On December 3, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, presented the latest data from its ongoing study focusing on early detection of breast cancer, utilizing Cchek, its artificial intelligence (AI) driven cancer detection technology, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy (Press release, Anixa Biosciences, DEC 3, 2018, View Source [SID1234531852]). 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 address cancer. The conference was held November 27–30, 2018 in Miami Beach, Florida.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Anixa presented data demonstrating the ability of Cchek to identify the presence of early stage breast cancer in a subject by using its AI technology to analyze a simple blood draw. The Cchek technology demonstrated a sensitivity of 89.3% when detecting early stage breast cancer (Stage I or II) and a specificity (the ability to correctly identify healthy subjects) of 94.7% when used to test blinded samples. Furthermore, Cchek was also able to detect the early stages of breast cancer (Stage 0) in subjects with biopsy-confirmed ductal carcinoma in situ (DCIS), a type of pre-cancerous/non-invasive breast lesion that often leads to invasive breast cancer, with 72% sensitivity. The presentation is available on Anixa’s website, or it may be requested by sending an email to AACR (Free AACR Whitepaper)[email protected] and including your name, title, and contact information.

"We are pleased to have made 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 was focused on using our Cchek technology to detect breast cancer in its early stages, primarily stage I and II when the cancer is more easily treated. 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. A major challenge with mammography is the large number of false positives resulting in overtreatment and many unnecessary biopsies," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "As our study continues, we hope to enable a better approach for identifying breast cancer as early as possible including even when a non-invasive breast cancer lesion is present, such as in the case of DCIS. We have previously announced that 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)," 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 December 3, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that previously announced interim data from the Company’s Phase 2 study evaluating prexigebersen as a treatment for acute myeloid leukemia (AML) were presented in a poster at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place from December 1-4, 2018 in San Diego, CA (Press release, Bio-Path Holdings, DEC 3, 2018, View Source [SID1234531869]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Maro Ohanian, M.D., Assistant Professor of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, presented the poster titled, "Interim Safety and Efficacy of Lower Intensity Induction Therapy with Intravenous Prexigebersen (BP1001) in Patients with Untreated Acute Myeloid Leukemia (AML)." The poster reviewed interim data from the Company’s open-label Phase 2 study evaluating the efficacy and safety of prexigebersen in conjunction with low-dose cytarabine (LDAC), a therapeutic regimen well established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy. The primary objective of the study is to determine whether the combination of prexigebersen and LDAC provides greater efficacy than what would be expected with LDAC alone in this de novo patient population.

Prexigebersen was safely administered to patients with untreated AML, who were considered unsuitable for standard chemotherapy. Of the 17 evaluable patients, there were four patients (24%) who achieved complete responses and four patients with stable disease including one patient who achieved a morphologic leukemia free state and two patients who had significantly reduced bone marrow blasts. In total, 47% of the evaluable patients showed some form of response, including stable disease, to the combination treatment. Efficacy data are encouraging in this challenging population in which the majority of patients had secondary AML or adverse-risk AML, and compares favorably to the reported CR (complete remission), CRp (complete remission with incomplete platelet recovery), and CRi (complete remission with incomplete hematologic recovery) rate with LDAC alone of 7-13%1.

"We are excited to be presenting these important data at ASH (Free ASH Whitepaper) before an audience of world-leading scientists and oncologists, as they demonstrate the potential for the combination of prexigerbesen and LDAC to safely and effectively treat these de novo AML patients, including doubling the complete response to treatment compared to LDAC treatment alone," noted Peter H. Nielsen, chief executive officer of Bio-Path. "We look forward to presenting final data from this study as we expect they will provide even better results for these patients suffering with AML."

