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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Sophiris Bio has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Sophiris Bio, 2018, MAR 21, 2018, View Source [SID1234524923]).

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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Cellectar Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Cellectar Biosciences, 2018, MAR 21, 2018, View Source [SID1234524922]).

AVEO Oncology Announces Publication of Long-term Follow-up Results from TIVO-1 Extension Study (Study 902) in TKI Refractory RCC

On March 21, 2018 AVEO Oncology (NASDAQ: AVEO) reported the publication of long-term follow-up results from Study 902, where patients were treated with tivozanib (FOTIVDA) as second-line treatment in advanced renal cell carcinoma (aRCC), in the European Journal of Cancer (Press release, AVEO, MAR 21, 2018, View Source;p=RssLanding&cat=news&id=2339191 [SID1234525460]). The publication, titled "Efficacy of Tivozanib Treatment after Sorafenib in Patients with Advanced Renal Cell Carcinoma: Crossover of a Phase 3 Study," was published online first and is available here. Tivozanib is an oral, once-daily, potent and highly selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).

In Study 902, a total of 161 patients with aRCC received tivozanib as second-line treatment subsequent to disease progression on sorafenib in the Phase 3 TIVO-1 study. As previously reported, median progression-free survival and median overall survival were 11.0 months and 21.6 months, respectively. Overall response rate was 18% and stable disease was 52% for an overall disease control rate of 70%. Tivozanib was generally well tolerated, with adverse events consistent with those observed in previous tivozanib trials. The activity shown in TKI refractory patients compares favorably with data published for other TKI agents in a similar population.

"Publication of Study 902 underscores the activity of tivozanib in the refractory setting, with evidence of encouraging clinical responses, disease control and overall survival outcomes in patients previously treated with a VEGFR TKI," said Michael Needle, M.D., chief medical officer of AVEO. "We believe these efficacy and safety findings in refractory patients support the rationale for our ongoing Phase 3 TIVO-3 study. We anticipate that the results of the TIVO-3 study, together with the results of the previously completed TIVO-1 trial of tivozanib in the first-line treatment of aRCC, will serve as a key component for a potential regulatory approval of tivozanib in the U.S. as a first- and third-line treatment for aRCC. When completed, TIVO-3 will be among the only large randomized datasets in third-line disease, a sizable and growing treatment segment thanks to advances in earlier lines of treatment, and in patients progressing on prior immunotherapy. Based on the current rate of progression-free survival events, we expect top-line results from this study to read out in the second quarter of this year."

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (aRCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models, enabling potentially enhanced activity when used in combination with immune modulating therapy. As part of a North American registration plan, tivozanib is currently being studied in the Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

Checkpoint Therapeutics Initiates Dose Expansion Portion of Phase 1 Trial of Anti-PD-L1 Antibody CK-301

On March 21, 2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a
clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development
and commercialization of novel treatments for patients with solid tumor cancers, reported the
completion of the dose escalation portion of the ongoing Phase 1 clinical trial of CK-301, a fully human
anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and the initiation of the first dose
expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks (Press release, Checkpoint Therapeutics, MAR 21, 2018, View Source [SID1234525087]).
James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "The completion of the dose
escalation portion of our Phase 1 trial marks an important milestone in the clinical development of our
anti-PD-L1 antibody, CK-301. Our focus now shifts to generating efficacy data in the dose expansion
portion of the trial through the enrollment of patients with tumor types believed to have a high potential
for objective response to anti-PD-L1 monotherapy. We look forward to reporting initial data from this
expansion cohort in the second half of 2018, and are targeting the initiation of our first registration trial
in first-line non-small cell lung cancer in the first quarter of 2019."

Preliminary data from the dose escalation portion of the Phase 1 trial suggest that CK-301 is safe and well
tolerated across three fixed dose levels ranging from 200 mg to 800 mg administered every two weeks.
Treatment-related adverse events were mild to moderate and consistent with other approved PD-L1
antibodies. No dose-limiting toxicities have been reported and no patients have discontinued therapy to
date.

