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TRACON Pharmaceuticals Announces TRC105, TRC253 And TRC102 Data Presentations At Upcoming AACR Annual Meeting

On March 27, 2019 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and, through our license to Santen Pharmaceutical Co. Ltd., wet age-related macular degeneration, reported that preclinical data from TRC105 and TRC253, as well as Phase 2 clinical data from TRC102, will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, to be held from March 29 to April 3, 2019, in Philadelphia, PA (Press release, Tracon Pharmaceuticals, MAR 27, 2019, View Source [SID1234534674]).

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Dr. Mark Schoonderwoerd and colleagues from Leiden University will present a poster featuring data from preclinical studies of TRC105 and PD-1 checkpoint inhibitors. The presentation details are as follows:

Poster Title: Synergistic inhibition of cancer invasion and metastasis by combined anti-PD1-TRC105-mediated Endoglin targeting on cancer-associated fibroblasts and endothelial cells
Abstract Link: View Source!/6812/presentation/3044
Session Category: Combination Approaches to Novel Therapies
Location: Section 12, Poster Board 291/12
Date: Sunday, March 31, 2019
Time: 1:00pm – 5:00pm EDT
Dr. Tammy Bush and colleagues from Janssen Research and Development will present a poster featuring preclinical data from TRC253, a small molecule antagonist of mutant and wild-type androgen receptor. The presentation details are as follows:

Poster Title: Antitumor activity of JNJ-63576253 (TRC253), a small molecule antagonist of F877L mutant and wild-type androgen receptor
Abstract Link: View Source!/6812/presentation/6162
Session Category: Novel Therapeutics and Pathways
Location: Section 14, Poster Board 2179/1
Date: Monday, April 1, 2019
Time: 1:00pm – 5:00pm EDT
Dr. Geraldine Coyne and colleagues from the National Cancer Institute will present a poster featuring data from the Phase 2 clinical trial of TRC102 and Temodar (temozolomide) in subjects with colorectal cancer. The presentation details are as follows:

Poster Title: A Phase II trial of TRC102 (methoxyamine HCl) in combination with temozolomide in patients with relapsed metastatic colorectal carcinoma
Abstract Link: Late-Breaking Abstracts are embargoed until March 29, 2019
Session Category: Late-Breaking Research – Molecular and Cellular Biology/Genetics 2
Location: Section 41, Poster Board LB-293/10
Date: Wednesday, April 3, 2019
Time: 8:00am – 12:00pm EDT
Posters will be available on the company’s website following presentation.

About TRC105 (carotuximab)

TRC105, the oncology formulation of 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. TRC105 is currently being studied in the pivotal Phase 3 TAPPAS trial in patients with angiosarcoma as well as multiple Phase 1 and Phase 2 clinical trials in other tumor types. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the US and EU. The ophthalmic formulation of TRC105, DE-122, is currently being studied in the randomized Phase 2 AVANTE trial in patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC253

TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F877L mutation. The AR F877L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR. TRC253 is currently being studied in a Phase 1/2 clinical trial in prostate cancer. For more information about the clinical trial, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php

About TRC102

TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute or Case Comprehensive Cancer Center. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

Seattle Genetics Highlights Antibody-Drug Conjugate Innovation and Immuno-Oncology Program at the American Association for Cancer Research (AACR) Annual Meeting

On March 27, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported data highlights from six presentations showcasing technology advances in the company’s antibody-drug conjugate (ADC) platform and an immuno-oncology program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 being held March 29-April 3, 2019 in Atlanta (Press release, Seattle Genetics, MAR 27, 2019, View Source [SID1234534673]).

"Our expertise in empowered-antibody innovation drives a substantial, advancing pipeline of clinical and preclinical programs, including both ADCs and immuno-oncology agents," said Dennis Benjamin, Ph.D., Senior Vice President of Research at Seattle Genetics. "For example, the research presented in an oral presentation at AACR (Free AACR Whitepaper) illustrates why we believe SGN-CD228A is well positioned for IND-enabling studies and a phase 1 study is planned in multiple tumor types. The program features a novel ADC targeted to CD228, which is highly expressed in several types of cancer. The ADC employs our proprietary auristatin technology and has shown antitumor activity in vitro and in vivo."

Abstracts can be found at www.aacr.org and include the following:

SGN-CD228A: A novel humanized anti-CD228 antibody-drug conjugate for the treatment of solid tumors (Abstract #2688)
Date: Monday, April 1, 2019
Time: 3:00 p.m. – 5:00 p.m. ET, Oral Presentation at 3:20 p.m. ET, Room B401

The cell-surface protein CD228 is highly expressed in several types of cancer, including melanoma, mesothelioma, non-small cell lung (NSCLC), breast, colorectal and pancreatic cancers. SGN-CD228A is an auristatin-based ADC targeted to CD228. The preliminary data show antitumor activity in preclinical evaluations in melanoma, NSCLC and triple negative breast cancer.

