1stOncology™: Cancer Intelligence Service – Page 11211 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

AVEO Oncology Regains Full Global Rights to Ficlatuzumab

On September 8, 2020 AVEO Oncology (Nasdaq: AVEO) reported that it has regained full global rights to ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities (Press release, AVEO, SEP 8, 2020, View Source [SID1234564718]). AVEO also announced today that it plans to fund the clinical manufacture of ficlatuzumab to enable a potential registrational Phase 3 clinical trial in head and neck squamous cell cancer (HNSCC), as well as additional potential development in Phase 2 studies in pancreatic cancer and acute myeloid leukemia (AML) . Following the decision, Biodesix, a leading diagnostic company, has exercised its contractual right to reduce its future financial obligations in exchange for reduced partnership economics. Under the terms of the agreement between AVEO and Biodesix, Biodesix will continue to fund 50% of the ongoing HNSCC Phase 2 trial, and will be entitled to a low double digit royalty on any future product sales as well as 25% of future licensing revenue, subject to certain limitations.

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!

"We are very pleased to regain full rights to another late-stage asset. This comes at a strategic point in our Company’s history, as we continue to build a commercial biopharmaceutical company with a broad oncology portfolio that has the potential to enable a long-term, sustainable growth model," said Michael Bailey, president and chief executive officer of AVEO. "The early data we have seen in the randomized, open-label HNSCC study with ficlatuzumab combined with cetuximab (ERBITUX) has led us to the decision to secure additional clinical manufacturing capacity, which we expect to fund within our previously announced cash runway guidance, in order to prepare for a potential HNSCC pivotal study. We look forward to presenting final results from the Phase 2 study in the middle of 2021, and to providing an update on our potential pivotal program within that timeframe."

Ficlatuzumab is being studied in an ongoing randomized, open-label confirmatory Phase 2 study in combination with cetuximab, an EGFR-targeted antibody, in cetuximab-resistant, recurrent metastatic HNSCC. The study was designed to confirm findings from a Phase 1 study of ficlatuzumab and cetuximab where the combination was well tolerated and resulted in a disease control rate of 67%, as well as prolonged progression free and overall survival compared to historical controls. The Phase 2 multi-center study is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center. Enrollment is expected to conclude in the fourth quarter of 2020, and results from the study are expected to be presented at a scientific meeting in 2021.

For more information, please refer to the Current Report on Form 8-K which will be filed by AVEO with the U.S. Securities & Exchange Commission on September 8, 2020.

Compugen Doses First Patient in Phase 1/2 Triple Combination Study of COM701 with Bristol Myers Squibb’s Opdivo® and Anti-TIGIT Antibody

On September 8, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the first patient has been dosed in the Phase 1/2 study evaluating the triple combination of COM701, Compugen’s first-in-class anti-PVRIG antibody, with Bristol Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), and their investigational anti-TIGIT antibody, BMS-986207 (Press release, Compugen, SEP 8, 2020, View Source [SID1234564717]).

The triple combination study is designed to evaluate the simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1, and will accelerate the clinical evaluation of Compugen’s DNAM axis hypothesis and biomarker strategy in patients with advanced solid tumors, including those who are refractory or unresponsive to standard-of-care immune checkpoint inhibitors. Compugen’s DNAM axis hypothesis suggests that PVRIG and TIGIT are two parallel and complementary inhibitory pathways in the axis and that blocking both PVRIG and TIGIT may be required in certain tumor types in order to generate or enhance an anti-tumor immune response.

"Dosing the first patient in this triple combination study propels our clinical development plan for COM701 forward, continuing our rapid execution in investigating what we believe is a foundational axis in immuno-oncology," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The science we have elucidated behind this axis, combined with the preliminary antitumor activity observed in our Phase 1 COM701 study, suggest that our highly differentiated clinical path of targeting PVRIG simultaneously with TIGIT and PD-1 blockers has the potential to expand cancer immunotherapy treatment options to new patient populations."

Dr. Cohen-Dayag added, "We are thrilled to have Bristol Myers Squibb as our partner in this study and are very pleased with their continued support and commitment to our collaboration."

Henry Adewoye, M.D., Senior Vice President and Chief Medical Officer, said, "While immunotherapies have been transformative in oncology, the majority of cancer patients do not respond to immunotherapy or relapse with currently available treatments. Our expectation is that inhibiting PVRIG and TIGIT, two distinct inhibitory checkpoints in the DNAM axis, together with PD-1, has the potential to translate to clinical benefit for patients by increasing response rates and durability of responses, thereby expanding the reach of this important class of drugs. We are highly encouraged by the durable partial responses observed in the monotherapy and dual combination dose escalation arms of our study evaluating COM701 and thus look forward to the results of this ongoing trial."

The open-label Phase 1/2 trial is designed to evaluate the safety, tolerability and preliminary antitumor activity of COM701 in combination with Opdivo and BMS-986207 during dose escalation as well as preliminary antitumor activity in tumor types selected for expansion in a biomarker-driven approach (to initially include ovarian cancer, endometrial cancer and a biomarker-driven arm of tumor types with high expression of PVRL2). An investigation of the contribution of the component parts of the triplet will be enabled in the context of the ovarian expansion cohort. Dose levels for Opdivo and BMS-986207 combinations have already been determined through prior testing by Bristol Myers Squibb, allowing for dose escalation of COM701 with fixed doses of Opdivo and BMS-986207. The study will initially enroll approximately 100 patients.

