On November 9, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported that Carlos Paya, M.D., Ph.D., President and Chief Executive Officer, will present at the Jefferies 2018 London Healthcare Conference on Wednesday, November 14, 2018 at 9:40 a.m. GMT / 4:40 a.m. ET (Press release, Immune Design, NOV 9, 2018, View Source [SID1234531093]).

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A live webcast of the presentation will be available online from the investor relations page of the company’s corporate website at View Source After the live webcast, an archive of the presentation will be available on the company website for 30 days.

On November 9, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that new preclinical data on SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, will be featured in a Spotlight poster discussion session at the San Antonio Breast Cancer Symposium taking place December 4-8 in San Antonio (Press release, Syros Pharmaceuticals, NOV 9, 2018, View Source [SID1234531109]). The data show that SY-1365 has dose-dependent inhibitory activity in hormone receptor-positive breast cancer cell lines that are resistant to treatment with CDK4/6 inhibitors.

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The abstract for this presentation is now available online on the SABCS website at View Source

Details on the presentation are as follows:

Presentation Title: Inhibition of CDK7 overcomes resistance to CDK4/6 inhibitors in hormone receptor-positive breast cancer cells
Session Date & Time: Friday, December 7, 7:00-9:00 a.m. CT (8:00-10:00 a.m. ET)
Session Title: Spotlight Session 7: Lobular Breast Cancer
Presenter: Dr. Cristina Guarducci, Dana Farber Cancer Institute
Abstract Number: 1008
Program Number: PD7-12
Location: Stars at Night Ballroom, Henry B. Gonzalez Convention Center

On November 9, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported data from a preplanned secondary efficacy analysis across human leukocyte antigen (HLA) allele subgroups from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of the combination of nelipepimut-S (NeuVax, NPS) +/- trastuzumab (Herceptin) targeting HER2 low-expressing breast cancer patient cohorts (Press release, Sellas Life Sciences, NOV 9, 2018, View Source [SID1234531195]). The data are being presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held November 7 -11, 2018.

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The data presented confirm the therapeutic potential of NPS for patients with early-stage TNBC in the adjuvant setting across HLA types A-02, -03, -24 and -26 which cover approximately 80-85% of the North American/European populations and 86-90% of Asian/Pacific basin populations. In the subgroup of triple negative breast cancer (TNBC) patients with the HLA-A24+ allele type, which is highly prevalent in the Asian population, treated with the combination of NPS and trastuzumab (n=47), the p-value is 0.003 with a 90.6% relative reduction in risk of relapse or death at 24 months and a hazard ratio of 0.08 in favor of the active (combination) arm.

"These data not only confirm the clinical effect of the NPS plus trastuzumab combination in TNBC, which we recently announced at ESMO (Free ESMO Whitepaper) with a p-value of 0.013 and a 75% relative reduction in the risk of relapse or death, but also positions NPS biologically as an agent that could potentially be used globally, considering the high prevalence of the HLA-A24 allele in populations across the Pacific basin and Asia. We are scheduled to meet with the U.S. regulatory authorities in December 2018 on the most optimal and expeditious development path for NPS in TNBC, and continue to advance ongoing interactions with potential partners," said Dr. Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

"In this preplanned secondary efficacy analysis, consistent positive clinical benefit was seen in the TNBC cohort, irrespective of patients’ HLA allele types in favor of the NPS plus trastuzumab combination arm. Specifically, the HLA-A24+ TNBC patients had a significant improvement in disease-free survival both by log-rank and landmark (24 month) analysis despite the lowest predicted binding potential between the E75 (NPS) antigen and this HLA-type," commented Elizabeth A. Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in Surgical Oncology, Director of Research, Breast Surgical Oncology Brigham and Women’s Hospital, Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer Center, and the Principal Investigator of the Phase 2b study.

"This suggests that NPS, which is able to bind to the lower-affinity MHC-I conformations (A24) in addition to the high-affinity ones, i.e., A02 and A03, may generate an optimally favorable immunologic response, possibly due to decreased exposure and tolerance to the E75 epitope. This is important, as other peptide vaccines can be tolerogenic and lead to progressively diminishing immunogenicity over time, something we do not expect to see with NPS," continued Dr. Mittendorf.

