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 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that multiple abstracts highlighting its Antibody Radiation Conjugates (ARCs) have been accepted for presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, including an oral presentation of preliminary feasibility and safety results from its pivotal Phase 3 SIERRA trial of Iomab-B (Press release, Actinium Pharmaceuticals, NOV 1, 2018, View Source [SID1234530487]). The ASH (Free ASH Whitepaper) Annual Meeting is being held December 1 – 4, 2018 in San Diego, California. Data presented will highlight Actinium’s lead product candidate, Iomab-B, that is intended to be a targeted conditioning agent prior to a bone marrow transplant for patients with active relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55. Patients with active relapsed or refractory AML do not routinely undergo allogeneic bone marrow transplant due to a lack of efficacy using standard approaches and typically the survival of such patients without a transplant is less than six months.

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Iomab-B Oral Presentation Details
Abstract # 1017
Title: Targeted Conditioning of Iomab-B (131I-anti-CD45) Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Relapsed or Refractory Acute Myeloid Leukemia (AML): Preliminary Feasibility and Safety Results from the Prospective, Randomized Phase 3 Sierra Trial
Session Name: 721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Conditioning Intensity and Novel Approaches with Targeted therapy
Session Date: Monday, December 3, 2018
Presentation Time: 6:45 PM
Room: Manchester Grand Hyatt San Diego, Seaport Ballroom A
Presenter: Dr. Agura, Baylor University Medical Center
Results as of July 5, 2018

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "We are honored that results from our ongoing Phase 3 trial have been accepted for an oral presentation at this year’s ASH (Free ASH Whitepaper) annual meeting as approximately just ten percent of accepted abstracts receive this designation. Most importantly, patients with active, relapsed or refractory AML have severely restricted access to bone marrow transplant, the only potentially curative treatment option, so we are we are elated that the initial feasibility and safety data from SIERRA has demonstrated the ability to enable transplant and engraftment for not only all patients initially randomized to Iomab-B but also all those that crossed-over from the control arm when salvage chemotherapy failed to produce a complete response. Importantly, this occurred in patients with high blast counts as the median blast count was 30% and 47% in the Iomab-B arm and cross-over patients, respectively. We look forward to having our data presented at ASH (Free ASH Whitepaper), providing additional updates on this important trial as it progresses and completing the SIERRA trial with the goal of bringing this important targeted conditioning agent to patients with a significant unmet need."

Sandesh Seth, Actinium’s Chairman and Chief Executive Officer said, "We are delighted that data representing an important cross-section of our Antibody Radiation Conjugate pipeline will be featured at this year’s ASH (Free ASH Whitepaper), particularly the presentation highlighting preliminary results from the SIERRA trial for our lead targeted conditioning asset, Iomab-B. Recognizing that a bone marrow transplant is a potentially curative treatment option for many hematologic diseases, Actinium is focused on improving bone marrow transplant access and outcomes through improved targeted conditioning, which is currently underserved by chemotherapy. We are excited that the data presented in the various forums at ASH (Free ASH Whitepaper) will demonstrate the capabilities of our highly differentiated ARC approach for targeted conditioning that we believe is unmatched by other technologies or approaches. We are committed to continuing to expand our targeted conditioning pipeline as we have done with Actimab-MDS with the goal of building an independent fully integrated company."

Data from the Company’s CD33 program ARC, Ac-225 – Lintuzumab, and the recently completed Actimab-A Phase 2 trial from for patients newly diagnosed with AML who are unfit for intensive chemotherapy has been accepted for poster presentation. Actinium recently announced in a CD33 program update that, based on the results of the Phase 2 Actimab-A trial, Actinium is continuing to develop Ac-225 – Lintuzumab in two combination trials for patients with relapsed or refractory AML, one being with Venetoclax and the other being with Venetoclax and Hypomethylating agents. Ac-225 – Lintuzumab is also being studied in patients with multiple myeloma and as a targeted conditioning agent to enable a bone marrow transplant for patients with high-risk Myelodysplastic Syndrome.

Actimab-A Abstract Details
Abstract # 1457
TITLE: A Phase 2 Study of Actinium-225 (225Ac)-Lintuzumab in Older Patients with Untreated Acute Myeloid Leukemia (AML) – Interim Analysis of 1.5 µci/Kg/Dose
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I
Date: Saturday, December 1, 2018
Presentation Time: 6:15 PM – 8:15 PM
Location: San Diego Convention Center, Hall GH

Actinium also submitted preliminary data from its Iomab-ACT program for next generation targeted lymphodepletion prior to CAR-T therapy. This data will be published online coinciding with the start of the 2018 ASH (Free ASH Whitepaper) Annual Meeting.

On November 1, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that eight abstracts–including two oral presentations–on the Company’s lead product candidate rivo-cel (formerly BPX-501), in addition to an abstract on its controllable CAR program, were accepted for presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Bellicum Pharmaceuticals, NOV 1, 2018, View Source [SID1234530503]).

