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Bionetix, ProQinase, and MercachemSyncom announce a joint research project from target Identification to clinical study

On January 24, 2020 Bionetix, a biotech company developing novel oncology drugs; ProQinase, an oncology-focused contract research organization (CRO) recently acquired by Reaction Biology Corporation (Malvern/PA, USA); and MercachemSyncom, a chemistry CRO specializing in medicinal chemistry and comprehensive medicinal chemistry (CMC), reported they have signed a joint multiyear integrated drug-discovery project, starting from target identification (TI) up to clinical candidate selection on an undisclosed target aimed at acute myeloid leukemia (AML) (Press release, Mercachem, JAN 24, 2020, View Source [SID1234553571]). The goal of the three-party team is to advance the project to the clinical phase by 2023. The total investment sum is "significant, of multimillion Euros", but details are not being disclosed.

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"We are excited to start this new project with MercachemSyncom and ProQinase," said Dr. DooYoung Jung, CEO of Bionetix. "They have proven their quality in another project of ours, which is currently in the early development phase. When this new opportunity came up, our decision was quick and easy. We are convinced that the team will advance this program very efficiently."

Dr. Frank Leemhuis, Managing Director of MercachemSyncom, commented: "Our skilled and experienced team has a proven track record in medicinal chemistry and CMC and built valuable research assets, as the result of a consistent innovation strategy. This research project is an opportunity to build on these qualities, with the goal of serving and creating value for our client. ProQinase is ourtrusted biology partner, through years of collaboration. Together with Bionetix, we look forward to making essential contributions to this oncology program."

"We are very grateful for our long-lasting partnership with MercachemSyncom, which enables us to deliver combined top-class scientific expertise to Bionetix," said Dr. Sebastian Dempe, Chief Executive Officer of ProQinase. "This new opportunity of a multiyear collaboration, utilizing our entire breadth of oncology preclinical services, aims to develop a high-value asset for our mutual client. Working together on solid but flexible research plans, combined with efficiency, allow for short lead times and robust datageneration processes, which are key to the success of such integrated drug-discovery projects. With MercachemSyncom, we will make sure that our promises to Bionetix are met."

Kitov Pharma Receives Notice of Intention to Grant European Patent Covering the Use of NT-219 in Combination with EGFR Inhibitors

On January 24, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported receipt from the European Patent Office (EPO) of a Notice of Intention to Grant for its patent application entitled "Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer (Press release, Kitov Pharmaceuticals , JAN 24, 2020, View Source [SID1234553552])." The patent, which expires in 2036, covers the treatment of NT-219, the company’s novel dual inhibitor of IRS 1/2 and STAT3, in combination with EGFR antibodies and inhibitors.

Kitov is currently advancing NT-219 in combination with cetuximab, an EGFR antibody, as a second-line or third-line therapy for the treatment of recurrent and metastatic squamous cell carcinoma of the Head & Neck Cancer (SCCHN). Kitov plans to initiate a phase 1/2 study in the second quarter of 2020.

"We believe strongly in our rationale for combining NT-219 with cetuximab and we are very pleased with this new addition to our patent estates in Europe," said Isaac Israel, Kitov’s chief executive officer. "Cetuximab is currently the only targeted FDA-approved treatment option for patients with a progressed disease following both prior platinum-based therapy and pembrolizumab. NT-219 has the potential to prevent tumor resistance and re-sensitize tumors to the anti-cancer activity of EGFR inhibitors, making this combination a very attractive drug candidate that will hopefully address the unmet medical need for recurrent and metastatic Head and Neck cancer patients."

Roche provides an update on Phase III study of Tecentriq in people with muscle-invasive urothelial cancer

On January 24, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMvigor010 study evaluating Tecentriq (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC) (Press release, Hoffmann-La Roche, JAN 24, 2020, View Source [SID1234553544]). Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.

"Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers."

The goal in treating MIUC early is to reduce the risk of the disease recurring or spreading to other parts of the body. More treatment options following surgery are needed as approximately half of people with MIUC will develop a recurrence of their disease within 2 years of surgery.1

In addition to ongoing Phase III studies in early and advanced bladder cancer, Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMvigor010 study
IMvigor010 is a global Phase III, open-label, randomised, controlled study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq compared to observation in 809 people with MIUC, who are at high risk for recurrence following resection. The primary endpoint is DFS as assessed by investigator, which is defined as the time from randomisation to invasive urothelial cancer recurrence or death.

About bladder cancer and muscle-invasive urothelial cancer
In 2018, there were over half a million new cases of bladder cancer diagnosed globally, with approximately 200,000 deaths from the disease.2 Urothelial cancer is the most common type of bladder cancer, accounting for about 90–95% of all cases.3 MIUC is a type of urothelial cancer that has spread into the muscle of the bladder, ureter or renal pelvis.4 Approximately 25% of new cases of bladder cancer are diagnosed with muscle-invasive disease,5 which is associated with a poorer prognosis than non-MIUC.4

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

CStone announces first patient dosed in the global proof-of-concept study of CS1001 in combination with Bayer’s regorafenib

On January 24, 2020 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that it has dosed the first patient in Australia in a clinical trial of CS1001, an investigational PD-L1 inhibitor developed by CStone, in combination with regorafenib, an oral multi-kinase inhibitor developed by Bayer Healthcare LLC ("Bayer") (Press release, CStone Pharmaceauticals, JAN 24, 2020, View Source [SID1234553543]). This is the first global proof-of-concept study carried out as a collaboration between CStone and Bayer. It is designed to assess the safety, tolerability, pharmacokinetics, and antitumor activity of the CS1001 plus regorafenib combination in patients with advanced solid tumors including gastric cancer, and to determine the recommended dose for subsequent studies.

