On February 22, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it has submitted annual safety summaries for 2017 on both Piclidenoson and Namodenoson to regulatory authorities around the world (Filing, 6-K, Can-Fite BioPharma, FEB 22, 2018, View Source [SID1234524124]).

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The safety reports, known as Development Safety Update Reports (DSURs), are required annually and serve to create timely and transparent communication between drug development sponsors and regulatory agencies. The DSURs summarize safety data from all clinical trials conducted during the year-long reporting period. Can-Fite is pleased to note that both of its molecules under clinical development continue to demonstrate favorable safety profiles in human clinical trials.

In the DSUR for Piclidenoson, Can-Fite notes that there were no deaths, serious adverse events (SAEs), serious adverse reactions (SARs), or suspected unexpected SARs (SUSARs) related to the use of the drug to treat inflammatory diseases during 2017. Furthermore, over the span of development, an estimated 1167 human subjects have received Piclidenoson, without evidence of emerging treatment-limiting toxicities. The Namodenoson development program includes patients with advanced hepatocellular carcinoma (liver cancer), in whom serious adverse events, cancer progression, and mortality are expected and occurred; nevertheless, despite the underlying illness of this population, no SARs or SUSARs were reported during 2017. To date, an estimated 115 human subjects have been dosed with Namodenoson, again without evidence of novel safety concerns.

Both Piclidenoson and Namodenoson target the A3 adenosine receptor, overexpressed in pathological but not in normal body cells. This means that when the drugs enter the body they specifically bind to the diseased but not to the normal cells. This unique drug characteristic is believed to account for the observed favorable safety profile.

The importance of these favorable data allow the Company to continue with the various clinical indications entailing Piclidenoson for the Phase III study in patients with rheumatoid arthritis and Namodenoson for the Phase II studies in advanced liver cancer and NAFLD/NASH.

Dr. Michael Silverman, Can-Fite’s Medical Director, commented: "Can-Fite’s Piclidenoson and Namodenoson drugs are unique in today’s autoimmune inflammatory, oncology and NASH drugs under development due to their favorable safety profile and the specific anti-inflammatory and anti-cancer effects. We are very happy to continue with our clinical development programs."

About Piclidenoson (CF101)
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies. Piclidenoson is currently under development for the treatment of autoimmune inflammatory diseases including rheumatoid arthritis (Phase III ongoing) and psoriasis (completed Phase II/III).

About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On February 22, 2018 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com) ("Provectus" or the "Company"), a clinical-stage biotechnology company developing the first small molecule oncolytic immunotherapy for solid tumor cancers, reported an update on the Company’s gastrointestinal ("GI") cancer clinical development program for its lead investigational drug PV-10, which is administered percutaneously when targeting GI cancer tumors (Filing, 8-K, Provectus Biopharmaceuticals, FEB 22, 2018, View Source [SID1234524118]).

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Provectus’ Phase 1 study of patients with hepatic lesions (a "basket study" open to patients with different hepatic tumor types and entitled A Study to Assess PV-10 Chemoablation of Cancer of the Liver, NCT00986661) has treated 18 patients at four U.S. sites to date: six patients with hepatocellular carcinoma ("HCC"), six patients with metastatic colorectal cancer ("mCRC") metastatic to the liver, and six patients with breast cancer, lung cancer, melanoma, ovarian cancer or pancreatic cancer liver metastases. A fifth U.S. site is currently projected to enroll patients in the first half of 2018 and focus on uveal melanoma metastatic to the liver.

The most recent data from this basket study was presented at the 9th Annual Symposium of Clinical Interventional Oncology ("CIO") in Hollywood, Florida on February 4-5, 2017 (a similar presentation was made at the 26th Conference of the Asian Pacific Association for the Study of the Liver in Shanghai, China on February 15-19, 2017). Results included:

● Two of six patients with HCC who remained alive for 58 and 75 months after treatment, the latter with no evidence of disease;

● Four of five patients with mCRC liver metastases who remained alive 9 to 73 months after treatment, including one patient with no evidence of disease at 73 months; and

● One patient with pancreatic cancer liver metastases who remained alive 12 months after treatment.

