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

(Filing, 10-K, DelMar Pharmaceuticals, 2017, SEP 27, 2017, View Source [SID1234520830])

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

(Filing, 10-K, Enzo Biochem, SEP 27, 2017, View Source [SID1234520829])

Mateon Therapeutics Announces Termination of FOCUS Study in Ovarian Cancer and Restructuring to
Prioritize OXi4503 for AML

On September 26, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported results from its third scheduled interim analysis of the phase 2/3 FOCUS study evaluating CA4P in combination with bevacizumab (Avastin) and physician’s choice chemotherapy in patients with platinum-resistant ovarian cancer (Press release, Mateon Therapeutics, SEP 27, 2017, View Source [SID1234520671]).

FOCUS was designed to evaluate whether the addition of CA4P improved progression-free survival (PFS), the primary endpoint of the study, as well as objective response rate (ORR) and other measures. All patients enrolled in the FOCUS study received either CA4P or placebo plus the current standard-of-care for platinum-resistant ovarian cancer: bevacizumab (Avastin) and chemotherapy. The current analysis is based on initial results from the first 70 patients in the study who have been treated for at least two months or discontinued from the trial. A total of 91 patients were enrolled in FOCUS.

Efficacy Results

ORR data is summarized in the table below.

CA4P Control
Complete Response
0 (0%) 0 (0%)
Partial Response
8 (23.5%) 13 (36.1%)
Stable Disease
16 (47.1%) 17 (47.2%)
Progressive Disease
5 (14.7%) 3(8.3%)
Not Evaluable
5 (14.7%) 3(8.3%)

PFS, the primary endpoint of the study, favored the CA4P group, with a 32 day increase in median PFS for the patients receiving CA4P compared to patients receiving control (202 days vs. 170 days; HR=0.844; p=0.688). Progression events are available from 24 of 70 (34.3%) patients: 12 patients (35.3%) in the CA4P arm and 12 (33.3%) patients in the control arm progressed or died while in the study.

Due to the lack of a meaningful improvement in PFS, combined with the unfavorable partial response data, the company does not believe that continuation of the study is appropriate. Therefore, Mateon is immediately terminating the FOCUS Study and further development of CA4P. Mateon will continue to support investigator-sponsored studies and preclinical studies in combination with immuno-oncology agents.

"We are clearly disappointed that CA4P did not show a clinically meaningful benefit when it was added to the current standard of care in platinum-resistant ovarian cancer," said William D. Schwieterman, M.D., President and Chief Executive Officer. "I want to thank our investigators and advisors, as well as the patients that we treated, for their efforts to advance future cancer care. These external participants, along with our internal team, did a great job planning and executing the study, but the outcome is clear, and unfortunately negative."

Safety Results

The safety profile of CA4P was favorable. Similar to prior analyses, most patients receiving CA4P experienced transient increases in blood pressure compared to the control arm. Other adverse events occurring more often in the CA4P arm than in the control arm included: hypertension, fatigue, nausea, vomiting, and abdominal pain. Most adverse events were mild or moderate in severity, with blood pressure increase being the only adverse event with a
significant increase in Grade 3 or above (29.4% in CA4P arm versus 5.6% in control). Six patients in the treatment arm (17.6%) withdrew from the study for adverse events compared to three in the control arm (8.3%).
Reduction in Expenses

Given the company’s limited financial resources, Mateon is implementing various near-term cost reduction measures, which include a significant reduction in personnel, representing a decrease in the company’s workforce of approximately 60% since the beginning of the year. The remaining members of the senior management team will take 50% salary reductions, effective immediately.

"We assembled a great team that, within the last two years, has planned, initiated and completed the FOCUS Study ahead of schedule. The team has also planned, initiated and completed five cohorts of an on-going OXi4503 study for relapsed/refractory AML. With the company’s needs now very different, it is disheartening to terminate most of these employees following their solid work performances," concluded Dr. Schwieterman. "Going forward, our immediate focus is to obtain value from our OXi4503 program in AML, which, within the last two months, has shown clear positive clinical outcomes in relapsed/refractory patients. As always, we are exploring all options for additional fundraising and adding value for our stockholders, which includes continuing to look for buyers for any or all of our assets."

