On November 1, 2018 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Jeong A Park from the Department of Pediatrics of Memorial Sloan-Kettering Cancer Center (MSK) will present preclinical data from the Company’s bispecific GD2 antibody in a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego, CA on December 3, 2018, at 9:00 PM Eastern (Press release, Y-mAbs Therapeutics, NOV 1, 2018, View Source [SID1234530534]). An abstract of the poster presentation will be made available online by ASH (Free ASH Whitepaper) on November 1, 2018 at 12:00 PM Eastern.

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Bispecific GD2 antibodies were tested in solid tumors in preclinical models with T-cells and were shown to exert anti-tumor effect against GD2(+) tumor xenografts or PDX tumors. Further, the bispecific GD2 antibodies induced rapid and quantitative T-cell homing to tumors, mediating antibody dependent T-cell mediated cytotoxicity (ADTC) against GD2, and were shown to infiltrate tumors with little to no immune response, also known as cold tumors

On November 1, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported financial results for the third quarter ended September 30, 2018 (Press release, Curis, NOV 1, 2018, View Source [SID1234530550]).

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"Following Curis’s recent leadership change, we are increasing our focus on the clinical execution of our three first-in-class therapeutics that have the potential to be significant and innovative cancer treatments. We expect all three drug candidates to progress rapidly in the clinic and have data readouts in 2019," said James Dentzer, President & Chief Executive Officer of Curis. "To achieve this goal, we are re-allocating resources to prioritize clinical operations and have implemented a reduction in headcount and expenditure on pre-clinical science, pipeline expansion, and general and administrative expenses. We expect these reductions will offset an increase in headcount and costs associated with clinical operations and result in net savings for the Company, reducing cash burn from approximately $11 million to $8 million per quarter. This renewed focus on clinical execution will benefit patients in need of life-changing medications and shareholders alike," Mr. Dentzer concluded.

Third Quarter 2018 Financial Results

Curis reported a net loss of $7.2 million, or $0.22 per share on a basic and diluted basis for the third quarter of 2018, as compared to a net loss of $15.5 million, or $0.53 per share respectively for the same period in 2017.

Revenues for the third quarter of 2018 were $2.8 million, as compared to $2.4 million for the same period in 2017. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $9.3 million for the third quarter of 2018, as compared to $16.9 million for the same period in 2017, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, resulting from payments to third-party university patent licensors associated with Genentech and Roche’s Erivedge net sales, were $0.2 million as compared to $0.1 million for the same period in 2017.

Research and Development Expenses. Research and development expenses were $5.0 million, as compared to $13.4 million for the same period in 2017. The decrease was primarily driven by decreased costs related to clinical activities and manufacturing for fimepinostat, CA-170 and CA-4948 and a payment to Aurigene of $3.8 million for an exclusivity option in September 2017.

General and Administrative Expenses. General and administrative expenses were $4.1 million as compared to $3.4 million for the same period in 2017. The increase in general and administrative expenses was primarily driven by higher personnel costs and professional and consulting services partially offset by lower stock-based compensation for the period.

Other Expenses. Net other expenses totaled $0.8 million as compared to $1.0 million for the same period in 2017. Net other expense primarily consisted of interest expense related to Curis Royalty’s (a wholly owned subsidiary of Curis) debt obligations.

As of September 30, 2018, Curis’s cash, cash equivalents and investments totaled $30.8 million and there were approximately 33.1 million shares of common stock outstanding.

Recent Operational Highlights

Precision oncology, fimepinostat (formerly CUDC-907):

Having received Fast Track designation for fimepinostat, Curis is working with the FDA and select clinical sites to initiate a combination study of fimepinostat (a MYC inhibitor) with venetoclax (a BCL-2 inhibitor) in DLBCL, including patients with DH/DE Lymphoma.
DLBCL with alterations in both the MYC gene and the BCL2 gene is defined as Double-Hit Lymphoma. In preclinical studies, the combination of fimepinostat with venetoclax has demonstrated highly synergistic effect, resulting in significant tumor size reduction.
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene collaboration):

Curis continues to enroll patients with relapsed or refractory non-Hodgkin lymphoma in a dose escalation study evaluating CA-4948, a first-in-class oral, small molecule IRAK4 kinase inhibitor. CA-4948 is designed to target cancers with MYD88 mutations in DLBCL and Waldenström’s macroglobulinemia.
Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene collaboration):

