On June 28, 2018 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that aldoxorubicin licensee NantCell, Inc., a private subsidiary of NantWorks, LLC, has dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with triple negative breast cancer (TNBC) (Press release, CytRx, JUN 28, 2018, View Source [SID1234527501]). This is the third trial conducted by NantCell which will investigate aldoxorubicin combined with immunotherapy or high-affinity natural killer (haNK) cell therapy in certain high unmet need cancer indications.The first trial in pancreatic cancer patients commenced in January 2018and the second trial, for patients with advanced squamous cell carcinoma, commenced in February 2018.

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Eric Curtis, CytRx’s President and Chief Operating Officer stated, "The initiation of this third clinical trial speaks to NantCell’s commitment to investigating aldoxorubicin in combination with their proprietary haNK cell therapy and working to identify effective treatment alternatives for women challenged by TNBC, an aggressive, difficult to treat type of breast cancer."

The trial titled "QUILT-3.067 NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy," (NCT03387085) is a single-center, open-label, Phase 1b/2 clinical trial designed to evaluate the safety and efficacy of several combination therapies, including combinations with aldoxorubicin, in subjects with TNBC who have progressed on or after standard of care therapies. This trial is expected to enroll approximately 79 patients. The primary endpoint for the Phase 1b portion of the trial is safety and the primary endpoint for the Phase 2 portion of the trial is objective response rate (ORR) by RECIST.

About Triple Negative Breast Cancer

Triple-negative breast cancer (TNBC) is a particularly aggressive form of cancer whose cells do not have estrogen, progesterone, or receptors of the HER2 protein. According to the National Institutes of Health, it is estimated that between 10 and 20 percent of breast cancer patients are diagnosed with TNBC and approximately 170,000 cases of TNBC have been reported annually worldwide, with higher rates among women under 50 years old and women of African American or Hispanic background. The disease may also be associated with inherited mutations in the BRCA1 gene.

On June 28, 2018 Kymab reported its clinical trial agreement with F. Hoffmann-La Roche Ltd under which Roche will provide its PD-L1 blocking antibody atezolizumab for use in combination with Kymab’s lead investigational anti-ICOS antibody therapy KY1044 in Kymab’s upcoming Phase I/II clinical studies in patients with advanced solid cancers (Press release, Kymab, JUN 28, 2018, View Source [SID1234537005]).

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"We have presented preclinical data demonstrating strong synergies between an anti-PD-L1 treatment in combination with KY1044 against multiple tumour types," says Arndt Schottelius, MD, PhD, Executive Vice President, Research and Development of Kymab. "We look forward to the initiation of our first studies and exploration of the potential synergy of our programs for the benefit of patients with advanced solid cancers."

Kymab will be responsible for conducting the clinical trials, and both companies will share data from the trials. Kymab continues to retain all commercial rights to KY1044.

KY1044 is designed to both deplete intratumoral Regulatory T-cells and stimulate T Effector cells to enhance the immune response against tumors.

Kymab plans to conduct a Phase I/II study in a variety of solid tumours both as monotherapy and in combination with atezolizumab. Indications that have elevated levels of both ICOS and FOXP3 might be especially responsive to this combination of checkpoint inhibitors.

Kymab will lead studies to evaluate this hypothesis: atezolizumab, an anti-PD-L1 antibody that acts as a checkpoint inhibitor, and KY1044, an antibody targeting ICOS expression, will be tested for synergistic action to recalibrate the immune response. Kymab plans to initiate monotherapy studies of KY1044 in the first half of 2019 and studies in combination with TECENTRIQ in the second half.

Notes to Editors
Issued Cambridge, UK, 28 June 2018

Read the PDF version of the issued Press Release

TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About KY1044
KY1044 is a fully human monoclonal antibody discovered by Kymab’s unique suite of technologies. KY1044 has now been tested in number of highly illustrative syngeneic models, which demonstrate that KY1044 strongly inhibits tumor growth in cancers both as a monotherapy and in combination with other immunotherapies.

Inducible T Cell Co Stimulator (ICOS), is expressed upon activation on T cells and at high levels on the majority of FOXP3+ regulatory CD4+ T cells. Importantly, available data demonstrate that depletion of these immunosuppressive cells from the tumor microenvironment enhances the patient’s anti-tumor immune response.

Scientific Posters and Presentations can be located in the pipeline section on the Company’s website: View Source

On June 28, 2018 BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, reported the treatment of the first patient in its clinical trial BA3021-001 for BioAtla’s BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC) (Press release, BioAtla, JUN 28, 2018, View Source [SID1234527502]). This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3021 in patients with advanced solid tumors including non-small cell lung cancer (NSCLC), triple negative breast cancer and soft tissue sarcoma. CAB-ROR2-ADC is BioAtla’s second CAB investigational product to enter clinical trials following BA3011, CAB-AXL-ADC in February of this year.

