On October 17, 2022 Eucure (Beijing) Biopharma Co., Ltd. ("Eucure"), a wholly owned subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen"), reported that the company has entered into a worldwide licensing agreement with Syncromune, Inc. ("Syncromune"), a US-based clinical stage biopharmaceutical company, for the development and commercialization of intratumoral immunotherapies along with Syncromune’s Syncrovax technology (Press release, Eucure, OCT 17, 2022, View Source [SID1234622078]).

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Under the terms of the agreement, Syncromune will acquire exclusive worldwide rights for development and commercialization of the intratumoral combination therapy containing Eucure’s YH002, and multiple other active ingredients as part of the Syncrovax therapy. Eucure/Biocytogen reserve all the global rights beyond Syncrovax. Pursuant to the agreement, Eucure has the potential to receive hundreds of millions of US dollars, including an upfront cash payment that reflects the projected clinical value of the molecules, significant development and regulatory milestone payments, as well as royalties and other incentives based on the long-term commercial value of the Syncrovax combination therapy. Eucure will be responsible for drug manufacturing and supply, and Syncromune will be responsible for clinical development and commercialization.

The Syncrovax platform is a next-generation personalized cancer therapy being developed to optimize intratumoral immunotherapy for the treatment of metastatic solid tumor cancers. The technology aims to generate a personalized autologous cancer vaccine using a patient’s own cancer antigens. This new approach to fighting cancer is designed to generate a robust anti-cancer response by overcoming the immunosuppressive characteristics of metastatic cancers and addressing the limitations of current systemic immunotherapies. Syncromune intends to initially develop combination therapies for metastatic breast, prostate, and lung cancer, with a robust pipeline aimed at six additional target cancers.

"YH002 is a co-stimulating molecule for the OX40 target which has shown favorable safety and promising anti-tumor activity against solid tumors," said Rong Chen, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of Eucure, and Vice President of Biocytogen. "We are excited to collaborate with Syncromune to realize the potential in intratumoral immunotherapy."

"We are excited to enter into an exclusive licensing agreement with Eucure/Biocytogen," said Eamonn Hobbs, President and Chief Executive Officer of Syncromune. "This license agreement is an important step in the development of our proprietary Syncrovax platform and further supports Syncromune’s strategy to maximize our platform to build a sustainable cancer therapeutics company."

"We believe the antibodies developed with Biocytogen’s unique platform may provide competitive advantages," said Charles Link, M.D., Executive Chairman and Chief Medical Officer of Syncromune. "The preclinical data suggests that these second-generation molecules might have best-in-class potential."

About YH002

YH002 is a recombinant anti-OX40 humanized IgG1 agonistic antibody. The specificity, safety, and anti-cancer efficacy of YH002 have been demonstrated in a comprehensive panel of pre-clinical studies. The totality of pre-clinical data supports progression of YH002 combination therapy into clinical studies in adult subjects with locally advanced or metastatic solid tumors. A first-in-human (FIH), multicenter, open-label, Phase I dose-escalation study is currently underway in Australia to evaluate the safety, tolerability, and pharmacokinetics and determine the MTD/RP2D of YH002 in subjects with advanced solid malignancies.

About Syncrovax

The Syncrovax platform therapy utilizes a combination approach of tumor activation and targeted delivery, aiming to synchronize the timing and location of tumor antigen release with the functional activation of immune cells. To achieve tumor activation, a portion of a target tumor is lysed to generate immunogenic cell death and the release of Damage Associated Molecular Patterns (DAMPs) and tumor antigens, changing the tumor microenvironment by creating an in situ vaccine. The second component of the platform, targeted delivery, involves the intratumoral infusion of a proprietary fixed-dose combination drug with 4 active ingredients into the lysed portion of the tumor. This is designed to provide immunostimulatory effects in the tumor microenvironment and draining lymph nodes, mitigate the cancer’s ability to block immune responses, and contribute to the activation of antigen presenting cells and cytotoxic T cells. The immune responses triggered by the in situ personalized vaccine enable the patient to vaccinate against multiple autologous antigens at the same time. The anti-cancer responses are expected to act at the site of the treated tumor as well as in metastases throughout the body.

On October 17, 2022 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ET140203 for the treatment of hepatoblastoma (HB), a rare childhood tumor in the liver that typically occurs in children under the age of 5 (Press release, Eureka Therapeutics, OCT 17, 2022, View Source [SID1234622077]).

