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OXIS ENTERS INTO A CO-DEVELOPMENT PARTNERSHIP AGREEMENT WITH ALTOR BIOSCIENCE FOR NOVEL TRIKE THERAPEUTIC

On June 13, 2017 Oxis International Inc. (OTCQB: OXIS and Euronext Paris OXI.PA) reported that it has entered into a co-development partnership agreement with Altor BioScience Corp. (Altor) in which the companies will collaborate exclusively in the clinical development of a novel 161533 TriKE fusion protein for cancer therapies using Oxis’ trispecific killer engager (TriKE) technology (Press release, OXIS International, JUN 13, 2017, View Source [SID1234539560]).

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Altor, based in Miramar, Fla., is a leading developer of novel cytokine-based immunotherapeutics for cancer and infectious diseases. Altor is run by Hing C. Wong, Ph.D., Founder and Chief Executive Officer and Chaired by Dr. Patrick Soon-Shiong, a noted cancer researcher who owns NantWorks, a network of healthcare companies.

The TriKE technology was developed by researchers at the University of Minnesota Masonic Cancer Center. As demonstrated in non-clinical models, this targeted immunotherapy directs immune cells to kill cancer cells while diminishing drug-related toxicity. Addition of Altor’s IL-15 superagonist technology to the 161533 TriKE molecule would further augment its ability to stimulate immune responses.

Under the partnership, Oxis and Altor will conduct a first-in-man Phase 1 FDA human clinical trial of the 161533 TriKE for the treatment of hematologic malignancies.

Anthony J. Cataldo, Chief Executive Officer of Oxis, believes that the partnership with Altor will greatly benefit Oxis and the University of Minnesota in their efforts to leverage the TriKE technology into approved cancer therapies. The TriKE platform technology has received considerable attention, including having recently won the "REACH" award from the NIH (National Institutes of Health) for technology most likely to achieve commercial success. A research study on 161533 TriKE molecule was also selected as "Editors’ Choice" by the journal Science Translational Medicine, which stated, "TriKEs were superior in restoring potent antigen-specific NK cell responses against AML targets and mediated robust and specific NK cell proliferation."

Mr. Cataldo further said, "Altor’s elegant design of a mutant IL -15 can further enhance the targeting and effective killing of myeloid malignancies by the 161533 TriKE."

Hing C. Wong, Ph.D., Founder and Chief Executive Officer of Altor, said: "The 161533 TriKE is an innovative second-generation immunotherapeutic fusion protein being developed by Oxis that targets human CD16 and human CD33. We are excited to have Altor’s proprietary IL-15 technology as an integral part of this molecule that is poised to rapidly enter into the clinic."

The clinical project will be managed by Jeffrey S. Miller, M.D., Deputy Director of the University of Minnesota Masonic Cancer Center and a member of the Oxis Scientific Advisory Board. Dr. Miller said, "The goal of a TriKE is to make NK cells antigen specific by creating an immune synapse between NK cells and tumor targets. Preclinical data suggest that use of an IL-15 linker not only boosts immune activation but it also delivers a proliferative signal to NK cells to sustain and further drive the immune response, a property that should overcome tumor induced immune suppression."

Threshold Pharmaceuticals Announces First Patient Dosed in Immunotherapy Clinical Trial of Evofosfamide and Ipilimumab

On June 13, 2017 Threshold Pharmaceuticals, Inc. (NASDAQ:THLD) a clinical-stage biopharmaceutical company developing novel therapies for cancer, reported that the University of Texas MD Anderson Cancer Center has dosed the first patient in a Phase 1 immunotherapy clinical trial investigating ipilimumab and evofosfamide for the treatment of patients with metastatic or locally advanced prostate cancer, metastatic pancreatic cancer, melanoma or human papillomavirus (HPV) negative squamous cell carcinoma of head and neck for which standard therapy does not offer the potential for increased survival (Press release, Threshold Pharmaceuticals, JUN 13, 2017, View Source [SID1234519545]).

“We believe that adding evofosfamide to certain immunotherapies has the potential to render some of the most therapeutically resistant cancers more sensitive to the immunotherapy and we are excited to have dosed the first patient in this study,” said Tillman Pearce, M.D., Chief Medical Officer at Threshold Pharmaceuticals. “Thanks to preclinical research conducted by Dr. Curran at MD Anderson Cancer Center, it is well-understood that certain tumors have hypoxic zones that resist infiltration by T cells, which are capable of attacking and killing tumor cells, and that combination therapy with evofosfamide and anti-CTLA-4/anti-PD-1 treatment opens up the hypoxic zones to T cell infiltration.”

