On November 8, 2018 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported it will present two posters highlighting preclinical data and the Phase Ib clinical trial design for ADCT-301 (camidanlumab tesirine) in advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, which is being held November 7-11 in Washington, DC (Press release, ADC Therapeutics, NOV 8, 2018, View Source [SID1234596074]).

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Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "ADCT-301 is already being evaluated in relapsed and refractory Hodgkin lymphoma, and at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting we will be updating our abstract data from June, at which time we had an overall response rate of 80.8 percent with a complete response rate of 50 percent in median 6th line patients. Based on the immune-oncology potential ADCT-301 demonstrated in preclinical studies, we are excited to be starting a clinical trial for ADCT-301 in solid tumors to see if we can make an impact and improve patient outcomes in multiple solid tumor cancers."

Patrick van Berkel, PhD, Senior Vice President of Research and Development at ADC Therapeutics, said, "ADCT-301 targets CD25, which is expressed on Tregs that infiltrate the local tumor environment. In preclinical models, a single dose of the CD25-targeted ADC induced strong and durable anti-tumor activity against established CD25 negative solid tumors with infiltrating Tregs. Moreover, re-challenged mice did not develop new tumors indicating the CD25-targeted ADC was able to induce tumor-specific protective immunity."

ADC Therapeutics’ posters will be located in Poster Hall E in the Walter E. Washington Convention Center. The Poster Hall will be open Friday, November 9 from 8 a.m. to 8 p.m. and Saturday, November 10 from 8 a.m. to 8:30 p.m. EST. Details of the posters are below.

Abstract Poster Number: P11
Title: A CD25 targeted pyrrolobenzodiazepine dimer-based antibody-drug conjugate shows potent anti-tumor activity in pre-clinical models of solid tumors either alone or in combination with a PD-1 inhibitor
Presentation Date and Time: Friday, November 9, 12:45-2:15 p.m. and 6:30-8 p.m. EST
Presenter: Francesca Zammarchi, PhD, ADC Therapeutics

Abstract Poster Number: P316
Title: Phase 1b dose-escalation and dose-expansion study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-301 (camidanlumab tesirine) in patients with advanced solid tumors
Presentation Date and Time: Saturday, November 10, 12:20-1:50 p.m. and 7-8:30 p.m. EST
Presenter: Francesca Zammarchi, PhD, ADC Therapeutics

For more information about the SITC (Free SITC Whitepaper) 2018 Annual Meeting, please visit View Source

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-expresing 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 a Phase Ib clinical trial in solid tumors (NCT03621982), as well as ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235).

On November 8, 2018 Palleon Pharmaceuticals, a leading biotech company focused on developing drugs that target Glyco-Immune Checkpoints to treat cancer, reported that the company will present preclinical data from its EAGLE platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting, in Washington, D.C (Press release, Palleon Pharmaceuticals, NOV 8, 2018, View Source [SID1234530957]).

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Palleon’s EAGLE platform enables the development of drugs that inhibit Glyco-Immune Checkpoints by disabling the immunosuppressive function of tumor cell surface glycans. The critical challenge in this area arises from the complexity, heterogeneity and rapidly evolving nature of the tumor glycans. Palleon’s EAGLE platform employs an enzyme/antibody bi-specific construct, which removes terminal sialic acids, the molecules that are responsible for suppressing the immune system, from cancer cell surface glycans in the tumor micro-environment. This enzymatic approach uniquely overcomes tumor glycan heterogeneity and makes tumors vulnerable to both innate and adaptive immune responses.

"Palleon’s EAGLE platform has allowed us to develop a first-in-class therapeutic modality that enhances both the innate and adaptive responses to cancer, which is critical for targeting patients who are resistant to current therapies," said Jim Broderick, M.D., chief executive officer and founder of Palleon. "In addition, the EAGLE platform is robust and adaptable, and it can turn any existing targeted antibody therapy into a potent immuno-oncology agent."

Poster #037, titled "A New Immunomodulatory Strategy of Inhibiting Glyco-Immune Checkpoints Using EAGLE Technology" will be on display in Hall E. Presentation hours are Friday, November 9 from 12:45 – 2:15 p.m. and 6:30 – 8:00 p.m. ET. Li Peng, Ph.D., vice president, biotherapeutics discovery at Palleon, will make an oral presentation on Sunday, November 11 at 9:25 a.m. ET during SITC (Free SITC Whitepaper)’s Next Generation Bispecifics and Antibody-Like Molecules session.