Patient treatment continues in the dose escalation study evaluating CA-170 in patients with advanced solid tumors or lymphomas.
Curis is working with select clinical sites to initiate a study of CA-170 in patients with mesothelioma, following evidence of mesothelioma tumor samples expressing high levels of VISTA. Recent publications have identified VISTA as a possible resistance mechanism to treatment with anti-PD1 antibodies in several cancer indications.
Curis collaborator Aurigene continues to enroll immunotherapy treatment-naïve patients in a clinical study of CA-170 at select trial sites in India.
Recent Corporate Highlights

In September, Curis announced change in leadership with the appointment of James Dentzer to the position of President and Chief Executive Officer.
In October, Curis implemented a 27% reduction in headcount and a re-allocation of pre-clinical resources to strengthen focus on clinical development. The Company expects the net result of expense reductions in pre-clinical R&D and G&A and targeted increases in clinical operations to result in a total cash burn reduction from approximately $11 million to $8 million per quarter going forward.
Upcoming Activities

Curis will provide an update on the dose escalation study of CA-170 at the annual SITC (Free SITC Whitepaper) conference in November.
2019 Data Catalysts

Curis expects to commence enrollment in a combination study evaluating a fimepinostat and venetoclax regimen in patients with R/R DLBCL, including patients with DH/DE Lymphoma, in the first half of 2019 and report initial data in the second half of 2019.
Curis expects to report initial data from an ongoing dose escalation study evaluating CA-4948 in patients with R/R DLBCL and WM, including patients with MYD88-altered disease, by mid-year 2019.
Curis expects to commence enrollment in a clinical study evaluating CA-170 in patients with mesothelioma (high VISTA expressors) in the first half of 2019 and report initial data in the second half of 2019.
Conference Call Information

Curis management will host a conference call today, November 1, 2018, at 8:30 a.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 (United States) or 1-412-317-5252 (International), shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section. A replay of the call will be available on the Curis website shortly after the commencement of the meeting

On November 1, 2018 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing monoclonal antibodies for the treatment of autoimmune disease, asthma and allergic diseases, and cancer, reported that initial data from its ongoing Phase 1 dose-escalation study of XmAb14045, a CD123 x CD3 bispecific antibody, in patients with relapsed/refractory acute myeloid leukemia (AML) will be presented in an oral session at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on Monday, December 3, 2018 (Press release, Xencor, NOV 1, 2018, View Source [SID1234530578]).

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Key Highlights from the Abstract

At data cut off on June 27, 2018, 63 patients with relapsed/refractory AML and one patient with B cell acute lymphoblastic leukemia had received XmAb14045. Patients had a median age of 61 years and were heavily pretreated, having a median of three prior therapies, and 30% (n=19/64) had undergone prior allogeneic stem cell transplantation.
No MTD was identified, and cytokine release syndrome (CRS) was the most common toxicity occurring in 49 of 64 patients (77%). Seven patients (11%) experienced Grade 3 or 4 CRS. CRS was generally manageable with premedication.
23% of evaluable patients with AML achieved either complete remission (CR) or CR with incomplete hematologic recovery (CRi) at the two highest dose levels studied to date (1.3 and 2.3 mcg/kg weekly; n=3/13).
Two patients with responses were bridged to stem cell transplantation, and the third was ineligible but remained in remission at 14+ weeks after initiating therapy.
"Initial results from the ongoing study of our lead bispecific antibody XmAb14045 in heavily pretreated patients with acute myeloid leukemia demonstrate that several patients achieved complete remissions," said Paul Foster, M.D., senior vice president and chief medical offer at Xencor. "XmAb14045 is a full-length immunoglobulin designed to be dosed intermittently. We continue to optimize dosing regimen as we advance the Phase 1 study."

Presentation Details

Abstract:

763

Title:

Complete Responses in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients on a Weekly Dosing Schedule of XmAb14045, a CD123 x CD3 T Cell-Engaging Bispecific Antibody: Initial Results of a Phase 1 Study

Presenter:

Farhad Ravandi, M.D., Professor of Medicine and Chief of Section of Developmental Therapeutics in the Department of Leukemia at the University of Texas – M.D. Anderson Cancer Center

Session:

616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Treatment Strategies

Date & Time:

Monday, December 3, 2018, 2:45 p.m. PST

Location:

Manchester Grand Hyatt San Diego, Seaport Ballroom F

The accepted abstract is now available on the ASH (Free ASH Whitepaper) conference website.

