On February 4, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported the initiation of an expanded access program (EAP) in the U.S. for tafasitamab, an investigational anti-CD19 antibody (Press release, MorphoSys, FEB 4, 2020, View Source [SID1234553831]). The EAP may provide access to tafasitamab for use in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) in combination with lenalidomide. Tafasitamab is an investigational medicine and its safety and efficacy have not been established.

According to the FDA, expanded access programs – sometimes called "compassionate use" – provide a pathway for a patient to receive an investigational medicine for a serious disease or condition. They are often made available when there are no comparable or satisfactory alternative therapies to treat the disease or condition; patient enrollment in clinical trials is not possible; potential patient benefit justifies the potential risk of treatment and providing the investigational medicine will not interfere with investigational trials that could support the medicine’s marketing approval for the treatment indication.

To qualify for the tafasitamab EAP, patients with r/r DLBCL need to meet the EAP inclusion/exclusion criteria that are aligned with the MorphoSys’ L-MIND study. Treatment of DLBCL patients in the EAP is recommended with tafasitamab in combination with lenalidomide according to the treatment schedule in L-MIND. The EAP will be available for a limited time while the FDA reviews MorphoSys’ Biologics License Application (BLA) for tafasitamab. Requests for expanded access to tafasitamab must be made by a U.S. licensed, treating physician.

The tafasitamab EAP will be administered by Clinigen Healthcare Ltd. Questions or inquiries regarding the tafasitamab EAP should be directed to [email protected].

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About Tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. MorphoSys is clinically investigating tafasitamab as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population.

On February 4, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported the launch of an Expanded Access Program (EAP) in the USA for tafasitamab, an anti-CD19 antibody currently under development (Press release, MorphoSys, FEB 4, 2020, View Source [SID1234553831]). Under certain conditions, patients with relapsed or refractory diffuse large B-cell lymphoma (r / r DLBCL) can have access to tafasitamab in combination with lenalidomide via the EAP. Tafasitamab is an active ingredient in development (investigational product), the safety and efficacy of which have not been established.

According to the FDA, programs for expanded access , sometimes referred to as "compassionate use", offer patients an opportunity to gain access to an investigational medication for the treatment of a serious illness. They are often provided when there are no comparable or satisfactory alternative therapies to treat the disease, when the patient cannot be enrolled in a clinical trial, when the potential benefit to the patient justifies the potential treatment risk, and when it is made available of the investigational medicinal product does not affect studies that could support the marketing authorization of the drug for the corresponding treatment indication.

To be eligible for the Tafasitamab EAP, r / r DLBCL patients must meet the EAP inclusion / exclusion criteria that correspond to those in the MorphoSys L-MIND study. Treatment of DLBCL patients under the EAP is recommended with tamasitamab in combination with lenalidomide according to the L-MIND treatment plan. The EAP will be available for a limited time while the FDA is reviewing MorphoSys’s application for a Biologics License Application (BLA) for Tamasitamab. Applications for inclusion in the Tafasitamab EAP must be made by a medical doctor approved in the United States.

The Tafasitamab EAP is from Clinigen Healthcare Ltd. managed. Questions or inquiries regarding the Tafasitamab EAP should be directed to [email protected] .

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About tafasitamab
Tafasitamab is a humanized Fc-modified monoclonal antibody against CD19. In 2010, MorphoSys licensed Xencor, Inc.’s worldwide development and marketing rights for tafasitamab. Tafasitamab has an Fc part modified with the XmAb (R) technology, which is said to lead to a significant increase in antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), and thus to improve a key mechanism of tumor cell killing. MorphoSys is investigating tafasitamab as a therapeutic option for malignant B-cell disorders in a number of ongoing combination studies. An open phase 2 combination study (L-MIND study) examined the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed / refractory DLBCL who were not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) Question come. Based on preliminary data from L-MIND, the FDA granted therapeutic breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017.

On February 4, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that clinical translational data supporting the mechanism of action of its lead compound, DPX-Survivac, will be presented during the 2020 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, being held on February 6 – 8, 2020 in Orlando, FL (Press release, IMV, FEB 4, 2020, View Source [SID1234553830]).

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"These translational data continue to validate the mechanism of action of our lead program in advanced ovarian cancer," said Frederic Ors, President and Chief Executive Officer at IMV. "We continue to believe DPX-Survivac may offer significant clinical utility and a potentially meaningful treatment option for patients in this setting, as well as in other hard-to-treat indications in which survivin is highly expressed. We look forward to reporting topline results from our Phase 1b/2 study evaluating DPX-Survivac in advanced ovarian cancer, in the first quarter of 2020."

As part of this analysis, the Company measured systemic immune responses, tumor immune infiltrates and clinical tumor response from pre- and post-treatment patient samples in connection with three Phase 1 and/or Phase 2 clinical studies, each evaluating DPX-Survivac alone or in a combination regimen in patients with platinum sensitive or resistant, advanced ovarian cancer. Highlights from these translational data include:

DPX-Survivac generated survivin-specific T cells in the blood of 80% of patients sampled

Clinical anti-tumor responses were correlated with increased infiltration of T cells into tumors following treatment with DPX-Survivac

DPX-Survivac induced enrichment in T cell, cytotoxic lymphocytes and B cell-specific signatures which correlate with clinical response

Antigen-specific T cells retained their functionality throughout the duration of treatment

DPX-Survivac is currently being evaluated in three Phase 2 studies in advanced ovarian cancer, relapsed/refractory diffuse large B-cell lymphoma and a basket trial of five solid tumors, all of which are expected to report topline results in the first half of 2020.

