On May 17, 2018 Oncolytics Biotech Inc. (TSX:ONC) (OTCQX:ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported an investigator sponsored study (IST) supported by Merck Inc (Press release, Oncolytics Biotech, MAY 17, 2018, View Source [SID1234534183]). (Merck), Northwestern University (Northwestern) and Oncolytics. This study is an extension of the previously reported phase 1 study (REO 024) that will investigate pelareorep in combination with Merck’s anti-PD1 checkpoint inhibitor Keytruda, to treat second line pancreatic cancer patients. The study, run by the principal investigator of REO 024, Dr. Devalingham Mahalingam, will plan to enroll approximately 40 patients with advanced pancreatic cancer and will be conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

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"This study using Merck’s Keytruda is our second I-O combination in human trials after our multiple myeloma study in combination with Celgene’s Imnovid and Revlimid," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We’re very happy with Merck’s increased involvement in our pancreatic studies and believe combining pelareorep with Keytruda poses an exciting opportunity to lay additional groundwork towards our ultimate goal – to expand the use of check point inhibitors as anti-cancer agents by promoting an inflamed phenotype in the tumor, or turning cold tumors hot."

"REO 024, a phase 1b study combining pelareorep and Keytruda in second line pancreatic patients, was designed to evaluate safety and tolerability of the combination," said Dr. Mahalingam, Associate Professor of Medicine (Hematology and Oncology), Northwestern University Feinberg School of Medicine. "The results from that study demonstrated that the combination is safe, but also that there was early evidence of clinical activity, including one patient that had a partial response lasting 17.4 months and two with stable disease of 126 days and 277 days. This new phase two study will enroll patients with advanced pancreatic cancer failing front line chemotherapy and will primarily evaluate overall response rate of the combination therapy. The study will also provide important biomarker data determined by analysis of pre- and post-treatment biopsies and blood-based immune markers."

Final study design and other details will be announced upon enrollment of the first patient, expected in the third quarter 2018.

On May 16, 2018 Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, reported that the independent data monitor committee (IDMC) completed a second, interim analysis of tolerability data from the first eleven treated patients and recommended expansion of the initial cohort to continue enrolment of an additional 20 patients to complete the trial (Press release, Tiziana Life Sciences, MAY 16, 2018, View Source;intolerable-Unresectable-or-Metastatic-Hepatocellular-Carcinoma-HCC-Patients [SID1234526674]).

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This phase 2a multi-centre and multi-country clinical trial (CDKO-125A-010) in sorafenib-refractory or -intolerable patients with unresectable or metastatic HCC is being conducted in Greece, Italy and Israel. Since, this was the first trial with milciclib in HCC patients, a second, interim analysis was scheduled following completion of treatment for the first 11 patients before initiating enrolment of the next 20 patients. Thus, demonstration of good tolerability with acceptable incidence of serious adverse events is an important milestone to initiate a phase 2b trial evaluating combination of milciclib with sorafenib (Nexavar; Bayer Germany (BAYN.GR)) in HCC patient.

Major findings were as follows:

Milciclib treatment was well-tolerated with manageable drug-related toxicities. The IDMC concluded that there were no major signals of tolerability concerns and therefore favours proceeding to expand enrolment.

Four patients have completed the study per protocol (6 cycles of treatment in 6 months). Two of these patients and their care provider opted to continue receiving milciclib at full dose as part of compassionate use. A third patient is awaiting ethical committee (EC) approval.

Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented: ”Establishment of tolerability of milciclib as a single agent in HCC patients is a key pre-requisite to initiate the phase 2b trial to evaluate dosing, tolerability and clinical activity of milciclib in combination with sorafenib (Nexavar; Bayer Germany) in HCC patients”.

Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences, commented: "We are pleased with the conclusion of IDMC that milciclib treatment showed no major signals of tolerability concerns in sorafenib-refractory or -intolerable HCC patients. These findings are consistent with the findings reported earlier on the long-term tolerability and clinical activity of milciclib in thymic carcinoma, thymoma1 and other solid cancers2. Results from these clinical studies strongly warrant further clinical development of milciclib for treatments of HCC and other cancers".

Cited References

1. Press Release on announcement of clinical data in thymoma and thymic carcinoma.
www.tizianalifesciences.com

2 . Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. (2017). Phase I dose-escalation study of Milciclib in combination with gemcitabine in patients with refractory solid tumors. Cancer Chemother Pharmacol. 79:1257-1265

About Hepatocellular Carcinoma

Hepatocellular cancer is the 5th most common cancer and the 3rd cause of cancer mortality worldwide. In 2007 the approval by the European Medical Agency (EMA) and Food and Drug Administration (FDA) of sorafenib in HCC represented the first systemic therapy for improving outcome in patients unsuitable for loco-regional and surgical therapies and created a new standard of treatment for the disease. However, although significant in respect to placebo, the benefits of sorafenib are modest; the response rate is less than 3%, the improvement in median survival is 2-3 months and the drug-related symptoms are not ordinary. Therefore, more effective systemic therapy is required for both naive patients presenting with unresectable, advanced stage and those who suffer recurrence after curative treatments (resection, ablation and transplantation).

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases (CDKs) such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in thymic carcinoma, pancreatic carcinoma and colon cancer.

