On November 3, 2015 Fate Therapeutics, Inc. (NASDAQ: FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapeutics for the treatment of cancer and immune disorders, reported business highlights and financial results for the third quarter ended September 30, 2015 (Filing, 8-K, Fate Therapeutics, NOV 3, 2015, View Source [SID:1234507925]).

"We have firmly established a leadership position in a unique and broadly applicable strategy for cancer immunotherapy — the production of T cells and NK cells from pluripotent cells, bringing an off-the-shelf approach to the field of cell-based immunotherapies," said Scott Wolchko, Chief Operating and Financial Officer of Fate Therapeutics. "Additionally, our clinical experience with PROHEMA, preclinical studies with PROTMUNE and research collaborations with Juno Therapeutics and the University of Minnesota all provide compelling support that the administration of programmed immune cells to patients fighting cancer will serve as a cornerstone treatment paradigm."

Recent Highlights & Upcoming Milestones

· Off-the-Shelf Cancer Immunotherapy Strategy to be Presented at ASH (Free ASH Whitepaper) 2015 Annual Meeting. The Company’s patent-protected pluripotent cell platform combines genetic engineering of pluripotent cells with rapid and efficient generation of immune cells, enabling production of off-the-shelf engineered T- and NK-cell-based therapeutics without requiring patient-sourced cells. Fate plans to present its novel strategy for developing off-the-shelf cancer immunotherapies using its pluripotent cell platform during two poster sessions at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2015 Annual Meeting.

· NK-Cell Cancer Immunotherapeutic Undergoing Preclinical Development. In July 2015, Fate entered into a collaboration with the University of Minnesota to enable clinical development of a novel population of "adaptive" NK cells, which exhibit prolonged persistence and enhanced anti-tumor activity mediated through CD16 signaling in preclinical studies. The Company’s development strategy seeks to use "adaptive" NK cells in combination with solid tumor-targeting antibodies to induce potent killing of cancer cells.

· PROTMUNE IND Filing Planned. The Company expects to initiate a first-in-human clinical trial in 2016 to investigate the potential of PROTMUNE to prevent the life-threatening complications of acute graft-versus-host disease (GvHD) and severe infections in patients undergoing mobilized peripheral blood (mPB) transplantation. During an ASH (Free ASH Whitepaper) 2015 Annual Meeting poster session, Fate plans to present scientific findings showing that a single administration of programmed peripheral blood cells resulted in a statistically-significant reduction in GvHD score and improvement in survival as compared to vehicle-treated peripheral blood cells in preclinical models.

· PUMA Study Reaches 70% of Target Enrollment. Fate is currently preparing a second interim data-cut from its ongoing Phase 2 PUMA study of PROHEMA in adult patients undergoing double umbilical cord blood transplantation for the treatment of hematologic malignancies. The Company expects to report additional data on neutrophil engraftment and severe infection-related adverse events from the PUMA study during the 2015 ASH (Free ASH Whitepaper) Annual Meeting.

· Leadership Transition. On October 12, 2015, the Company announced that Scott Wolchko, a Fate founder and the Company’s Chief Operating & Financial Officer, will succeed Christian Weyer, M.D., M.A.S., as President and Chief Executive Officer, effective December 1. The Company also announced that Stewart Abbot, Ph.D. has been named Chief Development Officer after joining Fate earlier this year from Celgene Cellular Therapeutics, where he was instrumental in developing the company’s hematopoietic cell-based immuno-oncology programs and partnerships. Fate also announced the promotions of Daniel Shoemaker, Ph.D., who joined the Company in 2009, to Chief Scientific Officer, and Cindy Tahl, J.D., who joined the Company in 2009, to General Counsel.

Financial Results

· Cash Position: Cash and cash equivalents as of September 30, 2015 were $72.9 million, compared to $49.1 million as of December 31, 2014. The increase is primarily driven by net proceeds from the Company’s public offering of common stock in May 2015 and cash generated from entering into a research collaboration and license agreement with Juno Therapeutics in May 2015, offset by cash used to fund operating activities.

