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Calyxt Expands its Patent Portfolio, Now Encompassing Broad Uses of Technologies such as CRISPR/Cas9, Zinc Finger Nucleases and TAL-effector Nucleases for Plant Gene Editing

On October 3, 2016, Clovis Oncology, Inc. ("Clovis") and Lonza Ltd ("Lonza") reported that it entered into a Manufacturing Services Agreement (the "Agreement") for the long term manufacture and supply of the active pharmaceutical ingredient ("API") for rucaparib (Press release, Clovis Oncology, OCT 3, 2016, View Source [SID:SID1234515608]). The terms and conditions of the Agreement are contingent upon the approval by the U.S. Food and Drug Administration of the initial New Drug Application for rucaparib, unless triggered earlier by Clovis. Clovis and Lonza are parties to a Development and Manufacturing Agreement, dated February 8, 2013, as amended, under which Lonza has supplied rucaparib API for clinical development.

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The Agreement provides that Lonza will be a non-exclusive manufacturer of the rucaparib API during the term of the Agreement, which expires on December 31, 2025, unless extended by mutual written consent of the parties. Under the Agreement, Lonza will construct, in an existing Lonza facility, a production train that will be exclusively dedicated to the manufacture of the rucaparib API. The dedicated production train will provide manufacturing capacity to meet Clovis’ currently anticipated needs for commercial supply of rucaparib API.

Clovis is obligated to make scheduled capital program fee payments towards capital equipment and other costs associated with the construction of the dedicated production train and, once the facility is operational, Clovis is obligated to pay a fixed facility fee each quarter for the duration of the Agreement.

Pursuant to the terms of the Agreement, Lonza will manufacture and store an advanced intermediate to be used in the subsequent production of the rucaparib API. Clovis will pay fixed fees on a per kilogram basis for quantities of the advanced intermediate and the rucaparib API ordered by Clovis under the Agreement, subject to certain adjustments. Until the dedicated facility is completed and operationally qualified, Lonza will manufacture the rucaparib API in existing Lonza facilities at pricing established in the Agreement.

Either party may terminate the Agreement due to a material breach of the Agreement by the other party, subject to prior written notice and a cure period. Clovis may terminate the Agreement, subject to 90 days’ prior written notice, in the event rucaparib is withdrawn from the market for certain reasons. In the event of such a termination by Clovis, or termination by Lonza due to material breach by Clovis, Clovis is obligated to compensate Lonza for any services rendered, or for which costs have been incurred by Lonza in anticipation of services to be provided to Clovis, and to pay to Lonza the remaining amount of any capital program fees and quarterly fixed facility fees for the remainder of the term of the Agreement. In the event the Agreement is terminated by Clovis due to material breach by Lonza, Lonza is obligated to repay all or a portion of the capital program fees previously paid by Clovis.

The foregoing is only a summary of certain provisions of the Agreement and is qualified in its entirety by the terms of the Agreement, a copy of which will be filed as an exhibit to Clovis’ annual report on Form 10-K for the year ending December 31, 2016. Clovis intends to submit a Confidential Treatment Request to the SEC pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting confidential treatment of certain portions of the Agreement.

Exelixis and Ipsen to Host Investor and Media Briefing to Discuss Data Presented at the ESMO 2016 Congress

On October 3, 2016 Exelixis, Inc. (NASDAQ:EXEL) reported that the company and its partner Ipsen will jointly host a live investor and media briefing at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress (Press release, Exelixis, OCT 3, 2016, View Source;p=RssLanding&cat=news&id=2208613 [SID:SID1234515574]). The event will be held on Monday, October 10, 2016, with the program beginning at 19:00 CEST (local Copenhagen time) / 1:00 p.m. EDT / 10:00 a.m. PDT following on-site registration starting at 18:30 CEST.

