1stOncology™: Cancer Intelligence Service – Page 13578 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Novocure Announces 10 Oral Presentations and a Special Session on Tumor Treating Fields at the 41st International Engineering in Medicine and Biology Conference

On July 22, 2019 Novocure (NASDAQ: NVCR) reported 10 oral presentations and a special session on Tumor Treating Fields at the 41st International Engineering in Medicine and Biology (EMB) Conference, July 23 through July 27, in Berlin (Press release, NovoCure, JUL 22, 2019, View Source [SID1234537651]). The volume of Tumor Treating Fields presentations marks a record number of abstracts for Novocure at this conference.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The conference, hosted by the IEEE Engineering in Medicine and Biology Society (EMBS) will focus on the theme, "Biomedical engineering ranging from wellness to intensive care." During an innovative and interactive special session on Tumor Treating Fields, a neurosurgeon, a radiologist, two biomedical engineers who have worked on novel solutions to treat brain cancer, and a glioblastoma patient will discuss the treatment process, evaluating candidate therapeutic technologies. The oral presentations will describe studies utilizing numerical simulations to better understand Tumor Treating Fields distribution within the body and how Tumor Treating Fields interact with cells. These studies are setting the foundation for optimizing Tumor Treating Fields dosimetry in treatment planning.

"The EMB Conference showcases the latest technologies, innovations and applications to human health and well-being and provides a roadmap for the future," said Dr. Uri Weinberg, Novocure’s Vice President of Clinical Development. "We are pleased that the focus on Tumor Treating Fields continues to expand at this conference. We look forward to participating in this important scientific exchange and exposing the biomedical engineering community to the science of Tumor Treating Fields therapy."

Oral Presentations

(SaA10.1) Advanced Imaging for monitoring response to TTFields in Glioblastoma patients. S. Mohan. 8:30 to 8:45 a.m. CEST on Saturday, July 27.

(SaA10.2) The Dielectric Properties of Brain Tumor Tissue. M. Proescholdt. 8:45 to 9 a.m. CEST on Saturday, July 27.

(SaA10.6) A computational study of Joule heating during TTFields therapy. P. Cavaleiro. 9:45 to 10 a.m. CEST on Saturday, July 27.

(SaA10.3) Determination of parameter values for conductivity, capacitance and inductance of microtubules and a refined model of their bioelectric circuitry elucidate the mode of action of TTFields. J. Tuszynsk. 9 to 9:15 a.m. CEST on Saturday, July 27.

(SaA10.5) A Theory Connecting Mechanisms Underlying 200 kHz AC Electric Fields Effects on Tumor Cell Structures. K. Carlson. 9:30 to 9:45 a.m. CEST on Saturday, July 27.

(SaA10.2) The Dielectric Properties of Brain Tumor Tissue. M. Proescholdt. 8:45 to 9 a.m. CEST on Saturday, July 27.

(FrA09.1) Skull-Remodeling with Tumor Treating Fields. The Role of Finite Element Methods in Surgery Planning and Treatment Evaluation. A. Korshoej. 8:30 to 8:45 a.m. on Friday, July 26.

(WeC10.3) Adapting water-content based electrical properties tomography for the creation of computational head models of brain tumor patients. C. Wenger. 2:30 to 2:45 p.m. on Wednesday, July 24.

(FrA09.3) Development of a Framework for Tumor Treating Fields Dosimetry and Treatment Planning using Computational Phantoms. Z. Bomzon. 9 to 9:15 a.m. on Friday, July 26.

(WeC10.4) A Method for High-Throughput Creation of Patient Specific Head Models. Z. Bomzon. 2:45 to 3 p.m. on Wednesday, July 24.

Special Session

A physician, an engineer and a patient walk into a room: A team-based approach to developing brain cancer treatments

Details: 2 to 3:30 p.m. CEST on Thursday, July 25

Organizers: Punit Prakash, Govindarajan Srimathveeravalli, Ze’ev Bomzon

About IEEE Engineering in Medicine and Biology Society

IEEE Engineering in Medicine and Biology Society (EMBS) is the world’s largest international society of biomedical engineers. The organization’s 11,000 members reside in some 97 countries around the world. EMBS provides its members with access to the people, practices, information, ideas and opinions that are shaping one of the fastest growing fields in science.