1 Heiblig, Mediterr J Hematol 2016; Kantarjian, J Clin Oncol 2012; Dohner, Blood 2014

On December 3, 2018 ArQule, Inc. (Nasdaq: ARQL) reported its presented preliminary results from the Company’s Phase 1 dose escalation study for ARQ 531, an orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK) in patients with relapsed or refractory hematologic malignancies at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego (Press release, ArQule, DEC 3, 2018, View Source [SID1234531820]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Brian Schwartz, Chief Medical Officer of ArQule commented, "We are encouraged by the pace at which this trial is progressing and by the level of target engagement we are observing as we continue to dose escalate. Four out of the five heavily pretreated CLL patients enrolled in the last two cohorts with the BTK-C481S mutation have experienced tumor shrinkage."

"These data provide further evidence of ARQ 531’s potential to become a new therapeutic option for patients with B cell malignancies," commented Paolo Pucci, Chief Executive Officer of ArQule. "There is significant unmet need for patients with relapsed or refractory B-cell malignancies in particular those with the C481S-mediated resistance to irreversible BTK inhibitors such as ibrutinib."

The reported data are from the ongoing Phase 1, open label, single arm dose escalation 3+3 study and include the first six cohorts (n=20) at dose levels of 5, 10, 15, 20, 30 and 45 mg once a day in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), Waldenstrom’s macroglobinemia and B-cell Non-Hodgkin lymphomas.

Key findings presented include the following:

ARQ 531 has demonstrated a manageable safety profile with no dose-limiting toxicities observed to date
Pharmacokinetic data are nearly dose proportional with a mean plasma half-life that supports QD dosing
Pharmacodynamic biomarkers for cohorts 4 through 6 showed profound pBTK inhibition
Anti-tumor activity, with reduction of tumor burden, was observed in 9 out of 20 patients
At the first assessment of tumor response, 80% of the ibrutinib refractory, heavily pretreated CLL patients (4 out of 5) in the highest dose cohorts (30 and 45 mg) experienced tumor shrinkages
Four out of 5 lymphoma patients derived benefit with shrinkages between 27 and 58%, including 1 PR in a Follicular Lymphoma patient who began at 5 mg, was dose escalated to 15 and then 45 mg, and remains on therapy after 70 weeks
The study is on-going and dose escalation continues
The presented poster, A Phase 1 Dose Escalation Study of ARQ 531 in Selected Patients with Relapsed or Refractory Hematologic Malignancies, is available on the company’s website at View Source

The Company will hold a conference call and webcast today at 9:00 a.m. ET to discuss these results. The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

About BTK and ARQ 531

Bruton’s tyrosine kinase, BTK, is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in blood cancers. ARQ 531 is an orally bioavailable, potent and reversible BTK inhibitor. Biochemical and cellular studies have shown that ARQ 531 inhibits both the wild type and C481S-mutant forms of BTK. The C481S-mutation is a known resistance mechanism for first generation irreversible BTK inhibitors. In preclinical studies, ARQ 531 has demonstrated good oral bioavailability as well as favorable pharmacokinetic, pharmacodynamic and metabolic properties.

On December 3, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported positive results from multiple preclinical studies which were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s (ASH) (Free ASH Whitepaper) 60th Annual Meeting & Exposition in San Diego, CA (Press release, Alpine Immune Sciences, DEC 3, 2018, View Source [SID1234531837]). Oral and poster presentations described promising efficacy of ALPN-101 in preclinical models of acute graft versus host disease (GvHD) and hemophagocytic lymphohistiocytosis (HLH), while a poster presentation described the company’s transmembrane and secreted immunomodulatory protein (TIP/SIP) platform to enhance the activity of engineered T cell therapies for cancer. Additionally, Alpine strengthened its Scientific Advisory Board with the addition of Anne Davidson, MBBS, Professor, Center for Autoimmune, Musculoskeletal, and Hematopoietic Diseases, Feinstein Institute for Medical Research.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ALPN-101 Preclinical Study Results

Djamilatou Adom, PhD, from the Indiana University School of Medicine laboratory of Sophie Paczesny, MD PhD, and one of Alpine’s collaborators, presented an oral abstract titled, "ICOSL+ Plasmacytoid Dendritic Cells as Biomarker and Inducer of Graft-Versus-Host Disease" (publication #355), highlighting the novel role ICOS ligand (ICOSL) plays in acute GvHD and describing a strong correlation between ICOSL-positive plasmacytoid dendritic cells and the gastrointestinal manifestations of GvHD. In the investigators’ model of GvHD, ALPN-101 significantly improved survival.

