On April 1, 2019 Exicure, Inc. (OTCQB:XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that it will present pre-clinical and clinical data for its TLR9 immune system agonist, AST-008, in two poster sessions at the AACR (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia from March 29 – April 03, 2019 (Press release, Exicure, APR 1, 2019, View Source;p=RssLanding&cat=news&id=2392886 [SID1234534808]).

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"On behalf of the Exicure team, we are pleased to announce these two posters which underscore the importance of Exicure’s SNA technology for immune therapy against cancer," said Dr. David Giljohann, Chief Executive Officer of Exicure. "The first poster shows the high potency activation of effector immune cells by our immune system agonist AST-008 after administration of AST-008 to healthy volunteers in a Phase 1 clinical trial. In the second poster, we are pleased to share for the first time, work conducted in collaboration with Celldex Therapeutics showing that Exicure’s TLR9 agonist leads to improved anti-tumor response when combined with CDX-301," said Dr. Giljohann.

The first poster, authored and presented by Exicure scientists, titled: "AST-008, a TLR9 agonist spherical nucleic acid, activated NK cells, T cells, and cytokines in healthy subjects in a Phase 1 clinical trial" demonstrates the utility of Exicure’s proprietary platform technology for targeting TLR9 to upregulate the immune system. Exicure’s drug, AST-008, is now enrolling patients in a Phase 1b/2 trial in patients with advanced solid tumors.

A second poster, to be presented by Celldex scientists, showcases data generated by Celldex Therapeutics, Inc. and Exicure through an ongoing scientific collaboration. The poster, titled: "Preclinical evaluation of the recombinant dendritic cell growth factor CDX-301 (Flt3L), and AST-008, a TLR9 agonist SNA" highlights improved anti-tumor activity after administration of AST-008 in combination with CDX-301.

Details of the posters:

Title: AST-008, a TLR9 agonist spherical nucleic acid, activated NK cells, T cells, and cytokines in healthy subjects in a Phase 1 clinical trial.
Abstract/Poster No: CT044/1
Date of poster presentation: April 01, 2019, 8:00 AM – 12:00 PM ET
Session Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17

Title: Preclinical evaluation of the recombinant dendritic cell growth factor CDX-301 (Flt3L), and AST-008, a TLR9 agonist SNA
Abstract/Poster No: 3217/27
Date of poster presentation: April 02, 2019, 8:00 AM – 12:00 PM ET
Session Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 23

On April 1, 2019 Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its CEO, Dr. David Giljohann, will give a company presentation on Monday, April 8, 2019 at 11:50 am GMT at the H.C. Wainwright Global Life Sciences Conference (Press release, Exicure, APR 1, 2019, View Source;p=RssLanding&cat=news&id=2392908 [SID1234534807]). The presentation will be made in the Stratton Suite of the Grosvenor House in London.

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A live audio webcast will be available on the Investors section of Exicure’s website: www.exicuretx.com. The webcast will be archived for approximately 30 days following the event.

On April 1, 2019 Triphase Accelerator Corporation, a company dedicated to acquiring and developing novel therapeutics for the treatment of cancer, and Catalent, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, reported that Triphase Accelerator’s TRPH-222, an anti-CD22 antibody-drug conjugate (ADC) for the treatment of patients with lymphoma, has been dosed in the first patient in a Phase 1 clinical trial (Press release, Catalent, APR 1, 2019, https://www.catalent.com/index.php/news-events/news/Triphase-Accelerator-Initiates-Phase-1-Clinical-Trial-of-TRPH-222-in-B-cell-Lymphoma-Next-Generation-Antibody-Drug-Conjugate-Developed-Using-Catalent-s-SMARTag-R-ADC-Technology [SID1234534806]). TRPH-222 was originally developed by Catalent’s subsidiary Redwood Bioscience, Inc. using the proprietary SMARTag platform, which provides optimized site-specific protein-modification and linker technologies. Triphase Accelerator obtained the worldwide rights to further develop this program and subsequently announced that Celgene had obtained the option to acquire all rights to the program as part of an expanded strategic collaboration.

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The Phase 1 clinical trial is a multi-center, open-label study of TRPH-222 monotherapy in subjects with relapsed and/or refractory B-cell non-Hodgkin lymphoma (NHL), which will be conducted in two stages, dose-escalation and dose-expansion. The study is currently enrolling patients at sites in the U.S. and Canada, including Roswell Park Cancer Center, University of Pennsylvania, Ohio State University, Sarah Cannon Research Institute, Princess Margaret Cancer Centre and Jewish General Hospital. Additional sites are planned to support the dose-expansion stage. More information about this study can be found at www.clinicaltrials.gov, Identifier NCT03682796.