Bristol-Myers Squibb: Advancing Research Across Thoracic Cancers with New Data at IASLC 18th World Conference on Lung Cancer

On September 27, 2017 Bristol-Myers Squibb Company (NYSE: BMY) reported the presentation of 28 abstracts for Opdivo (nivolumab), alone and in combination with Yervoy (ipilimumab), targeted therapy or chemotherapy, at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan, from October 15-18. Data from company-sponsored studies, clinical collaborations and investigator-sponsored research demonstrate the Company’s ongoing commitment to Immuno-Oncology research across many types of thoracic cancers (Press release, Bristol-Myers Squibb, SEP 27, 2017, View Source [SID1234520667]). Presentations will include late-breaking data in malignant pleural mesothelioma, clinical and real-world evidence in Opdivo in previously treated advanced non-small cell lung cancer (NSCLC), as well as research on Opdivo-based combinations in advanced NSCLC and patient-reported outcomes in advanced small cell lung cancer (SCLC).

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"Bristol-Myers Squibb is dedicated to driving scientific innovation and investigating potential treatment options for patients with difficult-to-treat cancers and will share new data from our broad thoracic development program at the upcoming WCLC," said Nick Botwood, M.D., development lead, thoracic cancers, Bristol-Myers Squibb. "We are committed to researching the potential of Opdivo and Opdivo-based combinations in high unmet need areas, such as NSCLC, SCLC and mesothelioma, with the goal of bringing I-O treatment options to more patients."

Research from the following abstracts will be presented:

Late-Breaking Data in Malignant Pleural Mesothelioma

•

A phase 2 study of nivolumab: a multicenter, open-label, single arm study in malignant pleural mesothelioma (MERIT)
Author: Goto
Abstract #MA 19.01
Late Breaking Abstracts Session
Wednesday, October 18, 11:00 AM – 12:30 PM, Room 315

Clinical and Real-World Data in NSCLC and SCLC

•
Nivolumab versus chemotherapy as post-platinum therapy for advanced NSCLC in a real-world setting (CheckMate -118)
Author: Garon
Abstract # P1.01-051
Poster Session: P1.01
Monday, October 16, 9:30 AM – 4:00 PM, Hall B and C

•
Non-small cell lung cancer patient characteristics and clinical care insights in Sweden: the SCAN-LEAF study
Author: Sandelin
Abstract #P1.06-012
Poster Session: P1.06
Monday, October 16, 9:30 AM – 4:00 PM, Hall B and C

•
Survival by response to first-line platinum-based therapy among patients with extensive disease SCLC
Author: Yuan
Abstract #P1.15-003
Poster Session: P1.15
Monday, October 16, 9:30 AM – 4:00 PM, Hall B and C

•
Treatment patterns in extensive disease SCLC across the United States, Europe and Japan
Author: Yuan
Abstract #MA 01.09
Mini Oral Presentation: MA 01
Monday, October 16, 11:00 AM – 12:30 PM, Room 503

•
Health status in patients with SCLC treated with nivolumab alone or combined with ipilimumab: CheckMate -032
Author: Camidge
Abstract #P2.07-034
Poster Session: P2.07
Tuesday, October 17, 9:30 AM – 4:00 PM, Hall B and C

•
CheckMate -169: safety/efficacy of nivolumab in Canadian pretreated advanced NSCLC (including elderly and PS 2) patients
Author: Juergens
Abstract #P2.07-029
Poster Session: P2.07
Tuesday, October 17, 9:30 AM – 4:00 PM, Hall B and C

•
Impact of brain metastases on the humanistic burden incurred by patients with advanced NSCLC
Author: Chirita
Abstract #P2.01-012
Poster Session: P2.01
Tuesday, October 17, 9:00 AM – 4:00 PM, Hall B and C

