On January 24, 2017 Actinium Pharmaceuticals, Inc. (NYSE:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, reported that recently appointed Chief Medical Officer, Dr. Mark Berger, has been selected to present at the 3rd Annual Think Tank on Integrating New Molecular Targets in Acute Leukemias and Myeloproliferative Neoplasms being held on January 27 – 28, 2017 in Dallas, Texas (Press release, Actinium Pharmaceuticals, JAN 24, 2017, View Source [SID1234517547]). This event is being sponsored by Dava Oncology as part of their Oncology Meeting Innovations program. Dr. Berger’s talk will focus on Actinium’s Iomab-B, which is currently in a pivotal Phase 3 clinical trial and upon approval is intended to simultaneously prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant.

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"I am looking forward to highlighting Iomab-B to the highly experienced group of physicians that will be attending this event," said Dr. Berger. "Iomab-B has the potential to revolutionize the way we transplant patients with acute leukemia, particularly amongst the most difficult to treat older patients with relapsed or refractory acute leukemia. I believe the attending hematologists and transplant physicians will come away from this event with great enthusiasm for Iomab-B."

About Iomab-B

Iomab-B is Actinium’s lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a hematopoietic stem cell transplant, also referred to as a bone marrow transplant, which 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 (MDA) age 50 and older, Iomab-B produced complete remissions in 100% of patients and patients experienced transplant engraftment at day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied 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). 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 January 24, 2017 Cue Biopharma, Inc., an immunotherapy company developing biologics engineered to selectively modulate disease-relevant T cell subsets to treat cancer and autoimmune disease, reported a total of $26 million of invested private capital, led by MDB Capital Group (Press release, Cue Biopharma, JAN 24, 2017, View Source [SID1234521075]). Guided by an experienced management team and preeminent board members and scientific advisors, Cue Biopharma will use the proceeds to accelerate development of its novel platform of T cell receptor (TCR) targeted biologics to control immune responses in patients. The Company was founded in 2015 with $10 million of seed funding, followed by a $16.4 million follow-on financing.

"It has become increasingly clear that more effective and less toxic approaches to immune modulation are needed via precise communication with and control of T cells," said Daniel Passeri, M.Sc., J.D., President and Chief Executive Officer of Cue Biopharma. "With our platform, we have demonstrated selectivity for and modulation of disease-relevant T cells. Our lead candidate has exhibited significant potential in preclinical cancer models and has shown impressive synergy when combined with checkpoint inhibitors. Our approach to modulating the immune system to treat disease could have great clinical benefit for patients, while reducing collateral toxicities often seen with less selective immunotherapies."

"Our biologics are engineered to engage and modulate specific disease-relevant subpopulations of T cells within a patient’s body, without activating T cells with similar signaling receptors, that are not relevant to the disease," said Steven Almo, Ph.D., Chair of the Department of Biochemistry at Albert Einstein College of Medicine, scientific founder of Cue Biopharma and Chairman of its Scientific and Clinical Advisory Board. "The company has made impressive progress and I look forward to working closely with the Company as it brings its drug candidates into the clinic and advances its growing pipeline."

The Cue Biopharma platform was developed in Dr. Almo’s laboratory at the Albert Einstein College of Medicine as part of a five-year, Specialized Center grant from the National Institutes of Health (NIH). This funding enabled the technology to be built into an industry-scale drug design platform capable of rapid and efficient molecular prototyping and development. The Company is leveraging these design capabilities in its discovery efforts.

Immune Responses, On Cue
Cue Biopharma has developed a highly productive platform for designing biologic drugs that generate tailored immune responses from disease-relevant T cell populations by emulating the signals, or cues, delivered by the body’s antigen presenting cells. This approach has the potential to be highly effective both as a monotherapy and also in combination with checkpoint inhibitors, while simultaneously avoiding the toxicity limitations experienced when non-specific T cell activation is involved.

