Tetraphase Pharmaceuticals to Present Data on Preclinical Activity of TP-2846 in Acute Myeloid Leukemia

On february 27, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel tetracyclines to treat life-threatening conditions, reported it will present three posters on TP-2846, the Company’s newly revealed pipeline candidate for acute myeloid leukemia (AML) (Press release, Tetraphase Pharmaceuticals, FEB 27, 2019, View Source [SID1234533750]). The posters will be presented at the 2019 American Association for Clinical Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place March 29 – April 3 at the Georgia World Congress Center in Atlanta. The poster presentations will include in vitro and in vivo data supporting TP-2846’s potential as a novel tetracycline antileukemia agent.

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"Decades of research have shown that tetracyclines hold potential as anticancer agents, but to date, optimizing a tetracycline for oncology has proven elusive," said Guy Macdonald, President and Chief Executive Officer. "Leveraging our proprietary and productive discovery platform, we identified TP-2846, a structurally diverse tetracycline and potential new antileukemia agent with potent in vitro and in vivo activity. We look forward to further discussing the potential of TP-2846 at AACR (Free AACR Whitepaper) and building on this encouraging preclinical dataset."

"TP-2846 represents a new mechanism of action with potential application for AML patients regardless of mutation status," said Jacques Dumas, Ph.D., Chief Scientific Officer. "By using our fully synthetic technology for building tetracyclines, we have been able to optimize TP-2846 for AML, warranting its further study in this patient population."

The details for the data presentations at AACR (Free AACR Whitepaper) are as follows:

Abstract Number: 3857
Title: Discovery and structure-activity relationship studies of TP-2846: a novel tetracycline antileukemia agent
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 2
Session Date and Time: Tuesday, April 2, 2019 from 1:00 PM – 5:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 12

Abstract Number: 3880
Title: In vivo activities of TP-2846: a novel tetracycline antileukemia agent
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 2
Session Date and Time: Tuesday, April 2, 2019 from 1:00 PM – 5:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 12

Abstract Number: 4802
Title: In vitro characterization of TP-2846: a novel tetracycline antileukemia agent
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 3
Session Date and Time: Wednesday, April 3, 2019 from 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 13

VACCIBODY AS TO PRESENT DATA ON VB10.NEO AND VB10.16 AT UPCOMING AMERICAN ASSOCIATION FOR CANCER RESEARCH ANNUAL MEETING

On February 27, 2019 Vaccibody AS reported that clinical and preclinical data will be presented at the upcoming 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which will be held from March 29- April 3, 2019 in Atlanta, Georgia (Press release, Vaccibody, FEB 27, 2019, View Source [SID1234533782]). The abstracts will be published in advance of the AACR (Free AACR Whitepaper) Annual meeting at the AACR (Free AACR Whitepaper) Online Itinerary Planner: View Source!/6812.

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"We are excited that four separate abstracts presenting Vaccibody’s pipeline have been accepted for poster presentation at this year’s AACR (Free AACR Whitepaper) Annual Meeting," said Agnete Fredriksen, PhD, President and CSO of Vaccibody. Two of the abstracts cover Vaccibody’s two lead candidates VB10.16 and VB10.NEO and are presenting the 6M interim data and the clinical design, respectively. In addition, two abstracts present preclinical data for VB10.NEO that demonstrates the progress we have made characterizing the unique Vaccibody platform and its ability to induce strong tumor protective immune responses alone and in combination with bempegaldesleukin (NKTR-214).

Details of the four poster presentations are as follows:

Abstract #CT209

Title: Safety, efficacy and immunogenicity of VB10.16, a therapeutic DNA vaccine targeting human papillomavirus (HPV) 16 E6 and E7 proteins for high grade cervical intraepithelial neoplasia (CIN 2/3): 6-month data from an exploratory open-label phase I/2a trial

Session Date and Time: Tuesday Apr 2, 2019 1:00 PM – 5:00 PM local time

Abstract #CT217

Title: An open-label, Phase I/IIa study of VB10.NEO (DIRECT-01) in combination with checkpoint blockade in patients with locally advanced or metastatic solid tumors including melanoma, NSCLC, renal cell carcinoma, urothelial cancer or SSCHN

Session Date and Time: Tuesday Apr 2, 2019 1:00 PM – 5:00 PM local time

Abstract #5033

Title: "Vaccibody DNA vaccine platform VB10.NEO induces strong neo-antigen specific CD8+ T cell responses critical to cure established tumors in pre-clinical models"

Session Data and Time: Wednesday Apr 3, 2019 8:00 AM – 12:00 PM local time

Abstract #2256

Title: "Combination of neoantigen DNA plasmid vaccine VB10.NEO and NKTR-214, a CD122-biased immunostimulatory cytokine, induces strong neoantigen-specific T cell responses and sustained tumor regression in pre-clinical models"

Session Data and Time: Monday Apr 1, 2019 1:00 PM – 5:00 PM local time

About VB10.16

VB10.16 is an investigational therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced pre-malignancies and malignancies. The drug candidate has demonstrated favorable 6M interim clinical data in a Phase I/IIa study in pre-cancerous HPV16 induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).

About VB10.NEO

VB10.NEO, is a proprietary therapeutic DNA vaccine which uses the patient’s own neoantigens for the personalized treatment of cancer patients. A phase I/IIa neoantigen clinical trial is currently enrolling patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck.

