On August 20, 2019 Q BioMed, Inc. (OTCQB: QBIO) and Chemveda Life Sciences are reported the successful chemical synthesis of a unique natural compound that has shown remarkable efficacy as a potential chemotherapy for the treatment of liver cancer (Press release, Q BioMed, AUG 20, 2019, View Source [SID1234538890]). This is a significant advancement for Q BioMed’s portfolio asset "Uttroside B" and the compound’s derivatives as a chemotherapeutic agent against, the most common form of liver cancer.

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Additional confirmatory cell line efficacy data from current testing is expected to be completed in the next few weeks. The collaboration will advance the Q BioMed portfolio asset "Uttroside B" and its derivatives as a potential chemotherapeutic agent against hepatocellular carcinoma. The efficacy of Uttroside B, a potent saponin, against liver cancer was recently demonstrated in a preclinical study published in the November 2016 issue of Scientific Reports, a Nature journal.

The compound was isolated and characterized from the leaves of Solanum nigrum Linn, a plant widely used in traditional medicines. In the Scientific Reports study, researchers showed that in animal models, Uttroside B was ten times more cytotoxic to the HepG2 liver cancer cell line than sorafenib, the only drug approved by the Food and Drug Administration for liver cancer approved at the time and the current first line treatment for hepatocellular carcinoma. Sorafenib has been shown to increase survival by less than 3 months and has significant serious side effects, including hypertension, hemorrhage, and cardiovascular events including decreased blood flow to the heart and heart attacks.

Uttroside B drastically shrunk tumors in mice bearing human liver cancer xenografts. In addition, in pre-clinical experiments Uttroside B induced cytotoxicity in all liver cancer cell lines, and researchers were also able to confirm its biological safety, both by in vitro and in vivo studies.

Denis Corin, Q BioMed CEO said, "Having a synthetic molecule and several derivatives to work with now makes the ultimate production of a clinical drug candidate possible. Along with our collaborators in the project, the Oklahoma Medical Research Foundation and The Rajiv Gandhi Centre for Biotechnology, we will now advance the most promising candidates into preclinical testing and validation over the next few months in anticipation of an orphan drug application and an IND clinical program in early 2020."

Bheema Paraselli, President & CEO, Chemveda Life Sciences said, "Obtaining Uttroside B, even in milligram quantities, from its natural source is very challenging. Our Chemveda scientists achieved the first total synthesis of the molecule, which can now be scaled in large quantities for clinical development and ultimate drug product. Uttroside is one of the most complex natural products we have seen and worked on. We are very glad to have achieved this significant scientific milestone and look forward to ensuring its pre-clinical and clinical success in the fight against liver cancer."

Chemotherapeutic options for liver cancer are limited, and the prognosis of patients remains challenging. According to the Centers for Disease Control and Prevention, it is the second most common cause of cancer deaths worldwide, claiming approximately 750,000 lives each year. In the US, the American Cancer Society estimates that 42,000 people will be diagnosed with liver cancer in 2019 and that 32,000 will die from the disease this year. Liver cancer incidence has more than tripled since 1980 and deaths in the US have increased 56% since 2003.

The Uttroside B technology is covered by a provisional patent application. To see the full Scientific Reports study, go to: View Source

Please visit www.QBioMed.com for more information on our various pipeline products.

On August 20, 2019 Boston Scientific Corporation (NYSE: BSX) is reported to participate in the 2019 Wells Fargo Securities Healthcare Conference on Thursday, September 5, 2019 in Boston (Press release, Boston Scientific, AUG 20, 2019, View Source [SID1234538889]).

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Mike Mahoney, chairman and chief executive officer, and Susie Lisa, vice president, Investor Relations, will participate in a 30-minute question-and-answer session with the host analyst beginning at approximately 8:35 a.m. EDT. A live webcast of the session will be available on the Investor Relations section of the Boston Scientific website at investors.bostonscientific.com. A replay of the webcast will be accessible at investors.bostonscientific.comView Source beginning approximately one hour following the completion of the event.

On August 20, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that Klaas Bakker has been appointed as the new Chief Medical Officer (CMO) for Oncopeptides, starting in November (Press release, Oncopeptides, AUG 20, 2019, View Source [SID1234538888]).

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Johan Harmenberg has reached retirement age and as the company continues to expand its activities, Johan has decided to step down as CMO but continue to work as a member of the company’s medical team.

From 2015 to present Klaas has worked at AstraZeneca in different roles with increasing responsibility and seniority, most recently as VP Medical for their Tagrisso -TDR Franchise with global responsibility. Klaas holds an MD and is a board certified neurosurgeon from the University of Groningen, the Netherlands, and was clinically active at the Groningen University Hospital until 2015. He also holds a PhD in immuno-hematology and has authored over 40 publications in international peer-reviewed journals.