The Company’s biologics are being designed to achieve a high level of specificity through the fusion of engineered T cell costimulatory signaling molecules (ligands) with a T cell receptor targeting complex (peptide-MHC) on a traditional antibody scaffold. The peptide interacts with disease-relevant T cells and the biologic delivers one of the Company’s engineered signaling ligands, thereby enabling exclusive modulation of the T cell population of interest. The Company’s biologics are expected to be capable of eliciting targeted T cell stimulation and expansion in the context of oncology or T cell downregulation in the context of autoimmune disease. The peptides capable of selectively targeting T cell subsets are interchangeable on the construct, allowing for rapid extension to different indications simply by changing the specific peptide.

The versatility and flexibility of the the Company’s platform allows for highly efficient design and development of biologics that provide a rapid path from concept to in-vivo validation and selection of clinical candidates.

Cue Names Management Team, Board of Directors, Scientific Advisory Board​

In conjunction with the launch of the company, Cue Biopharma is announcing the members of its management team, which will be led by Daniel Passeri, M.Sc., J.D., President and Chief Executive Officer; Ronald Seidel, Ph.D., Executive Vice President, Head of Research and Development; and Rodolfo Chaparro, Ph.D., Executive Vice President, Head of Immunology.

Daniel Passeri is a seasoned biotechnology executive with more than 20 years of experience managing drug discovery and development programs as well as business development activities on behalf of publicly traded companies, with deep experience in both oncology and strategic partnership generation. Prior to joining Cue, Mr. Passeri served as President and Chief Executive Officer as well as Vice Chairman of the Board of Curis, Inc.

Dr. Ronald Seidel is a co-founder of Cue Biopharma and co-inventor of its technologies, and previously served as Research Assistant Professor of Biochemistry and Associate Director of the Macromolecular Therapeutic Development Facility (MTDF) at the Albert Einstein College of Medicine.

Dr. Rodolfo Chaparro is also a co-founder of Cue Biopharma and co-inventor of its technologies, and previously served as a faculty member in the Department of Biochemistry at the Albert Einstein College of Medicine in New York.

Cue Biopharma also named the independent members of its Board of Directors, which include Peter Kiener, D.Phil.; Barry Simon, M.D.; and Steven McKnight, Ph.D. Dr. Kiener has deep experience in both biologics and immunotherapy, including as EVP and Global Head of Biologics at MedImmune/AstraZeneca, and is currently the Chief Scientific Officer at Sucampo. Dr. Simon is President and COO of NantKwest and has held senior level roles at several companies including F. Hoffmann-La Roche, Roche Labs, Connetics Corp. and Immunomedics. Dr. McKnight leads an active research laboratory at UT Southwestern Medical Center, was co-founder of San Francisco-based, Tularik, Inc., and founder of Dallas-based Peloton Therapeutics.

Cue Biopharma has formed an industry-leading Scientific and Clinical Advisory Board, comprising Steven Almo, Ph.D.; Hidde Ploegh, Ph.D.; and David Baker, Ph.D. Dr. Almo is best known for his high resolution structural and biochemical characterization of the CTLA-4 and PD-1 immune checkpoint proteins and their respective ligands. Dr. Ploegh is a member of the Program in Cellular and Molecular Medicine at Boston Children’s Hospital. He is also recognized for his contributions to molecular immunology. Dr. Baker is a Professor of Biochemistry, Director of the Institute for Protein Design, Investigator of the Howard Hughes Medical Institute, and adjunct professor of Genome Sciences, Bioengineering, Chemical Engineering, Computer Science, and Physics at the University of Washington. His research group is focused on the prediction and design of macromolecular structures, interactions and functions.

​

About Cue Biopharma

Immune Responses, On Cue. Cue Biopharma is an immunotherapy company developing biologics engineered to selectively communicate with disease-relevant T cell subsets to treat cancer and autoimmune disease. Cue Biopharma biologics have the potential to be highly effective as monotherapies as well as synergistic with existing checkpoint inhibitors, while reducing collateral toxicities often seen with less selective immunotherapies. Through this platform approach, Cue Biopharma has developed a promising pipeline with its lead candidate currently approaching the clinic. Headquartered in Kendall Square, Cambridge, MA, the Company is led by a strong, experienced management team and scientific and clinical advisory board with deep expertise in the design and clinical development of protein biologics, immunology and immuno-oncology.