"I’m excited about the potential of ALPN-101 in GvHD given its dual CD28/ICOS mechanism of action," said Dr. Paczesny, Professor of Immunology and Pediatrics at Indiana University School of Medicine and lead of the Biomarkers Stem Cell Transplantation Program. "Early biomarker development could identify patients at risk, specifically early quantification of ICOSL+ Plasmacytoid Dendritic Cells frequency may allow for identification of patients at risk of gastrointestinal and support ALPN-101 as an early intervention in this patient population."

In a poster titled, "Therapeutic Candidate ALPN-101, a Dual ICOS/CD28 Antagonist, Potently Suppresses Human/NSG Mouse Xenograft Graft vs. Host Disease (GvHD) in a Dose Ranging Study and Reduces Disease Activity in a Mouse Model of Hemophagocytic Lymphohistiocytosis (HLH)" (publication #2037), ALPN-101 was evaluated in a humanized model of GvHD and an experimental model of HLH. GvHD is a life-threatening disease reflecting immune-mediated attack of recipient tissue by donor T cells and is one of the leading causes of death following allogeneic stem cell transplantation. HLH is a rare, life-threatening inflammatory disease characterized by excessive T cell and macrophage activation. Results showed ALPN-101:

Humanized GvHD Model

Enhanced survival and suppressed disease activity in GvHD, even after administration of only a single dose.
Demonstrated superior efficacy to belatacept, an approved CD28 pathway inhibitor, in survival and disease activity, correlating with better suppression of activated T cells and circulating cytokines.
HLH Model

Reduced CD4+ T cell activation and liver inflammation
Did not appear to affect the activity of viral-specific T cells directed against lymphocytic choriomeningitis virus (LCMV), the virus used to induce the model.
The HLH data were generated in collaboration with the laboratory of Kim Nichols, MD, Director of the Cancer Predisposition Division at St. Jude Children’s Research Hospital. Dr. Nichols noted, "ALPN-101 clearly reduces inflammation in these models, but importantly the activity of viral-specific T cells was preserved, suggesting ALPN-101 may reduce pathogenic, but spare desired, immune responses."

"These results reinforce our confidence in ALPN-101 as a promising therapeutic candidate, not only in GvHD but multiple other autoimmune and/or inflammatory diseases," said Stanford Peng, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Alpine. "We remain on track to initiate a Phase 1 study in the first quarter of 2019."

Transmembrane and Secreted Immunomodulatory Protein (TIP/SIP) Data Presented

A second poster, titled "’Switch’ Transmembrane Immunomodulatory Proteins (TIPs) Consisting of High-Affinity PD-1 Extracellular Domains (PD-1 vIgDs) and Costimulatory Intracellular Domains Potently Enhance the Activity of TCR-Engineered T Cells" (publication #2052), described for the first time an application of Alpine’s variant immunoglobulin domain (vIgD) platform to enhance the activity of engineered T cells (ECTs). Multiple formats were demonstrated, in which vIgDs expressed by TCR and/or CAR-T cells in either transmembrane or secreted forms enhanced their activity as determined by T cell proliferation, cytokine production, and/or target cell killing. Examples included CD86 costimulatory TIPs, PD-L2 checkpoint inhibitory SIPs, and PD-1 "switch" TIPs incorporating costimulatory intracellular signaling domains, using HPV-specific TCRs, as well as HER2- and CD19-specific CARs. Importantly, the success of this work relied upon Alpine’s development of a proprietary transduction vector to achieve high T cell transduction efficiencies.

Dr. Peng added, "Engineered T cell therapies continue to hold great promise but have seemed so far to demonstrate only modest efficacy in solid tumors, possibly due to an immunosuppressive and/or insufficiently immuno-stimulatory tumor environment. These data suggest Alpine’s TIPs and SIPs may represent a next-generation strategy to overcome such obstacles. We look forward to continuing to develop this potential."