During the briefing, Exelixis and Ipsen management and invited guests will discuss and provide context for clinical data for cabozantinib presented at the ESMO (Free ESMO Whitepaper) 2016 Congress. Key topics will include CABOSUN, the randomized phase 2 trial of cabozantinib compared with sunitinib in patients with previously untreated advanced renal cell carcinoma, which will be the subject of a late-breaking oral presentation during ESMO (Free ESMO Whitepaper)’s Presidential Symposium 3 earlier in the day. Presenters will also review data from the ongoing phase 1b trial evaluating the combination of cabozantinib and nivolumab in patients with genitourinary tumors.

The briefing will also be webcast live and available via conference call starting at 19:00 CEST / 1:00 p.m. EDT / 10 a.m. PDT on Monday, October 10. To access the webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under Investors & Media. Please connect to the company’s website at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be required to listen to the event. To participate by phone, please dial 855-299-5224 (domestic) or 631-267-4890 (international/toll dial) and use passcode 234-026-024. Please see the Event Calendar page for details on replay options once available.

Teva Completes Acquisition of Anda, Inc.

On October 3, 2016 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported that it has completed its acquisition of Anda, Inc., a leading distributor of generic pharmaceuticals in the U.S., from Allergan plc (Press release, Teva, OCT 3, 2016, View Source [SID:SID1234515553]).

"We are pleased that Anda, Inc., one of the leading distributors of generic medicines in the U.S., is now part of Teva. This acquisition reflects our continued view that attractive growth opportunities, both external and organic, exist for our business and for our extensive supply chain network in particular," said Siggi Olafsson, President & CEO of Global Generic Medicines. "This acquisition enables us and our customers to provide more patients throughout the country with access to generic medicines."
"We are excited to become part of Teva’s distribution network to support our customers and patients across the country," said Charles D. Phillips, President & CEO of Anda. "By joining forces with Teva, Anda’s product offerings will significantly increase and we will be able to reach more patients in the United States."

Teva currently has over 300 product registrations pending FDA approval and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one-of-every six generic prescriptions dispensed in the U.S. is filled with a Teva product.

TRACON PHARMACEUTICALS ANNOUNCES SUCCESSFUL MEETINGS WITH FDA AND EMA FOR TRC105 (CAROTUXIMAB) IN ANGIOSARCOMA

On October 3, 2016 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age‐related macular degeneration and fibrotic diseases, reported the successful completion of an End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) and a Protocol Assistance Meeting with the European Medicines Agency (EMA) (Press release, Tracon Pharmaceuticals, OCT 3, 2016, View Source [SID:SID1234515559]). TRACON reached agreement with both regulatory agencies regarding key elements of the Phase 3 program for TRC105 in angiosarcoma and expects to initiate enrollment in the Phase 3 study by year-end.

"We appreciate the valuable discussions and guidance from our End-of-Phase 2 discussion with FDA and Protocol Assistance Meeting with EMA, and are confident that we have a robust design for TRC105’s first Phase 3 trial," said Charles Theuer, M.D., Ph.D., President and CEO. "With the successful completion of the regulatory meetings, we are focused on advancing TRC105 as the first potential therapeutic specifically for the treatment of angiosarcoma, an ultra-orphan indication with a high unmet need. We look forward to initiating our Phase 3 program before the end of the year."

End-of-Phase 2 Meetings and Phase 3 Study Design

The U.S. and European regulators separately determined the acceptability of the following key aspects of the proposed Phase 3 randomized trial:

One-to-one randomized trial of TRC105 in combination with Votrient (pazopanib) versus Votrient alone.
A planned total enrollment of 124 patients with an adaptive design based on an interim analysis that allows for sample size re-estimation up to a maximum of 200 patients, as well as enrichment of more responsive patients based on the subtype of angiosarcoma, visceral or cutaneous.
Primary endpoint of progression-free survival (PFS) with overall survival (OS) as a secondary endpoint.
Open label format with independent blinded assessment of endpoint data.
Eligible patients will be stratified by treatment naive versus greater than one prior cancer therapy and will not have received a prior VEGF inhibitor.
The trial will provide at least 80% power to determine an improvement in median PFS from 4.0 to 7.3 months using a two-tailed alpha of 0.05.
TRACON intends to submit the proposed protocol for special protocol assessment to FDA later this year.

