1stOncology™: Cancer Intelligence Service – Page 16948 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

AVEO Initiates the Evaluation of Tivozanib in Combination with Bristol-Myers Squibb’s Opdivo® (nivolumab) in Advanced Renal Cell Carcinoma

On August 15, 2016 AVEO Oncology (NASDAQ:AVEO) reported the initiation of a clinical evaluation of AVEO’s oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), tivozanib, in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo (nivolumab), in advanced renal cell carcinoma (RCC) (Press release, AVEO, AUG 15, 2016, View Source [SID:1234514542]). Bristol-Myers Squibb will supply nivolumab for use in the Phase 1/2 AVEO-sponsored TiNivo trial. The trial will be led by the Institut Gustave Roussy in Paris under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee.

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 Phase 1 trial will evaluate tivozanib in combination with nivolumab at escalating doses of tivozanib in patients with advanced RCC, and will be followed by an expansion Phase 2 cohort at the established combination dose.

"The introduction of immunotherapies has greatly improved outcomes in renal cell carcinoma, and combination therapy is the obvious next step in advancing treatment," said Professor Escudier. "There is already early evidence that combining VEGF inhibitors with immune checkpoint inhibitors can improve outcomes, but tolerability of the combination and, in particular, avoiding overlapping liver toxicities, fatigue and stomach disorders is critical to ensuring that both therapies can be delivered at effective levels. Tivozanib’s distinct tolerability profile among VEGF TKIs makes it a potentially unique candidate for use with nivolumab. I look forward to enrolling this study and to understanding how this combination translates to the clinic."

"Research suggests that, because VEGF inhibition may limit the presence of immunosuppressive cells, VEGF therapy may be an ideal primer and a natural combination for improving the efficacy of anti-PD-1 therapies such as nivolumab, which are designed to reveal the tumor to the immune system," said Michael Needle, MD, chief medical officer of AVEO. "This study has the potential to unlock a more effective, better tolerated new treatment approach in RCC. We appreciate Bristol-Myers Squibb’s support for this study, and we look forward to working with Dr. Escudier and his team to fully understand this potential."

About Tivozanib

Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). 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. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.

10-Q – Quarterly report [Sections 13 or 15(d)]

XBiotech has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, XBiotech, 2017, AUG 12, 2016, View Source [SID1234521566]).

8-K – Current report

On August 8, 2016 La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, reported financial results for the three and six months ended June 30, 2016 (Filing, Q2, La Jolla Pharmaceutical, 2016, AUG 12, 2016, View Source [SID:1234514551]).

Results of Operations

As of June 30, 2016, La Jolla had $100.6 million in cash and cash equivalents, compared to $126.5 million as of December 31, 2015. The decrease in cash and cash equivalents was primarily due to net cash used for operating activities. Based on current operating plans and projections, La Jolla believes that its current cash and cash equivalents are sufficient to fund operations into 2018.

La Jolla’s net cash used for operating activities for the six months ended June 30, 2016 was $25.1 million, compared to net cash used for operating activities of $11.2 million for the same period in 2015. La Jolla’s net loss for the three and six months ended June 30, 2016 was $15.6 million and $32.0 million, or $0.90 per share and $1.86 per share, respectively, compared to a net loss of $10.7 million and $19.6 million, or $0.70 per share and $1.29 per share, respectively, for the same periods in 2015. During the three and six months ended June 30, 2016, La Jolla recognized contract revenue of approximately $0.3 million and $0.5 million, respectively. The net loss includes non-cash, share-based compensation expense of $3.3 million and $7.0 for the three and six months ended June 30, 2016, respectively, compared to $3.9 million and $7.3 million, respectively, for the same periods in 2015.

The increases in net cash used for operating activities and net loss in the 2016 periods as compared to the 2015 periods were primarily due to increased development costs associated with our ATHOS 3 Phase 3 trial of LJPC-501 in patients with catecholamine-resistant hypotension and our Phase 1 trial of LJPC-401 in patients with iron overload. There also were increases in personnel and facility costs associated with the support of these increased development activities.

