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Cellerant Therapeutics, Inc. to Present Results of Phase 2 Clinical Trial of CLT-008 at American Society of Clinical Oncology (ASCO) 2018 Annual Meeting and European Hematology Association (EHA) 23rd Congress

On May 17, 2018 Cellerant Therapeutics, Inc., a clinical-stage company developing innovative immunotherapies for hematologic malignancies and other blood-related disorders, reported that investigators from Cellerant’s recently completed Phase 2 clinical trial of CLT-008 (romyelocel-L, human myeloid progenitor cells) will present key study results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago, June 1-5, 2018, and at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, June 14-17, 2018 (Press release, Cellerant Therapeutics, MAY 17, 2018, View Source [SID1234526782]).

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Cellerant is developing CLT-008, a universal, off-the-shelf cell therapy intended to prevent infections during neutropenia. Neutropenia is a serious side effect of myelosuppressive chemotherapy that leaves patients at high risk of serious, potentially life-threatening infections, leading to prolonged hospitalization and often reduced or delayed treatment doses. The Company conducted a randomized, controlled Phase 2 study of CLT-008 in patients newly diagnosed with acute myeloid leukemia (AML) who received induction chemotherapy.

"AML patients who undergo induction chemotherapy suffer severe and prolonged neutropenia, and the results from this study show significantly reduced infections in the CLT-008 group relative to control," said Ram Mandalam, Ph.D., CEO of Cellerant Therapeutics. "This product addresses a serious unmet need in AML patients. We are excited to present the study results at these two important medical meetings, and look forward to advancing CLT-008 to a Phase 3 study."

Presentation details are as follows:

ASCO Abstract #7043: Abboud, et al., A randomized controlled open label exploratory trial of CLT-008 myeloid progenitor cells (MPC) to decrease infections during induction for AML. Poster discussion on June 4, 2018, 8:00-11:30am CDT. Presenting author: Farhad Ravandi, M.D., Janiece and Stephen A. Lasher Professor of Medicine, University of Texas MD Anderson Cancer Center.

EHA Abstract #1405: Desai, et al., Decreased incidence of infection, use of antibacterials and days in hospital after administration of CLT-008 myeloid progenitor cells to subjects receiving AML induction therapy: Phase 2 Study Results. Oral presentation on June 16, 2018, 4:45-5:00pm CEST. Presenting author: Pinkal Desai, M.D., M.P.H., Assistant Professor of Medicine, Weill Cornell Medicine, New York.

TP Therapeutics Announces Phase 1 Data of Ropotrectinib (TPX-0005) to be Presented at the Annual American Society of Clinical Oncology Meeting

On May 17, 2018 TP Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company developing oncology therapies with a focus on addressing current drug resistance, reported that the Phase 1 data from the ongoing TRIDENT-1 Study of Ropotrectinib (TPX-0005) has been accepted for poster presentation and discussion on June 4 at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, TP Therapeutics, MAY 17, 2018, View Source [SID1234526781]).

TP Therapeutics Announces Phase 1 Data of Ropotrectinib (TPX-0005) to be Presented at the Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting

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The presentation is entitled "A phase 1 study of the next-generation ALK/ROS1/TRK inhibitor Ropotrectinib (TPX-0005) in patients with advanced ALK/ROS1/NTRK+ cancers (TRIDENT-1)".

The schedule for the poster display and discussion is as follows:

Poster Discussion
Time: 6/4/2018, 3:00 PM-4:15 PM

Title: A phase 1 study of the next-generation ALK/ROS1/TRK inhibitor Ropotrectinib (TPX-0005) in patients with advanced ALK/ROS1/NTRK+ cancers (TRIDENT-1)
Abstract Number: 2513
Session Title: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Location: S406
Discussant: Valentina Boni, MD, PhD, START Madrid CIOCC Hospital Universitario Sanchinarro

Poster Display Information: Monday, June 4, 2018, 8:00-11:30 am
Location: Hall A
Lead author: Alexander Drilon, MD, Memorial Sloan Kettering Cancer Center

About Ropotrectinib (TPX-0005)