About TRC105 (carotuximab)

TRC105 (carotuximab) is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation, and also expressed on fibroblasts, a cell that causes fibrosis. TRC105 is currently being studied in multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumor types in combination with VEGF inhibitors. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis. For more information about the clinical trials, please visit TRACON’s website at View Source

New Research From Bristol-Myers Squibb at ESMO 2016 Congress Reinforces Leadership in Immuno-Oncology and Differentiated Research Approach

On October 3, 2016 Bristol-Myers Squibb Company (NYSE:BMY) reported new data across eight tumor types evaluating Opdivo (nivolumab) and Yervoy (ipilimumab), as monotherapy or in combination, as well as new assets, to be presented at the 2016 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Copenhagen, Denmark from October 7–11 (Press release, Bristol-Myers Squibb, OCT 3, 2016, View Source [SID:SID1234515557]). Data presented at this congress underscore the Company’s commitment to its portfolio and to discover the next wave of transformational Immuno-Oncology medicines, including combination therapies, for difficult-to-treat cancers.

"Bristol-Myers Squibb continues to lead the scientific understanding of Immuno-Oncology with an extensive portfolio and a differentiated clinical development program where we have set a high bar of success to look for clear and differentiated improvements over currently available therapies," said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. "We remain focused on expanding the use of the Opdivo and Yervoy combination to more tumors, and bringing forward novel agents and combination regimens in earlier lines of therapy, to help even more patients with cancer."

Bristol-Myers Squibb assets featured in a total of 26 data presentations. A select listing of Presidential Symposia and oral abstract sessions is included below:

CheckMate -064: Baseline tumor T cell receptor sequencing analysis and neo-antigen load is associated with response and survival in melanoma patients receiving sequential Opdivo and Yervoy (Abstract #1047O). Data will be presented during an oral proferred paper session on Friday, October 7 at 4:45 – 5:00 p.m. CEST.
CheckMate -275: First disclosure of efficacy and safety of Opdivo monotherapy in patients with metastatic urothelial cancer who have received prior treatment (Abstract #LBA31_PR). Data will be presented during an oral proffered paper session on Saturday, October 8 at 9:15 – 9:30 a.m. CEST.
CA184-169: First disclosure of overall survival and safety data from a Phase 3 trial evaluating Yervoy at 3 mg/kg vs. 10 mg/kg in patients with metastatic melanoma (Abstract #1106O). Data will be presented during an oral proffered paper session on Saturday, October 8 at 3:37 – 3:50 p.m. CEST.
CA184-029 (EORTC 18071): Initial report of survival data from a Phase 3 trial evaluating Yervoy versus placebo after complete resection of stage III melanoma (Abstract #LBA2_PR). Data will be featured during the ESMO (Free ESMO Whitepaper) Press Program on Saturday, October 8 at 8:15 a.m. CEST and presented during a Presidential Symposium at 5:00 – 5:15 p.m. CEST.
CheckMate -040: Interim analysis of a Phase 1/2 study evaluating the safety and preliminary efficacy of Opdivo in patients with advanced hepatocellular carcinoma (Abstract #615O). Data will be presented during an oral proffered paper session on Sunday, October 9 at 12:00 – 12:15 p.m. CEST.
CheckMate -141: Evaluation of patient-reported outcomes data in recurrent or metastatic squamous cell carcinoma of the head and neck treated with Opdivo or investigator’s choice (Abstract #LBA4_PR). Data will be presented during a Presidential Symposium on Sunday, October 9 at 4:25 – 4:40 p.m. CEST.
CheckMate -026: Phase 3 trial of Opdivo versus investigator’s choice of platinum-based doublet chemotherapy as first-line therapy for stage IV/recurrent PD-L1 positive non-small cell lung cancer (Abstract #LBA7_PR). Data will be presented during a Presidential Symposium on Sunday, October 9 at 5:35 – 5:50 p.m. CEST.
The full set of data to be presented by Bristol-Myers Squibb include:

