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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

SELLAS Life Sciences to Present Phase 1/2 Clinical Data of Galinpepimut-S (GPS) in Ovarian Cancer at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 17, 2018 SELLAS Life Sciences Group Inc., (Nasdaq:SLS) (SELLAS) reported that data from the Company’s ongoing Phase 1/2 study of galinpepimut-S (GPS) in combination with Bristol Myers Squibb’s nivolumab in patients with Wilms Tumor 1 + ovarian cancer will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 1 – 5, 2018 in Chicago, Illinois (Press release, Sellas Life Sciences, MAY 17, 2018, View Source [SID1234526776]). Additionally, following the positive outcome in triple negative breast cancer patients (TNBC) from the Phase 2b trial for NeuVax, SELLAS will be conducting clinical and regulatory advisory board meetings at ASCO (Free ASCO Whitepaper) based on the independent Data Safety Monitoring Board recommendation to expeditiously seek regulatory guidance by the FDA for the development of NeuVax in TNBC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Clinical and immunological data from the ongoing Phase 1/2 GPS plus nivolumab trial evaluating GPS in patients with recurrent WT1+ ovarian cancer in second or greater clinical remission after salvage chemotherapy will be presented. Details for the presentation are as follows:

Title: A phase I study of concomitant galinpepimut-s (GPS) in combination with nivolumab (nivo) in patients (pts) with WT1+ ovarian cancer (OC) in second or third remission.
Presenter: Roisin E. O’Cearbhaill, M.D., Memorial Sloan Kettering Cancer Center
Abstract Number: 5553
Poster Session: Gynecologic Cancer
Date and Time: June 4, 2018, 1:15PM – 4:45PM CT
Location: McCormick Place, Hall A

Seattle Genetics Announces Data Presentations at 2018 ASCO Annual Meeting

On May 17, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that multiple abstracts from its robust clinical development portfolio will be presented at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois, from June 1-5, 2018 (Press release, Seattle Genetics, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349592 [SID1234526775]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The abstracts being presented at ASCO (Free ASCO Whitepaper) 2018 highlight the depth of our clinical program in multiple solid tumors and hematological malignancies," said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. "Of note, an oral presentation will feature updated data from a phase 1 study of enfortumab vedotin for patients with metastatic urothelial cancer. Data from this study formed the basis of the recent FDA Breakthrough Therapy Designation for enfortumab vedotin. In addition, multiple posters featuring sub-analyses from the ECHELON-1 trial of ADCETRIS provide continued strong rationale for ADCETRIS combination use in the treatment of patients with frontline Stage 3 and 4 classical Hodgkin lymphoma."

The abstracts published in advance of the ASCO (Free ASCO Whitepaper) meeting were made available yesterday on the ASCO (Free ASCO Whitepaper) website at www.asco.org.

Urothelial Cancer

(Abstract #4504) "Updated results from the enfortumab vedotin phase 1 (EV-101) study in patients with metastatic urothelial cancer (mUC)"

Presenter: J. Rosenberg, M.D., Memorial Sloan Kettering Cancer Center

Oral Abstract Session: Genitourinary (Nonprostate) Cancer

Date and Time: Sunday, June 3, 9:12 a.m.-9:24 a.m. CDT (session begins at 8:00 a.m.)

Location: Arie Crown Theater

(Abstract #TPS4590) "EV-201 Study: A single-arm, open-label, multicenter study of enfortumab vedotin for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor therapy"

Presenter: J. Rosenberg, M.D., Memorial Sloan Kettering Cancer Center

Poster Session: Genitourinary (Nonprostate) Cancer

Date and Time: Saturday, June 2, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #414a

Hodgkin Lymphoma

(Abstract #7534) "Improving outcomes with brentuximab vedotin (BV) plus chemotherapy in patients with newly diagnosed advanced stage Hodgkin lymphoma"

Presenter: D. Straus, M.D., Memorial Sloan Kettering Cancer Center

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #171

(Abstract #7541) "Brentuximab vedotin (BV) plus chemotherapy in patients with newly diagnosed advanced stage Hodgkin lymphoma (HL): North American results"