· Total Revenue: Revenue was $1.0 million for the third quarter of 2015, which was derived from the Company’s collaboration with Juno.

· Total Operating Expenses: Total operating expenses were $7.4 million for the third quarter of 2015, compared to $6.0 million for the third quarter of 2014. Operating expenses for the third quarter of 2015 include $0.6 million of stock compensation expense, compared to $0.5 million for the third quarter of 2014.

· R&D Expenses: Research and development expenses were $5.0 million for the third quarter of 2015, compared to $4.1 million for the third quarter of 2014. The increase in R&D expenses is primarily related to an increase in third-party professional consultant and service provider expenses to support the clinical development of PROHEMA, and an increase in personnel expense, including stock-based compensation expense, resulting from additional headcount to support the conduct of research activities.

· G&A Expenses: General and administrative expenses were $2.4 million for the third quarter of 2015, compared to $1.9 million during the third quarter of 2014. The increase in G&A expenses is primarily related to an increase in personnel expense, including stock-based compensation expense.

· Common Shares Outstanding: Common shares outstanding as of September 30, 2015 were 28.7 million compared to 20.6 million as of December 31, 2014. Common shares outstanding increased primarily as a result of the 6.9 million shares of the Company’s common stock issued pursuant to the May 2015 financing, and the 1.0 million shares of the Company’s common stock issued and sold to Juno pursuant to the collaboration.

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On November 3, 2015 Incyte Corporation (Nasdaq: INCY) reported 2015 third-quarter financial results, including revenue from Jakafi (Filing, 8-K, Incyte, NOV 3, 2015, View Source [SID:1234507900]).

The Company highlighted the continued strong revenue growth from Jakafi in the U.S. and royalties from sales of Jakavi (ruxolitinib) outside of the U.S. by the Company’s collaborator, Novartis, as well as significant progress across its development portfolio. During November 2015, Incyte expects detailed data from the remaining two Phase III trials of the global registration program for baricitinib in patients with rheumatoid arthritis (RA) to be presented at the American College of Rheumatology (ACR), as well as the first presentation of data from the proof-of-concept trial of epacadostat, Incyte’s selective IDO1 inhibitor, in combination with Merck’s anti-PD-1 antibody, pembrolizumab, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The Company recently announced an agreement with Merck to expand their clinical collaboration to include a pivotal trial of epacadostat plus pembrolizumab in first-line advanced or metastatic melanoma. Incyte has also recently initiated clinical trials of INCSHR1210, an anti-PD-1 monoclonal antibody, in patients with solid tumors, INCB53914, a selective pan-PIM kinase inhibitor, in hematological malignancies and topical ruxolitinib cream for the treatment of patients with alopecia areata.

"We are very pleased with the continued revenue growth from Jakafi during the third quarter, which was driven by strong underlying demand from both of its approved indications," stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. "We are successfully executing on our aggressive clinical development plans, and believe that the positive outcome of the pivotal RA development program for baricitinib and the progression of epacadostat into a global Phase III trial are both landmark events as we continue our transformation into a world-leading biopharmaceutical business."

2015 Third-Quarter Financial Results

Revenues For the quarter ended September 30, 2015, net product revenues of Jakafi were $161 million as compared to $98 million for the same period in 2014, representing 65 percent growth. For the nine months ended September 30, 2015, net product revenues of Jakafi were $419 million as compared to $252 million for the same period in 2014, representing 67 percent growth. For the quarter and nine months ended September 30, 2015, product royalties from sales of Jakavi outside of the United States received from Novartis were $18 million and $51 million, respectively, as compared to $12 million and $34 million, respectively, for the same periods in 2014. For the quarter ended September 30, 2015, contract revenues were $8 million as compared to $88 million for the same period in 2014. For the nine months ended September 30, 2015, contract revenues were $40 million as compared to $102 million for the same period in 2014. The $62 million decrease in contract revenues for the nine months ended September 30, 2015 compared to the same period in 2014 relates to a decrease in milestone payments earned from Novartis. For the quarter ended September 30, 2015, total revenues were $188 million as compared to $198 million for the same period in 2014. For the nine months ended September 30, 2015, total revenues were $510 million as compared to $388 million for the same period in 2014.

