On November 30, 2017 GT Biopharma, Inc. (OTCQB: GTBP and Euronext Paris GTBP.PA) ("GT Biopharma" or the "Company") reported that Dr. Jeffrey Miller, Deputy Director of the Masonic Cancer Center, University of Minnesota, will be presenting data on its second-generation anti-CD16-IL-15-anti-CD33 TriKE (OXS-C3550); another first of its kind, single-chain, tri-specific NK cell engager (TriKE) (Press release, GT Biopharma , NOV 30, 2017, View Source [SID1234539536]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The TriKE platform technology, developed by Dr. Miller and his colleagues at the University of Minnesota, is designed to enhance the activity of Natural Killer (NK) cells. NK cells are a type of white blood cell which are an important component of the innate immune system and play a major role in the rejection of tumor and virally infected cells.

The original anti-CD16-IL-15-anti-CD33 TriKE (OXS-3550) utilizes the inclusion of a modified Interleukin-15 (IL-15), a peptide that activates NK cells, while the "engager" further increases NK cancer-cell killing capabilities and improves their function in the tumor microenvironment (Vallera et al, 2016). OXS-3550 is expected to enter human clinical trials in 2018. OXS-C3550, the second-generation anti-CD16-IL-15-anti-CD33 TriKE, utilizes a modified anti-CD16 component while incorporating the wild-type IL-15.

The OXS-C3550 TriKE was developed following continued research with the TriKE platform 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.

The TriKE platform technology can be viewed as a protein version of CAR-T; but unlike traditional CAR-T platforms, it is anticipated that TriKEs could service a much larger part of the cancer population at a fraction of the cost. TriKEs are an antibody platform that could be tailored to treat any form of cancer, liquid or solid tumors.

OXS-C3550 will focus on acute myeloid leukemia (AML), the most common form of adult leukemia with 43,000 new cases each year. These patients will require frontline therapy, usually chemotherapy including cytarabine and an anthracycline, a therapy that has not changed in over 40 years. Also, about half of these patients are likely to have relapses and require alternative therapies. In addition, OXS-C3550 could be used to treat myelodysplastic syndrome (MDS), which has about 20,000 new cases diagnosed each year with minimal current treatment options (Siegel et al, 2014). At a minimum, OXS-3550 is expected to serve as a relatively safe, inexpensive, and easy to use therapy for resistant or relapsing AML. From a biologic standpoint, it could also be combined with chemotherapy as frontline therapy.

GT Biopharma Chief Medical officer (CMO) Dr. Raymond Urbanski said, "The data on our second-generation TriKE, which will be presented at the upcoming ASH (Free ASH Whitepaper) meeting, will be noticed by investigators in the field and will set the tone for all future discussions on the use of NK cells in the treatment of cancer. We believe the distinctions and potential benefits relative to other immunotherapies, including CAR-T, will become apparent."

GT Biopharma Chief Executive Officer (CEO) Dr. Kathleen Clarence-Smith said, "In collaboration with the experts from the University of Minnesota Masonic Cancer Center, GT Biopharma continues to advance the search for next generation anti-cancer treatments, especially on novel ways to enhance the cancer-killing capabilities of NK cells. In my view, the potential for the success of this immunotherapy approach is substantial and the possibility of extending it to solid tumors gives us even added hope."

GT Biopharma Executive Chairman Anthony J. Cataldo said, "This is another milestone achievement for the company as we continue to close out a very productive 2017."

On November 30, 2017 MorphoSys Increases Financial Guidance for 2017 Following Signature of Regional License Agreement for Antibody MOR202 with I-Mab (Press release, MorphoSys, NOV 30, 2017, View Source [SID1234556341])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and I-Mab announced today that they have entered into an exclusive regional licensing agreement to develop and commercialize MOR202 in China, Taiwan, Hong Kong and Macao. MOR202 is MorphoSys’s proprietary investigational antibody against CD38, for which recruitment of a European Phase 1/2a clinical study in relapsed/refractory multiple myeloma has been concluded.

Under the terms of the agreement, I-Mab Biopharma (a fully owned affiliate of I-Mab) will assume exclusive responsibility for all subsequent development and commercialization of MOR202 in the agreed territory. MorphoSys receives an immediate upfront payment of USD 20 million. MorphoSys will be entitled to receive additional success-based clinical and commercial milestone payments from I-Mab of up to approximately USD 100 million, as well as tiered, double-digit royalties on net sales of MOR202 in the territory.

