On November 10, 2017 CombiMatrix Corporation (NASDAQ: CBMX) ("CombiMatrix" or the "Company"), a family health molecular diagnostics company specializing in DNA-based reproductive health and pediatric testing services, reported that, based upon the final vote count for the Company’s Special Meeting of Stockholders held today, a majority of its stockholders voted to approve the previously announced merger agreement with Invitae Corporation (NYSE: NVTA) ("Invitae"), pursuant to which the Company would become a wholly owned subsidiary of Invitae upon closing of the proposed merger (Press release, CombiMatrix, NOV 13, 2017, View Source [SID1234521959]).

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Approximately 1.79 million of the common shares voting at today’s Special Meeting voted in favor of the approval and adoption of the all-stock merger agreement, which represented approximately 60.8% of CombiMatrix’s total outstanding shares of common stock as of the September 26, 2017 record date for the Special Meeting.

"We are delighted to receive approval for the merger with Invitae, which we believe is in the best interest of our stockholders," said Mark McDonough, President and Chief Executive Officer of CombiMatrix. "Combining CombiMatrix’s products and experience with Invitae’s scale and expertise will provide synergies that we believe will lead to opportunities to better serve patients."

The merger, which is expected to be completed in the fourth quarter of 2017, remains subject to additional closing conditions, including the condition that at least 90% of the Company’s Series F warrants outstanding immediately prior to the date of the merger agreement shall have been validly tendered and not withdrawn prior to the expiration of the related exchange offer being conducted by Invitae (toward which Invitae will count any and all exercises of CombiMatrix Series F warrants prior to the expiration of the exchange offer, including such exercises as are made contingent solely upon a closing of the merger).

On November 13, 2017 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, reported it will present at the upcoming 2017 Stifel Healthcare Conference taking place November 14-15, 2017 in New York City, New York (Press release, Zymeworks, NOV 13, 2017, View Source [SID1234522014]). The presentation will be November 15, 2017 at 3:30 p.m. ET.

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On November 13, 2017 Alexo Therapeutics, a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint mechanism exploited by cancer cells to evade the immune system, reported that ALX148 preclinical results have been selected for an oral presentation at the 59th ASH (Free ASH Whitepaper) Annual Meeting & Exposition, Dec. 9-12, 2017 in Atlanta, Georgia (Press release, Alexo Therapeutics, NOV 13, 2017, View Source [SID1234522015]).

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Oral Presentation Information
Title: ALX148 Is a High Affinity SIRPα Fusion Protein That Blocks CD47, Enhances the Activity of Anti-Cancer Antibodies and Checkpoint Inhibitors, and Has a Favorable Safety Profile in Preclinical Models
Session Name: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: New Tools and Emerging Immune-Modulatory Approaches for Non-Hodgkin’s Lymphomas
Session Date: Saturday, December 9, 2017
Presentation Time: 10:15 am ET
Room: Georgia World Congress Center, Building C, Level 1, C101 auditorium
Publication Number: 112

On November 13, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported the initiation of two new global pivotal clinical trials of BGB-3111, an investigational Bruton’s Tyrosine Kinase (BTK) inhibitor, including a Phase 3 trial of BGB-3111 in previously untreated patients with CLL/SLL and a pivotal Phase 2 trial of BGB-3111 in combination with GAZYVA (obinutuzumab) in patients with relapsed or refractory FL (Press release, BeiGene, NOV 13, 2017, View Source;p=RssLanding&cat=news&id=2316623 [SID1234521996]). Along with a global Phase 3 trial comparing BGB-3111 to ibrutinib in Waldenström’s macroglobulinemia (WM), initiated in early 2017, BGB-3111 is now being evaluated in global pivotal trials in three distinct indications. Additionally, BGB-3111 is being evaluated in a broad pivotal clinical development program in China, including ongoing pivotal Phase 2 trials in MCL, CLL, and WM, which was initiated in August 2017. BeiGene also announced today that enrollment in the pivotal Phase 2 trial of BGB-3111 in China in MCL patients was completed in September 2017.

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"The initiation of two additional pivotal trials expands our global registration-directed clinical development of BGB-3111 to additional indications, including patients with follicular lymphoma, a common B cell malignancy for which BTK inhibitors are not yet approved. We look forward to continuing the development of BGB-3111 as a potentially best-in-class BTK inhibitor for patients worldwide who suffer from hematological malignancies," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"We believe that these two new pivotal trials are supported by our growing clinical experience with BGB-3111, in which over 600 patients have been dosed to date. With the newly initiated Phase 3 CLL/SLL trial, we aim to investigate whether BGB-3111 could be an effective treatment option for a broad population of CLL/SLL patients requiring initial treatment. The initiation of the pivotal trial in follicular lymphoma is an effort to determine whether the combination of BGB-3111 and obinutuzumab represents an effective treatment option for a high-unmet-need population of relapsed or refractory patients to potentially support the pursuit of accelerated or conditional approval of this regimen," commented Jane Huang, M.D., Chief Medical Officer, Hematology.