Antibody-drug conjugates of NAMPT inhibitors: Discovery, optimization and preclinical characterization (Abstract #983)
Date: Monday, April 1, 2019
Time: 8:00 a.m. – 12:00 p.m. ET, Poster Session

At the AACR (Free AACR Whitepaper) Annual Meeting 2018, data were presented showing ADCs with a proprietary NAMPT inhibitor payload have a unique mechanism of action and an encouraging therapeutic window. This poster presentation will highlight preclinical results from the optimization of the novel payload and linker strategy, and application to ADCs, which data indicate drive tumor regression in models of Hodgkin lymphoma, non-Hodgkin lymphoma and acute myeloid leukemia (AML). The targeted delivery approach using ADCs demonstrates an improved safety profile relative to previously described unconjugated NAMPT inhibitors.

TIGIT directed human antibody modulates T-regulatory and effector cell function (Abstract #4986)
Date: Wednesday, April 3, 2019
Time: 8:00 a.m. – 12:00 p.m. ET, Poster Session

The immune checkpoint receptor TIGIT negatively regulates the function of adaptive (T cell) and innate (natural killer or NK) cells and blockade of TIGIT signaling may elicit an antitumor immune response. Preclinical data from an antibody program targeting TIGIT demonstrate in vitro activation of T cells and antitumor activity in several syngenic models.

Development of patient-derived acute myeloid leukemia xenograft models (Abstract #1062)
Date: Monday, April 1, 2019
Time: 8:00 a.m. – 12:00 p.m. ET, Poster Session

This poster presentation is focused on successfully establishing a collection of AML xenograft models that more accurately reflect the antigen expression and molecular genetics of AML patients. These models will enable a more precise assessment of therapeutic candidates in preclinical testing.

Functional cell surface proteomics of acute myeloid leukemia enables predictive modeling of antibody-drug conjugate cytotoxicity (Abstract #4546)
Date: Wednesday, April 3, 2019
Time: 8:00 a.m. – 12:00 p.m. ET, Poster Session

This poster profiles the cell surface landscape of more than 100 primary hematologic samples comprising leukemic blasts from patients treated in the Beat AML research consortium along with normal bone marrow cells from healthy donors. Based on cell surface proteomics, a number of highly expressed antigens were identified and targeted ADCs were evaluated on a panel of AML cell lines. CD317 was determined as a novel target for AML.

Tisotumab vedotin induces anti-tumor activity through MMAE-mediated, Fc-mediated, and Fab-mediated effector functions in vitro (Abstract #221)
Date: Sunday, March 31, 2019
Time: 1:00 p.m. – 5:00 p.m. ET, Poster Session

Tisotumab vedotin is an investigational ADC designed to target Tissue Factor (TF) antigen on TF-expressing cell surfaces and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside TF-expressing cells. The Tissue Factor antigen target is overexpressed in the vast majority of patients with cervical cancer and in many other solid tumors, including ovarian, lung, pancreatic, colorectal and head and neck. This poster presentation evaluates tisotumab vedotin’s antitumor activity through several mechanisms, including immunogenic cell death, bystander cytotoxicity, and antibody-dependent cellular phagocytosis in vitro.

Inovio Pharmaceuticals to Present at H.C. Wainwright Global Life Sciences Conference in London, UK

On March 27, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that management will present at the H.C. Wainwright Global Life Sciences Conference on Monday, April 8, 2019 at 4:10 p.m. local time (Press release, Inovio, MAR 27, 2019, View Source [SID1234534672]). The conference is being held at the Grosvenor House Hotel in London, UK.

Inovio Pharmaceuticals. (PRNewsFoto/Inovio Pharmaceuticals, Inc.)
A live webcast and replay of the presentation will be available on the Investors section of the company’s website, View Source

BioLineRx Announces Successful Engraftment Data From Phase 3 GENESIS Trial for BL-8040 in Multiple Myeloma Patients

On March 27, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported that hematopoietic stem cells (HSCs) mobilized by BL-8040 in combination with granulocyte colony-stimulating factor (G-CSF) were successfully engrafted in all 11 patients participating in the Part 1, lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase 3 trial comparing BL-8040 and G-CSF to G-CSF alone, in mobilization of HSCs for autologous transplantation in multiple myeloma patients (Press release, BioLineRx, MAR 27, 2019, View Source;p=irol-newsArticle&ID=2392451 [SID1234534671]). These data follow previously announced successful mobilization data which led the Data Monitoring Committee (DMC) to recommend proceeding to the randomized placebo-controlled Part 2 of the study.

