Heron Therapeutics to Initiate Phase 2 Clinical Study of CINVANTI® for COVID-19 Treatment

PR Newswire | July 17, 2020

Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the initiation of the GUARDS-1 Study, a Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable emulsion in early hospitalized patients with Coronavirus Disease 2019 (COVID-19). The study initiation follows clearance from the U.S. Food and Drug Administration (FDA) of Heron's Investigational New Drug application for CINVANTI for the treatment of COVID-19. CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist (RA) approved for use for the prevention of chemotherapy-induced nausea and vomiting in patients with cancer. Substance P, and its receptor NK1, is distributed throughout the body in the cells of many tissues and organs, including the lungs. COVID-19, which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is associated with lower respiratory tract inflammation that often progresses to Acute Respiratory Distress Syndrome (ARDS). ARDS is associated with high mortality. Heron's rationale for the investigation of CINVANTI for the treatment of COVID-19 is based on multiple potential mechanisms for activity. Suppressing the cytokine storm could be a crucial step to prevent the clinical deterioration of patients with COVID-19. Administration of aprepitant injectable emulsion to these patients is expected to decrease the production and release of inflammatory cytokines mediated by the binding of substance P to NK1 receptors, which could prevent the progression of lung injury to ARDS. A hallmark of COVID-19 is a non-productive neurogenic cough, likely due to the increased susceptibility of lung tissue to neurogenic inflammation caused by the disease. Recent studies have demonstrated that administration of oral aprepitant resulted in significantly decreased severity of cough in patients with neurogenic cough associated with advanced lung cancer. Additionally, aprepitant may have direct antiviral activity. Using a computational screening approach, aprepitant was found to have the ability to form hydrogen bonds to key residues within the binding pocket of the main protease of SARS-CoV-2, which is a key enzyme required for replication. CINVANTI is approved for administration as a 2-minute intravenous injection. For these potential benefits, the plasma concentrations of aprepitant produced with the 2-minute intravenous injection of CINVANTI could provide a unique advantage over other methods of administration.

Spotlight

Cannabis is increasingly becoming legal at the state level in the U.S., for either medical or recreational use. Each of these states has had to wrestle with the question of how to ensure the safety of a new product that is not covered under any existing safety guidelines. Safety testing in other agricultural industries is regulated by the FDA, the USDA, or by other federal agencies, all of which have been unable to assist the states in this case. The few states that have produced safety testing guidelines for Cannabis were forced to develop them from scratch, without the regulatory and scientific support that federal agencies typically provide.

Spotlight

Cannabis is increasingly becoming legal at the state level in the U.S., for either medical or recreational use. Each of these states has had to wrestle with the question of how to ensure the safety of a new product that is not covered under any existing safety guidelines. Safety testing in other agricultural industries is regulated by the FDA, the USDA, or by other federal agencies, all of which have been unable to assist the states in this case. The few states that have produced safety testing guidelines for Cannabis were forced to develop them from scratch, without the regulatory and scientific support that federal agencies typically provide.

Related News

DIAGNOSTICS

GRAIL Announces Strategic Collaboration With AstraZeneca to Develop Companion Diagnostic Tests to Enable the Treatment of Early-Stage Cancer

