On February 2, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that on February 1, 2018 in PST Amgen Inc. made an announcement regarding the top-line results from its Global Phase 3 D-CARE trial in which Daiichi Sankyo also participated (Press release, Daiichi Sankyo, FEB 1, 2018, View Source [SID1234523682]). Amgen Inc.’s D-CARE, placebo-controlled trial, evaluated AMG162 (generic name: denosumab) as adjuvant treatment for women with high-risk, early stage breast cancer receiving standard of care neoadjuvant or adjuvant cancer therapy.

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The trial did not meet its primary endpoint of bone metastasis-free survival. Adverse events observed in patients treated with denosumab were generally consistent with the known safety profile.

Detailed results will be submitted to a future medical conference or publication.

Daiichi Sankyo continues to contribute the field of medicine to patients and medical professionals.

About denosumab

Daiichi Sankyo licensed the rights to develop and market denosumab in Japan from Amgen Inc. (United States) in 2007, and began the Japanese sales of a 60 mg preparation as a therapeutic agent for osteoporosis under the product name PRALIA Subcutaneous Injection 60 mg Syringe in June 2013. PRALIA received approval for additional indication as a treatment for inhibition of the progression of bone erosion associated with rheumatoid arthritis in July 2017. In April 2012, Daiichi Sankyo began sales of a 120 mg preparation as a therapeutic agent for bone complications stemming from multiple myeloma and bone metastases from solid tumors under the product name RANMARK Subcutaneous Injection 120 mg. RANMARK received approval for additional indication as a treatment for giant cell tumor of bone in May 2014.

About the D-CARE Study

The D-CARE (Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence) study is an international, randomized, double-blind placebo-controlled trial of denosumab as adjuvant treatment for 4,509 women with early-stage breast cancer at high-risk of recurrence receiving standard of care neoadjuvant or adjuvant therapy. In this five year landmark study, patients were randomized to receive either subcutaneous denosumab 120mg or placebo every 3 or 4 weeks (Q3W or Q4W) for six months, followed by subcutaneous denosumab 120mg or placebo every three months for four and a half years, for a total treatment duration of five years (approximately 60 months). The primary endpoint for the study was bone metastasis-free survival and secondary endpoints included disease-free survival (DFS), DFS in the subset of post-menopausal women, overall survival and distant recurrence-free survival. Safety and tolerability were also evaluated.

On February 1, 2018 Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, reported receipt of two patent application allowances relating to its lead compound trans sodium crocetinate ("TSC") in the U.S (Press release, Diffusion Pharmaceuticals, FEB 1, 2018, View Source [SID1234523684]). The allowances include claims for both method of use and composition of matter.

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U.S. patent application number 14/993,047 includes claims relating to treating a number of cancers including brain cancers such as glioblastoma, and cancer of the pancreas, using bipolar trans carotenoids, including TSC, along with chemotherapy and radiation therapy.

U.S. patent application number 14/642,703, includes claims relating to novel compositions of bipolar trans carotenoids, including TSC, for oral delivery.

"We have worked hard to ensure our discoveries are protected and are grateful to receive these patent application allowances. We look forward to these patents being issued in the coming months," said David Kalergis, Chief Executive Officer of Diffusion Pharmaceuticals. "We believe strong intellectual property protections are vital to Diffusion’s ability to compete in the marketplace and to attract potential strategic partners. As we progress our pivotal Phase 3 study in inoperable glioblastoma patients who are administered TSC along with their standard therapies, we feel that it is imperative that our proprietary position be protected to add increased value to the Company."

On February 1, 2018 Planegg – Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immune-oncology company focusing on the development of T cell immuno-therapies for the treatment of cancer, reported the grant of US patent 9,862,755 by the US Patent Office (USPTO) covering a high affinity T cell receptor with an epitope tag (Press release, MediGene, FEB 1, 2018, View Source [SID1234523689]).

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Applying an epitope tag to a high affinity T cell receptor potentially allows ex vivo and in vitro assessment of adoptively transferred T cell therapeutics. Potential applications of this technology could include the tracking of TCR-modified T cells through all steps of patient-individualized cell manufacturing processes, monitoring of TCR-modified T cells after administration to patients for proliferation and persistence in blood and tissue samples and removing of such tagged T cells through antibodies.
Medigene holds an exclusive license to the patent that was issued to Helmholtz Zentrum Munich and Max-Delbrück-Centrum for Molecular Medicine in Berlin.

Prof. Dolores Schendel, CEO and CSO of Medigene and co-inventor of the underlying technology, explains: "This US patent complements our broad patent portfolio in the space of T cell immunotherapies and represents one of many examples of the kinds of precise tools that Medigene is developing. This patent also supports our long-term thinking on using T cell-specific antibodies, TABs, as designer tools with multiple potential uses. TABs will help us to develop better and safer products in the future."

About Medigene’s TCR technology: The TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient’s T cells outside the body (ex vivo).
Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.

On February 1, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that it will report financial results for the fourth quarter and year ending December 31, 2017 on Thursday, February 8, 2018, before the U.S. financial markets open (Press release, Alnylam, FEB 1, 2018, http://investors.alnylam.com/news-releases/news-release-details/alnylam-webcast-conference-call-discussing-fourth-quarter-and-9 [SID1234523699]).

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Management will provide an update on the Company and discuss fourth quarter and year-end 2017 results as well as expectations for the future via conference call on Thursday, February 8, 2018 at 8:30 am ET. To access the call, please dial 877-312-7507 (domestic) or 631-813-4828 (international) five minutes prior to the start time and refer to conference ID 9496435. A replay of the call will be available beginning at 11:30 am ET on the day of the call. To access the replay, please dial 855-859-2056 (domestic) or 404-537-3406 (international) and refer to conference ID 9496435.