"We are thrilled to advance the first SMARTag ADC into human clinical trials and evaluate its potential for better tolerability and an expanded therapeutic index as compared to conventional ADCs" said Dr. Mathias Schmidt, Executive Vice President and Head of Research & Development of Triphase Accelerator. "We look forward to assessing the potential clinical benefit of TRPH-222 in patients with relapsed/refractory B-cell lymphoma and remain convinced that this molecule can play an important role in the future treatment of lymphoma."

"We are excited to see Triphase Accelerator reach this important milestone with TRPH-222," added Mike Riley, Vice President and General Manager, Catalent Biologics. "The SMARTag technology has the potential to create ADCs with significantly higher tolerability and expanded therapeutic index. The improved conjugate stability and biophysical characteristics of TRPH-222 has translated to improved tolerability in preclinical testing, and we look forward to further validation in the clinic."

On April 1, 2019 F1 Oncology, an American relations company of Essex Biotech, reported that it will host the 2019 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Atlanta from March 29th to April 3rd, 2019 (Press release, Essex Bio, APR 1, 2019, View Source [SID1234534790]). Published four abstracts to support its innovative CAR-T technology for the treatment of malignant solid tumors.

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F1 Oncology is developing these new CAB-CAR-T therapies for solid tumors that reduce the potential for on-target/off-Tumor toxicity. These four abstracts reveal in depth that F1 uses its proprietary CAB-CAR-T technology to turn the negative effects of the tumor microenvironment (TME) into beneficial signals and enhance the safety of CAR-T treatment. F1 will highlight its proof-of-concept studies of bedside CAR-T treatments on the same day, as well as bioinformatics-driven methods to discover protein domain combinations that can selectively amplify CAR-T cells.

Dr. Gregory Frost, Chairman and CEO of F1 Oncology, said: "The information presented at the conference highlights the scientific advancement that F1 can significantly simplify the future CAR-T treatment of solid tumor malignancies. The company team is in the entity of CAB-CAR-T Significant progress has been made in understanding the role of neonatal cell therapy, and we look forward to the progress of these CAB-CAR-T programs in ongoing clinical research in the Shanghai partner unit."

The abstract can be obtained from the Program Section of the 2019 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference. The poster details are as follows:

• Chimeric antigen receptor (CAR) and adoptive cell therapy for the transduction and in vivo expansion of the driving member

The study examined the relationship between in vitro expansion time and poorly differentiated, potently enhanced CAR-T products, as well as the development of bedside treatments for adoptive cell therapy, reducing the potential for CAR-T cell immunotherapy complexity.

Poster number: PO.IM02.03 2327/26

Poster display date and time: April 1, 2019, 1:00 – 5:00 pm.

Venue: Georgia World Congress Center, Poster 22 Division

• A high-throughput screening strategy for identifying novel lymphocyte proliferation elements

A high-throughput screening method for the well-designed high-variation protein subdomain recombination libraries encoded by barcodes was developed to identify new combinations that selectively drive the expansion of CAR-T cells in vivo.

Poster number: PO.MCB09.05 3523/9

Poster display date and time: April 2, 2019, 8:00 am – 12:00 noon

Venue: Overseas Chinese Conference Center, Poster 22 Division

• CAB-CAR-T: a novel conditional initiation of adoptive immunotherapy that reduces potential "on-target/off-Tumor" toxicity

Adoptive immunotherapy for a novel conditional initiation (CAB) approach

Poster number: PO.IM02.04 3189/12

Poster display date and time: April 2, 2019, 8:00 am – 12:00 noon

Venue: Georgia World Congress Center, Poster 22 Division

• CAB-CAR-T: The superiority of conditional initiation biomolecules targeting cell surface proteins for the treatment of various solid tumors

Determine the best target from the cancer genome map. When using CAB-CAR-T, the most applicable population for various cancers

Poster number: PO.BSB01.05 5101/9

Poster display date and time: April 3, 2019, 8:00 am – 12:00 noon

Venue: Georgia World Congress Center, Poster 30

On March 31, 2019 Apexigen, Inc., a clinical-stage biopharmaceutical company, reported the presentation of new clinical data on APX005M in combination therapy in patients with metastatic pancreatic cancer (Press release, Apexigen, MAR 31, 2019, View Source [SID1234534792]). The data are being presented in a plenary session today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place March 29 – April 3, 2019 in Atlanta, GA, by Parker Institute for Cancer Immunotherapy (PICI) researchers at the University of Pennsylvania. Apexigen’s lead immuno-oncology (I-O) therapeutic, APX005M, a monoclonal antibody targeting CD40, is being evaluated in multiple clinical trials in different types of solid tumors.