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Research and development expenses

Research and development expenses for the quarter and nine months ended September 30, 2015 were $132 million and $363 million, respectively, as compared to $89 million and $249 million, respectively, for the same periods in 2014. Included in research and development expenses for the quarter and nine months ended September 30, 2015 were non-cash expenses related to equity awards to our employees of $10 million and $30 million, respectively. The increase in research and development expenses was primarily due to the expansion of the Company’s clinical portfolio, including costs related to external alliances. Also included in research and development expenses for the nine months ended September 30, 2015 was the one-time upfront payment to Agenus related to our license, development and commercialization agreement and for the quarter and nine months ended September 30, 2015, the one-time upfront payment to Jiangsu Hengrui Medicine Co., Ltd. related to our global license and collaboration agreement.

Selling, general and administrative expenses

Selling, general and administrative expenses for the quarter and nine months ended September 30, 2015 were $48 million and $144 million, respectively, as compared to $39 million and $117 million, respectively, for the same periods in 2014. Included in selling, general and administrative expenses for the quarter and nine months ended September 30, 2015 were non-cash expenses related to equity awards to our employees of $8 million and $22 million respectively. Increased selling, general and administrative expenses reflected additional costs related to the commercialization of Jakafi.

Unrealized loss on long term investment

Unrealized loss on long term investment of $31 million and $4 million, respectively, for the quarter and nine months ended September 30, 2015 represents the fair market value adjustments of the Company’s investment in Agenus.

Net income / (loss)

Net loss for the quarter ended September 30, 2015 was $40 million, or $0.22 per basic and diluted share, as compared to net income of $59 million, or $0.35 and $0.33 per basic and diluted share, respectively, for the same period in 2014. Net loss for the nine months ended September 30, 2015 was $49 million, or $0.27 per basic and diluted share as compared to a net loss of $12 million, or $0.07 per basic and diluted share, for the same period in 2014.

Cash, cash equivalents and marketable securities position

As of September 30, 2015, cash, cash equivalents and marketable securities totaled $635 million, as compared to $600 million as of December 31, 2014.

Product Update

Jakafi (ruxolitinib) — JAK1 and JAK2 Inhibitor

The pivotal Phase III JANUS 1 and JANUS 2 studies of ruxolitinib in second line metastatic pancreatic cancer are ongoing. Three Phase II trials of ruxolitinib are ongoing in colorectal, breast and non-small cell lung cancer (NSCLC) patients.

A Phase II trial of topical ruxolitinib cream has begun in patients with alopecia areata, the primary endpoint of which is the percentage of subjects achieving a Severity of Alopecia Tool score (SALT) 50 response in terminal hair (pigmented and non-pigmented) at 24 weeks.

baricitinib — JAK1 and JAK2 Inhibitor

In September 2015, the Company and Eli Lilly and Company ("Lilly") announced that the Phase III RA-BEGIN study of baricitinib met its primary endpoint of non-inferiority of baricitinib monotherapy to methotrexate monotherapy based on ACR20 response rate after 24 weeks of treatment. Additionally, baricitinib was superior to methotrexate based on ACR20 response. The RA-BEGIN study included RA patients who had limited or no prior treatment with methotrexate, and were naïve to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).

