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.

On March 31, 2019 Cyteir Therapeutics, a leader in the discovery and development of novel therapeutics based on the biology of DNA repair and synthetic lethality for the treatment of cancer and autoimmune diseases, reported the presentation of promising new preclinical data for the company’s lead compound, CYT-0851. The data are being shared this week at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and suggest that the novel RAD51 inhibitor could be active as a monotherapy against B-cell lymphomas and multiple solid tumors, including pancreatic cancer (Press release, Cyteir Therapeutics, MAR 31, 2019, View Source [SID1234534791]). Data also show that CYT-0851 is potentially synergistic in combination with PARP inhibitors and may overcome PARP inhibitor resistance. Cyteir expects to initiate clinical trials with CYT-0851 in mid-2019.

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Cyteir’s platform is based on the groundbreaking discovery of a relationship between activation-induced cytidine deaminase (AID), a DNA-damaging enzyme, and RAD51, a protein that is essential to the repair of DNA breaks. AID overexpression causes elevated DNA damage in high numbers of patients with B-cell malignancies and many patients with solid tumors. Cyteir is developing selective small-molecule compounds that the company believes inhibit RAD51. In preclinical models, reducing the ability of diseased cells to self-repair in this way causes them to become overwhelmed by their own DNA damage and undergo cell death – resulting in the therapeutic effect known as "synthetic lethality." Kevin Mills, Ph.D., Cyteir’s co-founder and chief scientific officer, led the research that first identified the synthetic lethality relationship between RAD51 and AID.

"The data being presented at this year’s AACR (Free AACR Whitepaper) meeting validate the mechanism-of-action underlying our novel synthetic-lethality approach and confirm that we have identified a potent, selective oral inhibitor that has the potential to broadly target multiple cancers with high levels of DNA damage induced by AID," said Markus Renschler, M.D., Cyteir president and CEO. "We are on track to file an IND mid-year and look forward to seeing how this exciting new mechanism performs in clinical trials as we look to improve outcomes for patients with advanced cancers."

Three presentations at AACR (Free AACR Whitepaper) 2019 support the potential of CYT-0851 to provide an effective, targeted new treatment option for a variety of hematologic cancers and solid tumors. Data presented by the company today demonstrate in vitro that CYT-0851 is synergistic and may be active as a combination therapy with PARP inhibitors (Poster Section 14, Board 363/24). Researchers tested five PARP inhibitors, each in combination with CYT-0851 in multiple tumor-derived cell lines with varying levels of AID expression and PARP inhibitor sensitivity. Findings suggest that CYT-0851 enhances the synthetic lethal activity of PARP inhibitors and may re-sensitize tumors that are resistant to this class of therapy.

Data scheduled for presentation tomorrow validate – in preclinical models – the mechanism-of-action of CYT-0851 in AID overexpressing cancers, demonstrating that the compound reduces activity of RAD51, reduces levels of DNA repair, and increases levels of DNA damage leading to the death of cancer cells (Poster Section 35, Board 2566/10).

On Wednesday, Cyteir will present data from a preclinical study evaluating the in vivo activity of CYT-0851 in AID-overexpressing B-cell lymphomas and solid tumors, particularly pancreatic cancer (Poster Section 10, Board 4730/20). In this study, oral administration of the compound in three patient-derived pancreatic cancer xenograft models led to significant anti-tumor activity.