Presenter: R. Ramchandren, M.D., Barbara Ann Karmanos Cancer Institute

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #178

(Abstract #7542) "Long-term follow-up of brentuximab vedotin +/- dacarbazine as first line therapy in elderly patients with Hodgkin lymphoma"

Presenter: J. Friedburg, M.D., University of Rochester Medical Center

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #179

(Abstract #7539) "Brentuximab vedotin with chemotherapy for stage III or IV Hodgkin lymphoma (HL): Impact of cycle 2 PET result on modified progression-free survival (mPFS)"

Presenter: R. Chen, M.D., Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #176

Breast Cancer

(Abstract #1015) "Clinical benefit of tucatinib after isolated brain progression: A retrospective pooled analysis of tucatinib phase 1b studies in HER2+ breast cancer"

Presenter: R. Murthy, M.D., University of Texas MD Anderson Cancer Center

Poster Session: Breast Cancer – Metastatic

Date and Time: Saturday, June 2, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #96

Discussed at Poster Discussion at Hall D1 on Saturday, June 2, 1:15 p.m.-2:30 p.m. CDT

Cervical Cancer

(Abstract #TPS5601) "A single-arm, phase 2, multicenter, international trial of tisotumab vedotin (HuMax-TF-ADC) in previously treated, recurrent or metastatic cervical cancer"

Presenter: R. Coleman, M.D., The University of Texas MD Anderson Cancer Center

Poster Session: Gynecologic Cancer

Date and Time: Monday, June 4, 1:15 p.m.-4:45 p.m. CDT

Location: Hall A, Poster Board #327b

Additional Cancers

(Abstract #3093) "SEA-CD40, a non-fucosylated CD40 agonist: Interim results from a phase 1 study in advanced solid tumors"

Presenter: J. Grilley-Olson, M.D., UNC Lineberger Comprehensive Cancer Center/University of North Carolina Chapel Hill

Poster Session: Developmental Therapeutics – Immunotherapy

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #307

Rocket Pharmaceuticals Announces Strategic Research Collaboration

On May 17, 2018 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a leading U.S.-based multi-platform gene therapy company, and the Stanford University School of Medicine reported a strategic collaboration to support the advancement of Fanconi Anemia (FA) and Pyruvate Kinase Deficiency (PKD) gene therapy research (Press release, Rocket Pharmaceuticals, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349565 [SID1234526774]). Rocket’s lentiviral vector (LVV)-based gene therapy program for FA is currently in clinical trials with academic partners in the U.S. and Europe. The LVV-based gene therapy program for PKD is currently in preclinical development in Europe.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Stanford will serve as a lead clinical trial research center in the United States for a planned upcoming registrational trial for FA, and would also be the lead site for PKD clinical trials. Maria Grazia Roncarolo, M.D., director of the Stanford Center for Definitive and Curative Medicine and co-director of the school’s Institute for Stem Cell Biology and Regenerative Medicine, will lead the school’s effort. The center is a joint initiative of the School of Medicine, Stanford Health Care and Stanford Children’s Health and is focused on bench to bedside development of innovative cell- and gene-based therapies.

Gaurav Shah, M.D., Chief Executive Officer and President of Rocket, commented, "Rocket is delighted to expand the reach of our gene therapy program in the U.S. and prepare for our registrational trial. We are committed to developing FA and PKD programs in collaboration with outstanding gene therapy centers and pioneers in the field. This collaboration with the Stanford Center for Definitive and Curative Medicine is a critical step within our overall strategy of building relationships with gene therapy experts, with investigators who have dedicated their careers to improving the care of patients afflicted with these disorders, and within the broader FA and PKD communities."

"This project will also evaluate the introduction of conditioning regimens for both FA and PKD, where we hope to develop best-in-class gene therapy approaches for both clinical indications. The regulatory design and preparation for our registrational trial for FA is ongoing and we remain on track to advance this program to a registration study in 2019. Our PKD program continues to advance in preclinical studies with an Investigational Medicinal Product Dossier (IMPD) expected to be filed in early 2019," continued Dr. Shah.

For more information about this news on the Stanford website, please visit View Source