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 Boston-based cancer company Partner Therapeutics, Inc. (PTx) reported that it has acquired the global rights to develop, manufacture, and commercialize Leukine (sargramostim) from Sanofi (Press release, Partner Therapeutics, FEB 1, 2018, View Source [SID1234610372]). Leukine is an immuno-stimulant that promotes the growth and activation of a broad range of white blood cells important in activating the body’s immune response to fight infections. Leukine is used to treat or prevent severe and life-threatening infections and is the only immune modulator approved by the FDA for the treatment of acute myelogenous leukemia (AML) in older patients and for use in both allogeneic and autologous bone marrow transplantation.

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In connection with the acquisition of Leukine, PTx will also acquire a dedicated manufacturing facility in Lynnwood, Washington. The facility is a state of the art biologics manufacturing plant that was certified for commercial production in 2012. The Lynnwood facility will serve as the core manufacturing and supply chain center for PTx’s operations.

Leukine is the only FDA-approved recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF). It has been demonstrated to promote growth and activation of monocytes, macrophages, neutrophils and dendritic cells. It is currently indicated for the treatment of AML in older adults to reduce the incidence of severe and life-threatening infections resulting in death; use in the treatment of allogeneic bone marrow transplants to reduce the incidence of bacteremia and other culture positive infections and shorten the median duration of hospitalization; and to prolong the survival of patients who are experiencing bone marrow transplant failure or delay.

PTx will support the development of Leukine for new indications. The product is being tested in a diverse set of clinical trials for its potential to improve survival and reduce adverse events in combination with leading immuno-oncology therapies. A 250 patient, randomized Phase II study in refractory melanoma in combination with ipilimumab demonstrated an improvement in survival (hazard ratio of 0.64) over ipilimumab alone1. Leukine is currently being tested in a Phase III trial in front-line melanoma in combination with ipilimumab and nivolumab, being conducted by the ECOG-ACRIN Cancer Research Group (Principal Investigator: F Stephen Hodi, MD, Director of the Center for Immuno-Oncology at Dana-Farber Cancer Institute) and sponsored by the National Cancer Institute (ClinicalTrials.gov Identifier: NCT02339571).

Leukine is also in development for the treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS). Data presented at the 2016 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), demonstrated Leukine’s ability to increase survival in non-human primates exposed to myelosuppressive doses of radiation without supportive whole blood transfusions or individualized antibiotics2. A supplemental biologics licensing application (sBLA) was filed in September of 2017 with the FDA requesting approval of Leukine for the treatment of H-ARS. In December, the application was granted Priority Review with a PDUFA date of March 29, 2018.

"We are delighted to have the opportunity to build a new future for Leukine and welcome the talented and dedicated team in Lynnwood to the PTx family", said Robert Mulroy, CEO of PTx. "The acquisition of Leukine provides us with an established commercial business, a product that has demonstrated a clear and substantial impact on outcomes, and a program with the potential to become a core component of immuno-oncology, the treatment of acute radiation syndrome and the treatment of infections."

"In contrast to other approved growth factors that stimulate one cell type, Leukine’s ability to stimulate a broader variety of cells, endows it with unique clinical potential to address serious medical needs across hematologic diseases and cancer as well as infectious, neurological and pulmonary disorders," said Dr. Debasish Roychowdhury, Chief Medical Officer. "We are excited to have the opportunity to work with investigators and healthcare professionals to explore new indications that can take advantage of Leukine’s unique biological and immuno-stimulatory attributes and clinical properties."

PTx plans to provide commercial and medical support of Leukine in the United States and explore commercialization opportunities outside the U.S.

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.