Herceptin is a registered trademark of Genentech, Inc. and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

SITC Presentation Information

Date: Friday, November 9th, 2018
Time: 12:45 p.m. to 2:15 p.m. and 6:30 p.m. to 8:30 p.m. ET.
Venue: SITC (Free SITC Whitepaper) 2018 Annual Meeting, Walter E. Washington Convention Center, Washington, DC
Location: Poster Hall E
Poster number: P159
Title: "Correlation between response and HLA type in a randomized phase IIb trial of NeuVax + trastuzumab in HER2 low-expressing breast cancer patients to prevent recurrence."

About SITC (Free SITC Whitepaper)

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy and serves scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world. Currently, SITC (Free SITC Whitepaper) has more than 2,000 members who represent 22 medical specialties in 42 countries around the world and brings together all aspects of the cancer immunology and immunotherapy community in its annual meeting.

On November 9, 2018 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported interim data Phase 1 dose-escalation study of CDX-1140, a fully human agonist anti-CD40 antibody (Press release, Celldex Therapeutics, NOV 9, 2018, View Source [SID1234531094]). CD40, expressed on dendritic cells and other antigen presenting cells, has long been an important target for immunotherapy, as it plays a critical role in the activation of innate and adaptive immune responses. The data were presented in a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting.

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"CDX-1140 was specifically designed to balance systemic dosing and safety, which has proven elusive for CD40-targeted activating therapeutics," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "We have completed four of the potential eight monotherapy dose levels and, to date, CDX-1140 has been well tolerated. Importantly, we are observing dose-dependent biological effects consistent with CD40-mediated immune cell activity. Based on these positive findings, we have expanded development of the program and recently initiated a combination cohort with CDX-301, our dendritic cell growth factor, to increase the number of dendritic cells which are critical to initiating antitumor immunity and a key target for CDX-1140. We also expanded the study to include patients with non-Hodgkin’s lymphoma as our preclinical work has demonstrated that CDX-1140 has direct killing effect on CD40-expressing NHL cells. We look forward to continued data updates from this study in the first half of 2019."

Potent CD40 agonist antibodies have shown encouraging results in early clinical studies; however, systemic toxicity associated with broad CD40 activation has limited their dosing. CDX-1140 has unique properties relative to other CD40 agonist antibodies: potent agonist activity resulting in dendritic cell and B cell activation is independent of Fc receptor interaction, contributing to more consistent, controlled immune activation; CD40 ligand (CD154) binding is not blocked, allowing potential synergistic, antigen-specific agonist activity; and the antibody promotes strong immune activation without significant adverse events in preclinical toxicology studies.

Study Highlights:
Seventeen patients with solid tumors were enrolled at the time of data analysis (n=13 monotherapy; n=4 combination). Four single-agent dosing cohorts have completed (0.01; 0.03, 0.09 and 0.18 mg/kg) and enrollment to the 0.36 mg/kg monotherapy cohort is ongoing. Enrollment to the first CDX-1140/CDX-301 combination cohort is ongoing (0.09 mg/kg and 75 ug/kg, respectively). Dose dependent biological effects consistent with CD40-mediated immune activation have been observed in the study and no maximum tolerated dose (MTD) has been identified to date. Continued enrollment is ongoing to define the MTD and select a dose for disease-specific expansion cohorts that will be monitored for clinical activity.

CDX-1140 has been well tolerated to date. One patient experienced a grade 3 dose-limiting toxicity (DLT) (pneumonitis and hypoxia) at the single-agent 0.18 mg/kg dose. Per protocol, three additional patients were enrolled in the cohort and no additional DLTs have been observed in this or subsequent cohorts.

There have been no significant drug-related changes observed to date in liver function tests or platelets, which have been observed with other CD40 agonists.