CS1001 is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. The drug candidate is being investigated in a number of clinical trials, including one Phase I bridging study in the U.S., one multi-arm Phase Ib study, two Phase II registrational studies and four Phase III studies in China for several tumor types. The Phase Ia/Ib results released at the 2019 Chinese Society of Clinical Oncology (CSCO) Annual Meeting have shown CS1001 to be well tolerated with promising antitumor activities across multiple cancers.

Developed by Bayer, regorafenib is an oral multi-kinase inhibitor that potently blocks protein kinases including VEGFR, FGFR, and CSF1R. Regorafenib has been approved in more than 90 countries, including China, for the second- or later-line treatment of patients with metastatic colorectal cancer, metastatic gastrointestinal stromal tumors, and advanced hepatocellular carcinoma.

In May 2019, CStone and Bayer entered into a global clinical collaboration in which CStone will sponsor clinical studies of the CS1001 in combination with regorafenib. Bayer will provide regorafenib for CStone-sponsored studies.

There is a large body of evidence demonstrating the clinical benefits of monotherapy with kinase inhibitor or anti-PD-1/L1 antibody in multiple malignancies. Preclinical studies revealed that targeted therapies such as regorafenib could bolster the efficacy of immune checkpoint inhibitors in select solid tumors through modulating the tumor immune microenvironment, implicating possible synergistic antitumor effects between the two mechanisms of action.

"Our collaboration with Bayer in this clinical program marks an important milestone in the implementation of CStone’s global strategy I am very pleased that the first patient has been dosed in this combination study.," said Dr. Frank Jiang, Chairman and CEO of CStone. "We hope this clinical program will strengthen CStone’s pipeline, and above all demonstrate the utility of this combination in improving the clinical outcomes for cancer patients who lack effective treatments."

"Preclinical studies in animal models have shown enhanced antitumor activity by the CS1001 plus regorafenib combination, lending evidential support to the design of this proof-of-concept study. In addition, a range of global studies of similar immuno-combination therapies have generated promising results in advanced or metastatic solid tumors," said Dr. Archie Tse, Chief Translational Medicine Officer at CStone. "We hope results from this trial will further validate the combination of multi-kinase inhibitors and immunotherapy in select tumors."

About Regorafenib (Stivarga)

Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R).

Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

Regorafenib is approved under the brand name Stivarga in more than 90 countries worldwide, including the U.S., countries of the EU, China and Japan for the treatment of metastatic colorectal cancer (mCRC) and metastatic gastrointestinal stromal tumors (GIST) and second-line treatment of advanced hepatocellular (HCC).

About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, potentially representing a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China, in which CS1001 showed good tolerability and produced sustained clinical benefits during the Phase Ia stage of the study.

CS1001 is being investigated in a number of ongoing clinical trials, including one Phase I bridging study in the U.S., one multi-arm Phase Ib study, two Phase II registrational studies and four Phase III studies in China for several tumor types.

BERG Presents Initial Clinical Data And Identification Of Response Biomarkers In A Phase 2 Pancreatic Cancer Trial Guided By Using The Interrogative Biology® Platform At ASCO-GI Meeting

On January 24, 2020 BERG, a biopharmaceutical company that merges biology with technology to map and identify drivers of diseases, reported the presentation of initial results from a Phase 2 clinical trial at the Gastrointestinal Cancer Symposium (ASCO-GI), being held in San Francisco from January 23 – 25, 2020 (Press release, Berg, JAN 24, 2020, View Source [SID1234553542]). The presentation provides details on the analysis of a Phase 2 clinical trial using BPM31510 in Pancreatic Ductal Adenocarcinoma (PDAC) refractory to current standard of care. Initial results demonstrated preliminary efficacy in patient’s refractory to chemotherapy regimens and identification of potential biomarkers of survival guided by the use of the BERG Interrogative Biology platform.

"Interrogative Biology has enabled BERG to unravel unique insight into interconnected pathways that drive cancer by mapping the nature of disease biology through patient data and Bayesian AI," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "The research presented this week at ASCO (Free ASCO Whitepaper)-GI further demonstrates how the BERG platform can enhance and improve development of treatments for pancreatic cancer through discovery and validation of biomarkers to improve patient outcomes."

"Pancreatic cancer has continually remained elusive to successful development of novel therapeutic compounds. The observation of an efficacy signal and the parallel use of BERG’s platform to identify biomarkers predictive of response significantly increases chances of successful development of BPM31510," said Dr. Madappa Kundranda, Director Gastrointestinal Cancer Program, Banner MD Anderson Cancer Center, AZ and Principal Investigator at his clinical trial site.

For this trial, BERG has collaborated with leading institutions such as Banner MD Anderson, Gilbert, AZ; Bart’s Cancer Institute, Queen Mary University of London, UK; Medical College of Wisconsin, Milwaukee, WI; Mary Crowley Cancer Center, Dallas, TX; Beth Israel Medical Center/Harvard Medical School, Boston, MA, Royal Free London, UK; Mayo Clinic, Phoenix, AZ; Atlantic Health Systems, Morristown, NJ; Global Cancer Research Institute, San Jose, CA; Sarcoma Cancer Center, Santa Monica, CA; and Vita Medical Associates Bethlehem, PA. BERG is grateful to its patients and family partners and their participation in these critical efforts to improve patient care.

Details of the data presentations include:
Abstract Submission ID: 284735
Abstract Number: 723
Poster Board: L12

Abstract Title: Phase II trial of BPM31510-IV plus gemcitabine in advanced pancreatic ductal adenocarcinomas (PDAC).
Session Information:
Poster Session B: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer
Session Date & Time:
1/24/2020, 12:00 PM-1:30 PM; 4:30 PM-5:30 PM