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"We are pleased to receive ODD for ET140203 following the FDA’s earlier grant of Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) designations to ET140203 for the treatment of HB," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "These designations highlight the significant unmet medical need for better pediatric liver cancer treatment options."

Eureka is currently recruiting patients in three Phase I/II clinical trials to investigate the safety and potential efficacy of ARTEMIS T cells that have been engineered to target specific liver cancer antigens. The ARYA-1 (adult) and ARYA-2 (pediatric) studies use ET140203 ARTEMIS T cells directed with a TCR mimic antibody to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex found on liver cancer cells. The ARYA-3 study uses ECT204 T cells to target the Glypican 3 (GPC3) protein expressed on the surface of liver cancer cells.

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

Patients, caregivers and health care professionals interested in Eureka’s clinical trials and technology can find more information by visiting eurekaconnectme.com.

About ARYA-2 Trial and ET140203

The ARYA-2 study is an open-label, dose escalation, multi-center, Phase I/II clinical trial designed to assess the safety/tolerability and preliminary efficacy of ET140203 T-cells in pediatric subjects who are AFP-positive/HLA-A2-positive and have relapsed/refractory hepatoblastoma (HB), hepatocellular malignant neoplasm, not otherwise specified (HCN-NOS), or hepatocellular carcinoma (HCC). Additional information about Eureka’s Phase I/II study may be found at ClinicalTrials.gov, using Identifier NCT: NCT04634357.

ET140203 is an investigational therapy during which a patient’s T cells are collected, engineered to express Eureka’s proprietary ARTEMIS cell receptor and infused back into the patient. Engineered ET140203 T cells express a TCR-mimic antibody to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex on liver cancer cells. In addition, ET140203 ARTEMIS T cells also incorporate Eureka’s proprietary tumor infiltration technology demonstrating enhanced ability to infiltrate solid tumors in animal models, potentially leading to improved efficacy in patients.

On October 17, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products, and services, reported the expanded commercial availability of CNSide for patients with metastatic melanoma (Press release, Biocept, OCT 17, 2022, View Source [SID1234622076]). Previously validated for lung, breast, and all other carcinomas, Biocept’s CNSide is a proprietary CSF assay designed to better detect and inform treatment decisions for patients with metastatic cancers involving the central nervous system (CNS).

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The new CNSide for melanoma assay uses a novel antibody cocktail optimized for the capture of melanoma cells based on unique cellular characteristics. This assay represents a significant development in the field of neuro-oncology related diagnostics. It is believed to be the first CLIA-validated assay designed for the quantitative identification of melanoma cells in CSF.

Melanoma is the third most common tumor type involved in CNS metastasis, with more than 60% of Stage IV melanoma patients developing CNS metastasis from their disease. Overall survival expectancy is low and patient management can be challenging due in part to diagnostic limitations. CNSide addresses a high unmet clinical need, as current standard of care approaches—CSF cytology and MRI imaging—have limited sensitivity for detecting CNS metastasis and are not adequate to assess the response to therapy. CNSide can also help identify molecular biomarkers considered targets for novel therapy approaches. Combined, these features help clinicians answer three key questions for patients with CNS metastasis: Is there tumor? Is there a target for treatment? Is there a trend or favorable response to treatment?

"Our early development experience evaluating patients with melanoma with CNSide is similar to what we have seen in carcinomas, supporting the expanded clinical use of this CLIA laboratory developed test," said Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. "Physicians are finding CNSide valuable for managing patients with CNS metastasis, particularly to assess treatment response. Declining CSF tumor cell counts have correlated well with successful response to therapy and symptom resolution, while better illustrating residual, recurrent or resistant disease. CSF can also be more frequently and easily evaluated while the patient is in the clinic, compared to follow-up radiologic imaging that might occur weeks later."

"We are pleased to expand the commercial use of CNSide for physicians treating patients with metastatic melanoma," said Samuel D. Riccitelli, Biocept’s Chairman, and interim President and CEO. "This is another step toward our goal of establishing CNSide as a new standard-of-care diagnostic test for patients with metastatic cancer that has spread to the CNS; patients who have no time to waste."

About CNSide

CNSide is based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the CNS, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers such as HER2 and EGFR in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to monitor the response to therapy more effectively than other current methods.

On October 17, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, reported the dosing of the first patient in the expansion cohorts of its ongoing Phase 1 study for IO-108 (Press release, Immune-Onc Therapeutics, OCT 17, 2022, View Source [SID1234622075]). The Company also entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) ("Regeneron") to evaluate IO-108 in combination with Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab), as part of its ongoing clinical development program.

