On November 1, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the third quarter ended September 30, 2018, and provided a business update (Press release, Corvus Pharmaceuticals, NOV 1, 2018, View Source [SID1234530625]).

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"We continue to make significant progress in the clinic both with CPI-444 and with CPI-006," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are encouraged by ongoing presentation of data related to both programs at medical meetings and in peer-reviewed journals. This includes biomarker data for CPI-444 that our team presented at the ESMO (Free ESMO Whitepaper) 2018 Congress on October 22, 2018. We also are looking forward to presenting additional new clinical and biomarker data for both programs at the SITC (Free SITC Whitepaper) annual meeting on November 9 and 10, 2018. Our progress continues to demonstrate that we are a leader in designing and developing medicines that modulate the adenosine pathway and that have demonstrated efficacy as monotherapies and in combination with other agents. We are also advancing our ITK inhibitor, CPI-818, toward the clinic and expect to initiate a clinical trial in early 2019."

Recent Achievements
CPI-444: A2A Receptor Antagonist of Adenosine

Continued enrollment of up to 50 patients with renal cell cancer (RCC) in an amended Phase 1/1b clinical trial evaluating CPI-444, the Company’s lead product candidate, administered alone and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. Patients in the study have failed no more than two prior treatment regimens, which must have included an anti-PD-(L)1 and a tyrosine kinase inhibitor, compared to having failed up to five (median three) prior treatment regimens in prior CPI-444 studies.
Continued enrollment of up to 60 patients with non-small cell lung cancer (NSCLC) in a Phase 1b/2 trial being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating CPI-444 and Tecentriq in patients who have failed no more than two prior regimens.
CPI-444 preclinical study results were published in and featured on the cover of the October issue of the journal Cancer Immunology Research, which is an official journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The results demonstrated that CPI-444 induces dose dependent anti-tumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies.
Presented new data on the "adenosine gene signature," a biomarker associated with patient response to therapy with CPI-444, in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress.
CPI-006: Anti-CD73 Antibody

Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with CPI-444, and in combination with an anti-PD-1. The trial is designed to select the dose and evaluate the safety, pharmacokinetics, immune biomarkers and efficacy in patients with NSCLC, RCC, and other cancers who have failed standard therapies.
CPI-818: A small molecule ITK inhibitor

Plan to submit an Investigational New Drug (IND) filing for CPI-818, the Company’s interleukin-2-inducible kinase (ITK) inhibitor, in early 2019.
Preclinical data on CPI-818 to be presented by Douglas H. Thamm, VMD, DACVIM (Oncology) at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium, November 13 through 16, 2018 in Dublin, Ireland.
Financial Results

As of September 30, 2018, Corvus had cash, cash equivalents and marketable securities totaling $122.6 million. This compared to cash, cash equivalents and marketable securities of $90.1 million at December 31, 2017.

Research and development expenses for the three months ended September 30, 2018 totaled $8.4 million compared to $10.7 million for the same period in 2017. The decrease of $2.3 million was primarily due to a decrease in CPI-444 clinical trial expenses.

General and administrative expenses for the three months ended June 30, 2018 totaled $2.8 million compared to $2.2 million for the same period in 2017. The increase of $0.6 million was primarily due to an increase of $0.3 million in patent and public company expenses, and an increase of $0.2 million in personnel costs.

The net loss for the three months ended September 30, 2018 was $10.5 million compared to $12.7 million for the same period in 2017. Total stock compensation expense for the three months ended September 30, 2018 was $1.8 million compared to $1.5 million for the same period in 2017.

On November 1, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that members of the management team will participate at the following upcoming investor conferences (Press release, Arcus Biosciences, NOV 1, 2018, View Source [SID1234530658]):

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Credit Suisse 27th Annual Healthcare Conference in Scottsdale, AZ on Tuesday, November 13, 2018, at 4:35 pm MT.
Piper Jaffray 30th Annual Healthcare Conference in New York City, NY on Tuesday, November 27, 2018, at 3:50 pm ET.
Evercore ISI HealthCONx in Boston, MA on Wednesday, November 28, 2018, at 10:15 am ET.
To access the live audio webcast of the presentations, please visit the "Events & Presentations" section of the Arcus website at View Source A replay of the webcast will be available for 30 days following the live event.