"Autologous HSC transplantation in multiple myeloma has been shown to improve overall survival compared to conventional chemotherapy. However, the effectiveness of the treatment relies, in part, upon the ability to collect an adequate amount of HSCs, typically obtained from peripheral blood," explained Dr. John F. DiPersio, Chief, Division of Oncology at the Washington University School of Medicine, and lead investigator of the study. "Current practice involves mobilizing HSCs from the bone marrow to the peripheral blood, after which the cells are collected by apheresis. Results so far show that mobilizing HSCs with a single BL-8040 dose combined with G-CSF is highly effective compared to using G-CSF alone, which typically requires up to 8 injections and multiple apheresis days. Furthermore, engraftment of the cells in all evaluable patients was successful. This is a very encouraging result which, if corroborated in the placebo-controlled part of the trial, will be of great value to patients as well as to the medical community."

The results, detailed in an abstract titled GENESIS – A Phase III Randomized Double-Blind, Placebo-Controlled Trial, Evaluating Safety and Efficacy of BL-8040 and G-CSF in Mobilization of HSCs for Autologous Transplantation in Multiple Myeloma were presented in an oral presentation at the 45th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2019), today, March 27, 2019, in Frankfurt, Germany.

Results of the first 11 patients show that 9/11 patients (82%) reached the primary endpoint threshold of ≥ 6×106 CD34 cells/kg with only one dose of BL-8040 and in up to 2 apheresis sessions. Furthermore, 7/11 patients (64%) reached the threshold of ≥ 6×106 CD34 cells/kg in a single apheresis session only. In addition, all 11 patients reached the desired threshold in 4 or less apheresis days, and for all patients with available data (9/11), successful engraftment with BL-8040 mobilized HSCs was observed, with time to engraftment and graft durability comparable to standard of care mobilization regimens.

About the GENESIS Study
The GENESIS study is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of BL-8040 in combination with G-CSF, compared to placebo and G-CSF, for the mobilization of CD34 HSCs for autologous transplantation in multiple myeloma patients. The placebo-controlled part is designed to include 177 patients in more than 25 centers. Treatment will include 5 days of G-CSF, with a single dose of BL-8040 or placebo on day 4, and with the option to expand treatment to up to 8 days of G-CSF and up to 2 doses of BL-8040. Apheresis for collection of CD34 cells will be performed on day 5. An additional 3 apheresis sessions may be conducted if needed in order to reach the goal of ≥ 6×106 mobilized CD34 cells/kg.

The primary objective of the study is to demonstrate the superiority of a single dose of BL-8040 in combination with G-CSF, over placebo and G-CSF, in the mobilization of ≥ 6×106 CD34 cells/kg in up to 2 apheresis sessions, in preparation for autologous stem cell transplantation in multiple myeloma patients. Secondary objectives include time to engraftment of neutrophils and platelets, durability of the engraftment, as well as safety and other efficacy parameters.

About BL-8040
BL-8040 is a short synthetic peptide for stem cell mobilization and for treatment of hematological malignancies and solid tumors. It functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor that is directly involved in the retention of stems cells in the bone marrow, as well as tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity.

HSCs express CXCR4 and are retained in the protective bone marrow niche via binding to CXCL12 (also known as SDF-1). Blocking of the CXCR4-SDF1 interaction by BL-8040 leads to the mobilization of HSCs into the peripheral blood. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of HSCs.

In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells, sensitization of cancer cells to chemo- and bio-based anti-cancer therapies, and direct anti-cancer effect by inducing programmed cell death (apoptosis). BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

Innovus Pharmaceuticals to Release its Annual 2018 Financial Results on Monday, April 1, 2019

On March 27, 2019 Innovus Pharmaceuticals, Inc. ("Innovus Pharma") (OTCQB: INNVD), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, reported that it will release its annual 2018 calendar year financial results on Monday, April 1, 2019, after the close of the U.S. financial markets (Press release, Innovus Pharmaceuticals, MAR 27, 2019, View Source [SID1234534670]). The Company will host a conference call at 4:15 p.m. ET/1:15 p.m. PT on the same day to discuss the financial results and recent business developments.

To participate in the call, please dial 1-877-883-0383 for domestic callers or 1-412-902-6506 for international callers or 1-877-885-0477 for Canadian callers and Participant Elite Entry Number: 7875805.

A replay of the call will be available for 30 days. To access the replay, dial 1-877-344-7529 domestically or 1-412-317-0088 internationally or 1-855-669-9658 for Canada and reference Conference ID: 10129968.

The replay will be available shortly after the end of the conference call.