On December 3, 2019 Kyn Therapeutics, a clinical-stage biotechnology company, reported it is rebranding to Ikena Oncology (Press release, KYN Therapeutics, DEC 3, 2019, View Source [SID1234551888]). The rebranding reflects the evolution of the Company beyond its continued achievements in immuno-metabolism, as well as its renewed commitment to biomarker-driven oncology drug development. The rebranding is accompanied by announcement of the clearance by the U.S. Food and Drug Administration (FDA) of the Company’s investigational new drug (IND) application for IK-175, a small molecule antagonist of AHR. In addition, Ikena unveiled a new discovery program aimed at modulating the Hippo signaling pathway for treatment of cancer. Ikena has five development and discovery programs with multiple clinical and regulatory milestones expected in 2020, including report of preliminary clinical data on its lead program IK-007, an EP4 antagonist.

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Mark Manfredi, Ph.D., President and Chief Executive Officer of Ikena Oncology, commented, "Ikena Oncology represents the growth and evolution of our vision, strategy, capabilities and values. We look forward to leveraging these drivers to build on our efforts to become an industry leader in novel therapeutics for patients battling cancer."

The new name "Ikena" is derived from the combination of "i" which refers to the individual patient and "ken" which means knowledge, thereby illustrating the Company’s focus on using its insights to identify patients most likely to benefit from its therapies.

Advancement and Expansion of Development Pipeline

The expanded Ikena Oncology development pipeline is composed of patient-directed programs addressing distinct molecular targets and biologic pathways within and outside of immuno-metabolism, including immunotherapies and tumor cell intrinsic product candidates:

IK-007: A highly selective, first-in-class, oral EP4 receptor antagonist targeting the prostaglandin E2 (PGE2) immunosuppressive signaling pathway. IK-007 (formerly ARY-007) is being investigated in two ongoing Phase 1b/2 studies in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with advanced or progressive microsatellite stable colorectal cancer (MSS CRC) and in patients with advanced or metastatic PD-1/L-1 refractory non-small cell lung cancer (NSCLC). Ikena is employing a robust, biomarker strategy by analyzing blood, tumor and urine biomarkers relevant to T cell checkpoint inhibitors and EP4 signaling. Ikena expects to report preliminary data in 2020.
IK-175: A selective oral AHR antagonist which prevents AHR-modulated tumor promotion through its influence on both the tumor and the immune system. The Company’s recently FDA-cleared IND enables the commencement of a first-in-human clinical study in which the anti-tumor activity of IK-175 (formerly KYN-175) will be evaluated as a single agent, and in combination with other therapies, in cancers with activated AHR. Ikena expects to initiate a clinical study evaluating IK-175 in early 2020. Ikena is employing a multi-assay AHR activation biomarker strategy to select lead cancer indications and enable prospective selection of patients believed most likely to benefit from IK-175. A patent application with claims directed to IK-175 has been deemed allowed by the United States Patent and Trademark Office. The AHR antagonist program is the subject of a global strategic collaboration with Celgene, now Bristol-Myers Squibb.
IK-412: A highly potent and stable kynurenine-degrading enzyme (or "Kynase") that may be able to overcome resistance to immune modulating agents. Ikena expects to file an IND for IK-412 (formerly KYN-412) in the second half of 2020. The first-in-human clinical study will be focused on patients with cancers that express high IDO1/TDO2. IK-412 is the subject of a global strategic collaboration with Bristol-Myers Squibb.
Hippo Program: The Hippo signaling pathway is a key tumor suppressor axis with tumor cell intrinsic dependence and immune system mechanisms of action. It is highly mutated in several cancer types, providing a streamlined path to clinical proof-of-concept. For example, there is a high prevalence of NF2 loss of function mutations in mesothelioma and LATS1/2 in bladder and renal cancers. Currently in the lead optimization stage, Ikena expects to identify a development candidate during the second half of 2020.
"As we launch our new corporate identity, we anticipate an exciting 2020 that includes multiple clinical and regulatory milestones. We are encouraged by the ongoing studies investigating IK-007 in combination with Keytruda in patients with MSS CRC and PD-1/L-1 refractory NSCLC, and look forward to continuing enrollment. Moreover, we aim to advance IK-175 into the clinic, file an IND for IK-412, and identify a development candidate for the Hippo program," concluded Dr. Manfredi.

The Company’s website is now available at IkenaOncology.com.