A live audio webcast of the call will be available on the Investors section of the Company’s website, www.alnylam.com. An archived webcast will be available on the Alnylam website approximately two hours after the event.

On February 1, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported additional preliminary patient data from two separate clinical studies of its lead NK cell engager candidate AFM13 (Press release, Affimed, FEB 1, 2018, View Source [SID1234523696]). The data demonstrate that AFM13 was well-tolerated and showed promising therapeutic efficacy both in combination with the anti-PD-1 antibody Keytruda (pembrolizumab) in Hodgkin lymphoma (HL) and as monotherapy in CD30-positive lymphoma.

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"We are extremely encouraged by these new data which indicate that the first-in-class NK cell engager AFM13 has achieved clinically meaningful responses both as single agent and in combination with a checkpoint inhibitor" said Dr. Adi Hoess, CEO of Affimed. "In particular, in our combination trial with Keytruda, we are excited to have increased both overall and complete metabolic response rates."

AFM13 in combination with Keytruda in relapsed/refractory HL

Best response preliminary assessment data from 9 patients treated at the highest AFM13 dose level (7 mg/kg) as reported by central read, showed an objective response rate (ORR) of 89% (8/9), including complete metabolic responses (CmR) in 44% (4/9) and partial metabolic responses

(PmRs) in 44% (4/9) of patients. One patient experienced stable disease (SD). This ORR of 89% compared favorably to the historical ORR of Keytruda (58-63%) as monotherapy in a similar patient population. Namely, these patients were R/R HL and post autologous stem cell transplantation (ASCT) or ineligible for ASCT and had failed brentuximab vedotin (BV). Importantly, the reported CR rate of 44% represents a doubled CR rate compared to previously reported anti-PD1 studies (9-22%).

The combination was well-tolerated with most of the adverse events observed mild to moderate in nature and manageable with standard of care.

The data shown here comprise six previously reported patients, including one patient evaluated as a PmR at the three-month assessment and who was converted into CmR at the six-month assessment, as well as three additional patients. In total, the extension cohort includes 21 patients and enrollment has recently been completed.

AFM13 as monotherapy in relapsed/refractory CD30-positive cutaneous lymphoma

In an ongoing investigator-sponsored Phase 1b/2a trial of AFM13 in CD30-positive lymphoma with cutaneous manifestation led by Columbia University Medical Center, an analysis of the first dose cohort (3 patients dosed at 1.5 mg/kg) has been completed. The data demonstrated that AFM13 could be safely administered and showed therapeutic activity as a single agent, with an ORR of 66% (2/3). In detail, one complete response (CR), one partial response (PR) and one stable disease (SD) were observed, as determined by global response score (GRS).

"AFM13 is a truly novel immuno-therapeutic that recruits NK cells and targets CD30-expressing lymphomas. Our early clinical experience has been impressive", said Dr. Ahmed Sawas, Assistant Professor of Medicine at the Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital and Principal Investigator of the study. "The treatment was well-tolerated and, importantly, it could provide a new treatment for relapsed/refractory CD30-positive lymphoma patients, who currently have limited to no options."

The data shown here comprise one previously reported patient as well as two additional patients. In total, the trial includes three cohorts of three patients each and enrollment is currently ongoing into the third dose cohort.

These data further highlight the clinical utility of NK cell engagement in CD30-positive lymphoma, an indication with high unmet medical need, providing an opportunity for AFM13 beyond classical HL.

About AFM13

AFM13 is a first-in-class tetravalent, bispecific NK cell engager that specifically binds to CD30 on tumor cells and to CD16A on NK cells. AFM13 is being developed in Hodgkin lymphoma (HL) and in other CD30-positive lymphomas. AFM13 has shown a favorable safety profile and signs of therapeutic efficacy in a monotherapy setting in studies in HL and CD30+ lymphoma with cutaneous manifestation. In addition, data from a combination study of AFM13 with Merck’s anti-PD1 antibody Keytruda (pembrolizumab) supports proof of principle for the combination of NK cell engagement with checkpoint inhibition.

About Affimed’s Phase 1b study of AFM13 in combination with Keytruda (pembrolizumab) (NCT02665650)

Ongoing Phase 1b study to evaluate the safety and tolerability of the combination of the Affimed’s lead product candidate AFM13 with pembrolizumab (Keytruda) as salvage therapy after failure of standard therapies including brentuximab vedotin (BV) in relapsed or refractory (R/R) Hodgkin lymphoma (HL). Patients received escalating doses of AFM13 in combination with pembrolizumab at a flat dose of 200 mg administered every 3 weeks following the classical 3+3 design. Recruitment has been completed into an extension cohort at the highest dose level explored during dose escalation. Response assessment is performed every 12 weeks by PET/CT according to the Lugano Classification Revised Staging System for malignant lymphoma.

About Columbia University’s Phase 1b/2a study of AFM13 in CD30-positive lymphoma (NCT03192202)

Ongoing investigator-sponsored translational Phase 1b/2a study of Affimed’s lead product candidate AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by the Columbia University Medical Center. Primary objective of this study is to investigate the biologic and immunologic effects induced by the administration of various doses of AFM13, when given as a single agent in a broad spectrum of CD30-positive lymphomas with cutaneous presentation. The study is designed to allow for serial biopsies, thereby enabling assessment of NK cell biology and tumor cell killing within the tumor microenvironment.