On March 21, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported the United States Patent and Trademark Office has granted a method of use patent for CLR 124, the company’s cancer imaging agent, which utilizes Cellectar’s proprietary phospholipid drug conjugate (PDC) delivery platform (Press release, Cellectar Biosciences, MAR 21, 2017, View Source [SID1234518227]).

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The recently issued patent, #9,579,406, titled "Phospholipid Ether Analogs as Agents for Detecting and Locating Cancer and Methods Thereof," outlines the use of CLR 124 in PET imaging to detect radiation-insensitive or chemotherapy-insensitive cancers and cancer metastases. Importantly, the patent also provides coverage for the use of CLR 124 in identifying the location of these cancers or cancer metastases specifically within an organ or tissue in a patient. This patent is a continuation-in-part of a previous patent application, #10,906,687, which has resulted in three previously issued patents. The current patent provides intellectual property protection through March 2, 2025.

"This patent further demonstrates the utility of our PDC delivery platform to effectively provide cancer targeting for both therapeutic and diagnostic oncologic payloads, potentially allowing for more effective treatment, regardless of the modality," said Jim Caruso, president and CEO of Cellectar. "We remain focused on developing our therapeutic assets, specifically CLR 131, for the treatment of multiple myeloma and other hematologic malignancies. However, the potential of the platform provides significant opportunity in a variety of clinical applications."

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.

On March 21, 2017 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the Company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for Iomab-B (Press release, Actinium Pharmaceuticals, MAR 21, 2017, View Source [SID1234518226]). In its correspondence to Actinium, the EMA commented that the trial design, primary endpoint and planned statistical analysis of the U.S. pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial are acceptable and can serve as the basis for submission of a Marketing Authorization Application. In addition, the EMA commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies. The EMA requested supporting data and information that is already being collected as part of the U.S. pivotal Phase 3 SIERRA trial. The SIERRA trial is a 150 patient, randomized controlled study of Iomab-B that is currently enrolling patients in the U.S. Upon approval, Iomab-B is intended to be an induction and conditioning agent prior to a bone marrow transplant (BMT), often referred to as a hematopoietic stem cell transplant (HSCT) with an initial indication in patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above.

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"We thank the EMA for their assistance throughout the Scientific Advice process and for this helpful feedback." said Sandesh Seth, Executive Chairman of Actinium. "We are excited that the EMA finds the design, endpoints and statistical analysis of the Iomab-B SIERRA trial acceptable. Their opinion is an extremely favorable outcome as this will potentially reduce the time and cost to gain marketing authorization in the EU, which is a larger addressable market than the U.S. in terms of number of patients and transplant procedures. With orphan designation for Iomab-B in the EU and now with this positive Scientific Advice, a clear regulatory pathway, we are well positioned to maximize the value of Iomab-B by working strategically to make this potentially curative therapy available to patients in the EU in addition to our efforts in the U.S."

The EMA provides scientific advice to companies regarding the appropriate studies for the development of a medicine. The goal of scientific advice is to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefits of patients. Scientific Advice helps companies make sure they perform the appropriate tests and studies, so that no major objections regarding the design of tests are likely to be raised during the evaluation of a marketing authorization application. The EMA created this program to increase the probability of positive outcomes and to reduce the risk of objections during the evaluation of a market-authorization application. Following the EMA’s advice increases the probability of a positive outcome.

About Iomab-B

Iomab-B, Actinium’s lead product candidate, is currently being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above. The SIERRA trial is being conducted at preeminent transplant centers in the U.S. with the primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival at one year. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant in a potentially safer and more efficacious manner than intensive chemotherapy conditioning that is standard of care in bone marrow transplant conditioning currently. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, BC8, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced complete remissions in 100% of patients and these patients experienced transplant engraftment at day 28. The overall survival rate of the 36 relapsed or refractory AML patients in the proof of concept study was 30% at one year and approximately 20% at two years. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in several Phase 1 and Phase 2 trials in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM) and is currently being studied in several ongoing physician trials. Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.

On March 21, 2017 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, reported the latest results of its ongoing Phase 2 clinical trial of HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), for the treatment of non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, MAR 21, 2017, View Source [SID1234518225]). Fifteen patients have completed the HS-110/nivolumab combination treatment to-date and 12 of these 15 patients were evaluable for ELISPOT analysis. Researchers reported a strong correlation between T cell activation, tumor reductions and increased overall survival in these 12 patients. These data reinforce preliminary results seen in the first eight patients as reported last December at the International Association for the Study of Lung Cancer Annual Meeting.

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Key findings:

Immune responses to HS-110 were observed in all 5 patients that exhibited tumor reductions.

No tumor reductions were observed in patients that did not mount an immune response to HS-110.

The timing of immune responses to HS-110 corresponded to the timing of observed clinical responses, and those responses appear to be sustained.

To-date, 5 patients have been enrolled in the low tumor infiltrating lymphocytes (TIL) cohort (patients with "cold" tumors). Three of these 5 patients (60%) have experienced significant tumor reduction, which is higher than the 10% response rate of low TIL patients reported for existing data on nivolumab alone.1
Researchers reported continued indications that patients are mounting a vaccine-mediated immune response to the vaccine lysate, as well as to peptides derived from cancer-specific antigens in their peripheral blood cells via ELISPOT analysis. ELISPOT analysis is the most widely used method for monitoring cellular immune responses in humans. This suggests that the HS-110 vaccine is making a measurable contribution to the desired cancer-specific immune response.

Of the 15 patients who have completed the HS-110/nivolumab combination treatment to-date, 12 were evaluable for ELISPOT analysis. Six of the 12 evaluable patients met the criteria for a positive ELISPOT response to vaccine lysate, and 5 of these 6 patients experienced tumor reductions and increased overall survival. All 5 patients who exhibited a clinical response also saw an immune response to HS-110. Of the 6 patients who did not respond by ELISPOT analysis, 5 patients saw tumor progression and 1 patient discontinued treatment due to a non-serious adverse event.

These data suggest that the 5 tumor reductions seen thus far in the 15 evaluated patients are the result of synergistic activity between HS-110 and anti-PD-1 therapy. Researchers also reported that the safety profile continues to be favorable in the HS-110/nivolumab combination, with no evidence of additional toxicities seen as compared to existing data on nivolumab alone.

"Checkpoint inhibitors, such as nivolumab, are currently effective in treating approximately 10% of lung cancer patients with low TIL and about 20% of patients overall in the 2nd line setting," said Jeff Hutchins, Ph.D., Heat’s Chief Scientific Officer and Senior Vice President of Preclinical Development. "Our results appear to further validate the expected mechanism of action of our approach in combination with checkpoint inhibitors, with a continuing trend towards early and sustained T cell activation in the peripheral blood cells. All patients who mounted a sustained immune response to HS-110 exhibited substantial tumor reductions. We do not see any tumor reduction in patients who did not mount a response to the vaccine. Furthermore, if ELISPOT assay results continue to correlate with clinical results, the combination of HS-110 and nivolumab may become an attractive therapeutic approach for the approximately 80% of patients that do not respond well to nivolumab alone, particularly with the positive safety profile of this combination seen to-date."

1Teng et al, Cancer Research 75(11) June 1, 2015