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Expanded medication assistance program increases access to cancer medications

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.

NAVROGEN AND LEVENA ANNOUNCE COLLABORATION TO DEVELOP ANTIBODY DRUG CONJUGATES TO TREAT HUMORAL IMMUNO-SUPPRESSED CANCERS

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.

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."

GlycoMimetics Advances GMI-1359 Program With Patent Issuance and FDA Designations

On February 4, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported several achievements for its GMI-1359 development program, including the issuance of a new patent and key designations granted by the U.S. Food and Drug Administration (FDA) that may provide future development support and marketing protections (Press release, GlycoMimetics, FEB 4, 2020, View Source [SID1234553827]). GMI-1359 is the Company’s novel drug candidate designed to simultaneously inhibit both E-selectin and CXCR4, two adhesion molecules involved in tumor trafficking and metastatic spread. Duke University investigators recently dosed the first patient in a proof-of-concept Phase 1b study to evaluate GMI-1359 drug candidate in patients with advanced breast cancer with bone metastases.

New Patent

GlycoMimetics today said that the United States Patent and Trademark Office has issued a patent for GMI-1359, covering composition of matter as well as pharmaceutical formulations, and will provide protection through 2035, excluding any patent term adjustments or extensions.

"The new patent for GMI-1359 will help protect the composition of matter of this innovative approach in oncology. GMI-1359 may have a role in treating rare pediatric cancers, such as osteosarcoma, as well as breast cancer and other solid tumors that metastasize to bone," stated Rachel King, Chief Executive Officer of GlycoMimetics. "This intellectual property, as well as that previously granted in Europe, will play a key role as the company advances the drug candidate, especially with the new orphan and rare pediatric disease designations granted by the FDA."

New FDA Designations

In parallel, GlycoMimetics reported that the FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to GMI-1359 for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States. These designations will aid in the development of this drug candidate, including making it eligible for the FDA’s Pediatric Priority Review Voucher.

"It’s encouraging for us as well as for patients and providers that the FDA recognizes the urgent need for new, more effective treatments for this devastating pediatric disease," stated Ms. King.

In addition to its clinical work in breast cancer, GlycoMimetics has conducted preclinical studies that have demonstrated strong support for the potential use of GMI-1359 in osteosarcoma. At the 2018 American Association of Cancer Research Annual Meeting, GlycoMimetics presented data establishing the biologic rationale for the use of a dual e-selectin/CXCR-4 inhibitor in pediatric and young adult patients with osteosarcoma. In that study, GMI-1359 was shown to inhibit tumor progression in an orthopedic model of osteosarcoma as well as inhibit the development of pulmonary metastases from primary osteosarcoma lesions. (View Source)

About Orphan Drug Designation

The FDA Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Among the benefits of orphan designation in the U.S. are seven years of market exclusivity following FDA approval, waiver or partial payment of application fees, and tax credits for clinical testing expenses conducted after orphan designation is received.

About Rare Pediatric Disease Designation

The FDA defines a "rare pediatric disease" as a serious or life-threatening rare disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years. Under the FDA’sRare Pediatric Disease Priority Review Voucher program, a sponsor who receives an initial approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.

About Osteosarcoma

Osteosarcoma is a rare cancer of the bone that usually affects the large bones of the arm or leg, often growing quickly and spreading to other parts of the body. It occurs most often in children and young adults between the ages of 10 and 30. Each year, about 800 to 900 new cases of osteosarcoma are diagnosed in the United States. For more information, please see the osteosarcoma fact sheets at the National Cancer Institute and the American Cancer Society.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as acute myeloid leukemia and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The newly initiated Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity.

A new publication by Prof. Francesco Bertoni LAB

On February 4, 2020 The lOR Institute of Oncology Research reported Antibody-drug conjugates (ADCs) are an effective therapeutic modality to deliver potent cytotoxic molecules to tumor cells bearing a specific antigen (Press release, The lOR Institute of Oncology Research, FEB 4, 2020, View Source [SID1234553826]). Following their previous work on the anti-CD19 ADCs huB4-DGN462 and coltuximab ravtansine (SAR3419) (PMID 30733273), the research team led by Prof. Francesco Bertoni has now characterized the novel ADC MEN1309/OBT076 targeting CD205 for its anti- lymphoma activity.

The work done by Dr Eugenio Gaudio, Dr Chiara Tarantelli and Colleagues, now published in the journal Haematologica, have provided the rationale to explore the compound in patients with relapsed or refractory CD205-positive lymphoma in the on-going phase I study (NCT03403725).

Targeting CD205 with the antibody drug conjugate MEN1309/OBT076 is an active new therapeutic strategy in lymphoma models

by Eugenio Gaudio*, Chiara Tarantelli*, Filippo Spriano, Francesca Guidetti, Giulio Sartori, Roberta Bordone, Alberto J. Arribas, Luciano Cascione, Mario Bigioni, Giuseppe Merlino, Alessio Fiascarelli, Alessandro Bressan, Afua Adjeiwaa Mensah, Gaetanina Golino, Renzo Lucchini, Elena Bernasconi, Davide Rossi, Emanuele Zucca, Georg Stussi, Anastasios Stathis, Robert S. Boyd, Rachel L. Dusek, Arnima Bisht, Nickolas Attanasio, Christian Rohlff, Andrea Pellacani, Monica Binaschi, and Francesco Bertoni

Clinical Cancer Research highlights OncoSec’s Merkel Cell Carcinoma Clinical Study on the Cover of its February Issue

On February 4, 2020 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported the publication of data showing that TAVO (plasmid-based interleukin-12) treatment, administered through OncoSec’s electroporation gene delivery system, resulted in regression of injected and non-injected Merkel cell carcinoma (MCC) tumors (Press release, OncoSec Medical, FEB 4, 2020, View Source [SID1234553808]). The study, a pilot with fifteen patients, is featured on the cover of the February issue of Clinical Cancer Research (print edition available here).

The study showed that all patients successfully received at least one treatment cycle of TAVO via electroporation, OncoSec’s lead product candidate, without significant systemic toxicity and with only transient, mild grade adverse events. Sustained intratumoral expression of IL-12 protein was observed, along with increased tumor-specific CD8+ T cell infiltration, as well as systemic immunologic and clinical responses. In the first cohort (A, n=3), two of three patients were recurrence-free at 44+ and 75+ months, respectively, and one of these patients experienced pathologic complete remission. In the second cohort (B, n=12), overall response rate was 25 percent, with two patients experiencing durable clinical benefit (16 and 55+ months, respectively).

"Achieving the cover study in Clinical Cancer Research is an important milestone, as it further validates the use of TAVO via electroporation as a meaningful immunotherapeutic agent in this cancer setting," stated Christopher G. Twitty, Ph.D., Chief Scientific Officer of OncoSec. "We believe this study reinforces the broad potential to treat multiple types of cancer using TAVO with our proprietary electroporation gene delivery system. We look forward to building on these studies and further investigating TAVO for the immunotherapy of cancer."