"The first half of 2016 was a productive period for La Jolla, highlighted by the continued enrollment of our ATHOS 3 Phase 3 trial of LJPC-501 and encouraging interim data from our Phase 1 trial of LJPC-401," said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. "Catecholamine-resistant hypotension and iron overload remain significant unmet medical needs, and we remain dedicated to bringing our potentially important therapies to patients as expeditiously as possible. We plan to report results from our Phase 1 trial of LJPC-401 in September 2016 and from our ATHOS 3 Phase 3 trial of LJPC-501 in the first quarter of 2017."

Cellectar Biosciences Announces Recent Key Accomplishments and Second Quarter 2016 Financial Results

On August 11, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) ("the company"), an oncology-focused biotechnology company, reported key accomplishments and its financial results for the second quarter of 2016, which ended June 30, 2016 (Filing, Q2, Cellectar Biosciences, 2016, AUG 12, 2016, View Source [SID:1234514544]).
Corporate highlights for the quarter include:

· USPTO issued patent for CLR 131 and other radiotherapeutics for the treatment of cancer stem cells in combination with external beam treatment

· USPTO issued patent for CLR 1600 series PDC’s protecting assets generated through the conjugation of our delivery vehicle with paclitaxel

· USPTO patent publication related to our delivery vehicle protecting assets generated through the conjugation of any existing or future cytotoxic agents

· Results of preclinical study of 1602, one of our paclitaxel PDC’s demonstrating improved in vivo cancer tumor targeting compared to other cells

· Completion of the first phase of NCI SBIR fast track grant; a preclinical study of CLR 125 which demonstrated activity in triple negative breast cancer models

· Closing of $8M financing

· Achieved all Nasdaq requirements for continued listing, successfully closing the listing qualifications matter

"In addition to expanding and strengthening our intellectual property portfolio this past quarter, we enhanced the company’s capital structure and continued to successfully execute on the corporate objectives established almost a year ago, including our rapid pivot to a therapeutic focused research and development company," said Jim Caruso, president and CEO of Cellectar Biosciences. "We now look forward to upcoming cohort 2 performance results of CLR 131 for Multiple Myeloma as well the first half of 2017 initiation of our NCI supported Phase 2 clinical study of CLR 131in hematologic malignancies."

Financial Results for 2Q 2016

During the second quarter of 2016, the company reported research and development expenses of $1.0 million, a reduction of $0.4 million from the second quarter of 2015. This improvement continues to be attributable to the company’s shift in strategic focus to therapeutic compound research and development efforts exclusively and the streamlined clinical trial approach it implemented during the second half of 2015.

Cellectar’s general and administrative expenses for second quarter 2016 totaled $1.4 million, which was $0.6 million higher than the prior year period. A significant portion of this increase was driven by specific charges related to legal fees and other consulting services that will not recur, in addition to increased personnel costs. Loss from operations was $2.3 million, which was similar to the same period last year.

The Company ended the second quarter with $7.9 million in cash and cash equivalents, compared to $3.9 million in cash and cash equivalents on December 31, 2015. The company estimates that its available cash and cash equivalents should fund its planned operations into the first quarter of 2017. The company expects that additional capital will be required to complete its planned clinical and preclinical development.

Cellectar will be holding a conference call at 8:30 AM ET on Monday, August 15, 2016 to review the company’s performance, as well as these financial results. The call can be accessed by calling 888-646-8293. The call will also be webcast via View Source, and replays will be available via the Investor Relations section of the company’s website: investor.cellectarbiosciences.com.

Ohr Pharmaceutical Reports Third Quarter 2016 Financial and Business Results

On August 9, 2016 Ohr Pharmaceutical, Inc. (NasdaqCM: OHRP), an ophthalmology research and development company, reported results for its third quarter ended June 30, 2016 (Filing, Q2, Ohr Pharmaceutical, 2016, AUG 12, 2016, View Source [SID:1234514538]).

