On June 15, 2017 Immune Pharmaceuticals Inc. (NASDAQ: IMNP) (‘Immune’) reported that it has signed an agreement with Meda, a Mylan NV company (‘Mylan’) to repurchase assets relating to Ceplene, including the right to commercialize Ceplene in Europe and to register and commercialize Ceplene in certain other countries (Filing, 8-K, Immune Pharmaceuticals, JUN 21, 2017, View Source [SID1234519644]). Immune sold certain of these Ceplene-related assets to Meda AB in 2012. Immune intends, through its Immuno-Oncology subsidary, Cytovia, Inc. (‘Cytovia’) to undertake commercialization efforts in Europe, Asia and Latin America. In addition, Cytovia intends to pursue continued development of Ceplene towards potential regulatory approval in the United States.

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"We are excited to regain Ceplene’s European and Asian rights from Mylan and to transition Immune, through Cytovia, into a revenue-generating phase of the company’s evolution. This agreement is an additional step forward towards our previously stated objective of executing a plan to establish an independent oncology business through Cytovia and follows the execution of the Letter of Intent with Pint Pharma related to licensing Ceplene in Latin America and investing in Cytovia", said Dr. Daniel Teper. "Proactive maintenance treatment for Acute Myeloid Leukemia (AML) has been recognized as highly essential for relapse prevention, and we are pleased for the potentail opportunity to become a leader in the AML remission maintenance space."

The assets acquired from Mylan include rights to marketing authorizations, trademarks, patents, and other intellectual property related to Ceplene and its use. Under the terms of the acquisition agreement, Immune has agreed to pay Mylan a fixed price, which is payable in installments, as well as additional amounts contingent on the achievement of certain milestones.

The market for AML therapeutics is steadily growing due to an aging population and medical need that has been unmet due to the complexity of AML. Unfortunately, most patients with AML who are able to achieve complete remission will eventually relapse, and survival following such a relapse is poor, with rates of 33% in younger patients but only 15-20% in patients over 60 years of age. In the therapeutic management of patients with AML, remission maintenance therapy is important for the prevention of relapse and the prolongation of disease-free survival.

About Ceplene

Ceplene (histamine dihydrochloride) is administered in conjunction with low dose interleukin-2 (IL-2), for maintenance of first remission in patients with Acute Myeloid Leukemia (AML). Ceplene has been shown in clinical studies to prevent leukemic relapses in AML patients in first remission and prolong leukemia-free survival while maintaining good quality of life during treatment. Ceplene acts by enhancing the immunostimulatory effect of IL-2 and countering ROS-induced dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong pharmacological rationale for this combination therapy. A recent Phase IV study presented at the meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in 2016 confirmed the safety and efficacy of Ceplene demonstrated in the international study that supported European approval.




About Acute Myeloid Leukemia (AML)

AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis, and typically become free of detectable leukemia, achieving "complete remission." However, within 1-2 years the majority (75-80%) of adult patients will experience a relapse of leukemia, of which survival prognosis is 33% in younger patients but only 15-20% in patients over 60 years of age. According to the American Cancer Society, there will be approximately 21,380 new cases of AML and 10,590 deaths from AML in the US in 2017. The prognosis following first remission is poor and there are no other effective remission therapies currently available, AML represents an orphan indication with particularly high unmet need.

On June 21, 2017 Celyad SA (EURONEXT Brussels and Paris: CYAD – NASDAQ Global Market: CYAD), a leader in the discovery and development of CAR-T cell therapies, reported it has published a special report in the peer-reviewed journal "Future Oncology" summarizing pre-clinical work undertaken on NKR-2, the CAR-T cell therapy currently tested in the company’s THINK trial(Press release, Celyad, JUN 21, 2017, View Source [SID1234519643]).

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Celyad’s special report entitled Exploiting Natural Killer Group 2D Receptors for CAR-T cell therapy discloses new results confirming the potency of CAR-T NKR-2 cells against various human cancer cell lines in vitro including leukemia, colorectal and pancreatic cancer. Furthermore, new data show the ability of CAR-T NKR-2 cells to effectively challenge established pancreatic cancer xenografts in humanized mouse models.

These pre-clinical studies were performed with Celyad’s long-term collaborator Professor Charles Sentman and further confirm the choice of indications being investigated in the ongoing THINK trial.

Dr. David Gilham, VP of Research & Development at Celyad: "This publication provides important additional pre-clinical evidence supporting the range of cancer indications being explored in the THINK trial. This is an example of our on-going work to further define and understand the mechanisms of action of CAR-T NKR2 cells that will provide greater insight to support our developing clinical program."

Dr. Christian Homsy, CEO of Celyad: "We are pleased to provide further pre-clinical evidence validating our approach in the THINK trial, in which we aim to demonstrate the potential of CAR-T NKR-2 cells as a disruptive technology in the treatment of cancer."

Celyad’s special report is available on Future Oncology’s website:
View Source

On June 21, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported the discovery of a metabolic inhibitor with the potential to treat pancreatic cancer (Press release, Moleculin, JUN 21, 2017, View Source [SID1234519641]).

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"We’ve received a lot of attention from the scientific community for our glucose decoy technology (WP1122 Portfolio, Moleculin Presents Preclinical Data of Novel Inhibitor of Glycolysis at 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, December 13, 2016) as a potential means to starve tumors to death by exploiting their hyper-dependence on glycolysis for energy production," commented Walter Klemp, Chairman and CEO of Moleculin, "and now we have identified possible new properties of our compound WP1234, a modification to WP1122. In pre-clinical testing, WP1234 has shown improved drug characteristics when compared with WP1122 and a 20 to 50-fold greater ability to kill pancreatic cancer cell lines when compared with traditional inhibitors of glycolysis. We know that pancreatic cancer thrives even in a reduced oxygen environment, which indicates it may be highly dependent on glycolysis to survive. This discovery now makes WP1234 a promising drug candidate to be studied for the treatment of pancreatic cancer."

Mr. Klemp continued: "Pancreatic cancer is still considered largely untreatable, so even modest gains in treating this disease could represent a significant clinical benefit. WP1234 improves on known inhibitors for glycolysis by increasing drug circulation time, which should increase the potential for drug uptake by and destruction of tumor cells. We are excited about the potential to pursue development opportunities with WP1234 for the treatment of pancreatic cancer. We are also pleased to report that this discovery was the direct result of our ongoing collaboration with M.D. Anderson Cancer Center and the science team there will be presenting detailed findings to the scientific community in the near future."