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

Enzon 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, Enzon, 2018, MAR 21, 2018, View Source [SID1234524926]).

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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]).

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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).

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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."

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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.