On June 12, 2019 Debiopharm (Debiopharm – www.debiopharm.com) and Ipsen (www.ipsen.com) reported renewal of their Decapeptyl agreement, which extends and strengthens their strategic partnership through 2034 for the development, manufacturing and distribution of Decapeptyl across Europe and certain Asian and African markets (Press release, Ipsen, JUN 12, 2019, View Source [SID1234537019]). Having established their collaboration in the 1980s, this extension represents a long-term commitment to patients, offering the benefits of Decapeptyl in the treatment of metastatic and non-metastatic patients with locally advanced prostate cancer, endometriosis, uterine fibroids, central precocious puberty and endocrine-responsive early-stage breast cancer.

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Under the renewed agreement, both parties will co-develop novel formulations and explore additional indications for other patient populations with high unmet needs.

"Our continued partnership remains critical to ensure that patients maintain access to Decapeptyl therapy for their various conditions. Furthermore, this renewed agreement represents an opportunity to refine and refocus our collaboration by further exploring our co-development capacity to potentially identify how Decapeptyl can respond to more unmet patient needs."

Thierry Mauvernay, President & Delegate of the Board Group, Debiopharm

"We are delighted to renew and extend this partnership with Debiopharm. This collaboration has been – and continues to be – a testament to our commitment to patients and our shared passion with strategic partners."

Ivana Magovčević-Liebisch, Executive Vice-President, Chief Business Officer

About Decapeptyl

Decapeptyl (triptorelin pamoate) is an agonist analogue of the natural gonadotropin-releasing hormone (GnRH), currently available in three sustained-release formulations (1, 3 and 6 months). First registered in France in 1986, triptorelin is currently marketed in more than 80 countries, being the market leader in many territories worldwide. The alliance between Debiopharm and Ipsen for Decapeptyl has successfully delivered sustained market growth with €372.6 million total sales in 2018, representing 8.1% annual growth.

The ASCO (Free ASCO Whitepaper) 2019 Annual Meeting bills itself as the world’s premier oncology event. 1stOncology provides all its users with a detailed guide to the new technologies, drugs, targets, start-ups, clinical results etc. emerging from this meeting. We’ve now made this guide open to all for 48h of free access, complete with all LBA’s from ASCO (Free ASCO Whitepaper).

This year we saw a major interest amongst Immunotherapies and Protein Kinase Inhibitors.

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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

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On June 11, 2019. Xspray Pharma (Nasdaq First North: XSPRAY) reported that the United States Patent and Trademark Office (USPTO) has granted Xspray two new patents in the United States for its product candidates HyNap-Sora and HyNap-Nilo (Press release, Xspray, JUN 11, 2019, View Source [SID1234649564]). The new patents are Xspray’s sixth and seventh product patents, respectively, in the United States, which is Xspray’s main market. The new patents will expire January 11, 2033.
"The new patents for HyNap-Sora and HyNap-Nilo make it significantly more difficult for our competitors to copy upcoming products from our unique platform technology. The patents are also essential for our ability to do good business deals and they strengthen our position in the US market," says Per Andersson, CEO of Xspray.

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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

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The new patents, US 10,314,829 and US 10,314,830 respectively, cover the pharmaceutical compositions of the company’s product candidates HyNap-Sora and HyNap-Nilo. Xspray is a product company with a broad portfolio of drug candidates in the same substance class that can be reformulated using the same technology platform.

At the end of 2018, Xspray was granted an additional patent for HyNap-Dasa for the US market. This patent, along with these two new ones, are strong and broad composition patents which relate to solid amorphous forms of the active substance. The original products for Dasatinib, Sorafinib and Nilotinib, had total US sales exceeding USD 2 billion in 2018.

On June 11, 2019 Nordic Nanovector ASA (OSE: NANO) reported that the company and its collaborators will present data and analyses from its preclinical studies with Betalutin (177Lu-lilotomab satetraxetan) and with 212Pb-NNV003, a next-generation targeted alpha therapy comprising Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) coupled with the alpha-particle-generator lead-212 (212Pb), at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2019 Annual Meeting, to be held in Anaheim, CA, USA on 22-24 June (Press release, Nordic Nanovector, JUN 11, 2019, View Source [SID1234553447]).

