On June 10, 2019 Sosei Group Corporation ("the Company"); (TSE: 4565) and its strategic alliance partner Pfizer reported that a new clinical candidate from their multi-target drug discovery collaboration was nominated to advance into clinical development (Press release, Sosei Heptares, JUN 10, 2019, View Source [SID1234552773]). Sosei Heptares will receive a $3 million milestone payment from Pfizer for this achievement. The first clinical candidate under this collaboration was nominated by Pfizer in May 2019.

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!

Dr. Malcolm Weir, Executive VP and Chief R&D Officer of Sosei Heptares, said: "We are very pleased to reach this development milestone for another candidate in our partnership with Pfizer so soon after nominating the first clinical candidate last month. The teams at Sosei Heptares and Pfizer have worked well together to generate and advance a novel molecule against a difficult GPCR target, highlighting again the power and potential of this approach and the combined capabilities being deployed."

The multi-target drug discovery collaboration between Sosei Heptares and Pfizer was signed in November 2015 to research and develop potential new medicines directed at up to ten GPCR targets across multiple therapeutic areas. Many of these targets have clinical or biological validation as key points for therapeutic intervention potentially targeting a range of diseases but have proven difficult to address with conventional discovery approaches because of inherent technical challenges.

In an effort to address these challenges, Sosei Heptares and Pfizer scientists worked closely together to leverage their respective complementary expertise in enabling GPCR-focused structure-based drug design (SBDD) and development initially directed to the GPCR targets selected by Pfizer. Pfizer will be responsible for developing and commercialising any potential therapeutic agents (small molecules or biologics) for each target and will have exclusive global rights to any potential resulting agents.

Sosei Heptares has delivered multiple stabilized receptors (StaR proteins), X-ray structures and biophysical data on certain programs, triggering milestone payments from Pfizer, including the US$3 million announced today, as well as $3 million in May 2019, both resulting from the nomination of new clinical candidates. Further possible milestones payments are contemplated under the agreement, with potential for royalties also payable provided the criteria under the agreement are satisfied.

Pfizer also made a US$33 million equity investment in Sosei Heptares in 2015. In the future, Pfizer and Sosei Heptares anticipate publication of select research findings from their collaboration.

On June 10, 2019 The U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as "BR"), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies (Press release, US FDA, JUN 10, 2019, View Source [SID1234536966]). Polivy is a novel antibody-drug conjugate, and DLBCL is the most common type of non-Hodgkin lymphoma.

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!

"Antibody-drug conjugates are an emerging class of targeted immunotherapies for cancer. This type of therapy, unlike traditional chemotherapy, is intended to target specific cells," said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Today’s approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked."

More than 18,000 people are diagnosed with DLBCL each year in the U.S. Although it can be cured, about 30 to 40% of patients suffer relapse. This type of cancer grows quickly in the lymph nodes and may affect the bone marrow, spleen, liver or other organs. Signs and symptoms of DLBCL may include swollen lymph nodes, fever, recurring night sweats and weight loss.

Polivy is an antibody that is attached to a chemotherapy drug. Polivy binds to a specific protein (called CD79b) found only on B cells (a type of white blood cell), then releases the chemotherapy drug into those cells. Efficacy was evaluated in a study of 80 patients with relapsed or refractory DLBCL who were randomized to receive Polivy with BR or BR alone. Efficacy was based on complete response rate and duration of response (DOR), defined as the time the disease stays in remission. At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a DOR of at least six months and 12 (48%) had a DOR of at least 12 months.

The most common side effects of Polivy plus BR include low levels of white blood cells (neutropenia), platelets (thrombocytopenia) and red blood cells (anemia); nerve damage (peripheral neuropathy); fatigue; diarrhea; fever; decreased appetite; and pneumonia.

Health care professionals are advised to monitor patients closely for infusion-related reactions, low blood counts and fatal and/or serious infections. Health care professionals should also monitor patients for tumor lysis syndrome (a complication from many tumor cells being killed off at the same time), liver damage (hepatotoxicity) and progressive multifocal leukoencephalopathy (PML), a fatal or life-threatening infection of the brain. FDA advises health care professionals to tell females of reproductive age to use effective contraception during treatment with Polivy and for three months after the last dose. Women who are pregnant or breastfeeding should not take Polivy because it may cause harm to a developing fetus or newborn baby.

Polivy in combination with BR was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on an endpoint that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Polivy’s clinical benefit.

The FDA granted this application Breakthrough Therapy and Priority Review designations. Polivy also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Polivy to Genentech.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

#

On June 10, 2019 Oncologie, an innovative biopharmaceutical company using proprietary biomarkers to drive clinical development of next-generation oncology therapeutics, reported that it has closed an $80M Series B financing (Press release, Oncologie, JUN 10, 2019, View Source [SID1234536984]). Existing investors, led by Nan Fung Life Sciences and Pivotal BioVentures China, are joined by a syndicate of new investors including Panacea Venture Healthcare and Korea Investment Partners.