Tiziana Reports Phase 2a Clinical Data with Milciclib Monotherapy in Sorafenib-refractory or -intolerant patients with unresectable or metastatic Hepatocellular Carcinoma

On July 22, 2019 Tiziana Life Sciences plc (NASDAQ: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, reported preliminary topline clinical data from a Phase 2a trial of Milciclib as a monotherapy in patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Tiziana Life Sciences, JUL 22, 2019, View Source [SID1234537650]). The primary endpoint of the study was overall safety. Under compassionate use, a few patients continued with total treatment for up to 16 months. Overall, treatment with Milciclib was well-tolerated and no drug-related deaths were recorded. Secondary endpoints of efficacy including progression-free survival (PFS) and time to progression (TTP) are currently being evaluated and will subsequently be reported.

This Phase 2a trial with Milciclib monotherapy was a multi-centered, single-arm, repeated-dose (100 mg once daily; 4 days on/3 days off every 4 weeks; defining each cycle), 6-month duration study to evaluate the safety, tolerability and anti-tumor activity of Milciclib in sorafenib-refractory or intolerant patients with unresectable or metastatic advanced HCC. This trial enrolled 31 patients in Italy, Greece, and Israel.

Among the 28 evaluable patients, 14 completed the 6-month duration study. Oral treatment with Milciclib was well-tolerated with manageable toxicities. The most frequent adverse events such as diarrhea, ascites, nausea, fatigue, asthenia, fever, ataxia, headache, and rash were manageable.

9 out of the 14 patients, after completing the 6-month trial period, requested to continue the treatment under compassionate use and were approved by their respective ethical committees. Four of the patients received Milciclib for a total of 9, 11, 13 and 16 months. The remaining 5 patients are continuing treatment with Milciclib are at 8th, 9th, 9th, 9th and 11th month currently.

Objective tumor assessments according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) guideline and the conventional RECIST 1.1 criteria are being conducted by Independent Central Review and data will be available in September 2019.

"We are very pleased with the clinical activity and tolerability of Milciclib in these advanced cases of HCC. It is an important milestone to move forward with further clinical development of Milciclib either as a single agent or in combination with other HCC drugs," said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana. These data are consistent with the earlier reported long-term safety and clinical activity of Milciclib in thymic carcinoma, thymoma1 and other solid cancers2.

The global market for liver cancer drugs is estimated to reach $1.47 billion by 2022. The current standard of care drugs is not entirely satisfactory due to low response rates and severe toxicities. Importantly, patients often become resistant or unresponsive to the treatment. Milciclib works through a unique mechanism of action and the Company therefore believes it may have the potential for long-term efficacy with a good safety profile in a larger subset of patients.

The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

Cited References

1. Besse, B., Garassino, M., Rajan, A., Novello, S., Mazieres, J., Weiss, G., Kocs, D., Barnett, J, Davite, C, Crivori, P and G. Giaccone. Efficacy of milcicilib (PHA-848125AC), a pan-cyclin D -dependent kinase inhibitor in tow phase II studies with Thymic carcinoma and B3 thymoma patients. (2018) J. Clin. Onc 36 (15 suppl): 8519

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.

Receive news and updates from Tiziana Life Sciences Plc by signing up to get email alerts straight to you on View Source

ESMO Accepts Trovagene AML Clinical Trial Abstract for Oral Presentation

On July 22, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company, reported the acceptance of three abstracts for presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference to be held from Sept. 27 to Oct. 1, 2019, in Barcelona (Press release, Trovagene, JUL 22, 2019, View Source [SID1234537649]).

"Having our AML clinical trial abstract chosen for an oral presentation by the ESMO (Free ESMO Whitepaper) Scientific Committee, indicates that we have achieved, with this trial, a level of interest in onvansertib that warrants a high profile venue for communicating its potential as a novel, first-in-class, PLK1 inhibitor to address this difficult-to-treat cancer," said Tom Adams, PhD, Chief Executive Officer and Chairman of Trovagene. "Additionally, onvansertib’s extension into solid tumor cancers will be showcased in a poster presentation providing an overview of our Phase 1b/2 trial in KRAS-mutated mCRC. As we continue evaluating onvansertib in other indications, we are also pleased to have a poster that will present preclinical data showing synergy in combination with paclitaxel in TNBC. ESMO (Free ESMO Whitepaper) is the ideal forum at which to present these data as this conference gathers leading experts across the oncology field."

The abstract accepted for an oral presentation (Abstract #2411), "Polo-like Kinase Inhibitor, Onvansertib, in Combination with Low-Dose Cytarabine or Decitabine in Patients with Relapsed/Refractory Acute Myeloid Leukemia in Phase 1b," will be presented by Amer Zeidan, MBBS, MHS, Yale University, and will feature safety and preliminary efficacy data, including patients who achieved a complete response, as well as biomarker data and correlation with treatment response.