Analyst & Investor Event and Webcast Information
Xencor will host an analyst and investor event on Monday, December 3, 2018 from 8:00 to 10:00 p.m. PST with formal remarks at 8:30 p.m. PST. The event will feature a discussion of the data presented at ASH (Free ASH Whitepaper) and Xencor’s bispecific oncology pipeline. The event will be webcast live and can be accessed under Events & Presentations in the Investors section of www.xencor.com, where it will be archived for 30 days.

About XmAb14045
XmAb14045 is a tumor-targeted antibody that contains both a CD123 binding domain and a cytotoxic T-cell binding domain (CD3) in a Phase 1 clinical trial for the treatment of acute myeloid leukemia (AML) and other CD123-expressing hematologic malignancies. An XmAb Bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on XmAb14045. CD123 is highly expressed on AML cells and leukemic stem cells, and it is associated with poorer prognosis in AML patients. Engagement of CD3 by XmAb14045 activates T cells for highly potent and targeted killing of CD123-expressing tumor cells.

On November 1, 2018 ImmunSYS, Inc. reported that Chairman & CEO Eamonn Hobbs presented on October 31st at the 2018 NYC Oncology Investor Conference, held at Rockefeller Center in Manhattan (Press release, ImmunSYS, NOV 1,2018, View Source [SID1234577208]). ImmunSYS was one of 31 companies accepted to present to investors attending the conference.

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The NYC Oncology Investor Conference 2018 hosted by OneMed Forum, and sponsored by the National Foundation for Cancer Research, the International Cancer Impact Fund, Klosters Innovation Partners, Venable LLP, Torreya Partners, and Marcum is the leading conference for early-stage private and public cancer investing.

Meeting attendees included leading life science and oncology venture capitalists, family offices, lawyers, pharma executives, startup public and private cancer companies, and cancer foundations. The conference provides a forum for discussion of trends, opportunities, and risks in oncology investing, corporate presentations by a select group of public and private oncology companies, and updates on cutting edge science.

On November 1, 2018 GT Biopharma, Inc. (OTCQB: GTBP and Euronext Paris GTBP.PA) ("GT Biopharma" or the "Company"), an immuno-oncology biotechnology company focused on innovative treatments based on the company’s proprietary NK-engager and Bispecific Antibody Drug Conjugate platforms, reported that its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) is now open and it is authorized to initiate a first-in-human Phase 1 study with GTB-3550 (OXS-3550), its first-in-class (TriKE), for the treatment of acute myelogenous leukemia (AML), myelodysplatic syndrome (MDS) and mastocytosis (Press release, GT Biopharma , NOV 1, 2018, View Source [SID1234539521]). The study will be led by Principal Investigator, Sarah A. Cooley, MD, MS, Associate Professor, Division of Hematology, Oncology and Transplantation at Masonic Cancer Center, University of Minnesota.

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"GTB-3550 is a protein immune engager that binds to natural killer (NK) cells and targets them specifically to leukemia cells," said renowned NK cell expert, Jeffrey Miller, MD, Deputy Director, Masonic Cancer Center, University of Minnesota. "Our team has been working on the optimal construct for years and we are excited to see it is ready for clinical testing. In addition, the same TriKE protein will deliver an interleukin-15 stimulus, a growth factor that makes NK cells proliferate and be more active."

"The clinical trials team at the University of Minnesota is excited to commence the Phase 1 trial testing this novel immunotherapeutic agent, GTB-3550," said Dr. Cooley. "Building on over a decade of successful trials using NK cell infusions from related donors to kill tumors, Masonic Cancer Center researchers designed this protein to activate a patient’s own NK cells and, importantly, to direct them to specifically kill CD33+ tumor cells. The pre-clinical data are extraordinarily compelling, and success with GTB-3550 in this study will allow us to develop a broad pipeline of TriKE agents against different tumor targets."

This single center, first-in-human Phase 1 clinical trial of GTB-3550 will enroll up to 60 subjects with CD33-expressing high risk for refractory/relapsed AML, MDS, or advanced systemic mastocytosis. Subjects will receive a single course of GTB-3550 TriKE given as 3 weekly treatment blocks. Each block consists of four consecutive 24-hour continuous infusions of GTB-3550 TriKE followed by a 72-hour break after Block #1 and #2. Disease response will be assessed by bone marrow biopsy performed between Day 21 and Day 42 after the start of the 1st infusion. Follow-up for response and survival continues through 6 months from treatment start. The primary objective from the Phase 1 dose finding portion of the study will be to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE defined as the dose level that most closely corresponds to a dose limiting toxicity rate (DLT) of 20%. The primary objective from the Phase 2 extended portion of the study will be the potential efficacy of GTB-3550 TriKE, measured using rates of complete and partial remission. Subjects experiencing clinical benefit and no unacceptable side effects may be considered for a 2nd course of GTB-3550 TriKE on a compassionate basis.