"The start of the Phase 3 registration program for Squalamine during the quarter marked a significant milestone in our overall development program for our lead drug candidate," said Jason Slakter, MD, Chief Executive Officer of Ohr. "There remains a significant need for new treatment options that can enhance visual acuity gains in wet AMD and provide a non-invasive treatment option. We believe that Squalamine, when administered as part of a combination therapy, meets these needs and has the potential to set a new standard of care. We look forward to an exciting second half of calendar 2016."

Third Quarter Highlights
· Commenced enrollment in the Phase 3 clinical development program to investigate Squalamine lactate ophthalmic solution, 0.2% ("Squalamine", also known as OHR-102) as a treatment to improve visual acuity for patients with wet AMD.
o The Phase 3 program includes two clinical trials designed as double-masked, placebo-controlled, multicenter, international studies of Squalamine administered topically twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis injections.
o The primary endpoint in both studies is a measurement of visual acuity gain at nine months, which is the most clinically meaningful endpoint for wet AMD patients. Subjects will be followed to two years for safety.
· Appointed David M. Brown, MD to serve as the chair of the Steering Committee for the Phase 3 clinical program of Squalamine in wet-AMD.
o Dr. Brown is Clinical Professor of Ophthalmology at Baylor College of Medicine, vice-chair for research at the Blanton Eye Institute, Houston Methodist Hospital, and partner at Retina Consultants of Houston.
· Completed an in vivo study demonstrating sustained pharmacological anti-angiogenic activity of OHR3031, an angiogenesis inhibitor
o Single intravitreal injection of microparticles containing OHR3031 produced clinically meaningful and statistically significant efficacy six weeks after dose administration in a rabbit model of laser-induced CNV.
o Dose response was observed in the reduction of average CNV lesion areas with OHR3031 compared to vehicle treatment, with the highest dose exhibiting a statistically significant effect at Week 6.
o Magnitude of difference in average CNV lesion size for the high dose of OHR-3031 compared to vehicle treatment at 6 weeks was comparable to that seen at 2 weeks with a currently approved anti-VEGF agent conducted in a previous study.
o OHR3031 was developed using SKS sustained release technology
· Presented two posters on the Squalamine Phase 2 IMPACT study and OHR3031 in vivo studies at the Association for Research in Vision and Ophthalmology (ARVO) Conference in May.

Financial Results for Third Quarter ended June 30, 2016
· For the third quarter ended June 30, 2016, the Company reported a net loss of approximately $7.7 million, or ($0.24) per share, compared to a net loss of approximately $3.3 million, or ($0.11) per share in the same period of 2015.
· For the third quarter ended June 30, 2016, total operating expenses were approximately $7.6 million, consisting of approximately $1.7 million in general and administrative expenses, $5.6 million in research and development expenses, and $0.3 million in depreciation and amortization. This compares to total operating expenses in the same period of 2015 of approximately $3.3 million, consisting of $1.6 million in general and administrative expenses, $1.5 million in research and development expenses, and $0.3 million in depreciation and amortization.
· At June 30, 2016, the Company had cash and cash equivalents of approximately $17.6 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.

Financial Results for the Nine-Months ended March 31, 2016
· For the nine months ended June 30, 2016, the Company reported a net loss of approximately $19.1 million, or ($0.61) per share, compared to a net loss of approximately $11.3 million, or ($0.41) per share in the same period of 2015.
· For the nine months ended June 30, 2016, total operating expenses were approximately $17.8 million, consisting of $5.8 million in general and administrative expenses, $11.8 million of research and development expenses, and $0.9 million in depreciation and amortization. This compares to total operating expenses of $14.3 million in the same period of 2015, comprised of approximately $5.7 million in general and administrative expenses, $7.4 million in research and development expenses, and $0.9 million in depreciation and amortization.

Conference Call & Webcast
Tuesday, August 9th at 5:00pm Eastern Time
Domestic: 877-407-0789
International: 201-689-8562
Conference ID: 13642605
Webcast: View Source

Replays – Available through August 16, 2016
Domestic: 877-870-5176
International: 858-384-5517
Conference ID: 13642605