On January 8, 2020 Inhibrx, Inc. (Inhibrx), a clinical-stage biotechnology company with a broad pipeline of biotherapeutics in development, reported the administration of the first dose of INBRX-106 in a Phase 1 dose-escalation clinical study (Press release, Inhibrx, JAN 8, 2020, View Source [SID1234552840]). INBRX-106 is a novel, hexavalent agonist of OX40 in development for the treatment of solid tumors. The ongoing clinical study aims to determine the safety of INBRX-106 as a single agent and in combination with Keytruda, as well as the recommended therapeutic dose level for future clinical development.

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INBRX-106 was engineered to bind and cluster six OX40 receptors and has been shown preclinically to significantly outperform bivalent OX40 agonist antibodies in co-stimulatory capacity and anti-tumor activity. INBRX-106 has demonstrated strong single agent activity in preclinical tumor models that do not respond to a PD-1/PD-L1 checkpoint inhibitor. This activity was improved in combination with a PD-1 blocking antibody.
"The preclinical activity profile of INBRX-106 suggests that it has the potential to significantly increase the response rate and patient survival over those achieved with single agent PD-1/PD-L1 blockade," said Mark Lappe, CEO of Inhibrx. "INBRX-106 was designed to overcome the limitations of previously explored OX40 targeting approaches and we are excited to have achieved our first dose in a cancer patient."

About INBRX-106
INBRX-106 is a hexavalent agonist of OX40. OX40 is a co-stimulatory receptor expressed on immune cells that is enriched in the tumor microenvironment. OX40 ligand is a trimeric protein that activates OX40 signaling through clustering. INBRX-106 was engineered to bind and cluster six OX40 receptors and has been shown preclinically to significantly outperform bivalent antibodies in co-stimulatory capacity and anti-tumor activity.

About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that are capable of enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

On January 8, 2020 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that Arnon Rosenthal, Ph.D., co-founder and chief executive officer of Alector, will present a company overview at the J.P. Morgan 38th Annual Healthcare Conference on Wednesday, January 15, 2020 at 4:30 p.m. PT (Press release, Alector, JAN 8, 2020, View Source [SID1234552839]). The conference is being held January 12-16, 2020 in San Francisco .

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A live webcast of the presentation will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 30 days following the event. For further information, please contact [email protected].

On January 8, 2020 Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses diagnostic technologies through its MolDX program, has expanded coverage of the clonoSEQ Assay to include monitoring minimal residual disease (MRD) in Medicare patients with chronic lymphocytic leukemia (CLL) (Press release, Adaptive Biotechnologies, JAN 8, 2020, View Source [SID1234552838]). This adds to existing Medicare coverage in B-cell acute lymphoblastic leukemia (ALL) and multiple myeloma, which was established in January 2019. Medicare coverage for clonoSEQ is aligned with clinical practice guidelines in covered disease states which support assessing MRD at multiple time points throughout therapy to monitor treatment response and help predict patient outcomes. This expanded coverage policy is effective immediately and continues the positive momentum for clonoSEQ with over 175M lives covered to date.

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"Patients with CLL who achieve undetectable MRD have better outcomes than those with detectable MRD," said Javier Pinilla-Ibarz, M.D., Ph.D., Senior Member and Head of the Lymphoma program in the Department of Malignant Hematology at Moffit Cancer Center. "As newer therapies emerge for CLL that can help patients achieve very deep remissions, assessment of MRD can help guide clinical care by determining a patient’s response to therapy and informing that patient’s prognosis."

MRD refers to the remaining number of cancer cells that may be present in a patient’s body during and after treatment and that may eventually lead to recurrence of the disease. MRD testing is performed as a series of tests throughout a patient’s cancer journey to monitor for remission, detect relapse, determine response to treatment and inform care. Controlled trials have shown that even the smallest amounts of residual disease significantly predict a patient’s long-term clinical outcomes.

"Data are mounting to support the clinical benefits of MRD measurement in lymphomas and leukemias, including CLL, to help assess a patient’s prognosis, measure response to therapy and inform treatment decisions," said Lance Baldo, chief medical officer, Adaptive Biotechnologies. "The Medicare coverage expansion validates this growing body of evidence and provides patients living with CLL greater access to highly sensitive, standardized MRD testing."

clonoSEQ is the only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease in any lymphoid cancer. At the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, an unprecedented amount of data was presented demonstrating the clinical significance of MRD in blood cancers and further validating it as one of the strongest predictors of patient outcomes.

About the clonoSEQ Assay

The clonoSEQ Assay was granted de novo designation and marketing authorization by FDA for the detection and monitoring of minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. clonoSEQ is the first and only FDA-authorized in vitro diagnostic assay for MRD testing. It is also the first clinical diagnostic powered by immunosequencing to receive FDA clearance. clonoSEQ leverages Adaptive’s proprietary immunosequencing platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and detect potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes are strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with ALL and MM. More than 175 million people in the US now have access to clonoSEQ through Medicare and private payor coverage.

clonoSEQ is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.

On January 8, 2020 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the first patient has been dosed in the Phase III GEMSTONE-304 study of the Company’s anti-PD-L1 antibody CS1001 in combination therapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC) (Press release, CStone Pharmaceauticals, JAN 8, 2020, View Source [SID1234552811]). The GEMSTONE-304 trial is a multicenter clinical study designed to evaluate the efficacy and safety of CS1001 in combination with 5-fluorouracil plus cisplatin (FP) doublet chemotherapy in the first-line treatment of unresectable locally advanced, relapsed, or metastatic ESCC.

