On October 22, 2021 Servier, a global independent pharmaceutical group, reported that the primary objective (progression free survival) of the Phase III SOLSTICE trial has not been met (Press release, Servier, OCT 22, 2021, View Source [SID1234591789]). SOLSTICE was designed to evaluate the superiority of LONSURF (trifluridine/tipiracil) + bevacizumab over capecitabine + bevacizumab in 1st line unresectable metastatic colorectal cancer (mCRC) in patients non-eligible for intensive therapy. The trial will continue as planned given that no deleterious effects and no new safety issues have been raised in either study arm.

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!

Data from the primary analysis will be presented at an upcoming medical congress.

"We remain committed to improving outcomes in mCRC and we will continue to follow patients as planned in order to perform the main secondary endpoint analysis on overall survival in 2023," said Patrick Therasse, M.D., Ph. D., Head of Late Stage and Life Cycle Management, and Deputy Head Oncology and Immuno-Oncology Therapeutic Area, Servier. "The clinical value of LONSURF in its current indications remains unchanged, and the ongoing Phase III SUNLIGHT trial (LONSURF + bevacizumab versus LONSURF in 3rd line mCRC) is proceeding as planned."

Nearly 1.4 million people are diagnosed with colorectal cancer (CRC) each year worldwide,1 equating to 10% of the global cancer cases.1 In Europe, CRC is the second most common cause of cancer death,2 and metastatic (when the cancer has spread from the primary site to other parts of the body) patients have a 5-year survival rate of just 11%.2 Standard chemotherapy regimens for mCRC include fluoropyrimidines, oxaliplatin, irinotecan or targeted treatments, such as those that target vascular endothelial growth factors (VEGF) or endothelial growth factor receptors (EGFR).

"Metastatic colorectal cancer patients who are not well enough to undergo intensive chemotherapy have limited options, and quality of life is a priority," said Professor Thierry André, MD, Saint Antoine Hospital, Paris, France, and Lead Investigator for the SOLSTICE study. "We are continuously searching for new ways to give these patients efficient treatment with low toxicities."

Servier is committed to developing new treatments to support patients in their fight against gastrointestinal cancer.

About SOLSTICE
SOLSTICE is an open-label, randomized, multicentre Phase III trial in 856 unresectable metastatic colorectal cancer patients who are not candidates for, or do not require, intensive therapy. Patients were randomized 1:1 to receive 1st line LONSURF + bevacizumab versus capecitabine + bevacizumab. The primary objective is to demonstrate superior progression free survival with LONSURF + bevacizumab over capecitabine + bevacizumab. The first patient was enrolled in March 2019.

For more information on SOLSTICE, please visit www.ClinicalTrials.gov (View Source). The ClinicalTrials.gov Identifier is NCT03869892.

About LONSURF
LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.

In the EU, LONSURF is indicated as monotherapy for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti- VEGF agents, and anti-EGFR agents. LONSURF is also indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer (mGC), including adenocarcinoma of the gastroesophageal junction (mGEJC), who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

As of October 2021, LONSURF has been approved in 96 countries for the treatment of advanced mCRC and in 80 countries for the treatment of advanced mGC/mGEJC.

LONSURF was discovered and developed by Taiho Pharmaceutical Co., Ltd. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico, and Asia.

On October 22, 2021 Chugai Pharmaceutical Co., Ltd. reported that has revised the full-year financial forecasts for the fiscal year ending December 2021 announced on February 4, 2021, considering the recent trend of business results, as follows (Press release, Chugai, OCT 22, 2021, View Source [SID1234591869]).

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!

