On December 14, 2022 Carina Biotech files its first IND application for a CAR-T cell therapy targeting a solid cancer (Press release, Carina Biotech, DEC 15, 2022, View Source [SID1234625251]). The IND application is directed at a first-in-human Phase 1/2a clinical trial in advanced colorectal cancer patients.

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has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for first-in-human Phase 1/2a clinical trial of CNA3103, its LGR5-targeted chimeric antigen receptor T cell (CAR-T) therapy candidate, in patients with advanced colorectal cancer.

"We are delighted to achieve the major milestone of submitting this first IND to the FDA for our lead LGR5 CAR-T cell therapy candidate as our team continues to advance Carina’s vision to create a future that defeats cancer," said Deborah Rathjen, PhD, Carina’s Chief Executive Officer.

"Colorectal cancer is a lethal cancer, and a clear need exists for more effective treatment options. CAR-T cell therapy is a revolutionary and targeted cancer treatment option that harnesses a patient’s own immune system to fight their cancer. We are targeting the recruitment of the first patients in the Phase 1/2a trial in early 2023."

"Carina’s CAR-T cell therapy candidate, CNA3103, is targeted at LGR5, a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers," stated José Iglesias, MD, Carina’s Chief Medical Officer. "In colorectal cancer patients, LGR5 expression has been correlated with a particularly poor prognosis and by targeting cancer stem
cells, this therapy may potentially reduce the tumor’s ability to generate new cancer cells, resulting in enhanced tumor suppression and preventing the relapses that are very common in patients with this disease."

Dr Iglesias added, "Colorectal cancer is the third most common cancer worldwide and the third most common cancer diagnosed in the United States, excluding skin cancers. Colorectal cancer is the deadliest cancer for young Australians and the second deadliest cancer for all Australians with its incidence rising in people under 50. Many younger people, who are often
diagnosed when their cancer is in its later stages, are given a very poor prognosis with very limited treatment options."

On December 14, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") reported that the newly-developed bispecific antibody-receptor recombinant protein drug (project number: IMM2520), targeting CD47 and PD-L1, obtained clinical research approval from the US FDA (Press release, ImmuneOnco Biopharma, DEC 14, 2022, View Source [SID1234655674]). This is the fourth IND approval for the company to date (others include IMM0306, IMM2902 and IMM40H), and it is another important milestone in the company’s development. Previously, IMM2520 was granted a Japanese patent and orther patents in China, the European union and the United States has been submitted. In November 2022, the IMM2520 has been approved by NMPA to carry out clinical trials. The approval by FDA for clincal trials strenthens the development of IMM2520 globally and consolidates the company’s leading position in the field of drug development for targeting CD47 and bispecific antibody research.

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Dr. Tian, Wenzhi, Founder and Chairman of ImmuneOnco, said:

"We are very pleased that our IMM2520 program has received clinical trial research approval from the US FDA. IMM2520 is an antibody-receptor recombinant protein (mAb-Trap) that targets both CD47 and PD-L1. We believe that IMM2520 has great clinical development value, and we will actively promote clinical research and strive to bring it to market as soon as possible, so as to benefit the cancer patients."

On December 14, 2022, Guangzhou Biosyngen Co., Ltd. (hereinafter as "Biosyngen") reported on the approval granted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the company’s IND application for BRG01 Therapy (Press release, BioSyngen, DEC 14, 2022, View Source;c=View&a=index&aid=91 [SID1234631943]). BRG01 Therapy is an autologous T cell therapy for relapsed/metastatic nasopharyngeal cancer (NPC) treatment. The principle of autologous T cell therapy is to genetically modify patients’ own T cells to express additional receptors for Epstein-Barr virus (EBV) antigen recognition and T cell activation upon EBV+ tumor cell engagement.

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"The IND approval of BRG01 Therapy marks a significant milestone for the company and in nasopharyngeal cancer treatment." said Joan Zhang, Chairman of Biosyngen. "As a biopharmaceutical company in immunotherapy, Biosyngen is committed to deliver more effective cancer therapy to address unmet needs for the benefit of cancer patients. Following this milestone, based on the company’s pipeline, Biosyngen has begun planning for multiple sponsor-initiated clinical trials which will lead to IND applications in China, the US and Singapore in the course of 2023. The indications targeted are hepatocellular cancer, colorectal cancer, gastric cancer, esophageal cancer and pancreatic cancer. Looking ahead, Biosyngen is assessing the marco environment in preparation for IPO within the next 18 months."

About BRG01

EBV is a human herpesvirus and has infected ~95% of population worldwide. It has been listed as Group 1 carcinogen ("Carcinogenic to humans") by World Health Organization (WHO) and proved to be associated with a range of diseases including nasopharyngeal cancer, EBV-positive gastric cancers, lymphoma and lymphoproliferative diseases. As one of the most common head and neck tumors, nasopharyngeal cancer, an epithelial carcinoma arising from the nasopharyngeal mucosal lining, is closely related to EBV infection. According to WHO, an estimated number of 133,000 new cases of nasopharyngeal cancer worldwide was reported in 2020; 50% of which was diagnosed in China. South China provinces such as Guangdong and Guangxi provinces make up for more than 60% of nasopharyngeal cancer patient population.

Though, existing practice such as immune checkpoint inhibitor has been applied in second-line and beyond treatment of nasopharyngeal cancer, overall response rates were mostly below 30%. In another words, more than 70% patients did not benefit from the existing therapy. Therefore, it is imperative to explore new approaches to improve efficacy and satisfy unmet medical needs.

