On July 6, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported it has entered into a Clinical Trial Collaboration and Supply Agreement ("Agreement") with Merck (known as MSD outside the United States and Canada) to evaluate the combination of OncoSec’s DNA-plasmid interleukin-12 (IL-12) TAVO (tavokinogene telseplasmid) with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a global Phase 3 randomized clinical trial, KEYNOTE-C87 (Press release, OncoSec Medical, JUL 6, 2021, View Source [SID1234584630]). The planned clinical trial will evaluate the overall survival of patients treated with the TAVO in combination with KEYTRUDA versus standard of care in late-stage patients with metastatic melanoma who are refractory to immune checkpoint therapy.

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!

TAVO has received Fast Track designation from the U.S. Food and Drug Administration (FDA), as a potentially first-in-class, intratumoral anti-cancer gene therapy that expresses IL-12 for the treatment of metastatic melanoma, following progression on KEYTRUDA or OPDIVO (nivolumab). KEYNOTE-C87 is intended to support accelerated approval by the U.S. FDA and/or serve as a pivotal study to support a full licensure. Under the terms of the Agreement, Merck will provide KEYTRUDA , while OncoSec will provide the investigational drug, TAVO. Each party will be responsible for its own internal costs, with OncoSec covering third party costs. Eligible patients must have Stage III or IV unresectable, metastatic melanoma, and must be refractory to prior checkpoint therapy. KEYNOTE-C87 intends to enroll approximately 400 patients and is planned to be conducted in the U.S., Canada, EU, and Australia.

"We are thrilled to enter into this collaboration and supply agreement with Merck – one of the world’s leading immuno-oncology companies – to help bring TAVO to patients with metastatic melanoma whose disease did not respond to initial checkpoint inhibitor therapy or who have developed progressive disease and therefore do not have additional treatment options available," said Brian Leuthner, Interim Chief Executive Officer of OncoSec. "This Phase 3 collaboration represents a crucial milestone for OncoSec as we advance TAVO through the clinic and toward potential approval globally, and expands upon our initial 2017 clinical collaboration and supply agreement with Merck. We look forward to our continued work and progress with Merck and its experienced team of immuno-oncology leaders as we continue to explore TAVO in combination with KEYTRUDA with the goal of helping more patients with cancer."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. OPDIVO is a registered trademark of Bristol Myers Squibb.

About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.

On July 6, 2021 EpimAb Biotherapeutics, a clinical stage biotech company specializing in bispecific antibodies, reported dose administration for the first patient in a Phase 1/2 clinical trial of EMB-02, a bispecific antibody targeting PD-1 and LAG-3, in patients with advanced solid tumors, as well as in a Phase 1/2 clinical trial of EMB-06, a bispecific antibody targeting B cell maturation antigen (BCMA) and cluster of differentiation 3 (CD3), in patients with recurrent and refractory multiple myeloma (Press release, EpimAb Biotherapeutics, JUL 6, 2021, View Source [SID1234584629]). The company also announced the approval of its Investigational New Drug (IND) application for EMB-02 by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).

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 excited to continue the momentum of our pipeline advancement with the dosing of the first patients in Phase 1/2 trials for our two new clinical programs, EMB-02 and EMB-06, as well as the IND clearance for EMB-02 in China," said Dr. Chengbin Wu, founder and CEO of EpimAb Biotherapeutics. "This validates the power of our FIT-Ig platform to efficiently generate novel bispecific programs, as well as its broad applicability across a variety of targets, which is important as we continue to pursue promising target combinations. We look forward to advancing additional preclinical and clinical assets derived from our FIT-Ig platform as well as expanding into utilizing additional proprietary platform technologies to develop complex multi-functional molecules with unique capabilities."