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On January 24, 2017 Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported an update on the progress of additional pending patent applications, since the recent allowance of the Company’s first key patent application in the US this year (Press release, Propanc, JAN 24, 2017, View Source [SID1234517563]).

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The Company received a written opinion from the International Search Authority regarding the novelty, inventive step and industrial applicability of a recent Patent Cooperation Treaty (PCT) application, filed in November 2016, in Australia. The PCT application titled "Proenzyme composition" is directed to a composition comprising trypsinogen and chymotrypsinogen, targeting specific weight ratios and certain dosage levels for the Company’s lead product, PRP. The majority of claims in the written opinion were considered novel and inventive, as determined by the Authorized Officer from the Australian Patent Office. The PCT assists applicants in seeking patent protection internationally for their inventions and can assist national patent offices with their patent granting decisions. By filing one international patent application under the PCT, applicants can simultaneously seek protection for an invention in over 150 countries.

Another patent application filed in Spain in January, 2016, titled "Cancer Treatment", was updated with animal data showing reduced density in tumors excised from mice post treatment with trypsinogen and chymotrypsinogen and as a result, a second application was filed with additional claims regarding a method of minimizing cancer progression, preventing recurrence, or preventing cancer in a subject by either reducing, or controlling the amount of cancer stem cells. The method may also include the step of identifying cancer stem cells in the subject.

"We are making new and exciting discoveries regarding the application of PRP in a clinical setting, which I firmly believe could become a breakthrough product that revolutionizes the way we treat cancer and reduces the threat of this killer disease for many different cancers," said Dr Julian Kenyon, Propanc’s Chief Scientific Officer. "I have been treating cancer patients for many years and have seen a number of innovations, particularly with the recent advancements of immuno-oncology. In my opinion, PRP, as a once daily IV administration with minimal toxicity, compared to standard treatments, whilst minimizing the threat of recurrence, or preventing cancer in patients, could become one of the most important discoveries made in the next 20 years."

The Company’s lead product, PRP, is a novel, patented, formulation consisting of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Currently in formal preclinical development and progressing towards first-in man studies, PRP aims to prevent tumor recurrence and metastasis in solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. The Company’s initial target patient populations include pancreatic, ovarian and colorectal cancers.

On January 23, 2017 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported it will prioritize its resources toward the development of CG’806, an oral preclinical compound being developed for patients with FLT3-driven acute myeloid leukemia (AML) and certain BTK-driven B-cell malignancies (Press release, Aptose Biosciences, JAN 23, 2017, View Source [SID1234539165]). Aptose will temporarily delay clinical activities with APTO-253, a phase 1 stage compound for AML, in order to elucidate the cause of recent manufacturing setbacks related to the intravenous formulation of APTO-253, with the intention of restoring the molecule to a state supporting clinical development and partnering.

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Although Aptose has two compelling cancer drugs, current resources can support the full development activities of only one at this time. Recent advances with CG’806 have elevated this agent as having the best risk-reward profile to pursue with those resources. Such data established CG’806 as a well-differentiated pan-FLT3 inhibitor that demonstrates tumor eradication in the absence of toxicity in AML xenograft models, and it is on track for development as a therapy for certain AML patients. In addition, CG’806 is a potent non-covalent inhibitor of proliferation among certain BTK-driven B-cell derived cancer cells. The encouraging properties of CG’806, including its potency against well-established targets in diseases of severe medical need, warrant expeditious advancement and prioritization of resources toward this molecule.

"Concurrent evidence of a unique activity profile with CG’806 along with manufacturing delays for APTO-253 have led us to reprioritize our corporate strategy," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "While we remain confident in the viability of APTO-253 as a potential treatment for AML, we believe the greater value proposition to shareholders and patients is to focus our available resources on CG’806."