"The opening of this IND allows us to proceed with our first-in-class TriKE, Phase 1 study and importantly, marks a significant step forward in our clinical development strategy of our potentially revolutionary product candidate," commented Raymond Urbanski, M.D., Ph.D., Chief Executive Officer of GT Biopharma. "We are privileged to be advancing this program with the world’s leading experts in NK cell-based therapy."

GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize cancer therapies using proprietary TriKE technology developed by researchers at the university to target NK cells to cancer.

About Acute Myelogenous Leukemia (AML)

AML is the most common form of adult leukemia with 21,000 new cases expected in 2018 alone, according to the American Cancer Society. AML patients typically receive frontline therapy, most commonly chemotherapy, which includes cytarabine and an anthracycline, a therapy that has not changed in over 40 years. However, there remains a significant unmet need in these therapies with about half of AML patients experiencing relapses or requiring alternative therapies. The Company is developing GTB-3550 to serve as a relatively safe, cost-effective, and easy-to-use therapy for resistant/relapsing AML and could also be combined with chemotherapy as frontline therapy thus targeting the larger patient population.

About Myelodysplastic Syndrome (MDS)

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become abnormal, leading to low numbers of one or more types of blood cells. There are several different types of MDS, based on how many types of blood cells are affected and other factors, although the most common finding in MDS is a shortage of red blood cells (anemia). The number of people with MDS diagnosed in the U.S. each year is estimated to be ~10,000. MDS is uncommon before age 50 and is most commonly diagnosed in people in their 70s. In about 1 in 3 patients, MDS can progress to AML, a rapidly growing cancer of bone marrow cells.

About Mastocytosis

Mastocytosis is a rare disorder characterized by abnormal accumulations of mast cells in the skin, bone marrow, and internal organs (liver, spleen, gastrointestinal tract and lymph nodes). Cases beginning during adulthood tend to be chronic and involve the bone marrow in addition to the skin, whereas, during childhood, the condition is often marked by skin manifestations with no internal organ involvement and can often resolve during puberty. In most adult patients, mastocytosis tends to be persistent, and may progress into a more advanced category in a minority of patients. Mastocytosis affects both males and females and can begin during childhood or adulthood. In children, 80% of cases appear during the first year of life, and the majority is limited to the skin. Adults who develop mastocytosis more often have systemic forms of the disease. Cutaneous forms of the disease account for less than 5% of adult cases. An estimate of prevalence from a recent population-based study is approximately 1 case per 10,000 people.

About GTB-3550

GTB-3550 (OXS-3550) is the Company’s first Tri-specific Killer Engager (TriKE) product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. When the NK stimulating cytokine human IL-15 is used as a crosslinker between the two scFvs, it provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study this anti-CD16-IL-15-anti-CD33 tri-specific killer engager, or TriKE, in CD33 positive leukemias, a marker expressed on tumor cells in AML, myelodysplastic syndrome, or MDS, and other hematopoietic malignancies. CD33 is primarily a myeloid differentiation antigen with endocytic properties broadly expressed on AML blasts and, possibly, some leukemic stem cells. CD33 or Siglec-3 (sialic acid binding Ig-like lectin 3, SIGLEC3, SIGLEC3, gp67, p67) is a transmembrane receptor expressed on cells of myeloid lineage. It is usually considered myeloid-specific, but it can also be found on some lymphoid cells. The anti-CD33 antibody fragment that will be used for these studies was derived from the M195 humanized anti-CD33 scFV and has been used in multiple human clinical studies. It has been exploited as target for therapeutic antibodies for many years. Improved survival seen in many patients when the antibody-drug conjugate gemtuzumab was added to conventional chemotherapy validates this approach. GT Biopharma believes that GTB-3550 could serve as a relatively safe, cost-effective, and easy-to-use therapy for resistant/relapsing AML and could also be combined with chemotherapy as frontline therapy thus targeting the larger patient population.