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).

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!

Know more, wherever you are:
Latest on Cancer Drug Development, book your free 1stOncology demo here.

"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.

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]).

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!

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."

On September 26, 2017 Amgen (NASDAQ: AMGN) and Simcere Pharmaceutical Group reported the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China (Press release, Amgen, SEP 26, 2017, View Source;p=RssLanding&cat=news&id=2302973 [SID1234520648]). The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology.

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!

Under the terms of the agreement, Amgen will remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars. Simcere will be responsible for distribution and commercialization in China, while Amgen will have a limited right to co-promote the products. The biosimilars included in the agreement are a part of Amgen’s existing biosimilars portfolio.

"We are pleased to enter this strategic collaboration with Simcere as we continue to enhance patient access through broader adoption of more competitive therapeutic options worldwide," said Scott Foraker, vice president and general manager of Biosimilars at Amgen. "This agreement brings together Amgen’s long-standing development and biologics manufacturing expertise with Simcere’s local development experience and strong commercial presence in China in the areas of inflammation and oncology."

"This agreement furthers Amgen’s efforts to reach more patients in Asia by bringing high quality biosimilars medicines to patients suffering from debilitating and potentially life-threatening conditions," said Penny Wan, regional vice president and general manager of Amgen’s Japan and Asia-Pacific Region. "We look forward to working with Simcere on these four biosimilar programs where we can build on their network and experience in China to make a big difference for patients."

"This strategic partnership between a world-renowned biotechnology company and a leading Chinese pharma will help to accelerate development and launch of United States and European approved biosimilars in China. By leveraging our sales network, it will also help to improve the accessibility of high quality therapeutic antibodies for Chinese patients," said Honggang Feng, president of Simcere. "This collaboration will allow both companies to further penetrate inflammation and oncology markets in China."

Dr. Hua Mu, chief scientific officer of Simcere said, "Recently, China Food and Drug Administration (CFDA) has formally joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and implemented major reforms on drug evaluation and approval systems, encouraging and supporting research and development of innovative, high quality medicines. This strategic alliance combines Amgen’s leading global research and development capabilities in biosimilars and Simcere’s domestic drug development and registration experience. It aims to bring more high quality and effective medicines to Chinese patients to meet the pressing unmet medical needs. It is also another important milestone in our international collaboration strategy to enrich Simcere’s biologics pipeline."

Specific financial terms of the agreement were not disclosed.

On September 26, 2017 UCL Business spinout company, Autolus Limited, a clinical-stage biopharmaceutical company focused on the development and commercialisation of next-generation engineered T-cell therapies, reported that it closed on a US$80 million (£59 million) Series C financing (Press release, UCLB, SEP 26, 2017, View Source [SID1234520650]).

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!

New investors Cormorant Asset Management, Nextech Invest and others joined founding investor Syncona Ltd, Woodford Investment Management and Arix Bioscience in this Series C round.

The funds will enable Autolus to establish clinical proof of concept for three programs: AUTO2 in multiple myeloma, AUTO3 in diffuse large B cell lymphoma and paediatric acute lymphoblastic leukaemia and AUTO4 in T-cell lymphoma. In addition, building on its advanced cell programming technologies Autolus plans to advance its pre-clinical pipeline products for solid tumour indications, and will set up the infrastructure required for bringing a CAR-T cell therapy rapidly and successfully to market.

Dr Christian Itin, Chairman and CEO of Autolus, commented:
"We welcome our new shareholders and the continued support of our existing investors, and are looking forward to delivering on the exciting promise of our growing pipeline of engineered T cell product candidates. Since our inception three years ago, Autolus has made substantial progress with two dual targeting programs in three clinical studies, a novel program for T-cell lymphoma’s clinic ready and a unique suite of cell programming technologies established for use in haematological and solid cancers. With the new financing we are well on our way to building a premier fully integrated Oncology Company that harnesses the unique power of T cells to combat cancer."

Bihua Chen, CEO Cormorant Asset Management, commented:
"The upcoming commercial launches of the first generation of CAR-T products herald an important advance in the treatment of cancer. We are excited to be part of a company that is poised to be at the forefront of the next revolution in this field. We are impressed by Autolus’ advanced cell programming and manufacturing capabilities, and a team which we believe has the ability to deliver the full potential of these potentially life-changing therapies in both haematological and solid cancers."

Dr. Martin Murphy, CEO Syncona Ltd., commented:
"Autolus is delivering on world class science with a mission to build a leading oncology business. As a founding shareholder of Autolus we are excited about the remarkable potential of T-cell therapies for the treatment of patients with cancer. Unlocking that potential requires deep innovation in all areas, from cell programming to manufacturing and supply chain, in order to deliver these potentially transformative treatments to patients. Success in this space requires building a new type of biopharma business, which we are excited to be part of."

Joe Anderson, CEO of Arix Bioscience, commented:
"CAR-T is a proven new approach and represents a substantial advance in the treatment of cancer. Autolus has the science and the team to develop the next generation of CAR-T therapies, with a differentiated technology and approach that has the potential to transform patients’ lives. Arix is privileged to be part of this and I look forward to working with my colleagues on the Autolus Board and our co-investors to help achieve these goals."

The Series C follows the £70 million Series A and B financings.

On September 25, 2017 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported the closing of its public offering of 8,846,154 shares of its common stock at a public offering price of $6.50 per share, before underwriting discounts (Filing, 8-K, Iovance Biotherapeutics, SEP 26, 2017, View Source [SID1234520655]). The shares of common stock issued and sold in the offering at the closing include 1,153,846 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price less the underwriting discount.

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 gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are approximately $57.5 million.

Jefferies LLC and Wells Fargo Securities, LLC were joint book-running managers, Oppenheimer & Co. Inc. was the lead manager, and H.C. Wainwright, LLC and Chardan were co-managers for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock offered in the public offering was previously filed and declared effective by the Securities and Exchange Commission (the SEC). A preliminary prospectus supplement relating to the shares of common stock sold in this offering was filed with the SEC on September 19, 2017. A final prospectus supplement relating to the offering was filed with the SEC on September 21, 2017. Copies of the final prospectus supplement and the accompanying prospectus may be obtained from Jefferies LLC, 520 Madison Avenue, New York, New York, 10022, or by email to [email protected], or by phone at (877) 821-7388; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, or by email to [email protected], or by phone at (800) 326-5897.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.