In connection with the license agreement with I-Mab, MorphoSys has increased its financial guidance. For the year 2017, MorphoSys now expects revenues in the range from EUR 63 to 66 million (up from previously EUR 46 to 51 million) and earnings before interest and taxes (EBIT) of EUR -66 to -71 million (up from previously EUR -75 to -85 million). Guidance for revenues and EBIT includes royalty income on Tremfya(R) sales in Q3 2017, but does not include any royalty income on Tremfya(R) sales in Q4 2017. Following the partnering of MOR202, proprietary R&D expenses will be in the range from EUR 96 to 100 million (previously EUR 85 to 95 million).

On November 30, 2017 Pfizer Inc. (NYSE:PFE) and Basilea Pharmaceutica Ltd. (SIX:BSLN), an international biopharmaceutical company specializing in the research and development of anti-infective and oncological medicines, reported they have entered into an agreement whereby Pfizer will be granted the exclusive development and commercialization rights in China and several countries in the Asia Pacific region to CRESEMBA (isavuconazole) (Press release, Pfizer, NOV 30, 2017, View Source [SID1234522326]). CRESEMBA is a novel antifungal medicine for the treatment of adult patients with diagnosed invasive aspergillosis and mucormycosis1, two serious infections associated with significant morbidity and mortality among immunocompromised patients, such as those with advanced HIV and those with cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Pfizer will have exclusive rights to develop, distribute and commercialize CRESEMBA in sixteen Asian Pacific countries and China (including Hong Kong and Macao). These rights do not include Japan. In addition, Pfizer will become the marketing authorization holder for the Asia Pacific Region and China. The specific financial terms of the agreement remain confidential. The agreement is subject to customary regulatory approval.

In July 2017, Pfizer completed an agreement with Basilea to obtain the exclusive commercialization rights to CRESEMBA in Europe (with the exception of the Nordic countries). Since that time, Pfizer has assumed responsibility for the commercialization of CRESEMBA in Austria, France, Germany, Italy, and the United Kingdom and successfully launched CRESEMBA in Spain with additional launches expected in 2018 and beyond.

CRESEMBA was developed in response to the urgent medical need for antifungal medicines for the treatment of invasive fungal infections, which are naturally resistant to many antifungal therapies and have become increasingly resistant to other available therapies. Today, invasive aspergillosis is the most frequently reported fungal infection in immunocompromised individuals within the Asian Pacific region.

"We are excited to extend our partnership with Basilea, a company that shares our passion and commitment to confronting the global challenges of infectious disease management," said Suneet Varma, global president of Pfizer APAC, Greater China and Global Brands. "We believe our extensive geographic footprint in APAC and China, together with our expertise in successfully commercializing innovative medicines, will help enable us to continue to address the unmet medical needs of patients, especially in the area of anti-infectives."

"CRESEMBA is a well differentiated drug that addresses a critical medical need in patients with invasive mold infections," said Ronald Scott, chief executive officer of Basilea. "We are very pleased to be expanding our partnership with Pfizer to China and Asia Pacific where it has a strong commercial presence and a proven track record of successfully developing and commercializing hospital antifungals. We have now established partnerships for isavuconazole with leading pharmaceutical companies in all major markets around the world."

About Pfizer Anti-Infectives

Today, Pfizer is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products. Since its pioneering work on penicillin in the 1940s, Pfizer has been actively engaged in the research and development of innovative medicines and creation of policies and educational programs to address the evolving needs of patients and physicians in the area of infectious diseases. In December 2016, Pfizer completed the acquisition of AstraZeneca PLC’s small molecule anti-infective business, which includes both marketed agents and clinical development assets primarily outside the United States.

About invasive aspergillosis and mucormycosis

Invasive fungal diseases (IFDs) are an increasingly common complication associated with high morbidity and mortality among immunocompromised patients such as those with advanced HIV infection and those with cancer. Rates of mortality associated with invasive fungal infections depend upon the pathogen, geographic location and underlying patient characteristics and can be as high as 80-90%. Today, there are limited treatment options available for patients diagnosed with invasive aspergillosis and mucormycosis.

About CRESEMBA (isavuconazole)

CRESEMBA is an intravenous (IV) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis. The European centralized marketing authorization was granted in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. The drug is commercialized in the US by Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. Pfizer does not have commercialization rights to CRESEMBA in the United States.