Evofosfamide (also known as TH-302) is Threshold’s proprietary, hypoxia-activated prodrug of a bis-alkylating agent that is preferentially activated under severe hypoxic tumor conditions, a feature of many solid tumors. In preclinical research conducted by Michael Curran, Ph.D., Assistant Professor at the University of Texas MD Anderson Cancer Center, evofosfamide has sensitized highly resistant solid tumor models to treatment with certain immune checkpoint inhibitors through evofosfamide-driven disruption of hypoxic zones. Specifically, hypoxia in the tumor microenvironment forms a barrier to T cell infiltration and fosters immunotherapy resistance in prostate cancer and other solid tumors.

The Phase 1 clinical trial is a single-arm, open label study that will enroll up to 69 patients with metastatic or locally advanced prostate cancer, metastatic pancreatic cancer, melanoma or HPV-negative squamous cell carcinoma of head and neck. Eligible patients will receive evofosfamide on Days one and eight of the first two cycles and ipilimumab on Day eight of a 28-day cycle. Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) response rate is the primary endpoint. Secondary endpoints include duration of response, progression-free survival, overall survival, safety, tolerability and pharmacokinetics. The study is open at MD Anderson Cancer Center in Houston, Texas. More details can be found here.

About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a bis-alkylating agent that is preferentially activated under severe hypoxic tumor conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic. Discussions remain ongoing with the Japanese PMDA regulatory agency on what additional clinical trials may be required to support submission of evofosfamide for the treatment of pancreatic cancer patients in Japan.

TG Therapeutics, Inc. Recaps Schedule of Clinical Data Presentations at the Upcoming 14th International Conference on Malignant Lymphoma & the 22nd European Hematology Association Annual Congress

On June 13, 2017 (GLOBE NWarp* TG Therapeutics, Inc. (NASDAQ:TGTX), reported the schedule of presentations featuring TG-1101 and TGR-1202 at the upcoming 14th International Conference on Malignant Lymphoma (ICML), being held June 14 – 17, 2017, in Lugano, Switzerland and the upcoming 22nd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress (EHA) (Free EHA Whitepaper), being held June 22 – 25, 2017, in Madrid, Spain (Press release, TG Therapeutics, JUN 13, 2017, View Source [SID1234519524]).

(Press release, TG Therapeutics, JUN 13, 2017, View Source [SID1234519524])

ICML PRESENTATION SCHEDULE:

Oral Presentations:

Title: Updated results of a multicenter phase I/Ib study of TGR-1202 in combination with ibrutinib in patients with relapsed or refractory MCL or CL
• Abstract Number: 040
• Presentation Date & Time: Wednesday, June 14, 2017 17:50 CEST
• Session Title: Chemotherapy-Free Combinations
• Presenter: Matthew S. Davids, MD, Dana-Farber Cancer Institute
Title: Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: Results of the GENUINE Phase 3 study
• Abstract Number: 101
• Presentation Date & Time: Friday, June 16, 2017 11:20 CEST
• Session Title: Session 7 – Advances in CLL
• Presenter: Anthony R. Mato, MD, University of Pennsylvania, Abramson Cancer Center
Title: Chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib is well tolerated and highly active in patients with advanced CLL and NHL
• Abstract Number: 102
• Presentation Date & Time: Friday, June 16, 2017 11:35 CEST
• Session Title: Session 7 – Advances in CLL
• Presenter: Loretta J. Nastoupil, MD, MD Anderson Cancer Center
Poster Presentation:

Title: Combination of TGR-1202, Ublituximab, and Bendamustine is safe and highly active in patients with advanced DLBCL and Follicular Lymphoma
• Abstract Number: 277
• Presentation Date: Friday, June 16, 2017 (Poster Session)
• Presenter: Mathew Lunning, DO, University of Nebraska, Omaha, NE
EHA PRESENTATION SCHEDULE:

Oral Presentation:

