On May 1, 2023 Innocare Pharma reported that Blood Advances, part of leading hematology journal Blood, also a Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper), recently published the clinical study result of BTK (Bruton Tyrosine Kinase) inhibitor orelabrutinib in Relapsed or Refractory (r/r) Mantle Cell Lymphoma (MCL) patients (Press release, InnoCare Pharma, MAY 1, 2023, View Source [SID1234630799]). The journal concluded that orelabrutinib showed substantial efficacy and was well tolerated in patients with r/r MCL after long-term follow-up.

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!

A total of 106 patients were enrolled in the study. After a median follow-up of 23.8 months, based on CT assessment, the overall response rate (ORR) was 81.1%, with 27.4% achieving complete response (CR) and 53.8% of partial response (PR), as assessed by the Independent Review Committee (IRC). The ORR and CR were 82.1% and 34.9% assessed by the investigator.

Patients achieved a rapid response. The median time to response (TTR) was 1.9 months. The median duration of response and progression-free survival were 22.9 and 22.0 months, respectively. The median overall survival (OS) was not reached and the rate of OS at 24 months was 74.3%. Orelabrutinib demonstrated a well-tolerated safety profile.

Professor Jun Zhu of Beijing Cancer Hospital said, "Orelabrutinib has shown potent activity in patients with r/r MCL and substantial improvement over early generation BTK inhibitor in response rates. In addition, orelabrutinib exhibited a favorable safety profile with a lower incidence of AE seen in the BTK inhibitor class, supporting a safe and highly effective treatment option for patients with r/r MCL."

Mantle cell lymphoma (MCL) is a subtype of B-cell non-Hodgkin lymphoma that results from malignant transformation of B-lymphocytes in the mantle zone of lymph node follicles. MCL occurs most frequently in men at a median age of 60 years, and the majority of patients are in an advanced stage of disease when diagnosed. Despite high response rates after first-line hemoimmunotherapy, the majority of patients relapse and require subsequent treatment. There is no standard therapy for relapsed/refractory MCL, and the therapies approved by the Food and Drug Administration for this patient population are still limited, with low rates of CR, short durations of remission, and unfavorable safety and tolerability for older patients.

Blood Advances, a Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper), founded in 2016 and published online and open access, provides an international forum for the publication of original articles describing basic laboratory, translational, and clinical investigations in hematology and related sciences.

Note: In addition to background information, the content of this press release is derived from this published article. Full text can be found in View Source

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25, 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of R/R MCL in Singapore. On April 20, 2023, orelabrutinib was approved for the treatment r/r MZL in China.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA). Patient enrollment of Phase II registrational trial for R/R MCL was completed in the U.S.

In addition, orelabrutinib’s global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) achieved proof of concept (PoC), and orelabrutinib’s phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) is ongoing in China.

On May 1, 2023 Systimmune, Inc. (SystImmune) reported that it will present clinical data from its lead programs at the ASCO (Free ASCO Whitepaper) Annual Meeting 2023 in Chicago in June (Press release, SystImmune, MAY 1, 2023, View Source [SID1234630798]). The clinical results to be presented will be from trials involving patients with several solid tumor types.

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!

"Through our commitment to innovative research, we are pleased to have multiple modalities selected to showcase our groundbreaking pipeline at this year’s ASCO (Free ASCO Whitepaper) meeting. Our focus on advancing the field of oncology is reflected in the clinical data that our distinguished clinical investigators will present, and we are excited to share our progress toward improving patient outcomes with the scientific community," said Yi Zhu, Ph.D., President & CEO of SystImmune.

"We are thrilled to be presenting our clinical data at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting, which includes our first-in-class bi-specific antibody-drug conjugate. The results of our trials highlight the potential of our innovative therapies to address unmet needs in a variety of solid tumor types. At SystImmune, we remain committed to advancing the field of oncology and expanding treatment options to benefit patients," said Martin Olivo, M.D., CMO of SystImmune.

Key highlights of data selected by ASCO (Free ASCO Whitepaper) include

Molecule Name

Abstract Title 

Abstract Number/ Presentation Details  

BL-B01D1

BL-B01D1, a first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic solid tumor: Results from a first-in-human phase 1 study.

Abstract #3001

Oral Presentation：

Monday, June 5, 8:00 -11:00 am CDT

SI-B001

SI-B001 plus chemotherapy in patients with locally advanced or metastatic EGFR/ALK wild-type non-small cell lung cancer: A phase II, multicenter, open-label study.

Abstract #9025

Poster Discussion Session

Poster Available: Sunday, June 4, 8:00 – 11:00 am CDT

Discussion:

Sunday, June 4, 4:30 – 6:00 pm CDT

SI-B001

Results from two phase II studies of SI-B001, an EGFR×HER3 bispecific antibody, with/without chemotherapy in patients (pts) with recurrent and metastatic head and neck squamous cell carcinoma (HNSCC).