GRAIL | June 06, 2022

GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced a broad strategic collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies. The collaboration will initially focus on developing companion diagnostic tests to identify patients with high-risk, early-stage disease, with plans to embark on numerous studies across multiple indications over the next several years. The parties are additionally planning to use GRAIL’s technology to enable recruitment of patients with early-stage cancer for AstraZeneca’s clinical studies. GRAIL has developed a novel approach to detect cancer signals in blood, regardless of whether or not the patient has clinical symptoms. We are excited to embark on this work with AstraZeneca to transform cancer outcomes through a broad, strategic collaboration, Through our collaboration, we hope to provide critical information to improve the identification of patients who may be eligible for clinical trials and change clinical paradigms for the treatment of early-stage cancers." Sir Harpal Kumar, President, Biopharma Business and Europe at GRAIL. Across the projects within this collaboration, GRAIL will use its methylation platform to perform testing for patients enrolled in AstraZeneca’s clinical trials. GRAIL will seek regulatory approval in key markets for the liquid biopsy companion diagnostics. Identifying and treating cancer early is at the heart of this strategic collaboration. Combining GRAIL’s innovative blood-based methylation profiling platform with AstraZeneca’s leadership in Oncology, we hope to accelerate the adoption of circulating tumor DNA across clinical trials and make our cancer medicines available at an earlier stage of disease when there is greater potential to transform patient outcomes, and even cure.” Susan Galbraith, Executive Vice President of Oncology R&D, AstraZeneca. GRAIL is developing its proprietary methylation platform for use in multiple post-diagnostic settings to identify patients at high risk of future cancer recurrence, detect the presence or absence of residual disease, and to inform treatment decisions, including identifying patients with cancer who may be eligible for neoadjuvant or adjuvant therapy. GRAIL’s technology platform is designed to optimize circulating tumor DNA testing to enable detection of early stage disease and minimal residual disease (MRD). About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021.

Read More

DIAGNOSTICS

Oxford BioTherapeutics Announces Research Collaboration with ImmunoGen to Develop Novel Antibody-Drug Conjugates

Oxford BioTherapeutics | June 14, 2022

Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, today announced a multi-year collaboration to research, develop and commercialize novel, first-in-class ADCs with ImmunoGen (IMGN), a leader in the expanding field of ADCs for the treatment of cancer. The companies will utilize ImmunoGen's linker-payload technology directed to novel targets identified via OBT's proprietary OGAP® discovery platform. The companies will support these R&D efforts through joint funding and by combining their respective proprietary technologies. "I am very enthusiastic about our new partnership with ImmunoGen, a leader in the development of ADCs," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. "The company's expertise, in combination with the unique targets from our OGAP® database, provides potential to strengthen our respective drug pipelines with novel and highly differentiated ADCs for cancer patients in need of novel therapeutic options." As part of the agreement, OBT will receive an upfront payment from ImmunoGen, reflecting OBT's preclinical programs to be included in the partnership. In addition, once antibodies generated by OBT have been coupled with ImmunoGen's proprietary linker-payload technology, each company will have the opportunity to select one or more development programs to further develop on its own. Each company is eligible to receive milestone payments based on the achievement of pre-specified development, regulatory, and commercial milestones, as well as tiered royalties as a percentage of worldwide commercial sales, with respect to each program selected by the other company. Once a company has chosen a given program, it will be solely responsible for all R&D costs associated with the specific program. "OBT has demonstrated expertise in identifying novel targets for the development of specific antibodies – two key components to generating successful ADCs," said Stacy Coen, ImmunoGen's Senior Vice President and Chief Business Officer. "This expertise, combined with ImmunoGen's portfolio of cancer-killing payloads and linkers, will be instrumental as both companies work to develop novel ADCs designed to address cancers with high unmet need. We look forward to working with OBT as we expand and diversify our investment in ADC research capabilities, deepen our pipeline, and transition to a fully-integrated oncology company." ImmunoGen's portfolio is comprised of next-generation maytansinoid, DNA-acting, and novel camptothecin toxins and proprietary linkers. This collaboration will utilize novel targets identified by OBT combined with ImmunoGen's proprietary toxins and associated linkers. OBT has clinical experience with ImmunoGen's ADC platform and DM4 payload, which is utilized in OBT's lead program OBT076, an ADC currently in clinical trials as a monotherapy, as well as in combination with checkpoint inhibitors, in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian, and lung cancer. About Oxford BioTherapeutics Oxford BioTherapeutics is a clinical stage oncology company based in Oxford, UK; San Jose, CA and Morristown, NJ, USA; with a pipeline of first-in-class immuno-oncology (IO) and antibody-drug conjugate (ADC) based therapies designed to fulfil major unmet patient needs in cancer therapeutics. OBT's lead clinical program, OBT076, an ADC utilizing an Immunogen toxin, initiated expansion in a U.S. Clinical Trial in 2021 in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian and lung cancer, where CD205 is overexpressed. Infiltration of tumors by immunosuppressive cells correlates with adverse outcomes (lower progression free and overall survival), suggesting that this process contributes to the progression of several cancers.