Comment from CEO Jakob Lindberg
"Johan will continue to work as a valued member of our medical team which is important as he has extensive experience and knowledge about melflufen as well as our network of clinicians. I am very pleased that we have been able to attract Klaas to take over as Chief Medical Officer with his global outlook and experience from oncology products in the market as we are rapidly moving towards a potential market authorisation. We welcome Klaas to Oncopeptide’s management team and look forward to working together", says Jakob Lindberg, CEO of Oncopeptides.

For further information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

This information was submitted for publication at 08.00 CET August 20, 2019.

On August 20, 2019 NuCana plc (NASDAQ: NCNA) reported that it has been informed by the Clatterbridge Cancer Centre, the sponsor of the ongoing Phase III ACELARATE study, that the enrollment of new patients has been suspended on the advice of the Independent Safety and Data Monitoring Committee (ISDMC) following completion of a prespecified futility analysis (Press release, Nucana BioPharmaceuticals, AUG 20, 2019, View Source [SID1234538887]). This study has enrolled 200 patients with metastatic pancreatic cancer who were not considered suitable for combination chemotherapy and is designed to evaluate the efficacy and safety of Acelarin monotherapy compared to gemcitabine, with further exploration of patient sub-groups that may derive additional benefit from Acelarin.

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A futility analysis was included in the ACELARATE study design to assess the likelihood of the study achieving its primary objective of Acelarin monotherapy demonstrating at least a 42% reduction in risk of death compared to gemcitabine. This analysis indicated that this efficacy objective was unlikely to be met in this difficult to treat patient population. Upon review of the interim data by the ISDMC, the sponsor decided to suspend recruitment, allow the data to mature and conduct additional sub-group analyses. Patients who are deriving benefit can continue treatment with Acelarin. There are 25 patients who are receiving or have received Acelarin monotherapy and who will continue to be followed by the study sponsor.

Professor Daniel Palmer, Director of the Liverpool CRUK/NIHR Experimental Cancer Medicine Centre and Chief Investigator of the ACELARATE study said: "Metastatic pancreatic cancer remains an area of high unmet need and the population included in ACELARATE have particularly poor outcomes and very limited treatment options. Importantly, there were imbalances in unfavorable prognostic factors for the patients in the Acelarin arm which may have impacted the futility analysis. In particular, 54% of the patients in the Acelarin arm were diagnosed at the most advanced stage T4, compared to 36% of patients in the gemcitabine arm. We need to allow the data to mature and conduct additional analyses, including biomarker assessment, in order to determine the most appropriate course of action."

Professor Palmer continued: "Although this futility analysis indicated that the study was unlikely to achieve its overall survival objective, I am encouraged by the positive survival trends observed in patient sub-groups receiving Acelarin. Furthermore, there were no new safety signals."

Hugh Griffith, NuCana’s Founder and Chief Executive Officer said: "When we agreed to provide Acelarin for this investigator-sponsored study, we were well aware of the challenges of treating patients with metastatic pancreatic cancer. We are encouraged by the positive survival trends in the various sub-group analyses and are committed to working with Professor Palmer and the wider study team to determine the optimal path forward for this study. We also look forward to assessing the data from this monotherapy study and remain excited about our ongoing efforts to develop Acelarin in additional indications and, in particular, our plans to develop Acelarin in combination with platinum-containing agents."

Professor Palmer was also a principal investigator for NuCana’s Phase Ib clinical study (ABC-08) that investigated Acelarin in combination with cisplatin in biliary tract cancer and said: "We look forward to participating in the Phase III NuTide:121 study that will investigate Acelarin plus cisplatin in biliary tract cancer. The data from ABC-08 were very encouraging and we are excited about investigating this combination in a registrational study."

On August 20, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported approval by the Emory University Clinical Trial Review Committee (CTRC) to move forward with an Investigator Initiated clinical trial of Moleculin’s immune-stimulating/transcriptional-modulator, WP1066, for the treatment of pediatric brain tumors (Press release, Moleculin, AUG 20, 2019, View Source [SID1234538886]). The trial will take place at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta.

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"Continued progress with the MD Anderson clinical trial of WP1066 in brain tumors has now cleared the way for a pediatric brain tumor trial with investigators from Emory University School of Medicine," commented Walter Klemp, Moleculin’s Chairman and CEO. "With CTRC approval, the investigators can now submit a request for IND from the FDA for this indication referencing the MD Anderson IND already in place. Consistent with one of our stated development milestones, we continue to expect this IND to be submitted before year end."

Dr. Tobey MacDonald, Professor of the Department of Pediatrics at Emory University School of Medicine, Director of Pediatric Neuro-Oncology at Aflac Cancer and Blood Disorders Center and Principle Investigator for this clinical trial commented: "We’ve done a lot of preclinical research suggesting that WP1066 may be beneficial in treating pediatric brain tumors, including medulloblastoma, where there continues to be a critical unmet need for more effective therapies. We are excited to finally get this trial moving."