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Among the highlights will be late interim analyses from the BP-004 trial in children with acute leukemias and nonmalignant blood diseases, as well as the comparator C-004 trial—a multicenter, observational study of similar pediatric patients receiving a matched unrelated donor (MUD) transplant. As part of these interim analyses, the presentations will include the first reports of transplant Event-Free Survival at 180 days, the primary endpoint of the studies that will serve as the basis for MAA filing in Europe. In addition, longer term follow-up of disease outcomes from several patient subsets, including ALL, AML, thalassemia major, and Fanconi anemia, will be presented. Finally, the cumulative clinical experience of patients in BP-004 who received rimiducid to treat steroid refractory Graft-versus-Host-Disease will also be presented. ASH (Free ASH Whitepaper) 2018 is being held in San Diego, California on December 1-4.

RIVO-CEL PRESENTATION DETAILS

Poster Presentation: "Administration of BPX-501 Cells Following αβ T and B-Cell-Depleted HLA-Haploidentical HSCT (haplo-HSCT) in Children with Malignant or Non-Malignant Disorders"
Abstract Number: 2171
Session Name: 732. Clinical Allogeneic Transplantation: Results: Poster I
Session Date:Saturday, December 1, 2018
Presentation Time:6:15 p.m. – 8:15 p.m. PT

Oral Presentation: "Administration of BPX-501 Cells Following αβ T and B-Cell-Depleted HLA Haploidentical HSCT (haplo-HSCT) in Children with Acute Leukemias"
Abstract Number: 307
Session Name: 732. Clinical Allogeneic Transplantation: Results: Optimizing Outcomes After Allogeneic Transplantation
Session Date:Sunday, December 2, 2018
Session Time:7:30 a.m. – 9:00 a.m. PT
Presentation Time:7:30 a.m. PT

Oral Presentation: "Administration of BPX-501 Following αβ T and B-cell Depleted Haplo-HSCT in Children with Transfusion-Dependent Thalassemia"
Abstract Number: 166
Session Name: 112. Thalassemia and Globin Gene Regulation: Clinical
Session Date:Saturday, December 1, 2018
Session Time:2:00 p.m. – 3:30 p.m. PT
Presentation Time:2:45 p.m. PT

Poster Presentation: "Administration of Rimiducid Following Haploidentical BPX-501 Cells in Children with Malignant or Non-Malignant Disorders Who Develop Graft-versus-Host-Disease (GvHD)"
Abstract Number: 2207
Session Name: 801. Gene Therapy and Transfer: Poster I
Session Date:Saturday, December 1, 2018
Presentation Time:6:15 p.m. – 8:15 p.m. PT

Poster Presentation: "Characterization of Allogeneic T Cells Expressing Inducible Caspase-9 Following Adoptive Transfer in Children Receiving an HLA-Haploidentical Hematopoietic Stem Cell Transplant for the Treatment of Myeloid Malignancies"
Abstract Number: 4534
Session Name: 703. Adoptive Immunotherapy: Poster III
Session Date:Monday, December 3, 2018
Presentation Time:6:00 p.m. – 8:00 p.m. PT

Poster Presentation: "Differential Expression of Inducible Caspase-9 (iC9) in Allogeneic T cells Allows Selective Depletion of Activated T Cells Following Exposure to Rimiducid and Permits In Vivo Allodepletion"
Abstract Number: 3496
Session Name: 801. Gene Therapy and Transfer: Poster II
Session Date:Sunday, December 2, 2018
Presentation Time:6:00 p.m. – 8:00 p.m. PT

Poster Presentation: "Administration of BPX-501 Cells Following αβ T and B-Cell-Depleted HLA-Haploidentical HSCT in Children with Fanconi Anemia"
Abstract Number: 4654
Session Name: 732. Clinical Allogeneic Transplantation: Results: Poster III
Session Date:Monday, December 3, 2018
Presentation Time:6:00 p.m. – 8:00 p.m. PT

Poster Presentation: "A Simplified Method for Transduction and Expansion of T Cells for Clinical Application"
Abstract Number: 4555
Session Name: 711. Cell Collection and Processing: Poster III
Session Date:Monday, December 3, 2018
Presentation Time:6:00 p.m. – 8:00 p.m. PT

CONTROLLABLE CAR PRESENTATION DETAILS

Poster Presentation: "Regulated Natural Killer Cell Expansion and Anti-Tumor Activity with Inducible MyD88/CD40"
Abstract Number: 4550
Session Name: 703. Adoptive Immunotherapy: Poster III
Session Date:Monday, December 3, 2018
Presentation Time: 6:00 p.m. – 8:00 p.m. PT

On November 1, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that it will announce financial results for the third quarter ended September 30, 2018 on November 8, 2018 before the Nasdaq market open (Press release, Loxo Oncology, NOV 1, 2018, View Source [SID1234530519]). At 8:00 a.m. ET that day, Loxo Oncology management will host a conference call to discuss these financial results, in addition to recent updates on development and corporate activities.

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A live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the company’s website at www.loxooncology.com. The conference call can be accessed by dialing (877) 930-8065 (domestic) or (253) 336-8041 (international) and referring to conference ID 8379404. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.