In October 2015, the Company and Lilly announced that the Phase III RA-BEAM study of baricitinib met its primary endpoint of improved ACR20 response compared to placebo after 12 weeks of treatment. The RA-BEAM study also included an active comparator group of RA patients taking Humira (adalimumab)*, and all patients were also treated with background methotrexate. The results of the RA-BEAM trial also showed that baricitinib was superior to adalimumab on key secondary objectives of ACR20 response and improvement in DAS28-hsCRP score after 12 weeks of treatment, and that following 24 weeks of treatment, baricitinib was superior to placebo in preventing progressive radiographic structural joint damage.

epacadostat (INCB24360) — IDO1 Inhibitor

Four clinical trials to evaluate epacadostat in combination with immune checkpoint inhibitors are all recruiting patients. These trials are evaluating epacadostat in combination with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab)*, AstraZeneca/MedImmune’s investigational PD-L1 inhibitor, durvalumab, Bristol-Myers Squibb’s PD-1 inhibitor, Opdivo (nivolumab)*, and Roche/Genentech’s investigational PD-L1 inhibitor, atezolizumab.

Initial proof-of-concept results from the combination trial of epacadostat and pembrolizumab are expected to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting & Associated Programs on November 6.

In October 2015, the Company and Merck & Co. announced an expansion of the companies’ ongoing clinical collaboration to include a Phase III study evaluating the combination of epacadostat with pembrolizumab as a first-line treatment for patients with advanced or metastatic melanoma.

INCB39110 & INCB52793 — JAK1-Selective Inhibitors

INCB39110, in combination with INCB40093, Incyte’s PI3Kδ inhibitor, is in development for patients with B-cell malignancies. INCB39110 is also in a Phase II trial, in combination with gemcitabine and nab-paclitaxel, in patients with pancreatic cancer.

The Company’s second JAK1-selective inhibitor, INCB52793, is in a Phase I/II monotherapy dose-escalation trial in advanced malignancies.

INCB40093 & INCB50465 — PI3Kδ Inhibitors

INCB40093 is in clinical development in combination with the JAK1-selective inhibitor INCB39110 in B-cell malignancies. An open-label, dose-escalation monotherapy study of INCB50465 in subjects with previously treated B-cell malignancies is underway.

capmatinib (INC280) — c-MET Inhibitor

Capmatinib is being investigated by Novartis in a variety of solid tumors, including advanced c-MET positive hepatocellular carcinoma, c-MET positive/EGFR-TKI-resistant NSCLC and glioblastoma multiforme, as well as in combination, including with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, nivolumab, in a Phase II trial of patients with NSCLC.

INCB54828 — FGFR Inhibitor

INCB54828 is in an open-label, dose-escalation study in subjects with advanced malignancies.

INCB54329 — BRD Inhibitor

INCB54329 is in an open-label, dose-escalation study in subjects with advanced malignancies.

INCSHR1210 — PD-1 inhibitor

During the third quarter of 2015, Incyte announced a global license and collaboration agreement with Jiangsu Hengrui Medicine Co., Ltd. for the development and commercialization of SHR-1210 (now INCSHR1210), an investigational anti-PD-1 monoclonal antibody. INCSHR1210 has now entered a proof-of-concept trial for the treatment of patients with advanced solid tumors.

INCB53914 — PIM Inhibitor

The Company has initiated an open-label, dose-escalation study of INCB53914, a selective pan-PIM kinase inhibitor, in subjects with hematological malignancies.

On November 3, 2015 Foundation Medicine, Inc. (NASDAQ:FMI) reported financial and operating results for its third quarter ended September 30, 2015 (Press release, Foundation Medicine, NOV 3, 2015, View Source [SID:1234507926]). Highlights for the quarter included:

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Third quarter revenue of $25.4 million, 54% year-over-year growth;
Third quarter revenue from biopharmaceutical customers of $11.7 million, 75% year-over-year growth;
Third quarter revenue from clinical testing of $13.7 million, 40% year-over-year growth;
8,012 clinical tests reported in the third quarter, 25% year-over-year growth;
Broadening molecular information solutions with the launch of GeneKit, a genomic solutions portal for pathologists, and expanding FoundationCORE to approximately 60,000 patient cases;
United Healthcare’s published medical policy for coverage of highly validated genomic profiling in patients with non-small cell lung cancer; and,

Launching the Precision Medicine Exchange Consortium(PMEC) with eight leading academic and community-based cancer centers, including The Cleveland Clinic’s Taussig Cancer Institute, Hackensack University Medical Center, and Sidney Kimmel Cancer Center at Thomas Jefferson University.

