On June 17, 2021 Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) reported that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC)(Press release, Bristol-Myers Squibb, JUN 17, 2021, View Source [SID1234584109]). MORAb-202 is Eisai’s first ADC and combines Eisai’s in house developed anti-folate receptor alpha (FRα) antibody, and Eisai’s anticancer agent eribulin, using an enzyme cleavable linker. It is a potential best-in-class FRα ADC with a favorable pharmacology profile and demonstrated single agent activity in patients with advanced solid tumors. Eisai is currently investigating MORAb-202 in FRα-positive solid tumors (inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Phase 1/2 clinical study in the United States. The companies are planning to move into the registrational stage of development for this asset as early as next year.

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 agreement, Eisai and Bristol Myers Squibb will jointly develop and commercialize MORAb-202 in the following collaboration territories: Japan; China; countries in the Asia-Pacific region*; the United States; Canada; Europe, including the European Union and the United Kingdom; and Russia. Bristol Myers Squibb will be solely responsible for developing and commercializing the drug in regions outside of the collaboration territories. Eisai will remain responsible for the manufacturing and supply of MORAb-202 globally.

Under the financial terms of the agreement, Bristol Myers Squibb will pay $650 million U.S. dollars to Eisai including $200 million U.S. dollars as payment toward Eisai research and development expenses. Eisai is also entitled to receive up to $2.45 billion U.S. dollars in potential future development, regulatory, and commercial milestones. The parties will share profits, research and development and commercialization costs in the collaboration territories and Bristol Myers Squibb will pay Eisai a royalty on sales outside of the collaboration territories. Eisai is expected to book sales of MORAb-202 in Japan, China, countries in the Asia-Pacific region, Europe and Russia. Bristol Myers Squibb is expected to book sales of MORAb-202 in the United States and Canada.

"MORAb-202 combines Eisai’s in-house discovered antibody and payload using the company’s advanced chemistry capabilities." said Haruo Naito, Chief Executive Officer at Eisai. "It is characterized by its payload of eribulin, which is a product of our modern synthetic organic chemistry that has already made contributions to patients with breast cancer and soft tissue sarcoma. Our collaboration with Bristol Myers Squibb will accelerate the development of MORAb-202 with the goal of bringing a potentially impactful treatment option to patients globally."

"This global collaboration with Eisai is an important strategic fit for Bristol Myers Squibb as it extends our leading position in oncology with a differentiated asset that complements our broad solid tumor portfolio and leverages our deep internal development expertise." said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. "We look forward to collaborating with Eisai as we work to bring this potential treatment option to patients in need as soon as possible.

On June 17, 2021 Bristol Myers Squibb (NYSE: BMY) reported that its Board of Directors has declared a quarterly dividend of forty-nine cents ($0.49) per share on the $.10 par value common stock of the company(Press release, Bristol-Myers Squibb, JUN 17, 2021, View Source [SID1234584108]). The dividend is payable on August 2, 2021 to stockholders of record at the close of business on July 2, 2021.

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!

In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable September 1, 2021 to stockholders of record at the close of business on August 10, 2021.

On June 17, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company, reported in partnership with Seer, Inc. (NASDAQ: SEER), a life sciences company commercializing a disruptive new platform for proteomics, a webinar to present the newest trends in proteomics for biomarker discovery and translational research(Press release, Biodesix, JUN 17, 2021, View Source [SID1234584107]). The webinar entitled "A New Era in Precision Medicine – Uncovering the Depth & Breadth of the Plasma Proteome with Novel Proteomic Technologies" will be presented by Robert Georgantas, III, PhD, Senior Vice President, Research and Translational Science at Biodesix and Daniel Hornburg, PhD, Principal Scientist from Seer. The webinar is scheduled at 11:00 am ET, Tuesday June 22, 2021 and participants are encouraged to REGISTER HERE.

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!

Proteomics is the next frontier in biomarker and translational research with new emerging technologies that are enabling researchers to see deeper and broader into the plasma proteome than ever before. Biodesix is a recognized leader in profiling patients’ immune response to all cancer types using blood-based solutions that combine proteomic and genomic insights with a proprietary AI analytics platform.

The webinar will include an overview of Seer’s Proteograph Product Suite, which uses proprietary engineered nanoparticles to survey plasma proteins, allowing researchers to identify and quantitate proteins across the dynamic range of the proteome. Additionally, learnings will be shared on how the Seer Proteograph Product Suite will help define the biological underpinnings of tests created by Biodesix and how it is being integrated into the Biodesix mass spectrometry-based workflows for biopharmaceutical and academic research.

On June 17, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the first patient was dosed in the global Phase 3 AdvanTIG-302 trial of BeiGene’s investigational anti-TIGIT antibody ociperlimab (BGB-A1217) in combination with its anti-PD-1 antibody tislelizumab, for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations(Press release, BeiGene, JUN 17, 2021, View Source [SID1234584106]). This marks the initiation of the first Phase 3 clinical trial in the planned global pivotal program for ociperlimab.

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!

"Ociperlimab is a potent anti-TIGIT antibody with intact Fc function, which we believe to be critical for the anti-tumor activities of TIGIT antibodies. Ociperlimab is our fourth internally discovered molecule entering the pivotal stage of clinical development, and now one of the most advanced anti-TIGIT antibodies in development globally. We intend to explore the potential use of ociperlimab in additional settings and indications in our late-stage development program," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. "We hope that the AdvanTIG-302 trial will support a new and improved chemotherapy-free regimen for a significant portion of first-line patients with NSCLC and potentially other cancer patients with unmet needs."