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 funding will be used to advance Oncologie’s three clinical stage programs, as well as its proprietary biomarker platform and in-licensing activities. Oncologie will initiate key clinical trials in the coming months, including a global proof of concept gastric cancer study with its lead compound, bavituximab, in combination with pembrolizumab (Keytruda). Bavituximab is an investigational immune-modulatory monoclonal antibody that targets phosphatidylserine (PS), a phospholipid that inhibits the ability of immune cells to recognize and fight tumors. Oncologie’s other programs include a TLR9 activator, lefitolimod, and a unique VEGF-targeting antibody, varisacumab. Oncologie’s biomarker platform is designed to better inform patient selection across the portfolio by matching patients lacking a genetic "driver" mutation with the right medicine and allowing for selection of patients for treatment based on the microenvironmental defects of their tumor. The Company will also continue to leverage its platform to identify best-in-class assets for licensing and development.

"Expectations for precision medicine are increasing worldwide. By matching the right drug to the right patient, Oncologie’s innovative biomarker platform is designed to build value by narrowing patient populations, accelerating development timelines and reducing failure," said Laura E. Benjamin, PhD, Founder, President, and CEO. "This funding allows us to accelerate the development of our pipeline and platform, and grow our portfolio through partnering or acquisition."

"Over the past year, Oncologie has assembled an outstanding team of experienced professionals and a robust pipeline around a truly innovative biomarker platform," said Peter Bisgaard, Managing Director for NanFung Life Sciences and Managing Partner of Pivotal BioVenture Partners. "I am particularly excited by Oncologie’s biomarker strategy and approach, which leverages cutting-edge science to optimize patient selection in the challenging arena of the tumor microenvironment. This team has ambitious and strategic growth plan for building a leading oncology therapeutics company around this platform and around a pipeline of next-generation immunotherapies. "

On June 9, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics reported that Aron Knickerbocker, Chief Executive Officer, is scheduled to present at the following two investor conferences (Press release, Five Prime Therapeutics, JUN 9, 2019, View Source [SID1234536958]):

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 Raymond James Life Sciences and MedTech Conference, on Wednesday, June 19th at 1:15pm ET / 10:15am PT
The 2019 Bank of Montreal Prescriptions for Success Healthcare Conference on Tuesday, June 25th at 3:00pm ET / 12:00pm PT
The presentations will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at: View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.

On June 9, 2019 CStone Pharmaceuticals ("CStone"; HKEX: 2616) reported that the company has entered into a global clinical collaboration with China focus with Bayer HealthCare LLC to evaluate the safety, tolerability, pharmacokinetics (PK) and antitumor activity of its PD-L1 monoclonal antibody CS1001 in combination with Bayer’s regorafenib, an oral multi-kinase inhibitor (targeting VEGFR, FGFR, CSF1R, etc.), as a treatment for multiple cancers including gastric cancer (Press release, CStone Pharmaceauticals, JUN 9, 2019, View Source [SID1234536959]). This is the first global proof of concept study carried out as a collaboration between the two companies. CStone will be the study sponsor and Bayer will provide regorafenib throughout the clinical trial program.

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!

Professor Lin Shen, Vice President at the Peking University Cancer Hospital, commented: "At present, patients with advanced gastric cancer lack safe and effective therapies. Preclinical and clinical evidence suggest that the combination of PD-1/PD-L1 antibodies with multi-kinase inhibitors that target VEGFR can induce significant synergistic anti-tumor effects. We hope this combination therapy can provide a new treatment option for patients suffering from gastric cancer and other serious malignancies."

CS1001 is one of CStone’s backbone immuno-oncology pipeline candidates, having demonstrated that it is well-tolerated and has promising anti-tumor activities across a variety of tumor types in clinical studies. Currently, CS1001 is being evaluated in 7 clinical trials, including 5 pivotal trials. Regorafenib is approved in over 90 countries for the treatment of metastatic colorectal cancer (mCRC) and metastatic gastrointestinal stromal tumors (GIST) and in more than 80 countries for the second-line treatment of advanced hepatocellular (HCC).

Dr. Frank Jiang, CStone Chairman and CEO, commented: "We are very pleased that Bayer has chosen CStone as its partner and recognizes CS1001’s potential. We hope, by complementing our two companies’ pipelines via this combination therapy, that we can develop better cancer treatments for patients. In addition, this collaboration will be a big step forward for CStone’s global strategy when we generate positive data."

Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division said: "Combining multi-kinase inhibitors, such as regorafenib, with checkpoint inhibitors is a rising trend in cancer therapy in order to find new solutions for the many treatment gaps that still remain for patients. We look forward to collaborating with CStone, an innovative biopharmaceutical company, and exploring regorafenib’s potential."

About CS1001

CS1001 is an investigational anti-PD-L1 monoclonal antibody being developed by CStone. Authorized by the U.S.-based Ligand Corporation, CS1001 was generated by the OMT transgenic animal platform, which can produce 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 potentially reduce the risk of immunogenicity and toxicities in patients, a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China and has demonstrated promising anticancer activity and good tolerance. CS1001 is currently being evaluated in multiple clinical trials including a bridging phase I trial in the USA, a multi-arm phase Ib study, two pivotal Phase II studies and three Phase III studies in China in various cancer types, respectively. It has not been approved by any health authority for marketing.

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 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). The product is also approved in more than 80 countries including the U.S., Japan, countries of the EU as well as China for the second-line treatment of advanced hepatocellular (HCC).

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.