On June 12, 2018 Moleculin Biotech, Inc. (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that it has entered into an agreement with the Jagiellonian University in Krakow, Poland, for the development of its STAT3 inhibitor, WP1732, for the treatment of ocular tumors (Press release, Moleculin, JUN 12, 2018, View Source [SID1234527285]).

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"Today there are very limited options for the treatment of ocular tumors," commented Walter Klemp, Chairman and CEO of Moleculin. "And, these tumors are believed to involve a significant upregulation of the activated form of STAT3. It is important to note that, in addition to the ability of WP1732 to inhibit the proliferation and survival of cancer cells in preclinical studies, as STAT3 inhibitor, it is designed to potently block cancer stem cells and induce immune system function to overcome tumor-induced immune tolerance. This could make WP1732 an ideal candidate for targeting these unique and highly metastatic tumors."

Mr. Klemp continued: "We remain committed to targeting accelerated approval pathways for WP1732 by focusing on significant unmet needs. This includes niche indications like ocular tumors and AML, as well as high-profile indications like pancreatic cancer."

On June 12, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the US Food & Drug Administration (FDA) has granted Fast Track designation to Betalutin (177Lu-lilotomab satetraxetan) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies (Press release, Nordic Nanovector, JUN 12, 2018, View Source [SID1234553499]).

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Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: "We are pleased to have been granted Fast Track designation for Betalutin. This designation is based on the promising safety and preliminary efficacy data in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma from the first part of the LYMRIT 37-01 study, and highlights the potential of Betalutin to be a new therapeutic option for these patients. We are now focusing the PARADIGME trial on 3L CD20-refractory FL patients, a population in urgent need of new therapies, and look forward to working with the FDA to advance the development of Betalutin".

PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin dosing regimens (15MBq/kg Betalutin following 40mg lilotomab pre-dosing; 20MBq/kg Betalutin following 100mg/m2 lilotomab pre-dosing) in 3L FL patients. PARADIGME aims to enrol 130 patients across 80-85 sites in approximately 20 countries.

The primary endpoint for the study is overall response rate (ORR) and secondary endpoints include duration of response (DoR), progression free survival (PFS), overall survival (OS), safety and quality of life. An initial efficacy and safety data read-out for PARADIGME is targeted for the first half of 2020.

About Fast Track designation

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. The designation provides the opportunity for more frequent meetings with the FDA over the course of drug development. In addition, the Fast Track programme allows for Rolling Review, which enables a company to submit individual sections of its Biologic License Application (BLA) for review as they are ready, rather than waiting until all sections of the BLA are complete, as well as for eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

-End-

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About Betalutin

Betalutin is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). CD37 is highly expressed in B-cell non-Hodgkin’s lymphoma (NHL), representing a novel therapeutic target. Betalutin is internalised in tumour cells and prolonged exposure of the nucleus to radiation destroys DNA leading to tumour cell death. Betalutin also has a crossfire effect limited to a radius of 40 cells, which destroys surrounding tumour cells. Betalutin has shown promising efficacy and tolerability in the Phase 1/2a LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL) and is currently in a pivotal Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to standard-of-care anti-CD20-based therapy (including rituximab).

On June 12, 2018 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the initiation of a Phase I trial of SRF373, a fully human antibody targeting CD73. SRF373, also known as NZV930, is the second of Surface’s immunotherapies to advance into the clinic this year (Press release, Surface Oncology, JUN 12, 2018, View Source [SID1234527367]).

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CD73 is an enzyme overexpressed by many tumors that is critical to the production of extracellular adenosine which in turn suppresses immune cell function and the ability of the immune system to recognize and attack tumors. In preclinical studies, NZV930 exhibited potent CD73 enzymatic inhibition, resulting in a reduction of adenosine and increased activity of immune cells.

The first-in-human study is being led by Novartis, which was granted a worldwide exclusive license to develop and commercialize NZV930 as part of its broad strategic collaboration with Surface. Under the collaboration, Surface is eligible to receive development and sales milestone payments for NZV930, as well as tiered royalties.

The Phase I study will evaluate the safety, tolerability, and preliminary anti-tumor activity of NZV930 as a single agent and in combination with other cancer immunotherapies. The initial dose escalation portion of the trial will include patients with triple negative breast cancer, ovarian cancer, microsatellite stable colon cancer, pancreatic cancer, non-small cell lung cancer, and renal cell carcinoma.

"We are very excited that Novartis has advanced our second product program into clinical development" said Rob Ross, M.D., chief medical officer of Surface Oncology. "We believe the profile of NZV930 is compelling and targeting adenosine reduction could play an important role in the treatment of patients suffering with a variety of types of cancer."

ABOUT SRF373 / NZV930

NZV930 is a fully human monoclonal antibody designed to inhibit CD73, an enzyme critical to the production of adenosine—an immunosuppressive metabolite within the tumor microenvironment. CD73 is overexpressed by many tumors making it a potential target with broad applicability. In preclinical studies, NZV930 exhibited potent CD73 enzymatic inhibition, resulting in a reduction of adenosine and increased T cell activity. Novartis holds a worldwide exclusive license to develop and commercialize NZV930.