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The first patient in the BA3021 clinical study was enrolled and dosed at Sarah Cannon Research Institute at Tennessee Oncology in Nashville, TN under the direction of the principal investigator, Howard A. "Skip" Burris III, MD. Dr. Burris, a recognized leader in clinical oncology, serves as chief medical officer and president of clinical operations at Sarah Cannon. "Innovative advancements in the treatment of cancer include tumor specific activation of therapy and promoting appropriate immune response. Providing access to cutting-edge therapies in clinical trials, such as the BA3021 clinical study, further supports our mission to advance care for cancer patients," said Dr. Burris.

The ROR2 transmembrane protein tyrosine kinase is an onco-fetal protein that acts as a non-canonical Wnt 5A receptor. ROR2 is found to be highly expressed during embryonic development and in several important cancer types, and the level of expression in tumors is tightly correlated with patient prognosis. Recently, ROR2 and its ligand Wnt 5A have been shown to be induced in cancers that are resistant to treatment with immune checkpoint inhibitors such as anti-PD-1 antibody immune therapy suggesting a mechanistic role of this receptor-ligand axis in resistance to standard cancer treatments resulting in relapsing, minimal residual disease. However, low to moderate levels of expression of ROR2 in multiple normal adult tissues are predicted based on RNA expression, histological analysis and functional studies. To minimize the risk of potential disruption of normal function of ROR2 receptors on normal cells, BioAtla applies its proprietary CAB technology to develop its CAB antibody-drug conjugate (ADC) targeting ROR2 with the intent to activate binding to the ROR2 receptor only in the tumor microenvironment and deliver the toxic payload to the cancerous cells. The CAB-ROR2-ADC BA3021 is designed to maximize efficacy on ROR2 expressing tumors while minimizing toxicity, leading to better clinical outcomes.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla’s proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

On June 28, 2018 MolMed S.p.A. (MLMD.MI), a medical biotechnology company focusing on research, development, manufacturing, and clinical validation of cell & gene therapies to treat cancer and rare diseases and AbCheck s.r.o., a technology company focusing on the discovery and optimization of high-quality human antibodies, reported that they have entered into a three-year Master Agreement aimed at providing MolMed with selected and optimized antibodies for the development of new Chimeric Antigen Receptors (CARs), targeting both liquid and solid tumors (Press release, MolMed, JUN 28, 2018, View Source [SID1234527504]).

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Under the agreement, AbCheck will use its proprietary discovery platform to select, optimize and deliver multiple human single-chain variable fragments (scFvs), specifically recognizing each MolMed target candidate. ScFvs are the extracellular regions of the CAR responsible for antigen recognition and binding, conferring specificity to the CAR.

The new and optimized scFvs delivered by AbCheck will allow MolMed to expand its proprietary pipeline in both autologous CAR-T and future allogenic CAR-NK platforms.

Riccardo Palmisano, MolMed CEO, commented: "This new collaboration plays a key role to complete the picture of the planned and announced enlargement of our CAR pipeline. Leveraging on the unique experience that we developed on CAR T CD44v6, now close to clinical stage in acute myeloid leukemia and multiple myeloma and on the recently signed partnership with Glycostem, with this agreement with AbCheck, a company with extensive expertise in antibodies selection and boasting partnerships with relevant companies and institutions in the CAR field, MolMed is fully prepared to build a robust autologous and allogeneic original CAR T pipeline, able to target both liquid and solid tumors".

Volker Lang, Managing Director of AbCheck, added: "AbCheck is recognized for its proven capability to reliably deliver high-quality human antibodies suitable for clinical development. We are very pleased to employ our unique technology suite to support MolMed’s dedicated team in adding novel therapeutic options to its diverse pipeline. Both CAR-Ts and CAR-NKs represent promising novel immuno-oncology approaches and we are confident that AbCheck’s abilities in antibody discovery and optimization will be an important asset in developing such approaches."

On June 27, 2018 Oxford Vacmedix, the UK based biopharma company focused on the development of a new generation of cancer vaccines, reported that its novel Recombinant Overlapping Peptide (ROP) technology had been presented at the 2018 Myongji International Cancer Symposium .

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The meeting was held in Seoul, South Korea and focused on new horizons in the development of treatments for cancer on immunotherapy and on precision medicine. Other speakers included researchers from the MayoClinic and the University of Chicago in the US as well as from St Luke’s International hospital in Japan.

Dr. Jiang, CSO and Founder of Oxford Vacmedix (OVM) and a researcher in the Department of Oncology at University of Oxford, presented the role of TNF as a potential target for cancer therapy and the exciting preclinical data of OVM’s leading development programmes for two Cancer vaccines. OVM-100 is an HPV vaccine targetedat cervicalcancer,and OVM-200 represents a new type of vaccine utilising survivin to target solid tumours. Bothvaccines are being developed as single agents and in combination with immuno-oncology agents. The company will also continue to develop its diagnostic kits for cellular immunity.

William Finch, CEO of Oxford acmedix said: "We were very pleased to present ROP technology at this important meeting and to have the opportunity to discuss the novel research and the exciting development programme which could lead to significant benefit for patients with cancer"

Wang-Jun Lee, Chairman of Myongji Hospital Group, added: "We are delighted DrJiang could participate in this meeting and we look forward to a productive collaborations with OVM especially in research and in clinical trials. We are confident that we can support the continued growth and development of the company"