"The target combination of PD-1 and LAG-3 has received industry attention recently for its potential in difficult-to-treat cancers that do not respond to standard anti-PD-1 monotherapies. Our preclinical data revealed that EMB-02 can show significant improvement in tumor models resistant to standard anti-PD-1 monotherapies," said Bin Peng, MD, Ph.D. CMO of EpimAb Biotherapeutics. "We look forward to establishing ourselves as a leader in the development of best-in-class bispecific therapeutics as we further evaluate the potential of EMB-02 in global clinical trials in the U.S., China and Australia. We are also eager to continue the advancement of EMB-06, a bispecific antibody targeting BCMA and CD3, and evaluate its potential to benefit patients with multiple myeloma."

The EMB-02 Phase 1/2 study is a multi-center, open label, multiple-dose, first in human study to assess the safety and tolerability of EMB-02 in patients with advanced solid tumors. The primary objective for the Phase 1 portion of the study is to identify the recommended Phase 2 dose (RP2D) and schedule assessed to be safe for EMB-02. Pharmacokinetics, immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed. After a recommended dose for the Phase 2 portion of the trial is determined, the efficacy of EMB-02 will be evaluated in an expanded cohort at the RP2D. The trial is being conducted at two clinical trial sites in the U.S. and one in Australia. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04618393).

The EMB-06 Phase 1/2, multi-center, open label, multiple-dose, first in human study is designed to assess the safety and tolerability of EMB-06 in patients with relapsed or refractory multiple myeloma. The primary objective for the study is to identify the recommended Phase 2 dose (RP2D) and schedule assessed to be safe for EMB-06. Pharmacokinetics, immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed. In the Phase 1 portion of the trial, patients will receive EMB-06 once weekly at different ascending dose levels. Once the RP2D is determined, an expanded cohort will receive EMB-06 at the RP2D. The trial is being conducted at 4 clinical trial sites in Australia and is being expanded to further countries. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04735575).

On July 6, 2021 GE Healthcare and SOPHiA GENETICS reported that they have signed a letter of intent to collaborate on advancing cancer care, with the goal of better targeting and matching treatments to each patient’s genomic profile and cancer type, helping to ensure the most effective and personalized treatment (Press release, GE Healthcare, JUL 6, 2021, View Source [SID1234584628]).

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 companies aim to develop new artificial intelligence (AI)-powered analytics and workflow solutions to serve both the clinical and biopharma markets. They’ll be deploying GE Healthcare’s extensive medical imaging and monitoring capabilities and Edison platform-enabled data aggregation with the SOPHiA DDM cloud-based software-as-a-service analytics genomic insights platform and related solutions, which are available in more than 750 hospitals, laboratories and biopharma companies.

GE Healthcare has deep expertise in clinical workflows, deep learning AI algorithms for image reconstruction and image segmentation, analytics and standardization, while SOPHiA GENETICS is a pioneer in data-driven medicine. Their cloud-based software-as-a-service analytics platform uses AI and machine learning to generate actionable insights for clinicians and researchers from complex multimodal datasets. The companies aim to break down the data silos across instruments and sites that so often delay or even prevent patients from getting the most appropriate treatment both in cancer and in other diseases.

As cases of cancer continue to rise and are predicted to reach 29.5 million new cases per year by 2040,1 there is a growing demand for data-driven medicine, both for clinical practice and clinical trials. GE Healthcare is utilizing its Edison platform to integrate data from diverse sources, such as electronic health records (EHR) and radiology information systems (RIS), imaging and other medical device data. This integrated data can be used to develop and deploy AI enabled solutions to help simplify oncology patient workflows, better understand increasingly complicated clinical patient data, and compare data from patient to patient.

"The integration of genomics-based artificial intelligence into oncology workflow solutions would be a major breakthrough for integrated cancer medicine and for future clinical research, which increasingly depend on the ability to select those patients most likely to respond to new therapies," said Jan Makela, President & CEO, Imaging at GE Healthcare. "This collaboration represents another step in GE Healthcare’s vision of making precision health—more efficient and personalized care— a reality."