On June 12, 2018 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported that the first patient has been dosed in the company’s Phase 1b portion of the Phase 1a/1b clinical trial of anti-TIGIT (OMP-313M32) in combination with anti-PD1 (nivolumab) (Press release, OncoMed, JUN 12, 2018, View Source [SID1234527286]). TIGIT (T-cell immunoreceptor with Ig and ITIM domains) is a next generation checkpoint receptor, and upon activation by the PVR ligand, a protein broadly expressed on tumor cells, it blocks T-cell activation. OncoMed’s anti-TIGIT candidate is an IgG1 monoclonal antibody checkpoint inhibitor which binds to the human TIGIT receptor on T-cells with a goal of improving the activation and effectiveness of T-cell and NK cell tumor-killing activity.

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"The dosing of the first patient in the Phase 1b portion of the anti-TIGIT trial marks an important milestone in the advancement of this therapeutic candidate through the clinic, where we will be evaluating the potential synergy of our anti-TIGIT monoclonal antibody with anti-PD1," said John Lewicki, Ph.D., president and chief executive officer of OncoMed. "We look forward to continuing our exploration of the potential anti-tumor activity of anti-TIGIT and its ability to combine safely with anti-PD1 in key clinical oncology settings. Simultaneously, dose escalation in the Phase 1a portion of the trial is nearing completion and dose expansion in select tumor types is planned."

The Phase 1b portion of the open-label Phase 1a/1b clinical trial is designed to assess safety, tolerability, preliminary efficacy, and biomarkers with escalating doses of anti-TIGIT in combination with anti-PD1 in the treatment of patients with selected advanced or metastatic solid tumors who have progressed after treatment with anti-PD1 or anti-PD-L1. The Phase 1a/1b trial is being conducted at 5 centers in the U.S., and OncoMed currently plans to enroll approximately 12 patients in the Phase 1b portion of the study. The trial will define a dosing regimen that could provide the basis for expanded studies of anti-TIGIT in combination with anti-PD1.

About TIGIT
TIGIT blocks T-cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed’s anti-TIGIT antibody (OMP-313M32) is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. At the 2018 AACR (Free AACR Whitepaper) Annual Meeting, OncoMed presented preclinical data (Abstract 5627) which demonstrated that anti-TIGIT treatment reduced the abundance of regulatory T-cells (Tregs) within tumors in animal models. Mechanistic studies demonstrated an important contribution of effector function for anti-tumor efficacy. Using a surrogate anti-TIGIT antibody, potent single-agent dose-dependent anti-tumor efficacy was demonstrated on large established CT26 WT tumors. Anti-TIGIT efficacy was shown to require effector function for tumor growth inhibition and biomarker analysis demonstrated reduction of Treg frequency and activation of T-cells and NK cells as part of the mechanism of action of anti-TIGIT. CD226, a co-receptor for TIGIT’s ligands PVR and PVRL2, was significantly upregulated in T-cells, Tregs and NK cells, reflecting a feedback loop activated by the inhibition of TIGIT activity. Additionally in a human tissue study, TIGIT expression on Tregs was found to be considerably higher than on CD8+ T-cells in multiplexed IHC panels across a panel of multiple solid tumors types. This program is part of OncoMed’s Celgene collaboration.

On June 12, 2018 PharmaMar (MSE:PHM) reported that basedmon recent receipt of OS (overall survival) data from lurbinectedin Phase II small-cellmlung cancer studies, including the monotherapy trial presented at ASCO (Free ASCO Whitepaper) on June 3rd that saw an OS of 11.8 months, a protocol amendment was submitted to FDA and other competent authorities to change the primary endpoint of the ATLANTIS Phase III trial from PFS (progression free survival) to OS (Press release, PharmaMar, JUN 12, 2018, View Source [SID1234527288]). The changes will begin when the competent authorities with responsibility for review and approval of the study approve of the changes, which in the US we expect to happen in the next few weeks. The safety of the patients and the integrity of this study are not compromised by these changes. PharmaMar remains blinded to the data, and
continues to expect completion of recruitment in the third quarter of 2018. This means PharmaMar expects the top line data, which is event driven, to readout in the second half of 2019.

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According to Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, "we feel that this change in endpoint to OS given what we have seen in the recent data, including those presented at ASCO (Free ASCO Whitepaper), offers us a better chance for success, especially as we know regulators prefer OS data over a surrogate endpoint subject to interpretation in this type of disease setting."

About Zepsyre
Zepsyre (lurbinectedin, PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

About small-cell lung cancer
SCLC is a very aggressive cancer that usually presents with distant metastases and has already spread at the time of diagnosis, thus limiting the role of traditional approaches and posing a worse prognosis compared to other lung cancer types. The 5-year survival rate is about 5%i About 18% of all the lung cancer cases diagnosed are SCLC, and only in the US more than 34,000 new cases are recorded everyyear. This tumor is strongly associated with tobacco smoking, posing an important public health problemii

After failure to treatment with a platinum-based therapy in first line, the therapeutic alternatives are very limited, and the approval of the last drug for this disease took place 20 years ago.