In addition, there will be two poster presentations at the conference. The first poster presentation (Abstract #3695), "A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation," will be presented by Heinz-Josef Lenz, MD, USC Norris Comprehensive Cancer Center, and will feature preliminary safety and efficacy data, as well as biomarker data showing changes in the KRAS mutation burden in patients treated in the initial dose level cohort.

The second poster presentation (Abstract #5818), "Polo-like Kinase 1 Inhibitor Onvansertib Synergizes with Paclitaxel in Breast Cancer Carrying p53 Mutation," will be presented by Antonio Giordano, MD, PhD, Medical University of South Carolina, and will feature preclinical in vivo data demonstrating synergy of onvansertib in combination with paclitaxel in xenograft models of triple-negative breast cancer carrying the p53 mutation.

About Onvansertib

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Trovagene believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.

Trovagene has an ongoing Phase 1b/2 clinical trial of onvansertib in combination with low-dose cytarabine or decitabine in patients with relapsed or refractory AML that was accepted by the National Library of Medicine (NLM) and is now posted to www.clinicaltrials.gov, with a NCT number of NCT03303339. Onvansertib has been granted orphan drug designation by the FDA in the U.S. and by the EC in the European Union for the treatment of patients with AML.

Trovagene has an ongoing Phase 2 clinical trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga. The trial was accepted by the NLM and is now posted to www.clinicaltrials.gov, with a NCT number of NCT03414034.

Trovagene has an ongoing Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation. The trial was accepted by the NLM and is now posted to www.clinicaltrials.gov, with a NCT number of NCT03829410. The trial is being conducted at three prestigious cancer centers: USC Norris Comprehensive Cancer Center, Hoag Cancer Center and The Mayo Clinic.

Trovagene licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.

Spectrum Announces Expansion of the Poziotinib Clinical Program

On July 22, 2019 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that it is further expanding its poziotinib clinical program by adding three new cohorts in its cornerstone poziotinib clinical trial, ZENITH20 (Press release, Spectrum Pharmaceuticals, JUL 22, 2019, View Source [SID1234537648]). The ZENITH20 trial is an open-label, multi-center, global phase 2 trial with sites in the U.S., Canada, and Europe, evaluating the impact of poziotinib treatment on non-small cell lung cancer (NSCLC) patients.

"With increased use of osimertinib as the treatment of first-line NSCLC patients with classical EGFR mutations, the emergence of osimertinib resistance is a growing occurrence in this setting," said Jeffrey Clarke, MD, Assistant Professor of Medicine at Duke University Hospital/Duke Cancer Institute. "One resistance pattern that is emerging is through the development of an additional EGFR mutation and recent pre-clinical publications suggest that poziotinib may be active against EGFR-dependent resistance mechanisms. Exploring the role of poziotinib as an investigational therapeutic option for those patients who fail first-line osimertinib and for those who have de novo atypical mutations is an exciting development and requires clinical confirmation."

Three new cohorts are currently open to patient enrollment in the ZENITH20 trial. Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Cohort 6 includes NSCLC patients with classical EGFR mutations who progressed while on treatment with first-line osimertinib and developed an additional EGFR mutation. Cohort 7 includes NSCLC patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains. All three new cohorts are now open to enrollment.

"Strong preclinical evidence led to the development of poziotinib in exon 20 mutations. Similarly guided by elegant science, we are expanding the poziotinib program to evaluate its potential in patients with additional difficult to treat mutations in non-small cell lung cancer," said Francois Lebel, M.D., F.R.C.P.C., Chief Medical Officer of Spectrum Pharmaceuticals. "The emergence of osimertinib resistance and the lack of effective treatments for atypical mutations are growing treatment voids that poziotinib may be uniquely suited to fill."

The ZENITH20 trial now consists of seven cohorts of NSCLC patients. Cohorts 1 (EGFR) and 2 (HER2) are in previously-treated NSCLC setting and are fully enrolled. Cohort 3 (EGFR) and 4 (HER2) are in the first-line setting and are currently enrolling patients. Cohorts 1- 4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is objective response rate (ORR). Additional endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and safety. Topline results from cohort 1 are expected in Q4 2019.

"Our poziotinib clinical program is aggressive, proactive and designed to provide us with a full understanding of poziotinib’s potential impact on non-small cell lung cancer," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Thus far, we are pleased with the rapid recruitment and are eagerly awaiting our first topline readout in patients with previously treated EGFR exon 20 insertion mutations in the fourth quarter of this year."