In November 2015, Aptose’s phase 1b trial of APTO-253 in patients with AML was placed on clinical hold. Since that time, the company has actively evaluated multiple formulation and production methodologies with the goal of developing a superior IV formulation. After successfully manufacturing multiple non-cGMP batches of a new drug product formulation for APTO-253, including a batch that has been stable and soluble for over six months, the company recently encountered an additional manufacturing setback which further delayed the return of APTO-253 to the clinic. While Aptose has made significant advances in understanding the novel c-Myc inhibitory mechanism of APTO-253, additional time will be required to define the cause of the cGMP manufacturing delay and to potentially restore APTO-253 to a state it can be developed clinically and partnered.

Based on information currently available, Aptose expects to report total cash and cash equivalents to be at a similar level as at September 30, 2016. As a result of activities to reprioritize its resources towards the development of CG’806, the cash on hand, which includes additional cash raised through its At-The-Market facility, is expected to provide sufficient resources to fund research and development and operations into Q4, 2017. Information reported above with respect to the financial year ended December 31, 2016 are preliminary and are subject to change and adjustment as the company’s 2016 financial results are finalized. Accordingly, investors are cautioned not to place undue reliance on the foregoing guidance. The company does not intend to continue to provide preliminary results in the future. Aptose expects to report its financial results for the financial year ended December 31, 2016 on or around March 14, 2016.

About CG’806

CG ‘806 is a once daily, oral, first-in-class FLT3/BTK inhibitor. This small molecule demonstrates potent inhibition of mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain), eliminates AML tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with FLT3-driven AML. Likewise, CG’806 demonstrates potent, non-covalent inhibition of the Cys481Ser mutant of the BTK enzyme, suggesting the agent may be developed for CLL and MCL patients that are resistant/refractory/intolerant to covalent BTK inhibitors.

Conference Call and Webcast

Aptose will host a conference call this morning, Monday, January 23, 2017 at 8:30 AM ET. Participants can access the conference call by dialing toll-free (844) 882-7834 (North America toll-free number) or (574) 990-9707 (international dial-in number), using the conference call passcode 58646784. The conference call can also be accessed here and will be available through a link on the Investor Relations section of Aptose’s website at ir.aptose.com. An archived version of the webcast will be available on the company’s website for 30 days.

On January 23, 2017 Domain Therapeutics reported that a collaboration and licensing agreement with Merck, a leading science and technology company, has been signed for the development of adenosine receptor antagonist drugs specifically designed for oncology and immuno-oncology (Press release, Domain Therapeutics, JAN 23, 2017, View Source [SID1234606730]).

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The agreement will involve close collaboration between Merck and Domain Therapeutics to develop and test new agents targeting key adenosine receptors. Merck will support research activities and gain worldwide rights to Domain Therapeutics’ next generation of adenosine receptor inhibitors. Under the terms of the agreement, Domain will be eligible for more than EUR 240 million in milestones, as well as undisclosed royalties.

"With its growing portfolio of immuno-oncology agents, Merck is the ideal partner to develop our adenosine programs," said Pascal Neuville, CEO, Domain Therapeutics. "As a strong collaborator with a leading investigational checkpoint inhibitor, we are confident that through Merck, our programs will progress rapidly."

Adenosine has been identified as a key component in resistance mechanisms for many tumors targeted by immune check-point inhibitors. While blocking certain adenosine receptors has been shown to increase the response to immune checkpoint inhibitors, antagonizing other adenosine receptors has also been shown to slow tumor progression.

"This new generation of adenosine receptor antagonists is an important addition to our immuno-oncology pipeline," said Laszlo Radvanyi, Senior Vice President, Head of Research in Immuno-Oncology at the biopharma business of Merck. "We plan to explore the promise of adenosine receptor antagonists and develop novel compounds to potentially use in new combination immunotherapies for cancer."