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New Data Published from Women & Infants Hospital Demonstrate Utility of Predictive Immune Modeling in Ovarian Cancer

On March 8, 2021 Cofactor Genomics, the company bridging the precision medicine gap, reported new data published in Frontiers in Oncology1 by Women & Infants Hospital of Rhode Island (Press release, Cofactor Genomics, MAR 8, 2021, View Source [SID1234576190]). The data highlight the utility of Cofactor’s Predictive Immune Modeling technology in elucidating the immune landscape of epithelial ovarian cancer (EOC) for immunotherapy development, and to identify prognostic indicators of response to frontline chemotherapy.

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EOC is the most lethal of all gynecological malignancies, with more than 21,000 diagnoses and almost 14,000 deaths anticipated from the disease in the United States in 2020.2 Currently, several EOC clinical trials center upon immunotherapy;3 however, while melanoma and non-small cell lung cancer (NSCLC) patients have seen a great benefit from targeting immune checkpoint inhibitors, such cytotoxic T lymphocyte-associated protein-4 (CTLA-4) or programmed cell death protein 1 (PD-1), EOC patients have only exhibited response rates of 10 to 15 percent.4 Despite these poor response rates, evidence suggests that EOC is an immunogenic cancer,5,6 and in the paper, the team led by Jennifer Ribeiro, Ph.D., at Women & Infants Hospital outlined how these results lay the foundation for the development of better immunotherapy agents.

The primary investigator on the study, Dr. Ribeiro, stated, "This study offers new insights into high grade serous ovarian cancer that have the potential to make an impact in how patients are treated in the future. Using the ImmunoPrism platform, we have shown that immunological signatures are indeed related to patient outcomes in ovarian cancer."

In the study, the authors utilized the Cofactor Genomics ImmunoPrism platform to evaluate a cohort of high grade serous ovarian cancer (HGSOC) tumors to identify an immune-related gene expression model that may serve as a prognostic indicator of response to frontline chemotherapy. They found that the immunological markers CTLA-4, LAG-3, and Treg immune cells are more abundant in HGSOC patients with longer progression-free survival (PFS). Moreover, they investigated which immunological features in a tumor led to improved outcomes, which represent opportunities for novel immunotherapeutic approaches. The study also revealed that ICOS was significantly more highly expressed in patients with longer PFS, and strongly correlated with CTLA-4, PD-1, and specific subsets of immune cell infiltration. The results from the tumor cohort were confirmed using The Cancer Genome Atlas (TCGA) ovarian cancer dataset where high ICOS and LAG-3 levels were also significantly associated with longer survival.

The study builds on Cofactor’s previously presented work using its Predictive Immune Modeling technology to identify novel immune signals in other disease indications, including sarcoma, non-small cell lung cancer (NSCLC), and recurrent and metastatic squamous cell carcinoma of the head and neck (RM-HNSCC). The company has also announced a list of disease targets for diagnostic development and is current recruiting clinical partners: View Source

Pathios Therapeutics boosted by award of significant Innovate UK funding

On March 8, 2021 Pathios Therapeutics Limited ("Pathios"), an innovative biotech company focused on the development of first-in-class therapies for cancer, reported that it has been awarded £350K (approximately US$475K) in the form a Smart Grant from Innovate UK, the UK Government’s innovation agency, to accelerate their cancer immunotherapy programme targeting the innate immune checkpoint, GPR65 (Press release, Lifescience Newswire, MAR 8, 2021, View Source [SID1234576189]). Pathios will collaborate on this project with researchers from the Department of Oncology at The University of Oxford to develop the key tools required to enable the rapid translation of small-molecule GPR65 inhibitors for treatment-resistant melanoma.

The advent of immunotherapy agents targeting T-cell checkpoints (PD-1/CTLA-4) has brought about significant improvements in the long-term survival of many melanoma patients. However, only a subset of patients receive sustained benefit from these treatments and it remains an ongoing challenge to identify additional therapies for the remaining non-responsive population.

Recent ground-breaking science suggests a key reason that some melanoma patients that do not respond well to anti-PD-1 therapies relates to the disarming of innate immune cells called tumour-associated macrophages (TAMs) by the acidic microenvironment that is inherent to advanced tumours. Activation of the pH-sensing receptor, GPR65, on TAMs by acidic pH leads to the suppression of a host of pro-inflammatory genes thereby shifting the characteristics of these cells from immune-stimulating to immunosuppressive(1). The importance of the GPR65 pathway in cancer is underscored by a small proportion of the population with inactivating polymorphisms showing stratified association with survival when analysed in The Cancer Genome Atlas (TCGA). Pathios’ ‘Macrophage Conditioning’ approach aims to deploy small-molecule GPR65 inhibitors to reverse pH-dependent immunosuppressive signalling in the vast majority of patients who do not carry this genetic change.

With this grant, Pathios will develop a range of tools to expedite the translation of small molecule GPR65 inhibitors for use in cancer immunotherapy. This will include the development of early clinical target engagement biomarkers as well as employing a range of bioinformatics techniques to identify those patients most likely to benefit from Pathios’ GPR65-targeted approach.