On November 29, 2017 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells, highlighted its planned activity at the upcoming 59th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting & Exposition being held December 9 – 12, 2017 in Atlanta, Georgia (Press release, Actinium Pharmaceuticals, NOV 29, 2017, View Source [SID1234522298]). Actinium’s Actimab-A Phase 2 trial will be highlighted in a poster presentation that will discuss results to date from the multi-center, open label Phase 2 trial that has been designed to assess overall response rates of patients receiving fractionated doses of Actimab-A. Patients enrolled in this trial are newly diagnosed with acute myeloid leukemia (AML) that are over the age of 60. Preliminary results from the Company’s recently announced Actinium Warhead Enabling (AWE) Technology Program will be presented by poster. The results contrast the superior celling killing power of Actinium-225 labeled daratumumab versus the unlabeled antibody, which is a blockbuster therapy targeting CD38 for patients with multiple myeloma marketed by Johnson & Johnson. In addition, experimental results supporting targeting of the CD33 antigen in multiple myeloma patients that provides the scientific rational for the Actimab-M trial will also be presented in an abstract.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of Actinium’s abstract poster presentations are as follows:

Title: A Phase 2 Study of Actinium-225 (225Ac)-Lintuzumab in Older Patients with Previously Untreated Acute Myeloid Leukemia (AML) Unfit for Intensive Chemotherapy
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II
Date: Sunday, December 10, 2017
Time: 6:00PM-8:00PM
Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Title: Actinium Labeled Daratumumab Demonstrates Enhanced Killing of Multiple Myeloma Cells over Naked Daratumumab
Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster III
Date: Monday, December 11, 2017
Time: 6:00PM-8:00PM
Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

An online abstract has been accepted highlighting experimental results supporting the rationale for targeting CD33 in patients with multiple myeloma, which will be accessible on December 8, 2017. Details for the online abstract are as follows:

Title: CD33 Is Expressed in a Significant Subset of Multiple Myeloma Patients in the US and May Represent a Viable Therapeutic Target
Session: 651. Myeloma: Biology and Pathophysiology, excluding therapy

"This year’s American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting & Exposition represents an inflection point for Actinium’s clinical development and research progress," said Dr. Mark Berger, Actinium’s Chief Medical Officer. "As shown in our abstract, Actimab-A generated strong response rates exceeding 50% in a tremendously difficult to treat AML patient population as a single agent and I look forward to the detailed results being presented at ASH (Free ASH Whitepaper) via our poster presentation. In addition to its strong efficacy, we have gained further insights into Actimab-A’s safety profile, namely its minimal extramedullary toxicities. I believe that this strength of Actimab-A will allow us to utilize Actimab-A in additional indications where patients have high unmet needs that can be addressed with strong single agent efficacy, a unique mechanism of action and robust myelosuppressive capabilities with minimal effects outside of the hematopoietic system."

Key Highlights of Actinium’s Activities Include:

Poster presentation highlighting data from Actinium’s Phase 2 trial of Actimab-A, a CD33 targeting agent, in patients newly diagnosed with AML unfit for intensive chemotherapy
Poster presentation highlighting new data from Actinium’s recently announced AWE Technology Platform
Abstract supporting the targeting of CD33 in multiple myeloma and the scientific rationale for Actimab-M
The Clinical Advisory Board will review the progress of the multi-center, Phase 2 trial of Actimab-A, Actinium’s CD33 targeting antibody radio-conjugate for AML
The Scientific Advisory Board will review the progress of the Phase 3 Iomab-B SIERRA trial for patients 55 and older with relapsed and refractory AML
Meeting with investigators from the 15 participating SIERRA clinical trial sites
Sandesh Seth, Actinium’s Chairman and CEO said, "This year’s ASH (Free ASH Whitepaper) annual meeting will be the most active in the Company’s history and will showcase Actinium’s strengthened capabilities in clinical development and research and development. I am proud of our team’s ability to leverage our AWE technology platform and drive our drug development strategically. As a result, we have demonstrated the potential of utilizing Actinium-225 with established commercial products as a means of developing biobetters, which we will be offering to potential biopharmaceutical partners. We have also identified via our clinical results additional strengths of our CD33 program. We believe that these findings offer additional clinical opportunities where we can leverage our strengths, experience and know-how in the field of bone marrow transplant and targeted alpha particle therapy. We look forward to the ASH (Free ASH Whitepaper) annual meeting where our clinical and experimental work on Actimab-A, Actimab-M and the AWE platform will be showcased via the posters and publications, and also in our meetings with the scientific and business community. In addition, we look forward to revealing new clinical opportunities at our December 5th Webinar."

