Karyopharm Collaborates with National Cancer Institute for XPOVIO Research

Karyopharm Therapeutics Inc. (KPTI) announced that it has inked a new collaboration with National Cancer Institute. The partnership will mainly focus on developing XPOVIO, an oral Selective Inhibitor of Nuclear Export (SINE) compound. Both the parties will work together on studies to assess the efficacy and safety of XPOVIO in various oncology indications.

Karyopharm will be dealing with National Cancer Institutes Cancer Therapy Evaluation Program, as stated in Cooperative Research and Development Agreement (CRADA). Sharon Shacham of Karyopharm said, The studies conducted under this partnership will be designed with the goal of identifying and optimizing combinations and indications that hold the greatest chance of clinical success. This CRADA is an important collaboration for Karyopharm as we work to realize the full potential of XPOVIO and bring this novel medicine to as many patients as possible. It is also expected that NCI may support non-clinical studies for exploring teaming XPOVIO with different targeted or standard of care cancer agents.

XPOVIO works by blocking XPO1, a cellular protein. This protein plays a prominent role in controlling the actions of various relevant oncoproteins including tumor suppressing proteins. XPO1 is found to be overexpressed in solid tumors as well as in hematologic tumors. There have also been indications that such overexpression is directly correlated with poor overall patient survival and higher tumor grade.

XPOVIO was endorsed by the FDA under its accelerated approval pathway. The drug candidate was approved to be used in conjunction with dexamethasone for treating adult patients with relapsed refractory multiple myeloma who have given at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Karyopharm has submitted a Marketing Authorization Application with the European Medicines Agency seeking conditional approval for Selinexor for treating relapsed refractory multiple myeloma. Further, its Supplemental New Drug Application is also pending with the FDA. This application pertains to label expansion for including treatment for patients with multiple myeloma after at least one prior line of therapy. The company has used the positive data from its Phase 3 BOSTON study for backing its application.

XPOVIO is also approved by the FDA for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma. It may also be used for treating DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Selinexor is currently being assessed in various mid stage and later stage clinical trials for different cancer indications. It is under evaluation as a potential backbone therapy in combination with approved myeloma therapies for treating liposarcoma and endometrial cancer among others.

Karyopharm Therapeutics is mainly engaged in developing novel therapies directed against nuclear export and related targets for treating major diseases including cancer. XPOVIO is the lead drug candidate for the company while it also has several other investigational programs in different stages of development including clinical and pre-clinical stage. The company also plans to test the drug candidate for treating severe COVID-19 patients.

ADC Therapeutics SA (ADCT) announced initiating the dosing of patients for its pivotal Phase 2 portion of LOTIS3 clinical trial. The study has 161 patients enrolled in it and will assess the efficacy and safety of Loncastuximab Tesirine. This phase of the trial will have three cohorts which are on-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma, GCB diffuse large B-cell lymphoma and mantle cell lymphoma.

Interim data from the Phase 1 portion of the Phase 1/2 clinical trial demonstrated an overall response rate of 75.0% and complete response rate of 58.3% at the Lonca dose of 60 g/kg. Phase 2 of the trial will be conducted using this dosage. Jay Feingold of ADC Therapeutics said, We are pleased to have dosed the first patient in the pivotal Phase 2 portion of this trial as we continue advancing Lonca as both a single agent and in combination with other therapies for patients with non-Hodgkin lymphoma. The company plans to use the data for supporting the submission of its supplemental Biologics License Application to the FDA.

The earlier data for the drug candidate showed manageable toxicity profile. The most common grade adverse events in patients were thrombocytopenia and anemia. Lonca is a CD19-targeted ADC while ibrutinib is a small-molecule inhibitor of Brutons tyrosine kinase. Their combination is expected to have high potential to treat the conditions.

Loncastuximab tesirine was formerly known as ADCT-402. It is an antibody drug conjugate and consists of a humanized monoclonal antibody directed against human CD19. In LOTIS 2, the drug candidate is being evaluated for its potential to treat patients with relapsed or refractory diffuse large B-cell lymphoma. LOTIS2 is a pivotal Phase 2 clinical trial. LOTIS3 is a pivotal Phase 1/2 trial and is designed to evaluate the drug candidate in conjunction with brutinib for treating patients with relapsed or refractory DLBCL or mantle cell lymphoma.

Luminex Corporation (LMNX) announced that it has received the FDA approval for emergency use of its xMAP SARS-CoV-2 Multi-Antigen IgG assay. As per the notification by the FDA, the product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

The test works by detecting antibodies of the immunoglobulin class G (IgG), which are an important component of an adaptive immune response. The company had filed for the FDA authorization in June this year. At the time, the company CEO Nachum "Homi" Shamir had said, Our xMAP technology is ideally suited for serology testing because of its proven ability to deliver extremely high specificity and sensitivity on a high-throughput, gold-standard multiplex platform."

Luminex already has two SARS-CoV-2 diagnostic tests out in the market. These tests, Magpix and Aries, are designed to be used by high-complexity, high-throughput reference labs as well as by moderate complexity, sample-to-answer testing locations. ARIES can process up to 144 tests per day and does not require any special training for this purpose. xMAP Technology uses a bead-based multiplexing assay approach for rapid detection and quantification of multiple analytes in a single sample.

The xMAP SARS-CoV-2 Multi-Antigen IgG assay uses multiplexing for simultaneous detection of antibodies to three SARS-CoV-2 antigens. It is equipped with multiple internal controls to provide a comprehensive and reliable evaluation of the immune response.

Luminex is mainly engaged in clinical diagnostics development, genomic and biomedical research and pharmaceutical drug discovery. The company also deals with food safety and biodefense research.

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