Additionally, Poster #676, from Palleon’s Scientific Advisory Board member, Heinz Läubli, titled, "Targeting the Sialoglycan/Siglec Pathway in Combination with Checkpoint Inhibitors for Cancer Immunotherapy" will be on display in Hall E. Presentation hours are Saturday, November 10 from 12:20 – 1:50 p.m. and 7:00 – 8:30 p.m.

About Glyco-Immune Checkpoints
Cancer uses multiple pathways to evade the immune system, and Glyco-Immune Checkpoints are a significant and under-appreciated axis of immunosuppression in cancer. Tumors exploit Glyco-Immune Checkpoints through the alteration of glycans on the surface of their cells, impairing both innate and adaptive immune cells and resulting in a broad, comprehensive suppression of the anti-tumor immune response. Glyco-Immune Checkpoints had been overlooked relative to other anti-cancer strategies due to the complexity of glycoscience, and, until recently, the lack of scientific tools to demonstrate its relevance to immuno-oncology. Palleon has assembled the technologies needed to overcome these barriers and make drug development in this field possible.

On November 8, 2018 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported its two poster presentations by its licensee NantCell, Inc. at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, taking place November 7-11, 2018 in Washington, DC (Press release, CytRx, NOV 8, 2018, View Source [SID1234530976]). The abstracts describe early safety and efficacy data from the Phase 1b portion of Phase 1b/2 clinical trials evaluating NantCell’s high-affinity natural killer (haNK) cell therapy in combination with anti-cancer agents, including aldoxorubicin, in patients with third-line or greater triple negative breast cancer (TNBC), fourth-line or greater head and neck squamous cell carcinoma (HNSCC) or recurrent metastatic pancreatic cancer.

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Preliminary Phase 1b Results in TNBC and HNSCC

In this Phase 1b, single-arm, open-label trial, treatment was administered in 3-week cycles of low-dose chemotherapy (aldoxorubicin, cyclophosphamide, cisplatin, nab-paclitaxel, 5-FU/L), antiangiogenic therapy (bevacizumab), engineered allogeneic high affinity CD-16 NK-92 cells (haNK), IL-15RαFc (N803), adenoviral vector-based CEA, MUC1, Brachyury, HER2 vaccine, yeast vector-based RAS, Brachyury and CEA vaccine, and an IgG1 PD-L1 inhibitor, avelumab plus cetuximab. All patients in both trials received aldoxorubicin. The primary endpoint is incidence of treatment-related adverse events (AEs). Secondary endpoints include overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

The abstract includes data from three patients with third-line or greater TNBC and two patients with fourth-line or greater HNSCC. All treatment was completed in the outpatient setting, with no immune-related AEs. Four hematologic dose limiting toxicities (DLTs) were observed and managed with a planned dose reduction of cisplatin. Of the three patients with TNBC, two (67%) experienced a partial response (PR). Of the two patients with HNSCC, both (100%) experienced objective tumor response (100% and 47% decrease, respectively). Overall, four out of the five TNBC and HNSCC patients (80%) had confirmed overall responses, including one patient (20%) with fifth-line metastatic disease who demonstrated a complete response (CR). All responding patients are still undergoing therapy. These preliminary data suggest that the NANT Cancer Vaccine (NCV), comprised of low-dose chemo-radiation combined with innate and adaptive immunotherapy, can be administered safely in an outpatient setting without any observed increase in immune-related AEs.

Preliminary Phase 1b Results in Metastatic Pancreatic Cancer

In this Phase 1b, single-arm, open-label trial, treatment was administered in 3-week cycles of low-dose chemotherapy (aldoxorubicin, cyclophosphamide, oxaliplatin, nab-paclitaxel, 5-FU/L), antiangiogenic therapy (bevacizumab), engineered allogeneic high affinity CD-16 NK-92 cells (haNK), IL-15RαFc (N-803), adenoviral vector-based CEA vaccine, yeast vector-based RAS vaccine, and an IgG1 PDL1 inhibitor, avelumab. All metastatic pancreatic cancer patients received aldoxorubicin. The primary endpoint is incidence of treatment-related AEs. Secondary endpoints include ORR, DCR, PFS, and OS.