Trial Design

The Phase 3 trial in CLL/SLL is designed to compare BGB-3111 to BR and will be conducted in North America, Europe, Australia, New Zealand, and Asia. The study will enroll previously untreated CLL/SLL patients ineligible for intensive chemo-immunotherapy (i.e., fludarabine, cyclophosphamide, and rituximab), who will be divided into two cohorts. The first cohort is designed to include 420 patients without a 17p deletion (del17p), who will be randomized in a 1:1 ratio to receive either BGB-3111 until progression or six cycles of BR. Crossover will be allowed in the BR arm upon progression. The primary endpoint will be progression-free survival (PFS), and secondary endpoints include overall response rate (ORR), duration of response (DOR), overall survival (OS), and patient-reported outcomes. Patients with del17p will be enrolled in a second cohort to receive BGB-3111 until progression and will be assessed for response and safety.

The pivotal Phase 2 trial in FL is designed to evaluate BGB-3111 in combination with obinutuzumab in patients who have had at least two prior lines of therapy and who progressed within 12 months of their last treatment or were refractory to their last treatment. The primary endpoint will be ORR and obinutuzumab monotherapy will be included as a comparator, in order to evaluate the contribution of BGB-3111. The trial is expected to enroll approximately 210 patients in North America, Europe, Australia, and New Zealand who will be randomized 2:1 to receive either BGB-3111 with obinutuzumab or obinutuzumab alone. Patients in the obinutuzumab arm will have the option to add BGB-3111 after 12 months if a response has not been achieved. Secondary endpoints of the study include DOR, PFS, OS, and time to response.

About BGB-3111

BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK. BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib, a BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency, based on biochemical assays, higher exposure than ibrutinib based on their respective Phase 1 experience in separate trials, and sustained 24-hour BTK occupancy in both the peripheral blood and lymph node compartments.

On November 13, 2017 Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer and infectious diseases, reported durable tumour responses and strong overall survival data from two Phase I clinical trials of its wholly owned, lead programme, IMCgp100, in metastatic uveal melanoma (Press release, Immunocore, NOV 13, 2017, View Source [SID1234521949]).

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The data, which show a near doubling in the average rate of overall survival compared with studies of other agents, was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting on Saturday 11th November 2017, at the Gaylord National Resort & Convention Center in National Harbor, Maryland, USA.

Immunocore’s intra-patient dose escalation Phase I IMCgp100 study in metastatic uveal melanoma patients demonstrates a one-year overall survival (OS) rate of 73% (95% confidence interval [46, 88]) and a one-year progression-free-survival (PFS) rate of 62% based on the irRC criteria as of the data cut-off in October 2017. Median OS has not been reached with median follow-up of 12.8 months in this cohort. The overall survival data from this study compare very favourably to studies with other agents, which show one-year OS rates of approximately 25-45%*.

Pharmacodynamic analysis demonstrated evidence of T cell infiltration and immune activation in tumours after IMCgp100 administration, with persistence of T cell infiltration in the setting of resistance, underpinning confidence in the efficacy observed with the T cell redirection technology of IMCgp100.

Commenting on the results, Dr Richard Carvajal, Head of Experimental Therapeutics at Columbia University, said: "Metastatic uveal melanoma is a condition with exceptionally high unmet medical need with no current standard of care in this setting. No therapies to date have shown survival benefits in trials. The exciting one year overall survival and progression-free survival data we have observed with IMCgp100 have given us confidence to move into pivotal trials measuring survival in this disease setting."

Christina Coughlin, Chief Medical Officer at Immunocore, said: "We believe this therapy has the potential to be a game-changer for medical practice in this devastating condition. At Immunocore, we’re optimistic that the exceptionally strong data we have seen with IMCgp100 in metastatic uveal melanoma have the potential to read across to other ImmTAC programmes, especially when addressing ‘cold’ tumours which are challenging for checkpoint inhibitors and other novel immuno-oncology agents to address. We believe that this underscores the broader applicability of Immunocore’s soluble TCR technology in cancer and beyond."

The details of the clinical trial can be found on clinicaltrials.gov.

Poster Presentation Information

Title: Safety, efficacy and biology of the gp100 TCR-based bispecific T cell redirector, IMCgp100 in advanced uveal melanoma in two Phase 1 trials

Authors: Richard Carvajal, Takami Sato, Alexander N. Shoushtari, Joseph Sacco, Paul Nathan, Marlana Orloff, Pippa Corrie, Neil Steven, Jeff Evans, Jeffrey Infante, Mario Sznol, Clive Mulatero, Omid Hamid, Leonel Hernandez-Aya, Nicola Little, Cheryl McAlpine, David Krige, Namir J. Hassan, Sanjay Patel, Ann-Marie Hulstine, Christina M. Coughlin, Mark R. Middleton

Category: Clinical Trials (Completed)

Date: Saturday 11 November 2017

Time: 12:30 – 14:00 & 18:30 – 20:00

Abstract Number: P208

To view the abstract, please visit the SITC (Free SITC Whitepaper) website at View Source