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In an interim analysis of an ongoing Phase 1b clinical trial, 20 of 24 evaluable patients with metastatic pancreatic cancer demonstrated tumor shrinkage following treatment with APX005M in combination with standard-of-care chemotherapy, with or without Bristol-Myers Squibb’s PD-1 inhibitor nivolumab. Several patients remained on therapy after one year of treatment.

"Our CD40 agonist APX005M is critical for activating the body’s innate and adaptive immunity, potentially enabling the immune system to fight even the most difficult-to-treat forms of cancer," said co-author Ovid Trifan, M.D., Ph.D., Chief Medical Officer and Senior Vice President of Clinical Development of Apexigen. "We are encouraged by these interim results and are excited to see this trial advance to the next phase in evaluating a novel combination therapy for patients with metastatic pancreatic cancer. In addition to these results, we look forward to a second presentation of clinical data at AACR (Free AACR Whitepaper) tomorrow on APX005M in combination therapy for patients with metastatic or unresectable melanoma who have progressed on anti-PD-1/PD-L1 therapy. We are committed to advancing a broad clinical development program for APX005M in multiple types of cancer as we work toward transforming the standard of care for patients across a wide range of cancer indications."

First author Mark H. O’Hara, M.D., Assistant Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania, commented, "In this interim analysis of this trial, we are encouraged by the safety and activity signals from anti-CD40 immunotherapy APX005M in combination with chemotherapy with or without checkpoint inhibition as a new approach to treating metastatic pancreatic cancer. Given that most patients with metastatic pancreatic cancer have evidence of progression of their cancer within about 5 months of starting first line chemotherapy, seeing several patients stay on treatment on this trial for more than one year is exciting. We look forward to exploring the benefits of CD40 activation to treat this aggressive form of cancer."

About the Phase 1b/2 Clinical Trial
In the Phase 1b portion of the clinical trial, previously untreated patients with metastatic pancreatic ductal adenocarcinoma received APX005M in combination with gemcitabine and nab-paclitaxel, a standard-of-care chemotherapy regimen for this patient population, and half of the patients also received Bristol-Myers Squibb’s PD-1 inhibitor nivolumab. The combination therapy treatment was well-tolerated. Several patients remained on treatment for about a year, and had a durable response. 20 of 24 evaluable patients demonstrated tumor shrinkage. The trial has progressed to the Phase 2 portion.

For additional information on this trial (NCT03214250), please visit www.clinicaltrials.gov.

APX005M Data Presentations at AACR (Free AACR Whitepaper) 2019 Annual Meeting
Plenary Session Presentation Title: A Phase 1b Study of CD40 Agonistic Monoclonal Antibody APX005M Together with Gemcitabine (Gem) and nab-Paclitaxel (NP) with or without Nivolumab (Nivo) in Untreated Metastatic Ductal Pancreatic Adenocarcinoma (PDAC) Patients (Abstract #CT004)
Presenter: Mark O’Hara, M.D., Assistant Professor of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
Plenary Session Date and Time: Sunday, March 31, 2019 2:25 PM – 2:45 PM ET
Plenary Session: Clinical Trials Plenary Session 1
Location: Georgia World Congress Center, Building A, Marcus Auditorium

Late-breaking Abstract Title: Phase Ib/II clinical trial of CD40 agonistic antibody APX005M in combination with nivolumab (nivo) in subjects with metastatic melanoma (M) or non-small cell lung cancer (NSCLC) (Abstract #CT089)
Poster Session Date and Time: Monday, April 1, 2019 1:00 PM – 5:00 PM ET
Poster Session: Phase 1 Clinical Trials
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16

About APX005M
APX005M is a humanized monoclonal antibody designed to stimulate the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) is believed to initiate a multi-faceted immune response that enables multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation therapy. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov.