On March 26, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next generation programmed T cell therapies for the treatment of cancer, reported to present insights into the science behind tumor defense mechanisms and the company’s novel programmed T cell therapy programs in development utilizing targeted, modular approaches designed to address these mechanisms at its inaugural R&D Day, in New York (Press release, Autolus, MAR 26, 2019, View Source [SID1234534687]). In addition, the company plans to provide an update on its AUTO3 program in pediatric acute lymphocytic leukemia (pALL).

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AUTO3 is the first dual-targeting CD19 and CD22 programmed T cell therapy in development for both pALL and relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Updated data from the ongoing AMELIA Phase 1/2 study in pALL demonstrates that 6 out of 6 (100%) patients treated at the highest dose (³3 x106/kg) achieved minimal residual disease (MRD) negative complete responses (CR). Ongoing MRD negative CR remissions were noted in 4 out of 6 (67%) patients, with duration of up to 10 months as of February 2019, the date of latest data follow-up. There have been no reported CD19 or CD22 negative relapses in CAR T naïve patients. Data also showed that AUTO3 continues to be generally well tolerated with no ³ Grade 3 CRS, no ICU admission, and no pressors or critical care support for CRS required. The Phase 2 portion of the study is expected to start in the second half of 2019. For more information about this trial and the inclusion criteria, visit www.ClinicalTrials.gov (NCT03289455).

"We are pleased to be hosting our inaugural R&D day, providing a unique opportunity to present an in-depth overview of our differentiated technology, multiple programs, market opportunities and the significant pipeline progress we have achieved, to date," stated Dr. Christian Itin, chairman and chief executive officer of Autolus. "We expect to report data on all of our active clinical programs at key medical conferences during 2019. Additionally, over the coming months, we expect to move two programs into registrational trials and to progress our next generation programs toward the clinic."

Today’s R&D program will include the following presentations:

Dr. Christian Itin, Chairman and Chief Executive Officer of Autolus – Welcome and Overview

Dr. Samir N. Khleif, Director of the Loop Immuno-Oncology Lab and Biomedical Scholar and Professor of Oncology, Georgetown University Medical Center – Immunotherapy, A Combinatorial Approach for Success

Dr. Muhammad Al-Hajj, Senior Vice President, Translational Sciences of Autolus – Translational Aspects of Tumor Heterogeneity

Dr. Martin Pule, Chief Scientific Officer and Founder of Autolus and Clinical Senior Lecturer at University College London Cancer Institute – Tackling Solid Tumors: A Modular Approach to T Cell Programming

Dr. Vijay Peddareddigari, Chief Medical Officer of Autolus – Clinical Update: Current and Next Generation Programs

LOGO

A live video webcast of the event will be available beginning at 8:00 am ET today on the Events section of Autolus’ website: View Source An archived replay will be available on the website for one year.

About AUTO3

AUTO3 is a programmed T cell therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in two clinical studies, AMELIA and ALEXANDER.

AMELIA is a single-arm, open label, multi-center Phase 1/2 clinical trial of AUTO3 in patients up to 24 years of age with high-risk relapsed or refractory B-lineage. The trial is also enrolling patients who previously received CD19 or CD22 targeting therapies including other CAR T cell therapy. The purpose of this study is to test the safety and efficacy, including the complete remission rate or minimal residual disease (MRD) negative response, of AUTO3. Autolus expects to enroll up to 54 patients in this trial.

ALEXANDER is a single-arm, open label, multi-center Phase 1/2 clinical trial of AUTO3 in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL). The purpose of this study is to test the safety and efficacy, including the overall response rate as per Lugano criteria, of AUTO3 followed by limited duration of consolidation with anti-PD1 antibody. Autolus expects to enroll up to 120 patients in this trial.

For more information about these trials and the inclusion criteria, visit www.ClinicalTrials.gov.