Evidence of tumor destruction in both target (injected) and bystander (non-injected) lesions was displayed. A copy of the CIO poster presentation is available on Provectus’ website. Provectus currently plans to present updated data from this basket study at a medical conference in the second half of 2018.

In February 2017, researchers at the University of Illinois at Chicago published work elucidating PV-10’s mechanism of action in colon cancer, whereby PV-10 may induce immunogenic cell death that contributes to specific antitumor immunity.1

In April 2017, the first patient was treated in the Company’s first expansion trial of the GI cancer program (A Phase 1 Study of PV-10 Chemoablation of Neuroendocrine Tumors Metastatic to the Liver, NCT02693067). The patient, who had multifocal disease refractory to Lutate (177Lu-DOTA-octreotate, a radio-labelled somatostatin analog; also known as LUTATHERA, which was approved earlier this month by the U.S. Food and Drug Administration), received percutaneous PV-10 to a single neuroendocrine tumor ("NET") metastasis, and subsequently received a second injection of PV-10 to a second NET metastasis.2 Since then, a second patient received a first injection.2 Provectus currently plans to present preliminary data from this study at a medical conference in the second half of 2018.

Provectus is planning to initiate a second expansion of its GI cancer program focused on metastatic pancreatic cancer. This new study will be the first clinical combination use of PV-10 in GI cancer:

● The study, with the preliminary title A Phase 1b/2 study of percutaneous PV-10 neoadjuvant to chemotherapy for metastatic pancreatic cancer, builds on the data from the Company’s hepatic basket and NET trials to address pancreatic cancer that has metastasized to the liver. Prior preclinical work by Moffitt Cancer Center established that PV-10 has therapeutic activity in pancreatic cancer murine models as both a single agent and in combination with gemcitabine, a standard chemotherapeutic agent used to treat this disease.3

Dominic Rodrigues, Chairman of the Company’s Board of Directors, said, "GI cancers as a group are responsible for more deaths than any other disease type. Provectus and its research collaborators have independently established PV-10 as an oncolytic immunotherapy in melanoma4, colon cancer, and pancreatic cancer. We will expand our GI cancer clinical development program by continuing to initiate trials where PV-10, either as a single agent or in combination with another class of agent, may address multiple different indications with substantial unmet need or that are rare diseases."

On February 22, 2018 -OncoPep, Inc. reported the initiation of a Phase 1b clinical trial evaluating its investigational vaccine product PVX-410 for the treatment of patients with metastatic triple negative breast cancer (TNBC) who are human leukocyte antigen A2 positive (HLA-A2+) (Press release, OncoPep, FEB 22, 2018, View Source [SID1234524117]). The investigator-sponsored study led by Steven Isakoff, M.D., Ph.D., at Massachusetts General Hospital, will assess the safety, tolerability and immune response to PVX-410 alone and in combination with the checkpoint inhibitor pembrolizumab (Keytruda, Merck, Inc.). PVX-410 is a multi-peptide investigational therapeutic cancer vaccine which may act to help stimulate an immune response against cancer cells.

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"This study will help determine if PVX-410 and pembrolizumab administered together can help the body’s immune system to recognize and potentially reduce or stabilize tumors in patients with metastatic triple negative breast cancer," said Dr. Isakoff, Associate Director for Breast Cancer Clinical Research at the Massachusetts General Hospital Cancer Center and Assistant Professor in Medicine at Harvard Medical School. "TNBC continues to be a disease with poor prognosis that disproportionally affects premenopausal women and African-American women and new treatment options beyond chemotherapy are desperately needed. I am pleased to be involved with this research initiative and look forward to assessing PVX-410 in this unique combination."

The open label, multi-center Phase 1b study is designed to evaluate the safety and immune response to PVX-410 alone and in combination with pembrolizumab in HLA-A2+ patients with metastatic TNBC. Patients will receive weekly injections of PVX-410 for six consecutive weeks, followed by booster PVX-410 vaccine doses at Week 10 and Week 28. Pembrolizumab will be administered every three weeks intravenously starting with Week 1. The trial is expected to enroll a total of approximately 20 patients at multiple trial sites, including Massachusetts General Hospital, Beth Israel Deaconess Medical Center and the Dana Farber Cancer Institute. More information on the trial can be found at clinicaltrials.gov, identifier number NCT03362060.