1. Revised consolidated financial forecasts for the full fiscal year ending December 2021 (January 1 to December 31, 2021)

2. Reasons for the revisions
Forecast of Revenues has been revised to ¥970.0 billion, an increase of ¥170.0 billion from the previous forecast. For domestic sales, forecasted sales amount attributable to the supply of Ronapreve to the government for the fiscal year has been included, and the progress and revised assumptions for each product including Avastin and Tecentriq, which have progressed better than the previous forecast have been reflected. For overseas sales, exports of Actemra and Hemlibra to Roche have been forecasted to be higher than the previous forecast. For royalties and other operating income, the forecast of income and one-time income for Actemra and Hemlibra has also been updated.

Core operating profit forecast has also been revised to ¥400.0 billion, an increase of ¥80.0 billion from the previous forecast. In addition to the above-mentioned revision of revenue forecast, higher cost to sales ratio due to a change in the product mix from the original assumption, etc., foreign exchange effects and increases in some expenses attributable to increased sales and profits have been included.

Core EPS is forecasted to be ¥178.00, an increase of ¥37.00 from the previous forecast. Year-end dividend forecast and the forecast for the Core dividend payout ratio have not been determined at this time.

The revised full-year consolidated forecasts are based on updated foreign exchange rate assumptions: 1CHF = 117 JPY, 1EUR = 130 JPY, 1USD = 107 JPY, and 1SGD = 81 JPY.

On October 21, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it has entered into a Research Collaboration and License Option Agreement with LegoChem Biosciences, Inc. ("LCB", KOSDAQ: 141080) for new antibody-drug conjugates (ADCs) (Press release, Antengene, OCT 21, 2021, View Source;license-option-agreement-with-legochem-biosciences-for-new-antibody-drug-conjugate-candidates-301405417.html [SID1234591684]).

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 this agreement, the two parties will jointly generate and evaluate ADC candidates using Antengene’s antibodies and LCB’s next generation ADC technology platform. Antengene will have an exclusive option to license global rights for the development and commercialization of the resulting ADC candidates. When the option is exercised, LCB will be eligible to receive upfront and milestone payments, as well as tiered royalties. In addition, LCB is eligible to receive a prespecified percentage of any sublicensing income received by Antengene.

ConjuAll is a next-generation ADC platform technology utilizing novel linker chemistry combined with site-specific conjugation. LCB’s platform provides solutions for site-specific conjugation enabling high-purity final ADCs with defined Drug-to-Antibody Ratio (DAR), plasma stability, and tumor-selective efficient payload release which are major unmet needs in ADC development.

"It is our pleasure to collaborate with LCB, a company with an industry-leading ADC technology platform," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. " This further complements our existing in-house discovery efforts and our deep experience in developing novel oncology medicines globally. Utilizing LCB’s next generation ADC platform, we aim to accelerate the discovery and development of innovative ADC candidates, furthering our vision of treating patients beyond borders worldwide."

"LCB and Antengene will team up to accelerate the development of new therapies that combine Antengene’s expertise in oncology with LCB’s clinically validated ADC technology platform." said Dr. Yong-Zu Kim, CEO & President of LCB.

On October 21, 2021 Oncodesign (ALONC – FR0011766229), a French biopharmaceutical company specialized in kinase inhibitor research and precision medicine, and TiumBio (KOSDAQ:321550), a company specializing in R&D for rare diseases, reported the signature of a research collaboration agreement on R&D of potential drug candidates for fibrosis (Press release, Oncodesign, OCT 21, 2021, View Source [SID1234591707]).

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 this agreement, Oncodesign will be responsible for identification, chemical synthesis and optimization of Nanocyclix drug candidates and their early-stage analysis, while TiumBio will be responsible for the advanced evaluation of fibrotic efficacy of the drug candidates. This initial phase of the collaboration will be funded by TiumBio.

Also, TiumBio has secured an exclusive option to in-license global development and commercialization rights of the discovered drug candidates after their evaluation upon reaching predefined success criteria. Financial conditions for this option, which might be lifted over the next year, cannot be disclosed at this stage.

