On November 15, 2018 Neovia Oncology reported that Substantial limitations in the response rates for cancer immunotherapy and increasing drug-resistance in cancer patients in general have led to a search for rational drug combination therapy (Press release, Neovia Oncology, NOV 15, 2018, View Source [SID1234531343]). It has been reported that Topoismerase types I (Topo I) and II (Topo II), already well recognized as important targets for inhibiting cellular DNA replication, are highly expressed in many cancers and also ‘cross-talk’ with Epidermal Growth Factor Receptor, which is the target of several recently approved cancer drugs. Moreover Topo I inhibitors have recently been shown to augment T-cell mediated antitumor immune response and enhance the efficacy of immunotherapy. Currently approved Topo inhibitor drugs, however, are single agents and known to be highly toxic even at low doses.

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Neovia’s NEV-801 investigational product is the result of structure-based drug design to create a covalently conjugating camptothecin and podophyllotoxin derivative multi-inhibitor (simultaneously inhibiting topo I and II) with potent anti-cancer efficacy through a synergistic immune response but with minimal toxicity. For example, when used as a single agent in preclinical studies of Chronic Myelogenous Leukemia models, NEV-801 causes tumor sizes to diminish, with 38% of tumors disappearing completely and a 98% tumor growth inhibition rate compared to 0% and 33%, respectively, for leading marketed drug Imatinib (Gleevec). Weight loss was effectively overcome within a week of continued administration. Additionally in an ovarian cancer model NEV-801 was shown to be synergistic with immune checkpoint inhibitors PD-1 and CTLA-4.

Neovia is currently studying NEV-801 in a Phase 1 dose-escalation, dose-confirmation trial, in which anti-tumor effects are also being evaluated to determine the tumor types to be targeted in Phase 2. Through cohort 3 (80 mg), NEV-801 has been well tolerated with no reported serious adverse events. Importantly, NEV-801 can also be used as an oral anticancer drug, which is strongly recommended for cancer therapy of patients, since PK data analysis demonstrates that it can pass the Caco-2 cell membrane with a high permeability of 9.2. This also explains the lower GI-related toxicity.

Neovia has a strong patent portfolio with protection into 2035, with plans to file for Orphan Drug designation that will extend exclusivity for 7 years in the US and 10 years in Europe after approvals.

On November 15, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it will present data from its ongoing studies in breast cancer utilizing Cchek, Anixa’s artificial intelligence (AI) driven early cancer detection technology, at the AACR (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy (Press release, Anixa Biosciences, NOV 15, 2018, View Source [SID1234531342]). The conference is designed to integrate multidisciplinary facets of basic cancer immunology and immunotherapy to broaden the understanding of ways to harness the immune system to treat cancer. The conference will be held November 27–30, 2018 in Miami Beach, Florida and will be attended by world-renowned oncologists and scientists who will offer new insights on systems biology, checkpoints, combination therapies, and molecular targets, all in the pursuit of finding new ways to manipulate the tumor immune microenvironment and creating better treatments. To receive a copy of the presentation, please email your request to AACR (Free AACR Whitepaper)[email protected] starting November 30, 2018 and include your name, title, and contact information.

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"We are pleased to make our presentation titled, Combining the immunophenotyping of MDSCs and lymphocytes with artificial intelligence (AI) to predict early stage breast cancer, at the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy conference. This data is focused on using our Cchek technology to detect breast cancer in its early stages. The majority of screening technologies currently used for breast cancer detection, such as mammography, have the ability to detect later stage breast malignancies rather successfully but have shown difficulty with earlier stages," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "As we have previously announced, our initial commercial focus is on a prostate cancer test for which we will be meeting with the USFDA on December 17, 2018. We recently presented our latest prostate cancer data at the 33rd Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), and we look forward to now present our latest breast cancer data at this AACR (Free AACR Whitepaper) special conference," added Dr. Kumar.

American Association of Cancer Research (AACR) (Free AACR Whitepaper)
The American Association of Cancer Research (AACR) (Free AACR Whitepaper) (www.aacr.org) is a 501(c)(3) public charity headquartered in Philadelphia, PA. The mission of the AACR (Free AACR Whitepaper) is to prevent and cure cancer through research, education, communication and collaboration. Through its programs and services, the AACR (Free AACR Whitepaper) fosters cancer research and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer causes, prevention, diagnosis and treatment throughout the world.

On November 15, 2018 Atlanta, GA and New York) Lori Chmura, CEO of Dune Medical Devices, reported that maker of the successful MarginProbe device is scheduled to present at the Canaccord Genuity Medical Technologies and Diagnostics Forum on Thursday, November 15th at 2:30 p.m. EST at the Westin Grand Central in New York, NY (Press release, Dune Medical Devices, NOV 15, 2018, View Source [SID1234531341]).

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The presentation will be available as a webcast at dunemedical.com/investors.

Dune Medical Devices is a commercial-stage company revolutionizing tissue characterization technology in breast cancer surgery, diagnosis and targeted treatment with its proprietary Radio-Frequency Spectroscopy Technology (RFST). Dune’s first commercial product, MarginProbe, in routine commercial use in 70 hospitals and in over 16,000 surgeries in the US and Israel, has been proven to identify positive margins during breast conservation surgery, enabling surgeons to immediately remove additional microscopic residual cancer, thereby reducing the need for repeat surgeries. The second generation of the RFST, in development, serves as a platform to enhance diagnostic accuracy by providing pathologists with tissue characterization data alongside biopsy samples to increase interpretation accuracy and eliminate unnecessary procedures and costs

Dune is entering a phase of commercial growth and expansion of its RFST platform to establish RFST data as a unique tissue biomarker that provides information complementary to molecular (e.g., genomic) biomarkers for optimal personalized treatment selection and adoption of new therapies

On November 14, 2018 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that data from Phase I clinical trials of ADCT-402 (loncastuximab tesirine) and ADCT-301 (camidanlumab tesirine) have been selected for oral and poster presentations at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held December 1-4 in San Diego (Press release, ADC Therapeutics, NOV 14, 2018, View Source [SID1234596073]).