BRG01 Therapy developed by Biosyngen is an engineered T cell therapy, also known as a type of adoptive immune cell therapy for nasopharyngeal cancer treatment. Patients’ T cells were isolated and genetically modified in a GMP-compliant facility to enhance their ability to recognize and attack specific antigens on cancer cells. The modified T cells are expanded ex vivo and infused back into the patient. The infused T cells would bind to the specific antigen on the cancer cells to mediate tumor killing. The preliminary safety and efficacy of BRG01 Therapy have been demonstrated in data from exploratory clinical trials.

The scientific direction of Biosyngen is focused on targeting multiple solid tumors and hematological tumors. The company has independently developed a number of exclusive technical platforms specifically for cancer immunotherapy, including IDENTIFIER, SUPER-T and MSE-T. These platforms greatly improved the company’s capability to overcome challenges in antigen identification, antibody TCR screening and identification of immune cell function.

On December 14, 2022 Cofactor Genomics, the diagnostics company bridging the precision medicine gap, reported commencement of a study of its OncoPrism assay in non-small cell lung cancer (NSCLC), the second indication being studied in the company’s national PREDAPT study that will ultimately encompass 11 cancers (Press release, Cofactor Genomics, DEC 14, 2022, View Source [SID1234626579]). OncoPrism is the company’s diagnostic platform that generates multidimensional immune biomarkers using Predictive Immune Modeling. This approach has been shown to predict immunotherapy responders with twice the accuracy of on-market PD-L1 assays, with the added benefit of requiring far less tissue than most commercial tests.

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By better identifying patients who will likely respond to immunotherapy, Cofactor’s OncoPrism will spare more patients from chemotherapy and its negative side effects. The low input of tissue required for the test also makes it easier for lung cancer patients in whom a core needle biopsy is the safest option for acquiring tissue. Published results in Nature Scientific Reports show that Cofactor’s approach predicted patient response to anti-PD-1 therapy in lung cancer and outperformed the indicated PD-L1 test and Tumor Mutational Burden.

The PREDAPT (Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies) Trial is evaluating use of the OncoPrism assay in effectively predicting a patient’s response to immunotherapy. To date, more than 20 healthcare systems have partnered with Cofactor in the study that will ultimately study 11 solid tumor cancers. The first indication opened for study was recurrent and metastatic squamous cell carcinoma of the head and neck (RM-HNSCC). HNSCC data presented at the AGBT Precision Health Meeting showed that Cofactor’s test is nearly twice as accurate as PD-L1 assays in determining patients that will benefit from immunotherapies, such as Keytruda (pembrolizumab) or Opdivo (nivolumab). Indications to be studied within the PREDAPT Trial include triple-negative breast, cervical, colorectal, esophageal, gastric, head and neck, kidney, liver, lung, and urothelial cancers.

"Lung cancer is the deadliest cancer in America, yet today less than 25 percent of cancer patients are matched to an immunotherapy that helps them. Our mission is to address that gap by leading the development of predictive diagnostics that can be a more effective matchmaker between patients and the treatments most likely to benefit them," said Sara Lapomarda, Director of Clinical Partnerships for Cofactor Genomics. "By studying our unique diagnostic approach in lung cancer, we hope to positively impact the trial-and-error approach to treating patients that can delay time to an effective treatment and spare them from unnecessary toxicities from chemotherapy in order to improve patient outcomes and survival for many. We intend to grow our clinical and biomarker team quickly to expedite validation of our lung cancer assay so it will closely follow our head and neck cancer assay in 2023."

About Predictive Immune Modeling

Predictive Immune Modeling (PIM) is Cofactor’s proprietary approach to immunotherapy predictive diagnostics. It is based on understanding the immune cell composition of a tumor, such as T cells, which has been shown to be predictive of immunotherapy response. It goes beyond testing individual markers by first building a model of the immune composition of patient responders to immunotherapy using 100+ RNA-based biomarkers processed with machine learning. Then, the company’s OncoPrism assay is used to compare a patient’s genetic profile to this model to determine how likely the patient is to be a responder themselves. This approach has been shown in published literature to be almost twice as accurate as the most commonly used biomarker, PD-LI, in identifying immunotherapy responders across a variety of cancers.

On December 14, 2022 (the "Execution Date") MacroGenics, Inc. (the "Company") entered into a Fifth Amendment (the "Amendment") to its existing lease agreement (the "Lease") with ARE-Maryland No. 45, LLC (the "Landlord"), for 122,600 square feet located at 9704 Medical Center Drive in Rockville, Maryland (the "Premises") (Filing, 8-K, MacroGenics, DEC 16, 2022, View Source [SID1234625356]). The Amendment provides for, among other things, an extension of the term of the Lease from August 15, 2027 to December 31, 2035, unless earlier terminated or extended (the "Modified Term"). During the Modified Term, base rent will be calculated annually on a per square foot basis, beginning at $46.37 per square foot and escalating annually by three percent thereafter. The Amendment also contains two options to extend the term of the Lease, which, if executed, would extend the lease to December 31, 2045. For a period of twenty-four months beginning on the Execution Date, the Landlord has granted the Company a rent abatement of fifty percent of the base rent payable for the Premises.

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The foregoing description of the Amendment is not complete and is qualified in its entirety by reference to the Amendment, along with the original lease and amendments, which the Company intends to file as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2022.