AdvanTIG-302 Trial of Ociperlimab in Combination with Tislelizumab in NSCLC

AdvanTIG-302 is a randomized, double-blind, multicenter, global Phase 3 clinical trial (NCT04746924), expected to enroll approximately 605 treatment-naïve patients with locally advanced, unresectable, or metastatic NSCLC whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations in the United States, Australia and other countries and regions across the globe. Patients will be randomized to receive ociperlimab and tislelizumab combination treatment, pembrolizumab, or tislelizumab alone. The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS) in the intention-to-treat (ITT) population; secondary endpoints include safety and other efficacy endpoints.

For more information about the trial, patients and physicians should email BeiGene at [email protected].

About Ociperlimab (BGB-A1217)

Ociperlimab (BGB-A1217) is an investigational humanized IgG 1 monoclonal antibody discovered and being developed globally by BeiGene. An immune checkpoint molecule, BGB-A1217 is one of the most advanced anti-TIGIT antibodies in development with intact Fc function.

Targeting TIGIT provides a potential mechanism to rescue immune cells (e.g., T cells, NK cells, and dendritic cells) from the immunosuppressive tumor microenvironment, to induce an efficient antitumor immune response. The TIGIT pathway has been understood to cooperate with PD-1 to maximize the suppression of effector tumor infiltrating immune cells as well as to promote resistance to anti-PD-1 therapy. TIGIT represents a promising target with the potential to significantly improve and/or extend the therapeutic benefit of anti-PD-1 therapy to a greater number of patients.

Ociperlimab is currently being investigated in combination with tislelizumab in multiple ongoing trials, including:

AdvanTIG-302: Phase 3 trial in untreated non-small cell lung cancer (NCT04746924);
AdvanTIG-202: Phase 2 trial in metastatic cervical cancer (NCT04693234);
AdvanTIG-203: Phase 2 trial in advanced esophageal squamous cell carcinoma (NCT04732494); and
Phase 1b trial in advanced solid tumors (NCT04047862).
About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab approval in three indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy; and conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, four supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, for patients with previously treated unresectable hepatocellular carcinoma, and for the treatment of patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors.

BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL; NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial of tislelizumab in patients with relapsed or refractory cHL (NCT03209973);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).

On June 17, 2021 Artios Pharma Limited (Artios), a leading DNA Damage Response (DDR) company exploiting a broad DDR-based platform and small molecule drug design capabilities to develop a diverse pipeline of product candidates for the treatment of cancer, reported the publication of a peer reviewed article titled, "Polθ inhibitors elicit BRCA-gene synthetic lethality and target PARP inhibitor resistance" in Nature Communications(Press release, Artios Pharma, JUN 17, 2021, View Source [SID1234584104]). Using novel small molecule tool compounds, the preclinical data generated in collaboration with researchers at the Institute for Cancer Research, London, and Cancer Research U.K., validates the Company’s approach to developing a potential first-in-class Polθ inhibitor, which demonstrated potent, selective Polθ inhibition, BRCA-gene synthetic lethality in a potentially PARP-resistant setting, and PARP inhibitor synergy.

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 Chris Lord, Professor of Cancer Genomics at The Institute of Cancer Research, London and study co-leader, said: "Polθ is an ideal DNA damage response drug target as it is tumor specific, overexpressed in many tumors and found at low levels in healthy tissues. These results show that Polθ inhibitors exhibited exquisite selectivity and on-target activity, affecting only Polθ-Mediated End Joining and not other forms of DNA repair. This specificity, combined with demonstrated synthetic lethality with BRCA mutations, as well as synergy with a PARP inhibitor, suggest small molecule Polθ inhibition has broad utility for targeted clinical development in genetic backgrounds that are reliant on Polθ activity. I look forward to seeing how Polθ inhibitors perform in clinical trials and hope they will be able to benefit patients by opening up a new way of overcoming drug resistance."

Dr. Graeme Smith, Chief Scientific Officer of Artios Pharma, said: "This preclinical dataset further strengthens the scientific foundation of our Polθ inhibitor program. This publication is a testament to the deep scientific heritage and expertise in DNA damage response that drives the Artios discovery platform and pipeline. The extensive efforts of our team have delivered insights into the genetics and mechanisms that underlie the activity of Polθ inhibitors, leaving us well positioned to pursue a strategic development plan in the clinic across a wide range of opportunities."

Dr. Niall Martin, Chief Executive Officer at Artios Pharma, said: "These published results provide a clear rationale for three high-value opportunities for Polθ inhibitors: in the monotherapy setting to treat Polθ dependent cancers; in combination with PARP inhibitors to expand the utility of this important drug class; and in combination with DNA damaging therapies such as ionizing radiation to provide effective and widespread use of these agents. We are on track to launch our Polθ clinical program before year end, building upon our strong execution which includes strategic partnerships with Merck KGaA and Novartis, and our ongoing Phase 1 study of ART0380, a potential best-in-class ATR inhibitor."

Publication highlights include:

• Artios’ small molecule Polθ inhibitors provided nanomolar potent, selective, allosteric inhibition of the polymerase function of DNA polymerase Polθ, selectively inhibiting Theta-Mediated End Joining DNA repair without targeting Non-Homologous End Joining or Homologous Recombination.
• Inhibiting Polθ elicited DNA damage and synthetic lethality in BRCA1- or BRCA2-mutant tumor cells and enhanced the effects of a PARP inhibitor.
• Genetic screening revealed defects in the Shieldin complex causing both PARP inhibitor resistance and synthetic lethality with Polθ inhibition, thus identifying a subset of PARP inhibitor resistant disease with the potential to be specifically targeted with Polθ inhibitors.
• Sensitivity of BRCA1, Shieldin-defective tumours to Polθ inhibition was confirmed in vivo laying the foundations for preclinical and clinical development.