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Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "We look forward to sharing updated data from our first-in-human clinical trials of ADCT-402 and ADCT-301 in multiple subtypes of lymphoma at the 2018 ASH (Free ASH Whitepaper) Annual Meeting. Interim data show that ADCT-402, which targets CD19, has demonstrated durable single-agent anti-tumor activity in patients with diffuse large B-cell lymphoma, follicular lymphoma and mantle cell lymphoma who have failed other therapies or have no available treatment options. In addition, new data on ADCT-301 highlight the CD25-targeting ADC’s impressive overall and complete response rates in heavily pretreated patients with classical Hodgkin lymphoma, as well as its encouraging clinical activity in T-cell lymphoma."

Oral Presentations

Title: Interim Results from the First-in-Human Clinical Trial of Adct-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody Drug Conjugate, in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Abstract Number: 398
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: New Agents
Date and Time: Sunday, December 2, 2018; 12:15 p.m. PT
Location: Marriott Marquis San Diego Marina, Pacific Ballroom 20
Presenter: John Radford, MD, FRCP, Manchester Academic Health Centre, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK

Title: Phase 1 Study of Adct-301 (Camidanlumab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody Drug Conjugate, in Relapsed/Refractory Classical Hodgkin Lymphoma
Abstract Number: 928
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Hodgkin Lymphoma: Chemotherapy and Response Adapted Approaches
Date and Time: Monday, December 3, 2018; 5:15 p.m. PT
Location: San Diego Convention Center, Room 6F
Presenter: Mehdi Hamadani, MD, Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI

Poster Presentations

Title: Safety and Efficacy of Adct-402 (Loncastuximab Tesirine), a Novel Antibody Drug Conjugate, in Relapsed/Refractory Follicular Lymphoma and Mantle Cell Lymphoma: Interim Results from the Phase 1 First-in-Human Study
Abstract Number: 2874
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
Date and Time: Sunday, December 2, 2018; 6-8 p.m. PT
Location: San Diego Convention Center, Hall GH
Presenter: Paolo Caimi, MD, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH

Title: Adct-301 (Camidanlumab Tesirine), a Novel Pyrrolobenzodiazepine-Based CD25-Targeting Antibody Drug Conjugate, in a Phase 1 Study of Relapsed/Refractory Non-Hodgkin Lymphoma Shows Activity in T-Cell Lymphoma
Abstract Number: 1658
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster I
Date and Time: Saturday, December 1, 2018; 6:15-8:15 p.m. PT
Location: San Diego Convention Center, Hall GH
Presenter: Graham P. Collins, MB, BS, DPhil, Oxford University Hospitals, NHS Trust, Oxford, UK

ADCT-402 is currently being evaluated in three clinical trials, including a pivotal trial in patients with relapsed or refractory diffuse large B-cell lymphoma. ADCT-301 is being evaluated in three clinical trials. To learn more about the company’s ADC programs, visit ADC Therapeutics’ Booth #117 located in the Exhibit Hall of the San Diego Convention Center.

For more information about the ASH (Free ASH Whitepaper) Annual Meeting, please visit View Source

About ADCT-402

ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (NCT03589469). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of DLBCL and mantle cell lymphoma.

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. Once bound to a CD25-expressing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will

trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. ADCT-301 is being evaluated in ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235), as well as a Phase Ib clinical trial in solid tumors (NCT03621982).

On November 14, 2018 Precision BioSciences (Precision) and MaxCyte reported they have entered into a non-exclusive, clinical and commercial license agreement that will allow Precision to use MaxCyte’s Flow Electroporation technologies to robustly deliver Precision’s proprietary ARCUS genome-editing technology for use in next-generation gene edited allogeneic T-cell immunotherapies designed to treat a broad range of cancers (Press release, MaxCyte, NOV 14, 2018, View Source [SID1234537623]).

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David Thomson, Chief Development Officer of Precision, expressed his support for the agreement, noting, "Precision’s therapeutic grade ARCUS editing platform is sufficiently compact and specific to use with a range of delivery systems. In considering these, we have found MaxCyte’s electroporation technology complements our approach to allogeneic T cell manufacturing, which is focused on preserving cell quality throughout the process while maximizing overall yield."

The clinical and commercial license builds upon an existing research and clinical license agreement between Precision and MaxCyte for the delivery of Precision’s ARCUS technology into T-cells. MaxCyte will supply its technology platform to Precision as part of the license agreement and will receive future payments including milestones and technology access licensing fees.

"The initiation of this commercial license agreement with Precision, a leader in genome editing with its own proprietary ARCUS technology, signifies a key milestone for MaxCyte and demonstrates the value and versatility of our platform, our intellectual property, and our ability to foster important collaborations with companies generating life-changing gene therapies," said Doug Doerfler, President & CEO of MaxCyte, Inc.

MaxCyte’s Flow Electroporation Technology enables the engineering of a variety of therapeutically-relevant cell types at high efficiency while maintaining high viability and recovery. Precision’s lead allogeneic CAR T programs rely on genome editing, where ARCUS tools are used to transform healthy donor cells into therapeutics using the MaxCyte technology. These cell therapies can specifically target cancer cells in patients, potentially enabling a unique and specialized approach to cancer treatment.