On March 26, 2019 Integral Molecular, the industry leader in discovering antibodies against multipass membrane proteins, reported that it will showcase updated data on its discovery of highly specific Claudin 6 MAbs at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference in Atlanta on Monday, April 1 (Press release, Integral Molecular, MAR 26, 2019, View Source [SID1234534628]). Claudin 6 is an established membrane protein target expressed in multiple cancers, including ovarian and gastric tumors, and absent from healthy adult tissues. Until now, the structural complexity of Claudin 6 and its similarity to proteins expressed on healthy tissue have limited its exploitation for targeted oncology therapies.

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"There is a strong need for therapeutic monoclonal antibodies that can provide more specific and less toxic treatments for ovarian cancer," said Ross Chambers, VP of Antibody Discovery. "Our lead antibody, isolated using our MPS Antibody Discovery platform, shows best-in-class Claudin 6 specificity. We are currently looking for partners to further develop these exciting assets."

Integral Molecular’s MPS Antibody Discovery platform encompasses a comprehensive technology suite that overcomes the obstacles of working with highly conserved and structurally complex membrane protein targets, like Claudin 6. This suite includes antigen engineering and presentation on Lipoparticles, immunization of divergent species, and the use of B-cell cloning to recover rare antibodies. Integral Molecular is currently isolating MAbs against dozens of membrane protein targets and welcomes antibody licensing opportunities and discovery partnerships.

On March 26, 2019 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing a new class of potent and selective miniature drug conjugates (Pentarins) for the treatment of patients with a wide range of solid tumors, reported that the company will present nonclinical data on PEN-221 at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, occurring March 29 – April 3, 2019 in Atlanta, GA (Press release, Tarveda Therapeutics, MAR 26, 2019, View Source [SID1234534644]).

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PEN-221 is a miniature drug conjugate designed to rapidly penetrate deep into solid tumors where it is highly selective for somatostatin receptor 2 (SSTR2) and accumulates its potent DM1 cytotoxic payload. The presenter will demonstrate the effectiveness of PEN-221 in combination with epigenetic modulation by an HDAC inhibitor in nonclinical models of human cancer. The data show that an HDAC inhibitor increases the tumor expression of SSTR2 with synergy of efficacy.

Details of the poster presentation are as follows:

Title: Epigenetic modulation of SSTR2 expression provides the potential to broaden PEN-221 treatment population
Date: Tuesday, April 2, 2019
Time: 1:00pm Eastern Time
Location: Georgia World Congress Center, Atlanta, GA

On March 26, 2019 Akrevia Therapeutics, a privately held biopharmaceutical company focused on developing highly-potent, tumor-targeted immuno-oncology therapeutics, and City of Hope, an independent research and treatment center for cancer, diabetes and other life-threatening diseases, reported that they have entered into an exclusive licensing agreement that will allow Akrevia to utilize innovative technology to engineer potent immune-activating cytokines that can be selectively activated in the tumor microenvironment (Press release, Akrevia Therapeutics, MAR 26, 2019, View Source [SID1234554019]).

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The tumor microenvironment has distinct physiological characteristics that can be exploited to help develop tools to deliver therapies that are more precise and potent than existing treatments. The new technology, licensed from the lab of John Williams, Ph.D., at City of Hope, is suited to a broad spectrum of cytokines – molecules for which current tumor activation approaches are not applicable. This novel Switchblade allows inactivated proteins to "flick open" at the point of attack, releasing potent anti-tumor agents precisely where they are needed, thus maximizing efficacy and minimizing the peripheral side effects that limit current cytokine therapies. This new platform can be applied to other highly potent biologic architectures, including diverse cytokine family members, chemokines and agonistic immune modulators which to date have proved intractable in clinical development. This new technology will augment Akrevia’s existing Aklusion platform technologies, and augments the existing technology previously licensed from City of Hope.

"Cytokines have immense promise as highly potent cancer immunotherapeutics, with well-understood biology – but their extreme potency and lack of tumor targeting have thwarted attempts to exploit this clinically," said Tim Clackson, Ph.D., president and executive vice president, R&D, Akrevia Therapeutics. "The new technology licensed from City of Hope will substantially complement our current platform portfolio, providing the ability to target tumor activation of the full range of potent, immune-stimulating molecules. Akrevia will use the newly licensed technology to aggressively advance our pipeline and build towards the next generation of targeted cancer treatments."