On December 3, 2019 QBiotics Group Limited (QGL), a life sciences company developing novel anticancer and wound healing pharmaceuticals, reported that it has dosed its first patient in a Phase I/II clinical trial evaluating the optimal dosing and safety of its lead product, tigilanol tiglate, in patients with head and neck squamous cell carcinoma (HNSCC) (Press release, QBiotics, DEC 3, 2019, View Source [SID1234551905]).

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Dr Victoria Gordon, Managing Director and CEO of QBiotics, said, "We are delighted to announce the treatment of our first patient in our multi-site clinical study, which includes trial sites in Australia and India. Cancers of the head and neck rank as the sixth most common cancer diagnosed worldwide[1] with more than 2 million[2] new cases each year. The high rate of HNSCC is largely driven by tobacco use, and increased infection with human papillomavirus (HPV)."

Dr Gordon continued, "This study marks an important advancement for QBiotics’ oncology pharmaceutical. It follows our successful first-in-man QBC46-H01 study[3] in a range of solid tumours, which demonstrated patients with squamous cell carcinoma, the most common type of head and neck cancer, had encouraging tumour responses when treated with tigilanol tiglate."

Surgery and radiotherapy are currently the primary local treatments for HNSCC. However, these treatments can come with challenges such as damage to healthy tissue and impacting a person’s ability to breathe, hear, see, smell, swallow or taste as well as adversely affecting appearance. Better local therapies are therefore needed. Direct intratumoural injection with tigilanol tiglate may offer advantages as it directly targets tumour cells and reaches infiltrating cancer cells that can be missed by surgery. This approach limits exposure and damage to surrounding healthy tissues, reducing the risk of functional or cosmetic impairment. Intratumoural injection also offers the potential for reduced toxicity due to localised (target site) treatment, compared to systemic toxicity induced by chemotherapeutic agents.

The Phase I/II open label "QBC46-H03" study, is a dose escalation study in patients with HNSCC aimed at determining the maximum tolerated dose (MTD) and recommended dose level for further studies. The study will also investigate safety, tolerability and tumour response following a single or multiple (two to three) doses of tigilanol tiglate. It will enrol up to 40 patients from the Tata Medical Centre in Kolkata, the Tata Memorial Hospital in Mumbai, the Princess Alexandra Hospital in Brisbane, and other clinical sites in Australia.

On December 3, 2019 Genomic Testing Cooperative, LCA (GTC) reported that they will be presenting data on their proprietary AI-based algorithms and RNA and DNA testing at the American Association of Hematology (ASH) (Free ASH Whitepaper) annual meeting (Press release, Genomic Testing Cooperative, DEC 3, 2019, View Source [SID1234553223]). In collaboration with multiple academic centers, GTC developed new approaches for the classification of diseases and prediction of response to combination therapy.

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Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer, stated "Cancer is complex disease and requires complex biomarkers for predicting its behavior. RNA Sequencing provides a wealth of information that can be used for predicting clinical course and response to combination therapy. RNA sequencing data, when combined with mathematical algorithms, can provide reliable means to manage and treat cancer. GTC is committed to be the leader in innovation in developing molecular biomarkers to help physicians select the proper combination therapy for their patients."

Highlights of GTC presentations include:
-Targeted next generation sequencing (NGS) of RNA is reliable and practical for routine clinical testing.

-RNA sequencing data when used with AI or Bayesian statistics can provide powerful means for predicting clinical behavior and response to combination therapy

-Testing for mutations using RNA may provide a new paradigm for better characterizing and monitoring of cancers

-Liquid biopsy provides important clinical information in patients with acute myeloid leukemia.

The following is a list of studies that will be presented by GTC and its collaborators at ASH (Free ASH Whitepaper):
1) 2891-Title: "Cell of Origin Classification of DLBCL Using Targeted NGS Expression Profiling and Deep Learning"

Collaborators: University of Texas MD Anderson Cancer Center, Houston, TX; University of California, Irvine, CA; University Hospital Basel, Basel, Switzerland; University of Verona, Verona, Italy; Columbia University Medical Center, New York, NY; Aalborg University Hospital, Aalborg, Denmark; Well Cornell Medical College, New York, NY; Cleveland Clinic, Cleveland, OH; San Raffaele Scientific Institute, Milano, Italy; San Raffaele Hospital, Milan, Italy; Odense University Hospital, Odense, Denmark; Instituto de Investigación Marqués De Valdecilla, Santander, Spain; University Hospital Nijmegen, Nijmegen, NLD; Houston Methodist Hospital, Houston, TX; Lerner Research Institute, Cleveland Clinic, Cleveland, OH.