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According to the GLOBOCAN data released in 2018, there are approximately 307,000 new incidences of esophageal cancer and 283,000 cases of esophageal cancer-related deaths in China annually. The incidence and mortality rates of esophageal cancer are ranked 5th and 4th respectively among all tumor types nationwide. Epidemiological data indicate that 90% of all esophageal cancer cases in China are ESCC, and around 70% of ESCC cases were locally advanced or metastatic at the time of diagnosis. The platinum-based doublet chemotherapy is the current standard of care first-line treatment for patients with advanced ESCC, but it has limited efficacy. Existing data on this first-line treatment for advanced ESCC suggest an objective response rate (ORR) of 35%, a median progression-free survival (PFS) of less than six months, and a median overall survival (OS) of less than one year. There are no alternative treatments for ESCC patients who have failed the first-line treatment.

CS1001 is an investigational anti-PD-L1 antibody developed by CStone. Results released at the 2019 Chinese Society of Clinical Oncology (CSCO) Annual Meeting have shown that, as of July 1, 2019, the Phase Ib trial of CS1001 in combination with the FP chemotherapy regimen in first-line treatment of ESCC achieved an ORR of 77.8% with durable response as well as good overall safety and tolerability.

"Esophageal cancer is one of the tumor types that are particularly prevalent in China, with over 50% of the world’s new esophageal cancer cases and related deaths occurring in the country. Furthermore, the lack of more effective treatments for this patient population has long represented an urgent unmet clinical need," said Dr. Frank Jiang, Chairman and CEO of CStone. "I am glad that we have dosed the first patient in the GEMSTONE-304 trial. I hope CS1001 will continue to demonstrate its clinical promise in its development programs, and soon be proven as a new treatment option for ESCC patients in China."

"Early symptoms of esophageal cancer are relatively silent; as a result, esophageal cancer patients are commonly diagnosed at advanced stages for which there are very limited treatment options. Furthermore, no immunotherapy has been approved for the first-line treatment of ESCC. Recent results from the Phase Ib trial of CS1001 have already demonstrated promising preliminary antitumor efficacy in advanced ESCC. We will continue accelerate this Phase III trial with our best effort. Should this clinical program lead to successful outcomes, it will be a major breakthrough for advanced ESCC patients who are in urgent need of effective therapies," noted Dr. Jason Yang, Chief Medical Officer of CStone.

About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, potentially representing a unique advantage over similar drugs.

CS1001 has completed a Phase 1 dose-escalation study in China, in which the drug showed good tolerability. During Phase 1a and 1b stages of the study, CS1001 produced sustained clinical benefits in multiple tumor types.

CS1001 is being investigated in a number of ongoing clinical trials, including one Phase 1 bridging study in the U.S. In China, its clinical program includes one multi-arm Phase 1b study, two pivotal Phase 2 studies, and four Phase 3 studies for several tumor types.

On January 7, 2020 Theolytics, a UK biotech harnessing viruses to combat cancer, reported the closing of a US $6.8 million (UK £5 million) Series A round (Press release, Theolytics, JAN 7, 2020, View Source [SID1234630929]). The round was co-led by Epidarex Capital and Taiho Ventures LLC with participation from existing investor, Oxford Sciences Innovation (OSI). The financing will be used to progress the company’s pipeline of candidates towards human clinical trials.

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Theolytics is focused on creating a step-change in the oncolytic viral therapy field, by using its phenotypic screening platform to discover and develop highly efficacious, targeted candidates, suitable for intravenous delivery and optimised for a chosen cancer patient population.

Charlotte Casebourne, CEO of Theolytics said, "Oncolytic viruses represent a unique therapeutic paradigm within oncology. Theolytics’ platform technology enables a fundamental shift in what is possible; combining the power of bioselection with a patient-centric approach to drug discovery, we are able to address many of the challenges that have prevented the field from delivering on its full potential. Our team are committed to discovering and developing candidates for some of the most challenging cancers, and I’m delighted that Epidarex and Taiho Ventures have chosen to support us on our journey."

Henning Steinhagen, Venture Partner at Epidarex Capital said, "The oncolytic viral therapy field continues to gain momentum and Theolytics caught our eye with their highly promising indication-specific bioselection platform. Theolytics combines multiple key features we are looking for when investing: world class science, highly driven innovators, and a disruptive technology that has the potential to generate a strong pipeline of proprietary and significantly more efficacious therapeutics. We look forward to supporting Theolytics in leveraging its innovative platform to establish a pipeline of patient-centric next-generation oncolytic viruses, which promises to dramatically improve the treatment of cancer."

Sakae Asanuma, President at Taiho Ventures, LLC, the corporate venture arm of Taiho Pharmaceutical Co. Ltd., said, "Taiho is delighted to co-lead this Series A financing and work with Theolytics to deliver the innovative oncolytic virotherapy generated by their unique proprietary platform technology, which should provide cancer patients with the promise of dramatically improving clinical outcomes."

Dr Kenneth Powell, Chair of the Board welcomed Henning Steinhagen, Venture Partner at Epidarex, and Sakae Asanuma, President at Taiho Ventures as new Board members, stating, "I look forward to working with our new investors to bring these promising approaches to cancer patients."