Scientific Advisory Board Appointment

Dr. Anne Davidson, MBBS, Professor, Center for Autoimmune, Musculoskeletal and Hematopoietic Diseases and Investigator at the Feinstein Institute for Medical Research, has been appointed to the Alpine Immune Sciences Scientific Advisory Board.

"We are pleased to have Anne join our ranks and lend her considerable expertise to the Alpine Scientific Advisory Board," said Andy Scharenberg, M.D., Chair of the Scientific Advisory Board. "She is a distinguished researcher and investigator, and her deep expertise in autoimmune disease processes will be valuable as Alpine works to advance its novel molecules in its autoimmune and inflammatory programs."

Dr. Davidson is a practicing rheumatologist at North Shore University Hospital and serves as program director of the Rheumatology Fellowship at Northwell Health. She has served on the medical advisory board for the S.L.E. Lupus Foundation and co-chairs a grant review committee for the Lupus Research Alliance. Her accolades include multiple grants from the National Institutes of Health, the Kirkland Scholar Award, the Dubois Award from the American College of Rheumatology, and the American College of Rheumatology Distinguished Investigator Award.

"I am pleased to join the Scientific Advisory Board at this pivotal time as Alpine advances its programs toward the clinic," said Dr. Davidson. "In particular, I am excited by what the ALPN-101 preclinical data has demonstrated to date, and I look forward to working with the team as Alpine explores this novel molecule’s potential application to a wide array of autoimmune disorders."

On December 3, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it will hold a R&D Update and 2018 ASH (Free ASH Whitepaper) Data Review Meeting today, December 3, 2016 at 8:00 PM Pacific Time (5:00 AM CET / 4:00 AM GMT on 4 December) (Press release, Genmab, DEC 3, 2018, View Source [SID1234531853]). The event will take place in San Diego, California, and will also be webcast live and archived on the company’s website. The meeting will include presentations by independent experts on data from daratumumab studies presented at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), including some key aspects of the Phase III MAIA study. Genmab speakers will also discuss pre-clinical data from Genmab’s DuoBody-CD3xCD20 and DuoHexaBody-CD37 programs presented at ASH (Free ASH Whitepaper), as well as the company’s progress and key goals for 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The following cancer experts and senior Genmab staff will be at the event:

Independent experts:

Dr. Meletios A. Dimopoulos, National and Kapodistrian University of Athens, School of Medicine
Dr. Nizar Bahlis, Arnie Charbonneau Cancer Institute, University of Calgary
Dr. Saad Usmani, University of North Carolina at Chapel Hill, Levine Cancer Institute

Genmab:

Dr. Jan van de Winkel, President and CEO, Genmab
Dr. Judith Klimovsky, Executive Vice President and CDO, Genmab
Dr. Kate Sasser, Corporate Vice President, Translational Research, Genmab
Key daratumumab abstracts to be discussed during the event include:

LB-2: Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA)

Abstract 156: One-year Update of a Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Patients (Pts) With Transplant-ineligible Newly Diagnosed Multiple Myeloma (NDMM): ALCYONE

Abstract 151: Efficacy and Updated Safety Analysis of a Safety Run-in Cohort from GRIFFIN, a Phase 2 Randomized Study of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide, and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Eligible for High-Dose Therapy and Autologous Stem Cell Transplantation

Abstract 1996: Three-Year Follow Up of the Phase 3 POLLUX Study of Daratumumab Plus Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma

Abstract 3270: Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib, and Dexamethasone in First Relapse Patients: Two-Year Update of CASTOR

Abstract 1995: Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Safety and Efficacy Update of the Open-label, Multicenter, Phase 1b Study (PAVO)

The event will take place at the Manchester Grand Hyatt in San Diego, California, Harbor G&H. Those wishing to attend in person may register on site.

The event can also be attended via webcast. To view this webcast visit: View Source Webcast viewers may submit questions during the Q&A portion of the live webcast via the webcast player. An archive of the webcast will be available on Genmab’s website. The webcast will be conducted in English.

This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.