•
Efficacy and safety of nivolumab therapy for advanced NSCLC in the expanded access named patient program in Taiwan
Author: Liao
Abstract #P2.07-027
Session P2.07
Tuesday, October 17, 2017, 9:30 AM – 4:00 AM, Hall B and C

•
Non-small cell lung cancer treatment and survival in Scandinavia: the SCAN-LEAF study
Author: Ekman
Abstract #MA 18.14
Mini Oral Presentation: Global Tobacco Control and Epidemiology II
Tuesday, October 17, 3:45–5:30 PM, Rooms 511 and 512

•
Nivolumab versus docetaxel in patients with previously treated advanced NSCLC and liver metastases (CheckMate -017 and CheckMate -057)
Author: Crino
Abstract #P3.07-012
Poster Session: P3.07
Wednesday, October 18, 9:30 AM – 4:00 PM, Hall B and C

•
Impact of tobacco smoking on the humanistic and financial burden of advanced NSCLC
Author: Chirita
Abstract #OA 11.01
Oral Abstract Session: Reducing Burden: Patient-Centered Care
Wednesday, October 18, 11:00 AM – 12:30 PM, Rooms 313 and 314

•
CheckMate -870 TiP: an open-label safety study of nivolumab in previously treated patients with NSCLC in Asia
Author: Lu
Abstract #P1.04-010
Poster Session: P1.04
Monday, October 16, 9:30 AM – 4:00 PM, Hall B and C

Research Evaluating Opdivo-based Combinations

•
Interim results of a Phase 1 study of nivolumab plus nab-paclitaxel/carboplatin in patients with NSCLC
Author: Goldman
Abstract #P1.03-026
Session: P1.03
Monday, October 16, 9:30 AM – 4:00 PM, Hall B and C

•
PIVOT-02: Phase 1/2 study of NKTR-214 and nivolumab in patients with locally advanced or metastatic solid tumor malignancies
Author: Papadimitrakopoulou
Abstract #P2.07-062
Session: P2.07
Tuesday, October 17, 9:30 AM – 4:00 PM, Hall B and C

•
Long follow up from Phase 1 study of nivolumab and chemotherapy in patients with advanced NSCLC
Author: Kanda
Abstract #P2.07-011
Session: P2.07
Tuesday, October 17, 9:30 AM – 4:00 PM, Hall B and C

•
First-line nivolumab plus platinum-based doublet chemotherapy for advanced NSCLC: CheckMate -012 3-year update
Author: Juergens
Abstract #OA 17.03
Oral Abstract Session: Immunotherapy II
Wednesday, October 18, 2:30–4:15 PM, Rooms 301 and 302
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O/radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how patients’ tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

Pelican Therapeutics Announces Manufacturing Agreement with KBI Biopharma
to Advance Cancer-targeting Immunotherapies

On September 27, 2017 Pelican Therapeutics ("Pelican"), a subsidiary of Heat Biologics, Inc. ("Heat") (Nasdaq: HTBX), entered into a manufacturing agreement with KBI Biopharma, Inc., a global biopharmaceutical contract development and manufacturing organization, for cGMP production of its PTX-35 antibody and PTX-15 fusion protein (Press release, Heat Biologics, SEP 27, 2017, View Source [SID1234520664]). PTX-35 and PTX-15 have the potential to improve clinical response in combination with Heat’s ImPACT therapeutic platform and other immunotherapy drugs by simulating the production of antigen-specific T-cells.

"We selected KBI as our manufacturing partner because, based on our assessment, they have strong development capabilities, and possess the agility and flexibility to help Pelican prepare for early development of both our Phase 1 and 2 clinical trials," said Rahul Jasuja, CEO of Pelican.

Under the agreement, KBI Biopharma will offer comprehensive development and manufacturing services, which Pelican expects will offer advantages such as speed, productivity, stability and flexibility over traditional approaches to cell line development.

In May 2016, Pelican was awarded a $15.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to support these manufacturing efforts, as well as to complete a 70-patient, Phase 1 clinical trial incorporating one or more of these compounds.