"By bringing together our global platform and insights-sharing network with GE Healthcare’s international reach and cutting-edge products, healthcare professionals will be able to leverage their expertise and work together for the benefit of patients all over the world. Cancer patients will be able to receive equal access to better diagnoses and treatments through secure data pooling and knowledge sharing, unlocking the promise of data-driven medicine at scale," said Jurgi Camblong, co-founder and CEO, SOPHiA GENETICS.

Next-generation sequencing (NGS) is rapidly becoming a new standard of care in cancer diagnostics, particularly as novel therapies require genomic information to be prescribed in a personalized way. Today, these sets of information and insights are often bespoke and difficult for clinicians to easily and quickly obtain and recall along the patient care journey.

On July 6, 2021 Biocept, Inc. (NASDAQ: BIOC), a leading provider of molecular diagnostic assays and services, reported that it has been awarded a South Korean Patent for its Primer-Switch technology, which detects rare mutations in circulating tumor DNA (ctDNA) using real-time PCR and associated analysis methods (Press release, Biocept, JUL 6, 2021, View Source [SID1234584627]). The patent (No. 2252447) is titled Methods for Detecting Nucleic Acid Sequence Variants.

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!

This is the fourth issued patent for the technology, which identifies rare cancer biomarkers found in tissue, blood, and cerebrospinal fluid (CSF). Primer-Switch provides a unique method for specifically enriching patient specimens for mutations of interest. It can be used to enhance the performance and specificity of the PCR method, the most widely used amplification approach for research and clinical diagnostic applications. It also enables the interrogation of fragmented DNA that is often found in biological fluids.

"Primer-Switch methodology adds to the capabilities of our Switch-Blocker technology used in our Target Selector assays, providing key information about cancer biomarkers to aid physician decision-making, with the goal of improving outcomes for patients with cancer," said Michael Nall, Biocept’s President and CEO. "Our strong and growing intellectual property portfolio enables Biocept to develop and commercialize our highly differentiated technologies and testing services."

Biocept’s core technologies and products are protected by more than 70 issued patents in the U.S., EU, Australia, China, Japan, and South Korea, as well as other countries. This includes worldwide patent protection on its highly sensitive methods for detecting cancer biomarkers that are used by physicians for treatment decisions.

On July 6, 2021 Eureka Therapeutics, Inc. reported that Eureka and Memorial Sloan Kettering Cancer Center (MSK) entered into a license agreement with Sanofi for the non-CAR use of a novel, human binding domain targeting GPRC5D (G Protein-Coupled Receptor Family C Group 5 Member D). The GPRC5D binding domain was discovered using Eureka’s proprietary E-ALPHA antibody discovery platform and developed under a collaboration agreement between Eureka and MSK.

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!

"GPRC5D is a novel target that has emerged as a promising option for the treatment of multiple myeloma, particularly for patients who have relapsed from other therapies," said Dr. Eric L. Smith, myeloma physician-scientist and an inventor on the patents.

"We are delighted to contribute technology for the development of next generation therapies against multiple myeloma," said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics. "Targeting GPRC5D has the potential to improve the durability of response from current therapies and to improve the long-term clinical benefits for patients."

Under the terms of the agreement, Sanofi has exclusive rights to the GPRC5D binder for non-CAR use. Eureka and MSK are eligible to receive an upfront payment and over $1 billion of potential development, regulatory and sales milestone payments. Eureka and MSK are also eligible to receive tiered royalties on net sales.

ABOUT MULTIPLE MYELOMA

Multiple myeloma is a cancer that affects a type of white blood cells called plasma cells that are specialized mature B-cells, which secrete antibodies to combat infections. Multiple myeloma is characterized by the uncontrolled proliferation of neoplastic plasma cells in the bone marrow, where they overcrowd healthy blood cells. Multiple myeloma is the second most common hematologic cancer and affects approximately 130,000 people. Each year, about 32,000 people in the US are diagnosed with multiple myeloma.