"OncoPep is now advancing multiple clinical studies of its investigational vaccine product PVX-410 as a stand-alone and combination treatment, including this new study with pembrolizumab in metastatic triple negative breast cancer and an on-going investigator-sponsored study in combination with durvalumab (Infinzi, MedImmune/AstraZeneca), an antibody against the PD-L1 ligand, in the adjuvant setting for patients with stage II or stage III triple negative breast cancer," said Doris Peterkin, Chief Executive Officer of OncoPep. "We are thrilled with the progress of our cancer immunotherapy program and the initiation of this Phase 1b investigator sponsored clinical trial in metastatic triple negative breast cancer and to be working with Dr. Isakoff’s team." More information on the adjuvant TNBC trial of PVX-410 in combination with durvalumab can be found at clinicaltrials.gov, identifier number NCT02826434.

About Triple Negative Breast Cancer
Triple negative breast cancer (TNBC) is a form of breast cancer that lacks the three receptors found most commonly on breast cancer cells: estrogen receptor (ER), progesterone receptor (PR), and hormone epidermal growth factor receptor 2 (HER-2). TNBC accounts for approximately 15-20% of all breast cancer cases and is more likely to spread and recur than other forms of breast cancer. TNBC disproportionally affects premenopausal women and African-American women. Patients diagnosed with metastatic TNBC have a median survival of just over 1 year, and patients with early stage TNBC have a median 5-year survival of 77% compared to 93% for non-TNBC. Residual disease after neoadjuvant chemotherapy (non-pathologic complete response) predicts a poor prognosis with nearly half of such patients experiencing a recurrence within 5 years.

About PVX-410
PVX-410 is a novel investigational therapeutic cancer vaccine currently in Phase 1b clinical trials in smoldering multiple myeloma and triple negative breast cancer. PVX-410 consists of four peptides from unique regions of three tumor -associated antigens which may act to help stimulate an immune response to the targeted tumor cell. PVX-410 was granted orphan drug designation from the U.S. Food and Drug Administration in 2013 for the treatment of multiple myeloma.

On February 22, 2018 MabSpace Biosciences reported on February 16th, 2018 FDA cleared Investigational New Drug (IND) for MSB2311, a humanized programmed death protein-ligand 1 (PD-L1) antibody for the treatment of patients with locally advanced/metastatic solid tumors (Press release, Mabspace, FEB 22, 2018, View Source [SID1234524110]). MabSpace plans to start a first-in-human, open label, multiple center, dose escalation and dose expansion study of MSB2311 in patients with locally advanced or metastatic solid tumors.

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PD-L1 is a key checkpoint protein employed by tumor cells to escape host immune surveillance. Multiple antibodies inhibiting PD-L1 have been approved by FDA for the treatment of various solid tumors. MSB2311 is differentiated by its distinct binding epitope and unique pH dependent PD-L1 binding and recycling property. MSB2311 is a human IgG1 with no FcR binding ability and thus has no ADCC-inducing activity. MSB2311 has shown to be safe in non-human primate and efficacious in multiple mouse tumor models, and has exhibited robust CMC profile.

MabSpace is a global biotechnology company focused on discovering and developing innovative antibody therapeutics using its proprietary immune tolerance breaking technology. MabSpace has built a pipeline focused on immuno-oncology with MSB2311 as its first molecule entering into clinic. With a panel of pipeline antibody molecules targeting various pathways regulating tumor immune cycle, MSB2311 will also serve as a key backbone agent for combination approach.

"The approval of MSB2311 IND by FDA marks an important milestone for MabSpace. Although there are several antibodies with pH dependent recycling property in late stage development, MSB2311 is the only PD-L1 antibody with this property globally. We are excited about this molecule in providing a differentiated and potentially more efficacious therapeutic agent for cancer patients around the world," said Xueming Qian, Ph.D, Founder, Chairman and CEO of MabSpace.

On February 22, 2018 Pieris Pharmaceuticals presented Investor Presentation, dated February 2018 (Presentation, Pieris Pharmaceuticals, FEB 22, 2018, View Source [SID1234524152]).

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