Ropotrectinib (TPX-0005) is a potent and orally bioavailable investigational small molecule kinase inhibitor for ALK, ROS1, and TRK family. The clinical benefits of targeting ALK, ROS1, or TRK fusion kinase have been demonstrated with multiple kinase inhibitors already approved for the treatment of ALK+ non-small cell lung cancer (NSCLC), in addition to crizotinib for ROS1+ NSCLC, and larotrectinib and entrectinib in clinical studies for TRK+ cancers. The successes of these therapies are overshadowed by the development of acquired resistance. The acquired solvent front mutations including ALK G1202R, ROS1 G2032R, TRKA G595R and TRKC G623R render a common clinical resistance to the current ALK, ROS1, and TRK inhibitors. TPX-0005 is a potent kinase inhibitor against wildtype and mutated ALK, ROS1 and TRK family kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple line treatments. Ropotrectinib may provide new opportunities in the clinic to inhibit the abnormal signaling of ALK, ROS1, or TRK family in solid malignancies, and overcome resistance seen in refractory patients. TPX-0005 is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1, NCT03093116). For additional information about ropotrectinib trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can also contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email [email protected].

Obsidian Presents Preclinical Data at ASGCT Showing Advancement of its Regulated IL12 and IL15 Programs to Enable Safer and More Effective CAR-T Therapies

On May 17, 2018 Obsidian Therapeutics, Inc., a biotechnology company dedicated to the development of next-generation cell and gene therapies with pharmacologic operating systems, reported that the company presented preclinical data on its regulated IL12 and IL15 programs at the Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in Chicago, IL (Press release, Obsidian Therapeutics, MAY 17, 2018, View Source [SID1234526779]).

Obsidian is developing CAR-T therapies that incorporate Destabilizing Domains (DDs) to regulate expression of immune cytokines, thereby providing pharmacologic control over these potent but potentially toxic molecules. DDs are small, fully-human protein domains that confer conditional stability to a fused payload protein that is engineered into a cell or gene therapy product. IL12 and IL15 are two important immune cytokines that play important roles in tumor response to adoptive cell therapy but which require precise control to optimize their therapeutic benefit.

"IL12 and IL15 are critical factors that promote CAR-T cell expansion, persistence, and penetration into solid tumors," said Vipin Suri, Ph.D., Vice President of Discovery of Obsidian. "However, unregulated expression of these cytokines by CAR-T or other adoptively-transferred cells can potentially compromise safety and efficacy. Obsidian’s technology allows the treating physician to control expression of IL12 and IL15 via the use of safe, FDA-approved small-molecule drugs, and the preclinical data we present today demonstrate the elegance and effectiveness of this approach."

Highlights of the two preclinical presentations follow:

Abstract number 113: Exogenous In Vitro and In Vivo Regulation of Interleukin-12 Secretion from T Cells Using Destabilizing Domain Technology
Presenter: Dexue Sun

Session: Cancer – Immunotherapy, Cancer Vaccines I

Construction of a single-chain regulated IL12 using a DD derived from FKBP
Demonstration of small molecule-regulated expression of IL12 in a variety of cell types including primary human T cells
Use of different promoters to tune expression level of the regulated cytokine
Demonstration of in vivo regulation of IL12 in adoptively transferred T cells
Development of a CD19 CAR construct co-expressing regulated IL12, with in vitro data showing effective performance of the regulated cytokine cassette
Abstract number 133: Dose dependent exogenous regulation of membrane bound Interleukin-15-Interleukin-15 receptor alpha fusion protein for adoptive T-cell therapy
Presenter: Christopher Reardon
Session: Cancer – Targeted Gene & Cell Therapy I

Design of regulated membrane-bound IL15-IL15 Receptor Alpha (mbIL15) fusion construct incorporating DDs for pharmacologic control with small molecule ligands
Construction of mbIL15-DD construct incorporating human DDs, regulated by FDA-approved small-molecule drugs
Dose- and time-dependent regulation of mbIL15 expression in multiple cell types
Regulation of mbIL15 expression on primary human T cells in vivo
About Destabilizing Domains

Obsidian uses Destabilizing Domains (DDs) to enable pharmacologic regulation of protein activity for next-generation cell and gene therapies. Obsidian’s DDs are small, fully-human protein domains that confer conditional stability to a fused payload protein. In the absence of a specific small-molecule ligand, the fusion protein is rapidly degraded, whereas in the presence of the ligand, the fusion protein becomes stable and functional. Obsidian uses this approach to equip engineered cells with controllable functions that can be precisely tuned by the administration of non-immunosuppressive, small-molecule medicines that are readily available and dispensed by the treating physician.