Bladder

CheckMate -275: Efficacy and safety of nivolumab monotherapy in patients with metastatic urothelial cancer who have received prior treatment; results from the phase 2 study

Author: Galsky
Abstract # LBA31_PR
Proffered Paper Session, Genitourinary Tumors, Non-Prostate
Saturday, October 8, 2016, 9:15 – 9:30 a.m. CEST, Madrid

CheckMate -032: Nivolumab monotherapy in metastatic urothelial cancer: Updated efficacy by subgroups and safety results

Author: J. Rosenberg
Abstract #784P
Poster Session, Genitourinary Tumours, Non-Prostate
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Colorectal

CheckMate -142: Nivolumab ± ipilimumab treatment efficacy, safety, and biomarkers in patients with metastatic colorectal cancer with and without high microsatellite instability

Author: M. Overman
Abstract #479P
Poster Session, Gastrointestinal Tumours, Colorectal
Saturday, October 8, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Glioblastoma

CheckMate -548: A randomized phase 2, single-blind study of temozolomide and radiotherapy combined with nivolumab or placebo in newly diagnosed adult patients with tumor O6-methylguanine DNA methyltransferase-methylated glioblastoma

Author: M. Weller
Abstract # 356TiP
Poster Session, CNS Tumors
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Head and Neck

Safety of the natural killer cell-targeted anti-KIR antibody, lirilumab, in combination with nivolumab or ipilimumab in two phase 1 studies in advanced refractory solid tumors

Author: N. Segal
Abstract #1086P
Poster Session, Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

CheckMate -651: A randomized, open-label, phase 3 study of nivolumab in combination with ipilimumab vs extreme regimen (cetuximab + cisplatin/carboplatin + fluorouracil) as first-line therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck

Author: A. Argiris
Abstract #1016TiP
Poster Session, Head and Neck Cancer
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

CheckMate -714: Double-blind, two-arm, phase 2 study of nivolumab in combination with ipilimumab versus nivo and ipi-placebo as first-line therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck

Author: R. Haddad
Abstract #1017TiP
Poster Session, Head and Neck Cancer
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

CheckMate -141: Evaluation of patient-reported outcomes data in recurrent or metastatic squamous cell carcinoma of the head and neck treated with nivolumab or investigator’s choice

Author: K. Harrington
Abstract # LBA4_PR
Presidential Symposium 2
Sunday, October 9, 2016, 4:25 – 4:40 p.m. CEST, Copenhagen

Hepatocellular Carcinoma

CheckMate -040: Safety and preliminary efficacy of nivolumab in patients with advanced hepatocellular carcinoma: Phase 1/2 interim analysis

Author: I. Melero
Abstract # 615O
Proffered Paper, Gastrointestinal Tumors, Non-Colorectal 2
Sunday, October 9, 2016, 12:00 – 12:15 p.m. CEST, Vienna

Lung

CheckMate -017 and -057: Healthcare resource utilization in patients with advanced non-small cell lung cancer based on treatment-related adverse events

Author: M. Venkatachalam
Abstract #1220P
Poster Session, NSCLC, Metastatic
Saturday, October 8, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Cost of care in first line advanced non-small cell lung cancer patients: Chemotherapy vs. targeted therapy

Author: J. Radtchenko
Abstract #1273P
Poster Session, NSCLC, Metastatic
Saturday, October 8, 2016, 1:00 – 2:00 p.m. CEST, Hall E

FRACTION-Lung: A phase 2, fast real-time assessment of combination therapies in immuno-oncology trial in patients with advanced non-small cell lung cancer

Author: P. Fracasso
Abstract #1295TiP
Poster Session, NSCLC, Metastatic
Saturday, October 8, 2016, 1:00 – 2:00 p.m. CEST, Hall E

The humanistic burden of small cell lung cancer: A systematic review of health-related quality of life literature

Author: C. Panter
Abstract: #1429P
Poster Session, SCLC
Saturday, October 8, 2016, 1:00 – 2:00 p.m. CEST, Hall E