Based on these data, Checkpoint has commenced its first dose expansion cohort evaluating the fixed dose
of 800 mg, the highest dose tested in dose escalation, every two weeks in up to 40 checkpoint therapynaïve
patients with select tumor types associated with high clinical response rates to anti-PD-1/L1
monotherapies, with a priority on enrolling first-line non-small cell lung cancer patients whose tumors
have high PD-L1 expression.
Additional information on the trial can be found on www.clinicaltrials.gov using the identifier
NCT03212404.

About the Phase 1 CK-301 Trial

The Phase 1, first-in-human, open-label, multicenter trial is evaluating the safety and tolerability of
ascending doses of CK-301 in checkpoint therapy-naïve patients with selected recurrent or metastatic
cancers. Secondary endpoints include the evaluation or characterization of the pharmacokinetics,
immunogenicity and preliminary efficacy of CK-301. Following dose escalation, up to four dose expansion
cohorts may be enrolled to further characterize the safety and efficacy of CK-301 in specific patient subgroups. The trial is currently enrolling patients at sites across Australia, New Zealand and Thailand.

Cernostics Raises $2.5 Million in Series A1 Financing, Led by Illumina Ventures

On March 21, 2018 Cernostics, a privately-held company focused on delivering next-generation cancer diagnostics and prognostics, reported that it has raised $2.5 million in Series A1 financing, led by Illumina Ventures (Press release, Cernostics, MAR 21, 2018, View Source [SID1234525085]). With this capital investment, Cernostics will be able to intensify its clinical and market development studies for the company’s TissueCypher Barrett’s Esophagus Assay — the first test of its kind to predict risk of development of esophageal cancer in patients with Barrett’s esophagus.

Barrett’s esophagus, which affects more than three million Americans, occurs when chronic exposure to acid from the stomach causes the esophageal cell lining to deteriorate, creating an environment for cancer. Without treatment, Barrett’s can lead to esophageal adenocarcinoma, the fastest-rising cancer in the U.S. Today, the most common approach to managing Barrett’s is surveillance, involving regular endoscopic procedures with biopsy, monitoring for disease progression, and GERD-related drug therapy to control symptoms and prevent injury to the esophagus.

Traditional management of Barrett’s esophagus has left gaps in the diagnosis and grading of the disease. While early detection makes esophageal cancer preventable, both endoscopists and pathologists face challenges in determining which patients are truly at risk for progression of the disease. Cernostics’ TissueCypher Barrett’s Esophagus Assay was specifically designed to address these challenges by linking test performance to clinical outcome or progression to cancer, not level of dysplasia. By validating TissueCypher against progression to cancer, the test helps to mitigate challenges associated with sampling error and subjective diagnosis of histology grade.

Esophageal cancer is highly lethal. By selecting the right candidates for treatment, we have tools to prevent people from getting this cancer," said Jacques Bergman, MD PhD, Professor of Medicine and Endoscopy, Academic Medical Center, Amsterdam. "Cernostics TissueCypher test is transformative for the gastroenterological field because it provides physicians with the precise information necessary to make the right decision about patient care."

Through the utilization of the TissueCypher Barrett’s Esophagus Assay and currently available endoscopic treatments there is no reason that a patient with Barrett’s esophagus should ever receive a diagnosis of esophageal cancer. We have the precision medicine tools and technology to transform the care of these patients today," said Mike Hoerres, Cernostics’ CEO. "With this investment by Illumina Ventures, Cernostics will accelerate efforts with GI community leaders and stakeholders to develop robust, transformative clinical evidence on the value of TissueCypher. Furthermore, we have a tremendous opportunity to impact a wider variety of GI diseases through development of additional precision medicine testing based on the TissueCypher Image Analysis Platform.

The best successes in reducing cancer deaths have been achieved through the use of precision molecular tools to identify cancer early, combined with effective early intervention, such as with cervical and colon cancer screening programs." said Tom Willis, Partner at Illumina Ventures. "The genomics revolution is ushering in a next generation of these tests, such as TissueCypher, and Illumina Ventures is seeking to enable their success.

With today’s investment from Illumina Ventures, Cernostics has raised a total of $13 million, including investments from UPMC Enterprises, Novitas Capital, Geisinger Health System, the Pittsburgh Life Sciences Greenhouse, and Ben Franklin Technology Partners of Northeastern PA.