About Sorafenib

Sorafenib (co-developed and co-marketed by Bayer and Onyx Pharmaceuticals as Nexavar) is a small molecular multi tyrosine kinase inhibitor drug approved for the treatment of primary kidney cancer (advanced renal cell carcinoma), advanced primary liver cancer (HCC), and radioactive iodine resistant advanced thyroid carcinoma. Treatment with sorafenib induces autophagy, which may suppress tumor growth. However, autophagy can also cause drug resistance.

On May 16, 2018 BerGenBio ASA (OSE: BGBIO) reported that the company and its collaborators will present new interim clinical and biomarker data from its extensive Phase II clinical development programme with bemcentinib, a selective, oral AXL inhibitor, at the 2018 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) at McCormick Place in Chicago, IL (1-5 June 2018) (Press release, BerGenBio, MAY 16, 2018, View Source [SID1234526697]). Abstracts are now available online at View Source and details of the presentations are below. The posters presented at ASCO (Free ASCO Whitepaper) will be made available on www.bergenbio.com in the Investors / Presentations section following the sessions.

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Presentations at ASCO (Free ASCO Whitepaper)
Monday 4 June, 8:00 AM – 11:30 AM Central Daylight Time (Hall A)

Phase II open-label, multi-centre study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC.
James Lorens, PhD et al
Session: Developmental Therapeutics – Immunotherapy
Poster Board: #292, Abstract 3078
Identification of predictive and pharmacodynamic biomarkers associated with the first-in-class selective AXL inhibitor bemcentinib across multiple Phase II clinical trials.

Robert J Holt, PhD et al
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Poster Board: #385, Abstract 2559
Analysis of anti-leukemic activity, predictive biomarker candidates, immune activation and pharmakodynamics in R/R AML and MDS in response to treatment with bemcentinib (BGB324), a first-in class selective AXL inhibitor, in a Phase II open-label, multi-centre study.

Bjørn T. Gjertsen, MD, PhD et al
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Poster Board: #80, Abstract 7020
To be discussed at the Poster Discussion Session on Monday 4 June, 11:30 AM – 12:45 PM, at E450
Monday 4 June, 1:15 PM – 4:45 PM CDT (Hall A)

A randomized Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma.
Oddbjørn Straume, MD, PhD et al
Session: Melanoma/Skin Cancers
Poster Board: #375, Abstract 9548
BerGenBio reception
Coinciding with ASCO (Free ASCO Whitepaper), BerGenBio will host a reception for collaborators, investors, analysts, media and other interested parties on 2 June at The School of the Art Institute Ballroom in Chicago. At this event, short presentations will be given by clinical investigators participating in the bemcentinib clinical trials and by KOL experts in AXL kinase function. For further details and to receive an invitation, please click here.

The presentations will be made available on BerGenBio’s website in the Investors / Presentations section following the event.

On May 16, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a biotechnology company specializing in the development of innovative drugs in oncology, notably against rare or resistant forms of cancer, reported its consolidated revenues and cash position at March 31, 2018 (Press release, Onxeo, MAY 16, 2018, View Source [SID1234526713]).

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Judith Greciet, Chief Executive Officer of Onxeo, said: "The first quarter of 2018 was highlighted by strong momentum in the development of AsiDNA, our lead product candidate. Following the significant efforts of our R&D team over the previous months, we recently initiated the DRIIV phase I clinical trial in order to evaluate the potential of AsiDNA, our first-in-class DNA repair inhibitor, administered intravenously, in patients with advanced solid tumors. We expect interim data from this study to be available in the second half of 2018. If these results confirm both the safety profile of AsiDNA and its activity, we will have achieved a key milestone in our AsiDNA development program. Importantly, we continue to advance our core R&D programs according to plan while maintaining strict cost control. As such, we expect that our current cash position of €9.2 million will support our currently planned activities until mid-2019, including through multiple potentially value-creating inflection points for our company.

On May 16, 2018 GT Biopharma Inc. (OTCQB: GTBP and Euronext Paris "GTBP.PA" or the "Company")), an immuno-oncology biotechnology company focused on innovative treatments based on the Company’s proprietary platforms, has reported that it expects to file the Investigational New Drug Application ("IND") for OXS-3550, the Company’s most advanced Tri-specific Killer Engager ("TriKE") product candidate, in mid-2018 (Press release, GT Biopharma , MAY 16, 2018, View Source [SID1234539530]).

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GT Biopharma is working in collaboration with the Masonic Cancer Center at the University of Minnesota under a program led by Dr. Jeffrey Miller, Deputy Director. Dr. Miller is a recognized leader in the field of Natural Killer ("NK") cell and IL-15 biology and their therapeutic potential.

"The expected filing of the IND for our first TriKE product candidate in mid-2018 is representative of the overall progress we are making as a company," said Shawn M. Cross, Chairman and Chief Executive Officer of GT Biopharma. "We look forward to updating our shareholders on our progress throughout 2018 as we continue to execute on our objectives."

The IND for OXS-3550 was filed in June 2017 by the University of Minnesota. Before the IND was transferred to the Company in October 2017, the FDA requested that additional preclinical toxicology be conducted prior to initiating clinical trials. The FDA also requested additional information and clarifications on the manufacturing (CMC) and clinical packages. The Company has reported that the requested additional information and clarifications have been completed and are being incorporated into the IND in eCTD format and that it expects to file the IND in mid-2018.