Foundation Medicine reported total revenue of $25.4 million in the third quarter of 2015, compared to $16.4 million in the third quarter of 2014 and $22.5 million in the second quarter of 2015. Revenue from clinical testing in the third quarter of 2015 was $13.7 million, compared to $9.8 million in the third quarter of 2014 and $12.4 million in the second quarter of 2015.

The company reported 8,012 clinical tests in the third quarter of 2015, a 25% increase from the same quarter last year. This number includes 7,000 FoundationOne tests and 1,012 FoundationOne Heme tests. The results of an additional 2,676 tests were also reported to biopharmaceutical customers in this year’s third quarter.

Revenue from biopharmaceutical customers grew to $11.7 million in the third quarter, a 75% increase from the same quarter last year and an increase of 17% from the second quarter of 2015. This growth underscores the diverse revenue streams generated by biopharmaceutical customers engaged with the company in clinical trial, molecular information data access, and companion diagnostic development activities.

"Foundation Medicine delivered 54% year-over-year revenue growth driven by particularly strong results from our biopharmaceutical business," said Michael Pellini, M.D., chief executive officer of Foundation Medicine. "While our third quarter clinical revenue and volume increased significantly year-over-year, these numbers also reflect that we have work to do in this nascent market. We believe we are well-positioned for continued growth over the near and long term with our fully integrated, diversified business, a growing pipeline of innovative products, a strong balance sheet and a global partner in Roche."

The company’s cancer knowledgebase, FoundationCORE, grew to approximately 60,000 clinical cases. FoundationCORE is a unique asset and critical component of the value that Foundation Medicine delivers to its biopharmaceutical and physician customers. The increasing scale and breadth of a high quality, clinically relevant oncology data set derived from the company’s analytically validated testing platform continues to enhance clinical practice and enable improved outcomes for patients.

Total operating expenses for the third quarter of 2015 were approximately $35.6 million compared with $21.9 million for the third quarter of 2014. Net loss was approximately $20.6 million in the third quarter of 2015, or a $0.60 loss per share. At September 30, 2015, the company held approximately $250 million in cash and cash equivalents.

Recent Enterprise Highlights

At the end of October, Roche Pharmaceuticals (Israel) Ltd. commenced commercial activities in support of the company’s molecular information products in oncology. Roche Israel will act as the exclusive distributor of Foundation Medicine’s products and services.

United Healthcare published a medical policy for coverage of highly validated genomic profiling in patients with non-small cell lung cancer.

In September, Foundation Medicine launched the Precision Medicine Exchange Consortium (PMEC) to advance the integration of molecular information in clinical oncology and accelerate the adoption of precision care. PMEC brings together thought leaders from academic medical centers, regional hospital systems and community oncology networks to exchange molecular information and outcomes data.

In September, Foundation Medicine expanded its molecular decision support offerings with GeneKit, a genomic solutions portal for pathologists. GeneKit easily integrates into the pathologist’s workflow and expedites and improves the interpretation, analysis and reporting of genomic data for clinical use.

In September, Foundation Medicine successfully completed the migration of its physician customers to the newest version of Interactive Cancer Explorer, FoundationICE, which also includes the PatientMatch application that was launched commercially in May 2015.

2015 Outlook

The company anticipates 2015 revenue will be in the range of $85 to $95 million.
The company expects to report between 32,000 and 33,000 clinical tests in 2015.
The company expects operating expenses in the range of $128 to $138 million, plus an additional $14.4 million one-time expense during the second quarter related to advisor fees in connection with the closing of the Roche strategic collaboration.
The company expects to launch a circulating tumor DNA (ctDNA) test for its biopharmaceutical partners by year-end, and a commercial ctDNA assay for clinical testing in 2016.