Transient dose-dependent pharmacodynamic effects have been observed including activation of immune cells and increases in pro-inflammatory cytokines and chemokines in the blood, which are consistent with CD40-mediated immune activation and the hypothesis that CDX-1140 may achieve dose levels optimal for systemic exposure.
A combination cohort with Celldex’s dendritic cell growth factor CDX-301 has been added to the CDX-1140 study. Dendritic cells, which express CD40, are rarely present or completely absent within the tumor microenvironment and are critical for initiating anti-tumor immunity. CDX-301 is being utilized to increase the number of dendritic cells in blood and tissue available for CDX-1140 activation. CDX-1140 should, in turn, activate the dendritic cells, an important step for enhancing anti-tumor immune responses. While this combination cohort just recently opened to enrollment, preliminary evidence of enhanced immune activation has been observed. Patients continue to be monitored for toxicity with no DLT observed to date.
The study has also been amended to allow for the inclusion of patients with CD40-expressing B cell lymphomas (subtypes of non-Hodgkin lymphoma or NHL) in up to two single-agent cohorts. Both immune activation and direct killing of CD40-expressing NHL cells by CDX-1140 have been shown to contribute to antitumor activity. Several B cell lymphomas, including diffuse large B-cell lymphoma and follicular lymphoma, also express both CD40 and CD27. Celldex’s varlilumab is a potent CD27 agonist and has been shown to synergize with CDX-1140 in NHL models and may be evaluated in combination with CDX-1140 in the future.
About CDX-1140
CDX-1140 is a fully human antibody targeted to CD40, a key activator of immune response that is found on dendritic cells, macrophages and B cells and is also expressed on many cancer cells. Potent CD40 agonist antibodies have shown encouraging results in early clinical studies; however, systemic toxicity associated with broad CD40 activation has limited their dosing. CDX-1140 has unique properties relative to other CD40 agonist antibodies: potent agonist activity resulting in dendritic cell and B cell activation is independent of Fc receptor interaction, contributing to more consistent, controlled immune activation; CD40 ligand (CD154) binding is not blocked, allowing potential synergistic, antigen-specific agonist activity; and the antibody promotes strong immune activation without significant adverse events in preclinical toxicology studies. CDX-1140 has also shown direct antitumor activity in preclinical lymphoma models. Celldex believes that the potential for CDX-1140 will be best defined in combination studies with other immunotherapies, including CDX-301, Celldex’s dendritic cell growth factor, varlilumab, Celldex’s potent CD27 agonist, checkpoint blockade, radiation and other conventional cancer treatments.

On November 9, 2018 Asterias Biotherapeutics, Inc. (NYSE American: AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, reported financial and operational results for the third quarter ended September 30, 2018 (Press release, Asterias Biotherapeutics, NOV 9, 2018, View Source [SID1234531180]).

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On November 7, 2018, Asterias entered into a merger agreement under which Asterias will become a wholly-owned subsidiary of BioTime, Inc. (NYSE American and TASE: BTX) and each outstanding share of common stock of Asterias not already owned by BioTime will be converted into 0.71 common shares of BioTime. The transaction is expected to close during the Company’s first quarter ending March 31, 2019, subject to the satisfaction of customary closing conditions.

Third Quarter 2018 Financial Results

Research and development expenses were $3.5 million in the third quarter. General and administrative expenses were $1.9 million in the third quarter. Total operating expenses were $5.4 million in the third quarter of 2018, compared to $8.7 million in the third quarter of 2017.

Net loss was $4.5 million, or $0.08 per share for the third quarter of 2018 compared to a net loss of $6.8 million, or $0.14 per share for the third quarter of 2017. For the quarter ended September 30, 2018, net cash used in operating activities was $2.9 million compared to $4.5 million for the quarter ended September 30, 2017.

On September 28, 2018, the Company entered into two new agreements with an affiliate of Novo Nordisk, a multinational pharmaceutical company based in Denmark, which included a $2.0 million upfront payment that was received in early October 2018. Following the receipt of such funds from the Novo transaction, on October 1, 2018 the Company had cash and cash equivalents of $8.5 million and $6.2 in marketable equity securities. The Novo transaction will also result in approximately $1.0 million of annual reduction in fixed overhead allowing Asterias to advance its development programs more cost-effectively.

Conference Call

As a result of the merger agreement with BioTime, the Company’s previously announced conference to provide an overview of the third quarter results as well as the recent corporate progress, scheduled for Monday, November 12, 2018 at 5:00pm ET have been cancelled.