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR (HER1) as well as HER2 and HER4. Importantly this leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer.

Spectrum received exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several trials in multiple solid tumors.

Xenetic Biosciences, Inc. Closes $15.0 Million Underwritten Public Offering and Completes Acquisition of Innovative CAR T Technology Platform

On July 22, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that it closed its previously announced $15.0 million underwritten public offering (Press release, Xenetic Biosciences, JUL 22, 2019, View Source [SID1234537647]). In conjunction with the closing of the offering, Xenetic completed its previously announced acquisition of the novel CAR T ("Chimeric Antigen Receptor T Cell") platform technology, called "XCART," a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, which has demonstrated proof-of-mechanism in B-cell Non-Hodgkin lymphomas. The XCART technology, developed by The Scripps Research Institute ("Scripps") in collaboration with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, is believed to have the potential to significantly enhance the safety and efficacy of cell therapy for B-cell lymphomas by generating patient- and tumor-specific CAR T cells.

"We believe that the XCART technology platform has the capability to expand the potential of CAR T cell therapy, an area driving new breakthroughs in the treatment of cancer. We are incredibly pleased to have closed this acquisition and look forward to leveraging this innovative technology to propel Xenetic into its next phase of growth," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "The XCART platform has demonstrated proof-of-mechanism and promising preclinical evidence of target specificity. We believe this acquisition positions us to drive momentum in the innovation and development of new oncology therapeutics where there remains significant unmet need. Our R&D efforts will initially focus on leveraging the XCART platform to develop cell-based therapeutics for the treatment of B-cell Non-Hodgkin lymphomas, an initial global market opportunity estimated to exceed $5 billion per year." [1]

The XCART technology platform was designed by its originators to utilize an established screening technique to identify peptide ligands that bind specifically to the unique B-cell receptor ("BCR") on the surface of an individual patient’s malignant tumor cells. The peptide is then inserted into the antigen-binding domain of a CAR, and a subsequent transduction/transfection process is used to engineer the patient’s T cells into a CAR T format which redirects the patient’s T cells to attack the tumor. Essentially, the XCART screening platform is the inverse of a typical CAR T screening protocol wherein libraries of highly specific antibody domains are screened against a given target. In the case of XCART screening, the target is itself an antibody domain, and hence highly specific by its nature. The XCART technology creates the possibility of personalized treatment of lymphomas utilizing a CAR with an antigen-binding domain that should only recognize, and only be recognized by, the unique BCR of a particular patient’s B-cell lymphoma.

An expected result for XCART is limited off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.

Under the terms of the acquisition, Xenetic acquired all outstanding shares of Hesperix S.A., a newly-formed Swiss entity to which all XCART owners and inventors other than Scripps have assigned their rights to XCART, and exclusively licensed Scripps’ rights in the technology, in exchange for an aggregate 625,000 shares of Xenetic common stock.

Maxim Group LLC served as the strategic advisor to Xenetic and provided a fairness opinion to the special committee of the Board of Directors of Xenetic in connection with the acquisition.

About the Offering

Under the terms of the underwriting agreement, Xenetic sold 2,300,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and also issued warrants to purchase up to an aggregate of 2,300,000 shares of the Company’s common stock. Each share of common stock was sold together with one warrant to purchase one share of common stock at a combined price to the public of $6.50 per share and warrant. The gross proceeds to Xenetic from the underwritten public offering were approximately $15.0 million before deducting underwriting fees and other offering expenses.

Xenetic also has granted to the underwriter a 45-day option to purchase up to an additional 345,000 shares of common stock and/or warrants to purchase up to 345,000 shares of common stock, at the public offering price less discounts and commissions. On July 19, 2019, the underwriter exercised its overallotment option with respect to 160,000 warrants resulting in additional proceeds of $1,600.

The warrants are immediately exercisable at a price of $13.00 per share of common stock and will expire five years from the date of issuance. The warrants are expected to begin trading on the Nasdaq Capital Market on July 19, 2019 or as soon thereafter as practicable, under the symbol "XBIOW." The warrants also provide that if the weighted-average price of common stock on any trading day on or after 30 days after issuance is lower than the then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis for one share of common stock.

Maxim Group LLC acted as sole book-running manager in connection with the offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus relating to the shares of common stock, pre-funded warrants and warrants was filed by Xenetic Biosciences, Inc. with the SEC. Copies of the prospectus relating to the underwritten offering can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.