On November 3, 2015 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported financial results for the third quarter ending September 30, 2015 (Filing, 6-K, Compugen, NOV 3, 2015, View Source [SID:1234507901]).

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Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen, stated, "We are very pleased by the continuing successful advancement of our early stage target pipeline with programs addressing substantial therapeutic opportunities in immuno-oncology, antibody drug conjugate therapy, and autoimmune diseases, all based on novel targets discovered by us."

Dr. Cohen-Dayag continued, "With respect to our multiple internal immuno-oncology programs, we continue to advance CGEN-15029 as the highest priority mAb program, and as such, have allocated additional resources to this program to advance it to clinical trials. This is a very exciting time for the Company, as we advance our first internal immuno-oncology program toward IND-enabling activities. With respect to programs addressing antibody drug conjugate therapy, we have established a diversified portfolio of target candidates for this promising mode of cancer therapy, and recently disclosed data suggesting broad first-in-class clinical opportunities for CGEN-15027 antibodies in the treatment of multiple solid tumor types."

Dr. Cohen-Dayag, added, "With respect to our collaboration with Bayer HealthCare based on CGEN-15001T and CGEN-15022, both Bayer and Compugen are excited by the potential of the two programs as additional understandings of the target biology are gained and the programs progress toward potential novel therapeutics for cancer immunotherapy."

Revenues for the third quarter of 2015 and for the nine months ending September 30, 2015 were $0.2 million and $1.0 million respectively, compared with $1.7 million and $5.8 million for the comparable periods in 2014. The decrease in revenues is attributable mainly to recognition of the non-refundable upfront payment under the August 2013 collaboration and license agreement with Bayer and a milestone payment in the amount of $1.2 million received in the second quarter of 2014 from Bayer.

Net loss for the third quarter of 2015 was $6.7 million, or $0.13 per basic and diluted share, compared with a net loss of $5.4 million, or $0.11 per basic and diluted share, for the comparable period in 2014. Net loss for the nine months ending September 30, 2015 was $19.7 million, or $0.39 per basic and diluted share, compared with a net loss of $9.6 million, or $0.20 per basic and diluted share, for the comparable period in 2014. The significant increase in net loss for the comparable periods largely relates to a decrease in revenues as noted above, and an increase in the Company’s R&D and business development activities relating to its Pipeline Program candidates.

As of September 30, 2015, cash, cash related accounts, short-term and long-term bank deposits totaled $89.3 million with no debt, compared with $108.4 million as of December 31, 2014.

On November 3, 2015 Merrimack (Nasdaq: MACK) reported that it will present research on several of its therapeutic candidates at the 2015 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), November 5-9, 2015 at Hynes Convention Center in Boston (Press release, Merrimack, NOV 3, 2015, View Source [SID:1234507928]). Presentations include recent preclinical data from Merrimack’s antibody engineering technology platforms.

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Data will be presented in three poster sessions:

Poster Sessions

Istiratumab (MM-141), a bispecific antibody co-targeting IGF-1R and ErbB3, potentiates the activity of immune checkpoint inhibitors (Abstract #A89)
Poster Session A
Session Title: Immune Modulators
Friday, November 6, 2015, 12:15 PM – 3:15 PM ET
Exhibit Hall C-D

MM-151 overcomes acquired resistance to cetuximab and panitumumab in colorectal cancer cells harboring EGFR extracellular domain mutations (Abstract #LB-B05)
Poster Session B
Session Title: EGFR/Her2
Saturday, November 7, 2015, 12:30 PM – 3:30 PM ET
Exhibit Hall C-D

Inhibition of ERBB3 with MM-121, IGF1-R with MM-141 or Met with MM-131 increases the activity of EGFR inhibitor MM-151 in colorectal cancer models expressing multiple resistance ligands (Abstract #LB-C25)
Poster Session C
Session Title: Drug Resistance and Modifiers
Sunday, November 8, 2015, 12:30 PM – 3:30 PM ET
Exhibit Hall C-D