On February 22, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported it will host a conference call to discuss the recent discovery of a new molecule for cancer treatment and provide a business update (Press release, Moleculin, FEB 22, 2018, View Source [SID1234524141]). The call will be at 4:30 p.m. ET on Wednesday, February 28, 2018.

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Participants can dial (800) 860-2442 or (412) 858-4600 to access the conference call, or can listen via a live Internet web cast, which is available in the Investor Relations section of the Company’s website at www.moleculin.com. A replay of the call will be available by visiting www.moleculin.com for the 90 days after the call or by calling (877) 344-7529 or (412) 317-0088, confirmation code 10117548, through March 7, 2018.

On February 22, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported the first patient has been dosed in a phase 1 study assessing the safety and tolerability of DS-1062, an investigational TROP2-targeting antibody drug conjugate (ADC), in patients with unresectable advanced non-small cell lung cancer (NSCLC) who are refractory to or have relapsed following standard treatment or for whom no standard treatment is available (Press release, Daiichi Sankyo, FEB 22, 2018, View Source [SID1234524126]).

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With the discovery of driver genes and introduction of targeted therapies, there has been improvement in patient outcomes for certain types of NSCLC. However, for patients with unresectable advanced NSCLC, there is still a need for new therapeutic strategies as the five-year survival rates for patients with advanced stages of NSCLC are low.1

DS-1062 is designed to target and deliver chemotherapy inside cancer cells expressing trophoblast cell-surface antigen 2 (TROP2), which is overexpressed in many cancers including NSCLC.2 Overexpression of TROP2 is a driver in cancer growth and has been associated with decreased patient survival, increased tumor aggressiveness, metastasis, and drug resistance in several tumor types.3

"We are initially focusing on evaluating DS-1062 in patients with advanced NSCLC with potential expansion into other tumor types depending on the results of this early critical test in a study designed to provide evidence supporting unique properties of this particular TROP2 ADC construct," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "With the initiation of this study of DS-1062, we move our third ADC into the clinic and continue to investigate the potential of the smart delivery of chemotherapy in various cancers including lung, breast and gastric cancer."

About the Study
The phase 1, open-label study will investigate the safety and tolerability of DS-1062 in patients with unresectable advanced NSCLC who are refractory to or have relapsed following standard treatment or for whom no standard treatment is available. The first part of the study (dose escalation) will assess the safety and tolerability of increasing doses of DS-1062 to determine the maximum tolerated dose and recommended dose for expansion. The second part of the study (dose expansion) will evaluate the safety and tolerability of DS-1062 at the recommended dose for expansion. Study endpoints include safety, pharmacokinetics, objective response rate, duration of response, disease control rate, time to response, progression-free survival, overall survival, biomarker analysis and immunogenicity. This portion of the study is expected to enroll approximately 40 patients with unresectable advanced NSCLC in the United States and Japan.

Following the outcome of both the dose escalation and dose expansion parts of the study in patients with unresectable advanced NSCLC, there may be two additional expansion cohorts opened for other solid tumors where high expression of TROP2 is frequently observed. For more information about the study, please visit ClinicalTrials.gov.

About DS-1062
Part of the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise, DS-1062 is an investigational TROP2-targeting ADC. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, DS-1062 is a smart chemotherapy comprised of a humanized anti-TROP2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered. DS-1062 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: DS-8201, an antibody drug conjugate (ADC) for HER2-expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/

refractory acute myeloid leukemia (AML) with FLT3-ITD mutations; and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.

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.