Title: Chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib is well tolerated and highly active in patients with advanced CLL and NHL
• Abstract Number: S772
• Presentation Date & Time: Sunday, June 25, 2017 8:45 – 9:00 CEST
• Session Title: Targeted therapies in relapsed chronic lymphocytic leukemia
• Location: Hall A
• Presenter: Loretta J. Nastoupil, MD, MD Anderson Cancer Center
Poster Presentation:

Title: Combination of TGR-1202, Ublituximab, and bendamustine is safe and highly active in patients with advanced DLBCL and follicular lymphoma
• Abstract Number: P563
• Presentation Date & Time: Saturday, June 24, 2017 17:30 – 19:00 CEST
• Session Title: Aggressive Non-Hodgkin Lymphoma- Relapsed/Refractory
• Location: Poster Area Hall 7
• Presenter: Matthew Lunning, DO, University of Nebraska Medical Center
Abstracts are available online, respectively through the ICML meeting website at www.lymphcon.ch, or through the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

Moleculin Announces Preparation to File an IND with the FDA for WP1220 for Treatment of Cutaneous T-Cell Lymphoma

On June 13, 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 it has begun taking steps to file an IND with the FDA for its molecule WP1220 for the treatment of Cutaneous T-Cell Lymphoma (CTCL), a rare form of skin cancer (Press release, Moleculin, JUN 13, 2017, View Source [SID1234519500]).

Moleculin’s WP1220 (aka MOL4239) has data demonstrating significant activity in preclinical studies and is being studied as a possible topical treatment for CTCL. The FDA previously granted an IND to WP1220 for development as a topical treatment of psoriasis, and although the molecule completed a Phase I clinical trial, providing initial data suggesting safety in humans, Phase II clinical trials did not demonstrate sufficient activity to warrant further development for that indication. To pursue further development of WP1220, the Company believes the data used to support the prior IND may allow for a quicker pathway to an IND for CTCL.

"Our primary focus has been further developing our most advanced and promising drug, Annamycin, for the treatment of acute myeloid leukemia," commented Walter Klemp, Chairman and CEO of Moleculin. "Nevertheless, we believe some of the less advanced technologies in our portfolio have significant potential in other cancer indications. WP1220 is a great example of such potentially useful technology, and because the FDA previously found the data package supporting an IND for WP1220 to be adequate in another context, we are hopeful that we can expeditiously move forward to studying the molecule in humans for the topical treatment of this potentially deadly skin disease."

Mr. Klemp added: "Developing WP1220 for indications like CTCL may provide opportunities for strategic collaboration and out-licensing while maintaining our ability to develop other molecules to their highest and best potential. We will be actively looking for such opportunities to help fund the projects we believe hold the most potential for Moleculin stakeholders."

OSE Immunotherapeutics Announces Strategic Multi-Year Research Collaboration with Memorial Sloan Kettering Cancer Center in New York

On June 12, 2017 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) reported that the Company has entered into a multi-year research collaboration on OSE-703, a cytotoxic monoclonal antibody against the alpha chain of Interleukin-7 Receptor (IL-7R), with Memorial Sloan Kettering Cancer Center (MSK) in New York (Press release, OSE Immunotherapeutics, JUN 13, 2017, View Source [SID1234519498]).

The collaboration will support a research program using OSE-703 (Effi-3), a humanized monoclonal antibody directed against the extracellular domain of the alpha-chain of the receptor for interleukin-7 (CD127), cytotoxic for human cells expressing CD127.

The research program will be conducted by physician-scientist Prasad S. Adusumilli, MD, FACS, a thoracic surgeon with expertise in tumor immunology and a focus on the development of chimeric antigen receptor T-cell (CAR T-cell) immunotherapy. The goal of this research collaboration is to explore IL-7R directed immunotherapy OSE-703 for solid tumors with non-small cell lung cancer (NSCLC) as the primary cancer model. From a large cohort of NSCLCs*, it has been shown that IL-7R was overexpressed in this type of cancer and associated with poor prognosis. "We are excited to collaborate with Dr. Adusumilli and one of the world’s most renowned cancer hospitals. The combination of his pioneering expertise in immuno-oncology, especially within CAR T-cell immunotherapy, and the therapeutic potential of OSE-703, will afford us optimal conditions to establish this promising product candidate’s efficacy profile and identify an appropriate development approach," said Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics. * Suzuki et al, J Clin Oncol. 2013 Feb 1; 31(4): 490–498.