Read More

MEDTECH

Solvias Acquires Cergentis to Bolster Biologics and Cell & Gene Therapy Capabilities

Solvias | July 18, 2022

Solvias, one of the world's leading independent pharmaceutical testing and manufacturing companies, announced today that it has acquired Utrecht, Netherlands-based Cergentis. The acquisition bolsters Solvias' platform of biologics and cell and gene therapy testing solutions. According to pharmaceutical market intelligence provider, Evaluate, global sales of cell and gene therapies are projected to accelerate at a 63% compound annual growth rate through 2026. As more researchers leverage emerging genetic engineering techniques to develop complex, novel medicines, they require sophisticated solutions to analyze their safety and effectiveness. With the addition of Cergentis, Solvias supports the increasing number of global pharmaceutical, biotech, and contract development and manufacturing organizations developing genetically engineered therapies with an expanded platform of testing services highlighted by a highly scientific team possessing advanced degrees and deep expertise steeped in emerging genome techniques and evolving regulatory requirements proprietary genomic analysis technology that delivers comprehensive data in a single experiment that enables effective decision-making and R&D program design a global network serving customers across three continents customized support for distinct genetic engineering applications, including cell and gene therapy, cell line development & genetically engineered models specialized knowledge in genomic sequencing of early-stage cell lines to support one of the first steps in the R&D process high-touch support encompassing end-to-end logistical services, digital project management and reporting capabilities to enable rapid turnaround time "We are relentlessly focused on ensuring the safety of new therapies in development. Cergentis is a cornerstone acquisition that expands our solutions supporting complex and emerging therapies. We will continue to pursue strategic acquisitions that add specialized capabilities to our offering and advance our goal of being a forerunner in our industry." Archie Cullen, CEO, Solvias Joris Schuurmans, CEO, Cergentis, added: "We are excited to become part of a global leader that complements our scientific expertise, innovation and customer service. Solvias and Cergentis share a deep commitment to providing our customers with the highest quality solutions and support to safely get their products into the hands of patients who need them." Effective immediately, Mr. Schuurmans will join Solvias' leadership team and continue to lead operations for Cergentis. Cergentis marks Solvias' second acquisition since partnering with health care investors Water Street Healthcare Partners and JLL Partners in 2020. The company has recruited industry leaders to join its board and commenced a program to significantly upgrade and expand its information technology platform and infrastructure to support its plans for global expansion. Financial terms of the acquisition are not being disclosed. Achelous Partners served as the advisor to Cergentis on the transaction. About Cergentis Cergentis is a trusted genomics-focused biotechnology company providing services and in-house solutions based on its proprietary genomic analysis platform to all leading biopharmaceutical companies and renowned research institutes. With widely published and recognized genetic analyses, Cergentis supports a global customer base in the characterization and QC of genetically engineered models, biopharmaceutical cell line development, and cell- and gene therapy products. By helping to de-risk R&D program decisions, minimizing time-to-clinic, providing objective genomic evidence for regulators, and supporting patient safety, Cergentis aims to support biopharmaceutical medicine development programs worldwide. About Solvias AG Solvias is a worldwide leader in contract research, development and manufacturing for the pharmaceutical, biotech, material science and cosmetic industries. Drawing on 20 years of scientific excellence, the company provides flexible and scalable analytical and manufacturing solutions that ensure the integrity of pharmaceutical and medical device products across their life cycle. Headquartered in Kaiseraugst near Basel, Switzerland, Solvias and its laboratories operate to the highest standards and in accordance with ISO, GMP, GLP and FDA regulations.

Read More