CheckMate -017 and CheckMate -057: Long-term outcomes with nivolumab versus docetaxel in patients with advanced non-small cell lung cancer: two-year update

Author: F. Barlesi
Abstract #1215PD
Poster Discussion, NSCLC, Metastatic
Sunday, October 9, 2016, 2:45 – 4:15 p.m. CEST (3:46 – 4:06 p.m. CEST), Oslo

CheckMate -057: Overall health status in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel

Author: M. Reck
Abstract #1217PD
Poster Discussion, NSCLC, Metastatic
Sunday, October 9, 2016, 2:45 – 4:15 p.m. CEST (3:46 – 4:06 p.m. CEST), Oslo

A phase 1/2 trial of a monoclonal antibody targeting fucosyl GM1 in relapsed/refractory small cell lung cancer: Safety and preliminary efficacy

Author: Q. Chu
Abstract #1427PD
Poster Discussion, Non-Metastatic NSCLC and Other Thoracic Malignancies
Monday, October 10, 2016, 3:00 – 4:00 p.m. CEST (3:20 – 3:30 p.m. CEST), Berlin

CheckMate -026: A phase 3 trial of nivolumab vs investigator’s Choice of platinum-based doublet chemotherapy as first-line therapy for stage IV/recurrent programmed death ligand 1−positive non-small cell lung cancer

Author: M. Socinski
Abstract #LBA7_PR
Presidential Symposium 2
Sunday, October 9, 2016, 5:35 – 5:50 p.m. CEST, Copenhagen

Melanoma

Baseline tumor T cell receptor sequencing analysis and neo antigen load is associated with benefit in melanoma patients receiving sequential nivolumab and ipilimumab

Author: J. Weber
Abstract #1047O
Proffered Paper, Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Friday, October 07, 2016, 4:45 – 5:00 p.m. CEST, Copenhagen

Overall survival and safety results from a phase 3 trial of ipilimumab at 3 mg/kg vs. 10 mg/kg in patients with metastatic melanoma

Author: P. Ascierto
Abstract #1106O
Proffered Paper, Melanoma and Other Skin Tumors
Saturday, October 8, 2016, 3:37 – 3:50 p.m. CEST, Copenhagen

Ipilimumab vs. placebo after complete resection of stage III melanoma: final overall survival results from the EORTC 18071 randomized, double-blind, phase 3 trial

Author: L. Eggermont
Abstract #LBA2_PR
Presidential Symposium 1
Saturday, October 8, 2016, 5:00 – 5:15 p.m. CEST, Copenhagen

Safety profile of nivolumab and ipilimumab combination therapy in patients with advanced melanoma

Author: M. Sznol
Abstract #1123P
Poster Session, Melanoma And Other Skin Tumors
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Safety of reduced infusion times for nivolumab plus ipilimumab and nivolumab alone in advanced melanoma

Author: S. Martin-Algarra
Abstract #1125P
Poster Session, Melanoma and Other Skin Tumors
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

PD-L1 expression as a biomarker for nivolumab plus ipilimumab and nivolumab alone in advanced melanoma: A pooled analysis

Author: G. Long
Abstract #1112PD
Poster Discussion, Melanoma and Other Skin Tumors
Monday, October 10, 2016, 11:00 a.m. – 12:00 p.m. CEST (11:30 – 11:50 a.m. CEST), Rome

Renal Cell Carcinoma

Cost-effectiveness of nivolumab in patients with advanced renal cell carcinoma in Sweden

Author: S. Johal
Abstract #1032P
Poster Session, Health Economics
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

CheckMate -016: Updated results from a phase 1 study of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma

Author: H. Hammers
Abstract #1062P
Poster Session, Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E

Pan-Tumor

Assessment of nivolumab benefit-risk profile from a 240-mg flat dose versus a 3-mg/kg dosing regimen in patients with solid tumors

Author: X. Zhao
Abstract #1098P
Poster Session, Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Sunday, October 9, 2016, 1:00 – 2:00 p.m. CEST, Hall E