first cohort of patients and look forward to bringing this drug-candidate another step closer to patients. Most importantly, we’d like to thank our dedicated investigators and patients for their willingness to participate in this trial and are excited for our continued future work together."

On May 23, 2024 Orna Therapeutics, a biotechnology company dedicated to designing and delivering a new class of fully engineered circular RNA therapeutics (oRNA), reported its acquisition of ReNAgade Therapeutics, a pioneer in unlocking the potential of RNA therapeutics that demonstrated industry-leading delivery to multiple extra-hepatic cells in non-human primate (NHP) models over the past 18 months (Press release, Orna Therapeutics, MAY 22, 2024, View Source [SID1234643612]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Amit D. Munshi, Chief Executive Officer of ReNAgade, will succeed Tom Barnes, Ph.D., to lead Orna as Chief Executive Officer.

"RNA-centric approaches are poised to eclipse traditional cell therapy-based methods and reshape the future of medicine," said Mr. Munshi. "This strategic acquisition unifies Orna’s and ReNAgade’s strengths and capabilities under one roof, expanding technological synergies and multiplying the companies’ depth and breadth of expertise to drive a unique RNA therapeutic-focused R&D engine. Orna will now advance an industry-leading approach combining the Company’s circular RNA expression technology with ReNAgade’s broad portfolio of LNP-based RNA delivery systems and comprehensive editing programs to solve the most pressing challenges in drug development."

An industry veteran of more than 30 years, Mr. Munshi is former President and CEO of Arena Pharmaceuticals Inc., which he built from a $300 million market cap into a late clinical stage company before its acquisition for $6.7 billion by Pfizer. Dr. Barnes will retain his position on Orna’s Board of Directors and serve as chair of its Scientific Advisory Board.

"Orna remains singularly focused on developing the right tools and technologies and building the right company to power an entirely new class of RNA-based medicines," said Dr. Barnes, founding Chief Executive Officer of Orna Therapeutics. "The combination of technologies positions Orna to advance best-in-classpanCAR in vivo CAR RNA therapies and expand existing gene editing delivery solutions with circular RNA to address the massive unmet need in multiple diseases."

"Both Orna and ReNAgade were founded on our bold vision to push the boundaries of RNA medicine," said Ansbert Gadicke, M.D., Managing Partner of MPM BioImpact. "The fusion of these industry leaders in circular RNA and delivery will transform the landscape of RNA therapeutics and accelerate clinical milestones leading to greater impact for patients living with cancer and autoimmune diseases. The combined company is supported by a substantial financial position enabling these milestones."

Built by MPM BioImpact, both Orna and ReNAgade bring significant financing. Orna launched with $100 million in Series A financing in February 2021, subsequently announcing in August 2022 a $221 million Series B in addition to a strategic partnership. ReNAgade launched in May 2023 with $300 million Series A financing. The combined company will have a robust pipeline with panCAR programs in oncology and autoimmune disease, vaccine programs partnered with Merck, and genetic disease programs.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On May 22, 2024 Nona Biosciences, a global biotechnology company providing a total solution from "Idea to IND" (I to ITM), ranging from target validation and antibody discovery through preclinical research, reported that it has entered into a license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for preclinical monoclonal antibodies that will be used to create targeted therapies in oncology (Press release, Nona Biosciences, MAY 22, 2024, View Source [SID1234643547]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Nona Biosciences shall receive US$19 million upon completion of the transaction. Nona is eligible to receive an additional US$10 million in potential near-term milestone payments and up to US$575 million upon achieving specified development, regulatory, and commercial milestones, as well as tiered royalty payments on net sales. In addition, Nona is eligible to receive payments for the option programs should AstraZeneca exercise these options.

"We are delighted to announce this agreement with AstraZeneca, global leaders in developing tumor targeted therapies, to maximize the potential of our novel antibodies," said Jingsong Wang, M.D., Ph.D., Chairman of Nona Biosciences. "This agreement further validates our leading antibody discovery platform, and we look forward to seeing our antibodies developed into potential new medicines for cancer patients."

Puja Sapra, Senior Vice President, Tumour Targeted Delivery, Oncology R&D, AstraZeneca, said: "The global license agreement with Nona Biosciences is an exciting opportunity to further develop these antibodies derived from Nona’s innovative biologics discovery engine into novel tumor targeted therapies using AstraZeneca’s industry-leading capabilities."

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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