Stuart Hughes, Chief Executive Officer of Pathios: "We are delighted to have secured this highly competitive funding from Innovate UK to accelerate our programme against GPR65 and to continue to build our scientific links with cancer researchers at The University of Oxford. This award boosts our ongoing programme and is a significant endorsement of our novel approach to targeting the innate immune system in hard-to-treat cancers. We look forward to developing the tools that will drive forward our GPR65-based ‘Macrophage Conditioning’ technology and help deliver on the company’s goal to provide a first-in-class treatment approach for those melanoma patients who currently have limited treatment options".

Immodulon announces Notices of Allowance and Intention to Grant for four patent applications related to IMM-101 in combination with immune checkpoint inhibitors in US, Japan and Europe

On March 8, 2021 Immodulon, the immuno-oncology company, reported that it has received Notices of Allowance from the U.S. Patent and Trademark Office and the Japanese Patent Office; and a Notice of Intention to Grant from the European Patent Office for Immodulon’s patent applications No’s. 16/820,058 (US), 16/820,132 (US), 2016-541474 (Japan) and EP3319635 (Europe) (Press release, Immodulon Therapeutics, MAR 8, 2021, View Source [SID1234576188]). These patent applicationsrelate to combining IMM-101, the Company’s investigational treatment comprising heat-killed Mycobacterium obuense, with various immune checkpoint inhibitors (CPIs) for the treatment of various tumour types.

The allowed claims in the two US patent applications relate to Immodulon’s first CPI combination patent family, and cover methods of treating sarcoma with IMM-101 in combination with anti-PD1, anti-PD-L1 or anti-CTLA4 antibodies, in addition to methods of treating colorectal cancer with IMM-101 in combination with anti-PD-L1, anti-PD-L1 or anti-CTLA4 antibodies. Upon grant, both patents are expected to expire in 2034. This allowance followed earlier allowances for two other US patent applications with similar claims related to pancreatic cancer and melanoma. The company intends to conduct further clinical studies related to the allowed claim scope and advance IMM-101 into other such cancers with high unmet need.

In addition, Immodulon also received a Notice of Allowance in Japan for a patent application related to its first CPI combination patent family. The allowed claims cover IMM-101 in combination with anti-PD1 or anti-PD-L1 antibodies for the treatment of any cancer. Upon grant, this Japanese patent is expected to expire in 2034.

Furthermore, Immodulon received a Notice of Intention to Grant from the European Patent Office for a patent application related to its second CPI combination patent family. The allowed claims cover IMM-101 in combination with pembrolizumab, atezolizumab or tremelimumab for the treatment of any cancer. Upon grant, this European patent is expected to expire in 2036.

Dr Jaap Kampinga, Chief Executive Officer of Immodulon, commented:
"We are pleased to have received these Notices of Allowance and Intention to Grant which cover methods of treating cancers with IMM-101 in combination with immune checkpoint inhibitors. Immodulon has 11 patent families with 30 patents granted globally and it is pursuing multiple avenues for securing and enhancing additional intellectual property protection for IMM-101. These new patents support ongoing discussions with third parties as well as clinical studies in several stages of preparation. These include the treatment of various stages of pancreatic cancer, the key focus of the company; soft tissue sarcoma, for which we have an Investigational New Drug (IND) Application; and colorectal cancer."

Transactions in connection with share buy-back program

On March 8, 2021 Genmab A/S (Nasdaq: GMAB)reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAR 8, 2021, View Source [SID1234576187]).

The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from March 1, 2021 to March 5, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 129,977 shares as treasury shares, corresponding to 0.20% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

Exelixis Enters into Exclusive License Agreement with WuXi Biologics to Support Further Expansion of its Growing Oncology Biologics Pipeline

On March 8, 2021 Exelixis, Inc. (Nasdaq: EXEL) and WuXi Biologics ("WuXi Bio") (2269.HK) reported the companies have entered into an exclusive license agreement to support the continued expansion of Exelixis’ oncology biologics pipeline (Press release, Exelixis, MAR 8, 2021, View Source [SID1234576186]). The agreement is the latest in a series of biologics-focused transactions for Exelixis as the company builds out its pipeline behind CABOMETYX (cabozantinib), its flagship product and global oncology franchise, which received its fourth approval from the U.S. Food and Drug Administration in January.

Under the terms of the agreement, Exelixis will make a modest upfront payment to WuXi Bio in exchange for an exclusive license to a panel of monoclonal antibodies to a preclinically validated target, discovered based on WuXi Bio’s integrated technology platforms, for the development of antibody-drug conjugate, bispecific, and certain other novel tumor-targeting biologics applications. WuXi Bio will be eligible for development and commercialization milestones, as well as tiered royalties on net sales of any potential products commercialized from the panel.

"Exelixis is pursuing a broad range of targets and therapeutic modalities to maximize the potential of our biologics pipeline to help patients with cancer," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "Our agreement with WuXi Bio enhances our growing biotherapeutics portfolio by providing an approach to a preclinically validated target that has already shown early clinical potential in cancer. We’re looking forward to building on WuXi Bio’s significant technical foundation and applying our own expertise as we bring this promising program into the Exelixis discovery organization."

"We’re glad to support Exelixis’ growing biotherapeutics pipeline with antibodies discovered through our integrated biologics technology platforms," said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. "WuXi Biologics will continue to develop globally leading next-generation technologies to accelerate and transform biologics discovery, development and manufacturing. With globally recognized technical capabilities and unparalleled capacities, we are transforming how biologics are developed in the global setting."