Under the agreement, Akrevia gains exclusive commercial rights for application of the technology to the development of proprietary products. City of Hope, internationally recognized for pioneering technology that enabled the creation of numerous breakthrough cancer drugs, developed this technology to help investigators and researchers shield their selected antibodies for targeted therapies and to improve drug delivery. The nonprofit institution is working to improve precision medicine for all patients.

"At City of Hope, our research teams focus on rapidly developing technologies that can quickly move from laboratory research to clinical treatment," said Williams, professor of Molecular Medicine, City of Hope. "Our team has developed a novel approach to unlock the potential of multiple important immuno-oncology mechanisms to deliver potent, targeted agents to patients. We look forward to our continued collaboration with Akrevia to harness the therapeutic potential of this technology with the goal of improving treatment for patients."

On March 26, 2019 BioInvent International AB (OMXS: BINV), a biotech company focused on the discovery and development of novel immuno-regulatory antibodies to treat cancer and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, reported the extension of their collaboration to co-develop multi-functional oncolytic viruses (OV) encoding for undisclosed antibodies sequences capable of treating a broad range of solid tumors (Press release, Transgene, MAR 26, 2019, View Source [SID1234534629]).

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Under the terms of the extension agreement, Transgene will contribute its industry-leading OV design and engineering expertise, some non-antibody transgenes, as well as its proprietary engineered vaccinia virus (TK-, RR-) backbone, which forms the basis of its Invir.IO platform. BioInvent will provide its cancer biology and antibody expertise to the collaboration as well as one or more antibodies sequences, generated through its proprietary n-CoDeR/F.I.R.S.T. platforms. Certain sequences for an undisclosed target will be selected for encoding within Transgene’s Invir.IO backbone to create a multi-functional OV.

In November 2018, Transgene and BioInvent presented positive data from their initial collaboration at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). These initial data covered the collaboration’s work on an anti-CTLA-4 antibody-armed oncolytic vaccinia virus, based on Transgene’s proprietary vaccinia virus (TK-, RR-) backbone. This enhanced oncolytic vaccinia virus demonstrated its ability to ensure the expression of BioInvent’s anti-CTLA-4 antibody in the tumor with low systemic exposure. It also showed improved efficacy and a better safety profile when compared to the combination of the antibody and the non-armed corresponding oncolytic virus given individually in pre-clinical models.

Consistent with the initial collaboration, research and development costs as well as revenues and royalties from the multifunctional OVs generated as a result of the new collaboration will be shared 50:50.

Encoding BioInvent’s antibodies sequences in Transgene’s proprietary Invir.IO platform, for a direct expression into the tumor, promises to optimize the efficacy and tolerability of these antibodies. Both Transgene and BioInvent believe that these novel multifunctional OVs could be significantly more effective than co-administering an OV and an antibody together.

Commenting on the agreement, Martin Welschof, CEO of BioInvent, said: "The extension of our collaboration with Transgene opens up further opportunities for both companies to combine their expertise and knowledge to develop antibody oncolytic virus combinations capable of treating a broad range of solid tumors. By leveraging BioInvent’s unique and proprietary n-CoDeR/F.I.R.S.T. platforms, we will be able to develop a number of novel first-in-class antibodies that could be delivered directly into the tumor via Transgene’s vaccinia viral backbone, potentially enhancing their efficacy and improving their side effect profile."

Philippe Archinard, PhD, Chairman and CEO of Transgene, said: "We are pleased to extend the scope of our highly productive collaboration with BioInvent. We believe that the next generation of multi-functional oncolytic viruses expressing BioInvent’s highly targeted immune modulators directly in the tumor micro-environment will deliver much improved overall survival outcomes in patients with solid tumors. This agreement further expands Transgene’s broad portfolio of oncolytic viruses in development, the first of which is expected to enter the clinic in 2020."