About COM701
COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, and blocks the interaction with its ligand, PVRL2. TIGIT, an immune checkpoint discovered computationally by Compugen in 2009, and PVRIG constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory receptor on T cells and NK cells. Preclinical data suggest that the blockade of PVRIG induces a robust anti-tumor immune response and demonstrates synergistic activity when used in combination with inhibitors of TIGIT and/or PD-1. Currently, COM701 is being evaluated in a Phase 1 clinical study. Data from the ongoing study have shown that COM701 is well-tolerated and demonstrated preliminary signals of anti-tumor activity in a heavily pretreated patient population.

Biomica Announces Positive Pre-Clinical Results in its Immuno-Oncology Program

On September 8, 2020 Biomica Ltd., an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN, TASE: EVGN), reported positive pre-clinical in-vivo results in its immuno-oncology program for a follow-on combination of bacterial strains (Press release, Evogene, SEP 8, 2020, View Source [SID1234564716]). In these studies, Biomica tested BMC128, which consists of four live bacterial strains derived from Biomica’s drug candidates BMC121 and BMC127. Treatment with BMC128, both prior to and in combination with ICI, significantly improved anti-tumor activity in mice.

These positive results supplement additional positive data using Biomica’s initial bacterial strain combinations BMC121 and BMC127, which demonstrated anti-tumor activity in animal studies. BMC128 was selected based on further predictive analysis of the results of Biomica’s studies with BMC121 and BMC 127.

Biomica’s immuno-oncology program is based on the premise that the gut microbiome affects the efficacy of cancer immunotherapy, specifically that of the ICI involving the blockade of PD-1 or PD-L1 and CTLA-4, as suggested in scientific literature.1 In the current study, BMC128 was administered to mice bearing cancer tumors prior to and during ICI therapy. BMC128 is a rationally-designed microbial consortium derived from Biomica’s earlier candidates BMC121 and BMC127, which had been identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene’s MicroBoost AI platform.

1 Zitvogel et al. 2018, Science 359 (6382)

Biomica’s current results demonstrate that treatment with BMC128 prior to and in combination with the administration of ICI, significantly reduced tumor volume and increased animal survival compared to ICI therapy alone. Moreover, treatment with BMC128 affected several immunological factors, including specific immune-cells populations known to be involved in tumor destruction.2

The study indicates that treatment with BMC128 conditions the immune system and primes it for an efficient, well-orchestrated anti-tumor response. This is in-line with numerous scientific publications, demonstrating the effect of the gut microbiome on the response to ICI, and more specifically a reduced response to ICI in patients with compromised microbiome following treatment with antibiotics.3

As previously disclosed, Biomica has initiated scale-up processes for Good Manufacturing Practice (GMP) production of its drug candidates in its immuno-oncology program in preparation for the expected first-in-man proof-of-concept clinical trials next year, following expected additional pre-clinical studies during 2020.

Dr. Elran Haber, CEO of Biomica stated: "We are very excited with the results of this study using BMC128, which demonstrate the potential of Biomica’s drug candidates in improving care for cancer patients treated with immunotherapy. We believe these results indicate that live biotherapeutic drugs may potentially be used as a stand-alone priming therapy or as combination therapy with ICI in order to improve the response of cancer patients. We look forward to providing incremental updates as we work towards first-in-man proof-of-concept clinical trials."

Ofer Haviv, Chairman of Biomica and Evogene’s President and CEO stated: "I am very proud of Biomica’s rapid progress. We believe that these pre-clinical results are a clear demonstration of the advantages that can be provided by predictive biology, powered by big data analysis and artificial intelligence, for increasing the efficacy of immunotherapy. In addition, we believe that this success underpins the broad applicability of Evogene’s unique Computational Predictive Biology (CPB) platform in multiple major market areas."

About BMC121, BMC127 and BMC128

Developed as Live Bacterial Products (LBPs), BMC121 and BMC127 are rationally-designed LBP consortia comprised of unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity though multiple biological processes.

2 Zitvogel et al. 2018, Science 359 (6382); Hsu J, et al. Contribution of NK cells to immunotherapy mediated by PD-1/PD-L1 blockade. J Clin Invest. 2018;128(10):4654-4668. doi:10.1172/JCI99317
3 Thompson J, Szabo A, Arce-Lara C, et al: Microbiome & immunotherapy: Antibiotic use is associated with inferior survival for lung cancer patients receiving PD-1 inhibitors. J Thorac Oncol 12(suppl 2):S1998, 2017
Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

BMC128 consists of four bacterial strains derived from Biomica’s drug candidates BMC121 and BMC127

Spectrum Pharmaceuticals to Present at Two Upcoming Investor Conferences in September

On September 8, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that management will present an overview of the company’s business strategy and development-stage programs at two upcoming virtual investor conferences (Press release, Spectrum Pharmaceuticals, SEP 8, 2020, View Source [SID1234564715]):

Rodman & Renshaw 22nd Annual Global Investment Conference, Sponsored by H.C. Wainwright, Monday, September 14, 2020 at 2:00 p.m. ET.
Cantor Virtual Global Healthcare Conference, Thursday, September 17, 2020 at 10:40 a.m. ET.
A live webcast of the presentations will be available from the Investor Relations section of the company’s website at View Source with a replay available shortly after each event.

Sesen Bio to Provide Business Update at the H. C. Wainwright 22nd Annual Global Investment Conference

On September 8, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported it will be featured as a presenting company at the H. C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 (Press release, Sesen Bio, SEP 8, 2020, View Source [SID1234564714]).

Event: H. C. Wainwright 22nd Annual Global Investment Conference
Date: September 15, 2020
Time: 10:30 – 10:50 AM ET

A live webcast of the Company’s presentation will be accessible from the Investors & Media section of the Sesen Bio website, www.sesenbio.com. An archived replay of the webcast will be available on the Company’s website for 90 days after the conference.