Poster Presentation Details:

Poster Title: DPX-Survivac, a novel T cell immunotherapy, induces robust T cell responses in advanced ovarian cancer with significant anti-tumor efficacy Presenter: Oliver Dorigo, M.D., Ph.D., Associate Professor of Obstetrics and Gynecology (Oncology), Stanford University Medical Center

Abstract Number: 6 – Poster Session A

Date and Time: Poster will be displayed all day on February 6, 2020

ASCO-SITC has published the official abstracts on its meeting website in advance of the Clinical Immuno-Oncology Symposium on February 3rd, 2020 at 5:00PM EST.

The final conference poster presentation will include additional data collected between the abstract submission on October 15, 2019 and the presentation itself. The poster will be available under Events, Webcasts and Presentations in the investors section of IMV’s website on the day of presentation.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of targeted immunotherapies designed to elicit antigen-specific functional, robust and sustained de novo T cell response. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of five unique HLA-restricted survivin peptides formulated in IMV’s proprietary DPX drug delivery platform and known to induce a cytotoxic CD8+ T cell response against survivin expressing cancer cells.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

On January 4, 2020 The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) reported that it has helped more than 30,000 patients gain access to vital medications valued at more than $500 million, and a new program expansion will further increase access to vital cancer therapies for patients with the greatest financial need (Press release, The Ohio State University, FEB 4, 2020, View Source [SID1234553829]).

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"Financial toxicity is a very real concern for families facing a cancer diagnosis. As an institution, we want to do all that we can to reduce additional stressors for patients so they can focus on getting well," explains Julie Kennerly-Shah, PharmD, a pharmacist and associate director of pharmacy at the OSUCCC – James. "Our financial counselors work with patients so they don’t have to make decisions about whether they can afford potentially life-saving treatment."

In February 2019 the pharmacy assistance program expanded with the implementation of a drug repository program that allows patients to donate no-longer-needed oral cancer therapy drugs for the benefit of other cancer patients through new state rules spearheaded by the State of Ohio Board of Pharmacy and OSUCCC – James.

"In cancer, it is quite common for patients to switch to a new medication or experience a medication dose reduction. As a result, we end up with a lot of wasted medication that must be disposed of," explains Kennerly-Shah. "This new program allows patients to donate these unneeded medications for re-dispensing to patients in financial need through our existing hospital-based Medical Assistance Program."

New rules adopted in November 2019 by the State of Ohio Board of Pharmacy states donated medications must be within expiration dates, stored as prescribed and otherwise untampered with. Pharmacists will then go through an eight-point inspection of the drug to ensure that it is safe to re-dispense at a future date to patients in need. Previous rules allowed only for the collection of unopened medication that was dispensed for the prescribed patient but never picked up.

The cancer drug repository initiative is a new component of the overall Medical Assistance Program (MAP) at the OSUCCC – James. The MAP consult service was established to help patients who are unable to afford their medications due to financial hardship. The program consists of pharmacists, medical assistance program coordinators, clinical financial case managers and other support personnel who work one-on-one with patients to reduce healthcare costs associated with cancer treatment.

"Ohio State has been a leader in medication-assistance programs and has taught many people across the country how to optimize various manufacturer programs and grant programming. We want to be an asset to other hospitals considering implementation of a cancer drug repository as well," adds Kennerly-Shah. "Our hope is that our repository is a first step toward a much bigger solution long-term that could be modeled beyond our individual hospital and state."

The OSUCCC – James is the first hospital in Ohio, and among the first in the United States, to launch a cancer drug repository program. The new cancer drug repository program is housed at the OSUCCC – James Outpatient Pharmacy. The program will accept donations of unused medications from individual patients, pharmacies, hospitals and non-profit clinics to be re-dispensed to patients in treatment at the OSUCCC – James who cannot afford the cost of the medications. Patients interested in donating non-expired, no-longer-needed capecitabine or temozolomide should contact the OSUCCC – James Outpatient Pharmacy.

On February 4, 2020 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, and Levena Biopharma, a company specialized in developing antibody drug conjugates (ADCs), reported the expanded collaboration to develop ADCs targeting humoral immuno-suppressed cancers (Press release, Navrogen, FEB 4, 2020, View Source [SID1234553828]). ADCs developed under this collaboration combine Levena’s linker and cytotoxic payload chemistry expertise along with Navrogen’s cancer-targeting antibodies discovered using its proprietary Humoral Immuno Oncology (HIO) platform technologies.

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Navrogen’s antibodies are able to specifically target and combat HIO-suppressed cancers that produce factors that dampen antibody-mediated immune-effector activity as well as decrease ADC internalization and subsequent release of their cytotoxic payloads which is required for killing. This collaboration will also include the use of Levena’s process development and GMP capabilities.

"Our collaboration with the exceptional scientists at Levena has enabled us to create a number of ADCs to specifically treat HIO-suppressed cancers," stated Luigi Grasso, Ph.D., Chief Scientific Officer at Navrogen. "The expansion of this collaboration will enable us to proceed with their advancement towards clinical trials."

Tong Zhu, Ph.D., Executive Director, Chemistry at Levena commented, "we have employed several of our technologies with the Navrogen team over the past year to identify HIO-refractory ADC formats. We look forward to continue supporting their development plans that can benefit from our expertise and technologies."