The abstract includes data from ten patients with third-line or greater metastatic pancreatic cancer. All treatment was safely administered in the outpatient setting. AEs were primarily hematologic which were managed by appropriate planned chemo dose reductions. No DLTs have occurred and no haNK-related AEs have occurred to date. Of the ten evaluable patients, nine have achieved stable disease (SD) for ≥ 8 weeks for a DCR of 90%. Median PFS was 5.8 months (95% confidence interval: 3.3 – 8.8) and OS was 9.5 months (95% CI: 5.0 – upper limit not yet reached) with patients continuing treatment. One patient demonstrated resolution of a metastatic lung tumor within 8 weeks of initiating NCV therapy. These preliminary results suggest that the NCV treatment regimen was well tolerated and support the safety and tolerability of the regimen. These preliminary efficacy results are encouraging and the overall survival of 9.5 months currently exceeds all standards of care for patients at this advanced stage of disease.

Eric Curtis, CytRx’s President and Chief Operating Officer, stated, "The data presented by NantCell at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting are optimistic. We are pleased to see that these NCV regimens including aldoxorubicin are well tolerated and support the overall thesis being investigated. These data may ultimately lead to more combinations of aldoxorubicin with cutting edge therapies being studied in tumor types with high unmet needs. We look forward to seeing more data as these clinical trials progress."

"In the oncology marketplace, we have seen clear treatment trends by Big Pharma and recent regulatory approvals moving toward combining the category of potential Centurion drug candidates such as LADR 7, 8, 9 and 10 with immunotherapy."

Aldoxorubicin is a rationally-engineered cytotoxic which employs a linker bound to albumin to deliver doxorubicin directly into the tumor. CytRx out-licensed global development, manufacturing, and commercialization rights for aldoxorubicin to NantCell, Inc., a private subsidiary of NantWorks, LLC, in July 2017.

These data were highlighted at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting in a presentation titled, "First in Human Data in Advanced Solid Tumors of NANT Cancer Vaccine: A Novel Temporospatial Orchestration of the Innate (NK) & Adaptive Immune System to Induce Antigen Cascade & Immunogenic Cell Death" which took place on Wednesday, November 7, 2018 from 5:45-6:00pm ET.

About the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Established in 1984, SITC (Free SITC Whitepaper), a 501(c)(3) not-for-profit organization, serves scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world. Currently, SITC (Free SITC Whitepaper) has more than 2,000 members who represent 22 medical specialties in 42 countries around the world. Through emphasis on high-caliber scientific meetings; dedication to education and outreach activities; focus on initiatives of major importance in the field; and commitment to collaborations with like-minded domestic and international organizations, government and regulatory agencies, associations and patient advocacy groups, SITC (Free SITC Whitepaper) brings together all aspects of the cancer immunology and immunotherapy community. Through educational programs that foster scientific exchange and collaboration, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere.

On November 8, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Credit Suisse 27th Annual Healthcare Conference on Tuesday, November 13, 2018 (Press release, Eli Lilly, NOV 8, 2018, View Source [SID1234531002]). Enrique Conterno, senior vice president of Lilly and president of Lilly Diabetes and Lilly USA, will participate in a fireside chat at 3:40 p.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On November 8, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that a new mechanism of action may have been uncovered expanding the potential use of its inhibitor of glycolysis, WP1122 (Press release, Moleculin, NOV 8, 2018, View Source [SID1234531034]).

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A study recently published in the American Cancer Journal of Cancer Research (Am J Cancer Res 2018;8(9):1837-1846) involving researchers at MD Anderson and the Peking University Cancer Hospital & Institute has found that 2-deoxyglucose (2-DG) has the potential to decrease resistance to immune checkpoint blockade therapy in triple-negative breast cancer (TNBC) in a process known as "glycosylation."

"This study provides a strong rationale for targeting glycosylation with 2-DG in order to improve outcomes for TNBC," commented Dr. Donald Picker, Moleculin’s Chief Science Officer. "Historically, 2-DG hasn’t been successfully developed into a drug because of its lack of drug-like properties, including a very short half-life. Fortunately, based on preclinical data, WP1122, a proprietary prodrug of 2-DG, appears to address that problem and significantly increases the circulation time of 2-DG and its ability to reach specific organs harboring tumors, including the pancreas."

Walter Klemp, Moleculin’s Chairman and CEO added, "The timing of this discovery is perfect for us. We were already pushing forward with IND-enabling preclinical testing of WP1122 for use in brain tumors and pancreatic cancer and now we see a significant expansion of its potential uses."