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IO-108 is a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) in adult patients with advanced or refractory solid tumors.

"We are incredibly excited to have enrolled the first patient in an expansion cohort of the IO-108 study. To date, IO-108 has been well tolerated and has demonstrated promising clinical activity in various tumor types, both as a monotherapy and in combination with an anti-PD-1 antibody," said Paul Woodard, M.D., chief medical officer of Immune-Onc. "Additionally, on the heels of initiating this important phase of our study, we are excited to enter into a supply agreement with Regeneron, which enables us to accelerate the global development of IO-108 in multiple expansion cohorts of select solid tumors. We hope to establish our pipeline products as the preferred combination agents with T cell checkpoint inhibitors and other standard of care therapies."

The Phase 1 expansion phase includes IO-108 monotherapy cohorts and IO-108 combination cohorts with anti-PD-1 antibodies (pembrolizumab or cemiplimab, depending on tumor types). Under the terms of the agreement, Immune-Onc will sponsor and fund the planned clinical trials and Regeneron will provide cemiplimab (Libtayo). Immune-Onc retains global development and commercial rights to IO-108.

"I have been very encouraged by both the pre-clinical and early clinical data observed for IO-108 in the ongoing Phase 1 study, and look forward to better understanding how combination therapy with various anti-PD1 therapies can further activate the body’s immune system to attack some of the hardest-to-treat cancers," said IO-108 Phase 1 investigator, Matthew H. Taylor, M.D., assistant member, Developmental Cancer Therapeutics Laboratory and co-medical director, Providence Melanoma Program, Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon. "Currently, 70-80 percent of cancer patients with solid tumors do not achieve durable responses to T-cell checkpoint therapies alone, and people with many types of cancer have yet to benefit from the promise of this class of immunotherapy. This underscores the need for investigating novel combination regimens."

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s annual meeting and the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.

The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation and is actively enrolling several expansion cohorts, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab). To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab. The company is also actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors.

On October 17, 2022 Ankyra Therapeutics, a company developing targeted immune potentiating agents for the treatment of cancer, reported the appointment of Joseph J. Elassal, M.D., as chief medical officer (Press release, Ankyra Therapeutics, OCT 17, 2022, View Source [SID1234622074]). Dr. Elassal will fill the role formerly served by Howard Kaufman, M.D., who was recently promoted to president and chief executive officer of Ankyra Therapeutics.

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"Joe is a well-respected leader in our field who brings a breadth of experience to Ankyra, having held roles within the biotech and financial industries, while also serving as a practicing physician for 20 years," said Dr. Kaufman. "Joe has spent a large portion of his career focused on leading efforts to advance intra-tumoral applications of immunotherapy – expertise that will be critical to enabling Ankyra to rapidly progress our lead compound, ANK-101, into the clinic. We are delighted to welcome Joe to the team at this important stage of our development, and I, along with the rest of the management team and the board, look forward partnering with him."

Dr. Elassal has served as an attending physician at Stamford Hospital for nearly 20 years, while also holding industry roles across the pharmaceutical and financial industries. Most recently, he served as enior medical director, global medical affairs – oncology at Regeneron, where he led efforts on cemiplimab and other immunotherapy approaches for patients with cervical and non-melanoma skin cancer. He also held roles within the inflammation and immunology, and cardiovascular and metabolic divisions at Regeneron. His other industry roles included senior medical director at Replimune, biosimilars medical affairs at Pfizer, deputy vice president at Pharmaceutical Research and Manufacturers of America (PhRMA), and vice president, senior medical director at Cline Davis & Mann. Prior to industry, Dr. Elassal was a research associate at JP Morgan Securities. Dr. Elassal earned his M.D. from Eastern Virginia Medical School and MBA from Columbia Business School. He completed his internship and residency at Columbia University/New York Presbyterian Hospital and is certified by the American Board of Internal Medicine.

"I am excited to join Ankyra, a company which is at the forefront of intratumoral oncology drug development. Ankyra’s anchored immunotherapy platform has the potential to transform the therapeutic application of cytokine drugs by delivering enhanced efficacy and limiting systemic exposure, a challenge experienced with many cytokine-based therapies today," said Dr. Elassal. "I look forward to joining a strong and dedicated team at Ankyra working to advance our lead compound ANK-101 into the clinic as well as additional pipeline opportunities in the future."