On November 1, 2018 Ceylad presented a Corporate Presentation (Presentation, Celyad, NOV 1, 2018, View Source(1).pdf [SID1234532502]).

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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.

On November 1, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) reported the presentation of data on its investigational hemato-oncological drug candidates MOR208 and MOR202 at the upcoming 60th American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting, taking place from December 1-4, 2018 in San Diego, California (Press release, MorphoSys, NOV 1, 2018, View Source [SID1234530482]). All three abstracts submitted to ASH (Free ASH Whitepaper) 2018 were accepted, resulting in two oral and one poster presentation.

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"This year’s ASH (Free ASH Whitepaper) Meeting will see a number of important updates from our investigational compounds in various blood cancer indications," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "We are particularly excited that we have been selected to present updated preliminary results on all 81 enrolled patients in the L-MIND study, in an oral presentation at ASH (Free ASH Whitepaper). This study is designed to evaluate efficacy and safety of our Fc-enhanced CD19 antibody MOR208 in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL). Based on the U.S. FDA breakthrough therapy designation received last year, we are committed to developing MOR208 plus lenalidomide as a new treatment option for patients with r/r DLBCL, where there is a particularly high unmet medical need."

Details about MorphoSys’s abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2018:

Single-Arm Phase II Study of MOR208 Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: L-Mind

The oral presentation will include clinical data from all 81 patients enrolled in the ongoing phase 2 L-MIND study of the investigational Fc-enhanced CD19 antibody MOR208 plus lenalidomide in adult patients with r/r DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).

Abstract publication number: 227
Session name: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)-Results from Prospective Clinical Trials"
Session date and time: Saturday, December 1, 2018, 4:00pm-5:30pm PST
Presentation time: 5:00pm PST
Room: Marriot Marquis San Diego Marina, Pacific Ballroom 20, San Diego, California.

Two-Cohort Phase II Study in R/R CLL (COSMOS): First Preliminary Safety and Efficacy Results of anti-CD19 MOR208 Treatment in Combination with Venetoclax in Patients Who Discontinued Prior BTK Inhibitor Therapy

The poster presentation will include preliminary safety and efficacy results from the phase 2 trial COSMOS of the investigational Fc-engineered CD19 antibody MOR208 in combination with venetoclax in patients with relapsed/refractory CLL/SLL who discontinued a prior BTK inhibitor therapy.

Abstract publication number: 4433
Session name: 642. CLL: Therapy, excluding Transplantation: Poster III
Presentation date and time: Monday, December 3, 2018, 6:00pm-8:00pm PST
Location: San Diego Convention Center, Hall GH, San Diego, California.

MOR202 with Low-Dose Dexamethasone (Dex) or Pomalidomide/Dex or Lenalidomide/Dex in Relapsed or Refractory Multiple Myeloma (RRMM): Primary Analysis of a Phase I/IIa, Multicenter, Dose-Escalation Study

The oral presentation will include results from the phase 1/2a trial of the investigational CD38 antibody MOR202 alone, MOR202 in combination with pomalidomide and MOR202 in combination with lenalidomide, each together with low-dose dexamethasone, in relapsed/refractory multiple myeloma (MM).

Abstract publication number: 153
Session name: 653. Myeloma: Therapy, excluding Transplantation: Novel Antibody Combinations in Myeloma
Session date and time: Saturday, December 1, 2018, 12:00pm-1:30pm PST
Presentation Time: 12:30 pm PST
Room: Marriot Marquis San Diego Marina, Pacific Ballroom 7, San Diego, California.

In addition to the presentations, the abstracts will also be published online in the November supplemental issue of Blood. Additional information, including the abstracts can be found in the online meeting program at www.hematology.org.

MorphoSys will hold an investor & analyst event after the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2018 on December 5, 2018, 10:00am EST (3:00pm GMT, 4:00pm CET) in New York. The presentation, a live webcast and a replay of the webcast will be made available at View Source