CRISPR Therapeutics Announces Presentations at the American Association for Cancer Research 2019 Annual Meeting

On February 27, 2019 CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of the CRISPR team will present two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held March 29 to April 3, 2019, at the Georgia World Congress Center in Atlanta, GA (Press release, CRISPR Therapeutics, FEB 27, 2019, View Source [SID1234533813]).

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Title: Allogeneic CRISPR/Cas9 gene-edited CAR-T cells targeting CD33 show potent preclinical activity against AML cells (abstract #1428, poster)
Time and Date: Monday, April 1, 2019, from 8:00 a.m. to 12:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 21

Title: Targeting multiple solid tumor types with anti-CD70 allogeneic CAR-T cells (abstract #3184, poster)
Time and Date:Tuesday, April 2, 2019, from 8:00 a.m. to 12:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 22

NewLink Genetics Announces Clinical Trial Abstract Presentation at AACR Annual Meeting

On February 27, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported that a late-breaking abstract reporting results from a Phase 2 study of NLG207, a nanoparticle formulation of the topoisomerase 1 inhibitor, camptothecin, has been accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 being held at the Georgia World Congress Center, March 29 – April 3, in Atlanta, Georgia (Press release, NewLink Genetics, FEB 27, 2019, View Source [SID1234533735]).

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Abstract 7933 (Poster 17) entitled, A phase II study of NLG207 (formerly CRLX101) in combination with weekly paclitaxel in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer, Duska, L., et al, will be presented during the poster session entitled, "Phase II-III Clinical Trials: Part 1," in Exhibit Hall B, Poster Section 16 on Tuesday, April 2, 2019 from 8:00 a.m. – 12:00 p.m. ET.

The complete text of this abstract will be posted to the AACR (Free AACR Whitepaper) website on Friday, March 29, at 3:00 p.m. ET.

About NLG207

NLG207 (formerly CRLX101) is an investigational nanoparticle-drug conjugate (NDC) composed of a cyclodextrin-based polymer backbone conjugated to camptothecin, a topoisomerase-1 inhibitor. NDCs enhance drug delivery to tumors where gradual payload release inside cancer cells augments antitumor activity while reducing toxicity. Topoisomerase 1 inhibitors are a class of drugs that modify DNA damage responses in cancer cells. NewLink Genetics is evaluating NLG207 in a series of clinical trials in advanced refractory ovarian cancer patients.

ALX Oncology to Present Preclinical Data on SIRPα Antibody Program at Upcoming Conferences

On February 27, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that preclinical data for its SIRPα antibody research program will be presented at the 2019 Keystone Symposia Conference (Keystone), Cancer Immunotherapy in Whistler, British Columbia and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia (Press release, ALX Oncology, FEB 27, 2019, View Source [SID1234533751]).

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CD47/SIRPα interaction is a key checkpoint mechanism exploited by cancer cells to escape immunological surveillance. While CD47 is widely expressed in human cells, SIRPα, the CD47 inhibitory receptor, is mainly expressed in myeloid cells and neurons. ALX148, a CD47 blocker with an inactive Fc domain, is generally well tolerated and demonstrates anti-cancer activity in combination with trastuzumab and pembrolizumab in patients with anti-HER2 and checkpoint inhibitor resistant/refractory disease (SITC 2018, P335). Another approach to block this interaction is to target SIRPα.

"Targeting the CD47/SIRPα pathway is an exciting new approach that shows promise in clinical trials. By targeting SIRPα, we can investigate the similarities and differences of an orthogonal strategy to inhibit this axis," said Hong Wan, Ph.D., ALX Oncology’s Chief Scientific Officer. "Our panel of proprietary high affinity monoclonal antibodies provides diverse epitope coverage across the extracellular surface of SIRPα. These antibodies are cross-reactive to human, monkey and rodent SIRPα variants, which enables robust clinical translation. Importantly, these antibodies bind to all human SIRPα variants, a critical attribute for a global patient population."

ALX Oncology’s SIRPα antibodies enhance the antitumor activity of immune checkpoint inhibitors, with reduction of metastases, eradication of tumors, and acquisition of memory immune response in tumor-bearing mice with intact immune systems. The cellular immune response in syngeneic models shows that these SIRPα antibodies enhance innate and adaptive anti-cancer immunity, providing a rationale for combination with other immunotherapies. In an exploratory toxicology study in monkeys, the selected SIRPα antibodies demonstrate a favorable pharmacokinetic, target occupancy and tolerability profile.

Together, these preclinical data provide a compelling rationale to advance the development of anti-SIRPα therapy for patients with cancer.

Keystone Presentation Information
Title: Discovery of monoclonal antibodies targeting myeloid checkpoint SIRPα to enhance anti-tumor immunity
Session: Poster session 3
Session Date: Wednesday, March 13, 2019
Location: Whistler Conference Centre
Poster Number: 3022

AACR Presentation Information
Title: Antibodies to SIRPα enhance innate and adaptive immune responses to promote anti-tumor activity
Session Category: Immunology
Session Title: Therapeutic Antibodies 1
Session Date and Time: Sunday, March 31, 2019 1:00 PM – 5:00 PM ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 23
Abstract Number: 562