Hun-Taek Kim, CEO of TiumBio, stated: "We are delighted to work with Oncodesign to achieve our common goal of developing treatments for rare and incurable diseases. If we combine Oncodesign’s kinase inhibitor-based platform technology and our fibrosis-centered R&D experience and expertise in rare diseases, I am confident that we can develop new and innovative drugs in the fibrosis area."

Philippe Genne, CEO and founder of Oncodesign, said: "This new collaboration with TiumBio, an expert company in fibrosis in South-Korea, further expands the global reach of our unique technologies. Following earlier collaborations with international pharmaceutical companies including BMS (Bristol-Myers-Squibb), Ipsen, Sanofi, Servier and UCB, our platform technology Nanocyclix again is poised to bring solutions in a difficult area. I am thrilled to team up with TiumBio to find solutions for patients suffering from Fibrosis."

Jan Hoflack, CSO of Oncodesign, added: "This agreement is another example where an expert pharma company looking for compounds with unique and hard-to-meet criteria comes to benefit from our Nanocyclix technology platform, looking for high potency and exquisite selectivity. Upfront testing of the Nanocyclix diversity set has allowed to identify starting points satisfying TiumBio’s initial criteria and has led to this exciting collaboration."

About Fibrosis

Fibrosis occurs in most tissues of the human body, which is a phenomenon of fibrous connective tissue formation. As the disease progresses, the function of the corresponding organ is defected, which can lead to various chronic fatal disease conditions such as pulmonary and liver fibrosis. In addition, fibrosis accounts for about 45% of all cause disease mortality1, and since there are few effective treatments currently available, it is a disease area with a very high unmet medical demand from patients.

On October 21, 2021 Sumitomo Dainippon Pharma Oncology, Inc., a clinical-stage company focused on research and development for novel cancer therapeutics, reported the first patient has been dosed in a Phase 1 study evaluating its investigational agent DSP-0390, an emopamil-binding protein (EBP) inhibitor, for the treatment of patients with recurrent high-grade glioma (Press release, Sumitomo Dainippon Pharma, OCT 21, 2021, View Source [SID1234591740]).

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!

High grade gliomas are the most common type of malignant brain tumor and cause significant morbidity and mortality.1 Preclinical studies have shown DSP-0390 may have anti-tumor activity that may help address this persistent unmet medical need.

"Dosing the first patient in this study represents another important milestone for SDP Oncology and broadens our fight against brain tumors along with our investigational agent WT1 immunotherapeutic cancer vaccine," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "We look forward to generating data to guide the development of DSP-0390 with the goal of developing meaningful treatments for patients with brain cancer."

The primary objective of the first-in-human, open-label, dose-escalation study is to assess the safety and tolerability of DSP-0390 in patients with recurrent high-grade glioma. The trial will also determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE). The secondary objective is to characterize the pharmacokinetic (PK) profile of DSP-0390.

Following the completion of the dose-escalation portion of the trial, the study will move into a Part 2 expansion to evaluate whether there is preliminary antitumor activity of DSP-0390 and establish the recommended Phase 2 dose (RP2D) in recurrent World Health Organization (WHO) Grade III or IV malignant glioma.

The trial is being conducted in the United States and Japan. Additional information, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT05023551).

About DSP-0390

DSP-0390 is an emopamil-binding protein (EBP) inhibitor, that is currently being investigated in a Phase 1 study in patients with recurrent high-grade glioma (NCT05023551). EBP is an endoplasmic reticulum membrane protein involved in cholesterol biosynthesis.2 Since most cancer cells are characterized by an upregulation of the various pathways responsible for their biosynthesis and the demand for cholesterol to support cell proliferation is high,3,4,5 the inhibition of EBP by DSP-0390 therefore is expected to lead to disruption of cholesterol homeostasis and induce cell death in cancer cells.6,7 Moreover, as EBP is reported to be highly expressed in several types of cancer and correlates with an aggressive phenotype of certain types of cancers, DSP-0390 has the potential to have anti-tumor activity in these cancers.8,9