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Details of the presentations are:

Combination of 177Lu-lilotomab satetraxetan with rituximab synergistically improves in-vivo therapeutic efficacy in a rituximab-resistant non-Hodgkin lymphoma (NHL) model

Authors: M.M. Malenge, A.H. Ree, T. Stokke, J. Dahle and A.H.V. Repetto-Llamazares
Abstract: 351 (click to access abstract online)
Session: 42. Oncology, Basic and Translational (Basic Science) III
Date/time: 24 June, 17:25-17:35 Pacific daylight time (PDT)

Targeted alpha therapy with 212Pb-NNV003 for the treatment of CD37 positive B-cell chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL)

Authors: A. Saidi, A.F. Maaland, J. Torgue, H. Heyerdahl and J. Dahle
Abstract: 354 (click to access abstract online)
Session: 42. Oncology, Basic and Translational (Basic Science) III
Date/time: 24 June, 17:55-18:05 PDT
The posters will be added to www.nordicnanovector.com in the section What We Do/Scientific Publications/Scientific Posters on 24 June to coincide with the sessions in which they are presented.

On June 11, 2019 GT Biopharma, Inc. (GTBP) and (Euronext Paris: GTBP.PA) (the "Company"), an immuno-oncology biotechnology company focused on innovative treatments based on the Company’s proprietary platforms, reported preliminary clinical data taken from an interim review, or snapshot, of the OXS-1550 Phase 1/2 trial following a Bi-Specific Antibody Drug Conjugate (ADC) Advisory Board meeting and follow up discussions (Press release, GT Biopharma , JUN 11, 2019, View Source [SID1234539529]). OXS-1550 is a bi-specific scFv recombinant fusion protein-drug conjugate composed of the variable regions of the heavy and light chains of anti-CD19 and anti-CD22 antibodies and a modified form of diphtheria toxin, its cytotoxic drug payload. OXS-1550 targets cancer cells expressing the CD19 receptor, the CD22 receptor or both receptors.

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OXS-1550 is being evaluated in an open-label, two-stage, investigator-led, Phase 1/2 trial at the Masonic Cancer Center, University of Minnesota. The trial has two arms including patients diagnosed with relapsed/refractory B-cell lymphomas (NHL) and leukemias (ALL). Eighteen patients have been enrolled to date, including 12 NHL and six ALL patients. At the time of the interim review, 13 patients met the evaluation criteria, including nine NHL and four ALL patients.

At the interim review more than 50% of patients (seven of 13) exhibited a clinical benefit, defined as stable disease plus partial response or complete remission at Day 29. Of the seven patients, one demonstrated a complete remission (CR), one demonstrated a partial response (PR) and five demonstrated stable disease (SD).

The efficacy signal was most prominent in ALL patients with 75% (three of four) exhibiting clinical benefit including one CR, one PR and one SD. In the NHL population, four of nine patients exhibited SD. Adverse events were mostly grade 1 and 2 and reversible. One patient had a grade 4 low platelet count, two patients had a grade 3 increase in liver function tests, or LFTs, and one patient had a grade 3 capillary leak.

GT Biopharma’s President and Chief Medical Officer (CMO) Dr. Raymond Urbanski said: "In light of these data and discussions with the Bi-Specific ADC Advisory Board, I am increasingly encouraged by OXS-1550 and its potential to have a significant role in an oncologist’s armamentarium. I also remain convinced that the bi-specific ADC platform has the potential to generate additional attractive product candidates. I look forward to continuing to work closely with the University of Minnesota team and other members of the Bi-Specific ADC Advisory Board with the goal of optimizing next steps for this program and the broader bi-specific ADC platform."

The Bi-Specific ADC Advisory Board has recommended that additional ALL patients be enrolled in the trial followed by another interim data review. The Company currently expects final data for this trial to be available in the fourth quarter of 2018 or the first quarter of 2019.

The Bi-Specific ADC Advisory Board is composed of distinguish clinicians, academics and researchers from several well-known institutions. Members include Dr. Jeffrey Miller, Deputy Director at the Masonic Cancer Center, University of Minnesota and Chair of GT Biopharma’s Scientific Advisory Board. Dr. Veronika Bachanova, hematologist/oncologist and the principal investigator of the Phase 1/2 study and Dr. Daniel Vallera, lead researcher for the bispecific ADC program, both at the Masonic Cancer Center. Also included are Drs. Mark Litzow and Arthur Frankel. Mark R. Litzow, M.D., is Professor of Medicine in the Division of Hematology at Mayo Clinic. Arthur E. Frankel, M.D., is the inaugural holder of the Arlene and Mayer Mitchell Endowed Chair in Medical Oncology, Chief of Medical Oncology at Mitchell Cancer Institute (USA-MCI), Interim Associate Director for Basic & Translational Sciences and Professor of Oncological Sciences.