2) 2730-Title: "Higher Stability of Mutant IDH1/2 mRNA As Compared to Wild-Type mRNA in Patients with Acute Myeloid Leukemia"

Collaborators: Departments of Leukemia, Stem Cell Transplantation, and Hematopathology, UT MD Anderson Cancer Center, Houston, TX

3) 1314-Title: "Expression Profiling of mRNA By Next Generation Sequencing and the Development of Algorithm for Predicting Response in Acute Myeloid Leukemia"

Collaborators: Department of Computer Science, Georgia Southern University, Savannah, Georgia;
Departments of Leukemia, Stem Cell Transplantation, and Hematopathology, UT MD Anderson Cancer Center, Houston, TX

4) 1499-Title: Higher Stability of Mutant mRNA As Compared to Wild-Type mRNA in Diffuse Large B-Cell Lymphoma

Collaborators: University of Texas MD Anderson Cancer Center, Houston, TX; University of California, Irvine, CA; University Hospital Basel, Basel, Switzerland; University of Verona, Verona, Italy; Columbia University Medical Center, New York, NY; Aalborg University Hospital, Aalborg, Denmark; Well Cornell Medical College, New York, NY; Cleveland Clinic, Cleveland, OH; San Raffaele Scientific Institute, Milano, Italy; San Raffaele Hospital, Milan, Italy; Odense University Hospital, Odense, Denmark; Instituto de Investigación Marqués De Valdecilla, Santander, Spain; University Hospital Nijmegen, Nijmegen, NLD; Houston Methodist Hospital, Houston, TX; Lerner Research Institute, Cleveland Clinic, Cleveland, OH.

5) 2592-Title: Sequencing of Circulating Cell-Free DNA in Patients with AML Detects Clinically Significant Mutations Not Detected in Bone Marrow: The Role for Complementary Peripheral Blood and Bone Marrow Genomic Analysis

Collaborators: Departments of Leukemia, Genomic, and Hematopathology, UT MD Anderson Cancer Center, Houston, TX.

On December 3, 2019 FORMA Therapeutics Inc., a clinical stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported that the company will present at two meetings in December (Press release, Forma Therapeutics, DEC 3, 2019, View Source [SID1234551872]):

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31st Annual Piper Jaffray Healthcare Conference, Thursday, Dec. 5, 2019 at 8:10 a.m. EST in New York, NY.
FORMA Investor Lunch at the 2019 ASH (Free ASH Whitepaper) Annual Meeting, Monday, Dec. 9, 2019 at 12:00 p.m. EST at the Hilton Orlando. Presentations will highlight FT-4202, a novel, selective pyruvate kinase-R (PKR) activator in sickle cell disease, and olutasidenib, an IDH1m inhibitor that acts as a single agent or in combination with azacitidine in acute myeloid leukemia (AML) and myelodysplastic syndrome. This event will be webcast and can be accessed through FORMA Therapeutics Investor page. A replay of the webcast will be available approximately two hours after the completion of the live event.

On December 3, 2019 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T-cell therapies to treat cancers, reported that new clinical data from its first-in-human study of ET019003, an anti-CD19 T-cell therapy for relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL), will be presented in a poster session at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 8, 2019 (Press release, Eureka Therapeutics, DEC 3, 2019, View Source [SID1234551889]). ET019003 is engineered by incorporating a co-stimulatory molecule into T-cells expressing an anti-CD19 antibody T-cell receptor (AbTCR) core structure, representing the next generation of Eureka’s novel T-cell therapy generated with the ARTEMIS T-cell platform.

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"We are excited to be selected for poster presentation at the 2019 ASH (Free ASH Whitepaper) Meeting," said Dr. Cheng Liu, Founder & CEO of Eureka Therapeutics. "This is significant recognition of the progress we are making in the development of novel T cell therapies from our ARTEMIS platform, and we look forward to sharing additional updates from our additional programs at the conference."

Details of the poster presentation are as follows:

Title:

First-in-Human Study of ET019003, a Next Generation Anti-CD19 T-Cell Therapy, in Patients with Relapsed/Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)

Publication:

2870

Session:

626

Date:

Sunday, December 8, 2019

Time:

6:00 – 8:00pm EST

Location:

Orange County Convention Center, Hall B

Presenter:

Pengcheng He, the First Affiliated Hospital of Xi’an Jiaotong University, China

The ASH (Free ASH Whitepaper) abstract is now available at www.hematology.org. The poster presentation will include additional data not available in the abstract.