About Actimab-A

Actimab-A, Actinium’s most advanced alpha-particle therapy product candidate, is currently in a 53-patient, multicenter Phase 2 trial for patients newly diagnosed with AML age 60 and above that are ineligible for standard induction chemotherapy. Actimab-A is being developed as a first-line therapy and is a monotherapy that is administered via two 15-minute injections that are given 7 days apart. Actimab-A targets CD33, a protein abundantly expressed on the surface of AML cells via the monoclonal antibody, HuM195, which carries the potent cytotoxic radioisotope actinium-225 to the AML cancer cells. Actinium-225 gives off high-energy alpha particles as it decays, which kill cancer cells and as actinium-225 decays it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in almost 90 patients in four clinical trials. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML in patients 60 and above by the U.S. Food and Drug Administration.

About Actimab-M

Actimab-M is being investigated in patients with refractory multiple myeloma. Multiple myeloma is a currently incurable cancer of plasma cells, which are white blood cells that produce antibodies. Actimab-M is currently being studied in a Phase 1 dose escalation study in up to 12 patients that is designed to establish safety, maximum tolerable dose and proof of concept. Actimab-M consists of actinium-225, an alpha-emitting radioisotope coupled to the anti-CD33 monoclonal antibody, HuM-195. CD33 has been shown to be expressed on myeloma plasmocytes in 25% to 35% of multiple myeloma patients and has also shown to be correlated with poorer outcomes.

About Our AWE Technology Platform

The Actinium Warhead Enabling (AWE) Technology Platform enables a highly potent and selective form of targeted therapy that combines the powerful alpha-emitting radioisotope actinium-225 with targeting agents, which are designed to seek out cancer cells in the body that express particular markers. Actinium-225 emits significant alpha radiation making it a potent treatment modality against targeted cancer cells while limiting damage to healthy tissues as its radiation travels extremely short distances in the body. When labeled to targeting agents, actinium-225 can be delivered directly to cancer cells where the high linear energy transfer resulting from the emission of alpha particles results in irreparable DNA double stranded breaks and ultimately cancer cell death. Despite this superior cell killing power, actinium-225 when delivered in a targeted manner is sparing of the surrounding environment in the body due to the short path length of its alpha-particle radiation and can result in a superior safety profile. Actinium Pharmaceuticals owns or has licensed the rights to several issued and pending patents that pertain to its AWE Technology Platform including technology to manufacture actinium-225 in a cyclotron. In addition, the Company obtains actinium-225 from various sources such as the U.S. Department of Energy at Oak Ridge National Laboratories and has developed considerable know-how, expertise and validated processes related to production of radioimmunoconjugates, management of the supply chain and dealing with various regulatory bodies. The AWE Technology Platform can be utilized to potentially improve the cell-killing power of targeting agents such as antibodies, peptides, Fab fragments, nanobodies etc. via labeling with actinium-225. In addition to increased efficacy, these actinium-225 enhanced targeting agents can offer optimized dosing or administration and in the case of approved targeting agents provide an opportunity to extend intellectual property protection by the creation of "Biobetters" or improved versions of the approved agent. The Company’s Actinium Warhead Enabling (AWE) Program can be accessed by biopharmaceutical companies that are interested in creating Biobetters through the utilization of the AWE Platform Technology. To learn more about the AWE Technology Platform or the AWE Program please contact Keisha Thomas, Ph.D., Corporate Development at [email protected].

On November 29, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration (AMD) and fibrotic diseases, reported that the first patient has been dosed in its Phase 1b clinical trial of TRC105 in combination with Opdivo (nivolumab) in patients with non-small cell lung cancer (Press release, Tracon Pharmaceuticals, NOV 29, 2017, View Source;p=RssLanding&cat=news&id=2319234 [SID1234522312]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Endoglin is expressed on activated myeloid derived suppressor cells, a cell type implicated in tumor resistance to immunotherapy. To date, we have observed promising signs of activity with our endoglin antibodies in combination with PD-1 inhibitors in a number of preclinical syngeneic mouse tumor models," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are excited to advance a combination of TRC105 with an immune oncology agent into the clinic to further assess our antibody’s immunomodulatory activity."

About the Phase 1b Clinical Trial of TRC105 and Opdivo in Lung Cancer

The Phase 1b clinical trial is an open-label, dose-escalation and expansion cohort study of TRC105 and Opdivo in patients with non-small cell lung cancer that have received prior chemotherapy. The primary objectives of the Phase 1b study are to assess the safety of TRC105 when given with Opdivo, determine its recommended Phase 2 dose with Opdivo and evaluate the response rate. The trial incorporates tumor biopsy testing to correlate tumor myeloid cell infiltration with response, in order to allow for potential biomarker-directed therapy of lung cancer patients.

Further details of the study are available on www.clinicaltrials.gov, identifier NCT03181308.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in the pivotal Phase 3 TAPPAS trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.