Alexo Therapeutics Initiates ALX148 Clinical Trial Combination Cohorts for the Treatment of Patients with Advanced Solid Tumors and Lymphoma

On May 17, 2018 Alexo Therapeutics, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported it has initiated ALX148 combination dosing with targeted antibody therapies in its Phase 1 clinical program in patients with advanced solid tumors and lymphoma (Press release, Alexo Therapeutics, MAY 17, 2018, View Source [SID1234526778]). The Company will present updated data on ALX148 at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

Poster Presentation Information
Title: A Phase 1 Study of ALX148, a CD47 Blocker, Alone and in Combination with Established Anti-Cancer Antibodies in Patients with Advanced Malignancy and Non-Hodgkin Lymphoma
Session Name: Developmental Therapeutics-Immunotherapy
Session Date: June 04, 2018
Presentation Time: 8:00am – 11:30am CT
Abstract Number: 3068

"The initiation of ALX148 combination cohorts marks the next important milestone in Alexo’s development," said Sophia Randolph M.D., Ph.D., Chief Medical Officer of Alexo Therapeutics. "ALX148 is designed to enhance the efficacy of antibody-based therapies, while avoiding the dose-limiting toxicities that have been seen with other CD47-targeted approaches in the clinic. ALX148 is generally well tolerated in patients with advanced tumors and exhibits favorable pharmacokinetics and CD47 target occupancy at doses evaluated. No maximum tolerated dose of ALX148 was reached. With broad therapeutic potential across many types of cancer, we are eager to now be evaluating ALX148 in combination with select anti-cancer therapeutic antibodies."

The ALX148 Phase 1 clinical trial is a two-part study that evaluates the safety, pharmacokinetics, and pharmacodynamics of ALX148. Enrollment to the single-agent dose escalation phase is complete and the combination therapy portion in which ALX148 is administered with approved anti-cancer antibodies is ongoing. Clinical data will be presented at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting. For more information about the Phase 1 study, please visit clinicaltrials.gov, identifier number NCT03013218.

About ALX148
ALX148 is a fusion protein comprised of an engineered high affinity CD47 binding domain of SIRPα linked to an inactive Fc region of human immunoglobulin. ALX148 potently and specifically binds CD47 and blocks its interaction with SIRPα, thus inhibiting a key immune checkpoint mechanism exploited by cancer cells. In preclinical studies, ALX148 bridges innate and adaptive immunity to enhance anti-tumor response in combination with targeted anti-cancer antibodies and checkpoint inhibitors with no adverse effect on CD47-expressing normal blood cells. ALX148 is currently being investigated in a Phase 1 study in combination with checkpoint inhibitors and targeted anti-cancer antibodies (NCT03013218)

Protagonist Therapeutics Announces Two Oral Presentations Accepted for 23rd Congress of the European Hematology Association

On May 17, 2018 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) reported that clinical and preclinical abstracts for PTG-300, the Company’s injectable hepcidin mimetic in development for treatment of anemia and iron overload in rare blood disorders, have been accepted for oral presentations at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (Press release, Protagonist, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349672 [SID1234526777]). The Annual Congress of EHA (Free EHA Whitepaper), a flagship meeting with 11,000 participants that encompasses the entire spectrum of hematological diseases, takes place in Stockholm, Sweden, June 14-17, 2018.

Protagonist Therapeutics, Inc. (PRNewsFoto/Protagonist Therapeutics, Inc.)

The details of the oral presentations are as follows:

Presentation Title: Hepcidin mimetic PTG-300 for treatment of ineffective erythropoiesis and chronic anemia in hemoglobinopathy diseases
Date and Time: Saturday, June 16 from 11:45 AM to 12:00 PM CEST
Session: Thalassemias
Location: Stockholm International Fairs Convention Center, Room K2

Presentation Title: Hepcidin Mimetic PTG-300 induces dose-related and sustained reductions in serum iron and transferrin saturation in healthy subjects
Date and Time: Saturday, June 16 from 5:00 PM to 5:15 PM CEST
Session: Iron metabolism, deficiency and overload
Location: Stockholm International Fairs Convention Center, Room A13