Abstract #6037

Poster Available:
Monday, June 5, 1:15 – 4:15 pm CDT

GNC-038

GNC-038, A tetra-specific antibody, in patients with R/R non-Hodgkin lymphoma or acute lymphoblastic leukemia: A phase 1 study design and rationale.

Abstract #TPS2668

Poster Available:

Saturday, June 3, 8:00 -11:00 am CDT

SI-B003

SI-B003 (PD-1/CTLA-4) in patients with advanced solid tumors: A phase I study.

Abstract#: e14668

online

SystImmune Programs Profiled at ASCO (Free ASCO Whitepaper)

About SI-B001

The company has developed SI-B001, also known as izalontamab, an EGFR×HER3 bispecific antibody that can target both EGFR and HER3. The bi-specific SI-B001 is built on a tetravalent platform having two binding domains for distinct Growth Factor Receptors that drive cancer cell proliferation and survival. The SI-B001 primary mechanism of action is the blocking of EGFR and HER3 signals to cancer cells, and secondarily, through a wt FC receptor mediating innate immune effector functions toward the cancer cells.

About BL-B01D1

The company is developing BL-B01D1, a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3. These proteins are highly expressed in most epithelial tumors. The tetravalent BL-B01D1 has two binding domains for distinct Growth Factor Receptors that drive cancer cell proliferation and survival. Inheriting the SI-B001 mechanisms of action, BL-B01D1 blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Upon antibody mediated internalization, BL-B01D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induced genotoxic stress activating pathways leading to cancer cell death.

About GNC-038

The company is developing GNC-038, also known as emfizatamab, the world’s first anti-tumor tetra-specific antibody drug in human trials. The GNC-038, octavalent, tetra-specific T cell engager is designed to target CD19 expressing B cell malignancies. The GNC-038 molecule can bind CD3 and CD19 to redirect T cell cytotoxicity toward specified cancer indications defined by CD19 expression. The molecule can also redirect T cell cytotoxicity toward PDL1 high-expressing cells, representing its potential to convert cancer cell adaptive resistance into drug sensitivity. The GNC-038 can also engage 41-BB in a non-cytolytic fashion, transducing an educational signal to T cells that lead to increased functionality throughout dosing cycles.

About SI-B003:

The company is developing SI-B003, also known as danvilostomig, a tetravalent molecule having two binding domains along the T cell checkpoint axis, PD-1, and CTLA-4. The primary targets for this molecule are exhausted tumor-specific T cells, which demonstrate enhanced functionality upon treatment with PD-1 and CTLA-4 blocking antibodies, restoring their anti-tumor activity. By combining bi-valency with bi-specificity in the tetravalent format, the dual checkpoint molecule utilizes avidity and bi-specificity to improve anti-cancer immune cell function. The specificity enhancement both synergistically enhances and expands the breadth of immune cell activity that is diminished in cancer patients.

On May 1, 2023 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, reported that an abstract highlighting pre-clinical data for CRB-601, its avβ8 blocking antibody, has been accepted for oral presentation in the main program of the New York Academy of Sciences’ 2023 Frontiers in Cancer Immunotherapy meeting, taking place in New York, NY May 2-4, 2023 (Press release, Corbus Pharmaceuticals, MAY 1, 2023, View Source [SID1234630797]).

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!

Presentation

Title:

CRB-601, an avβ8 blocking antibody, prevents activation of TGFβand exhibits anti-tumor activity associated with immune cell remodeling of the tumor microenvironment

Authors:

Daqing Wang, Ph.D; Vaishali Shinde, MS; Maneesh Singh, Ph.D.; Rachael Brake, Ph.D.; Andrew Kolodziej, Ph.D.

Date & Time:

May 3, 2023 at 4:30pm Eastern Time

On May 1, 2023 Quantum Leap Healthcare Collaborative (Quantum Leap) and Athenex, Inc. (Nasdaq: ATNX) reported that findings of the I-SPY 2 TRIAL evaluation of Athenex’s oral paclitaxel plus encequidar in combination with GSK’s dostarlimab in the neoadjuvant setting will be presented at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference (Press release, QuantumLeap, MAY 1, 2023, View Source [SID1234630796]).

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!

Athenex, a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions collaborated with GSK and Quantum Leap in two study arms of the I-SPY 2 TRIAL. The two arms included oral paclitaxel plus encequidar in combination with GSK’s dostarlimab, an investigational antibody binding PD-1, with and without carboplatin followed by adriamycine and Cytoxan. The goal of the study was to evaluate the safety and efficacy of oral paclitaxel plus encequidar with dostarlimab +/- carboplatin in Stage 2/3 HER2- breast cancer patients and plus trastuzumab in HER2+ patients. The ultimate goal was to determine if this course of treatment increased the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy alone for any of the tumor subtypes established at trial entry, and to determine the predictive probability of success in a subsequent Phase 3 trial.

In December, Quantum Leap, who sponsored the trial, reported that oral paclitaxel plus encequidar in combination with a PD-1 inhibitor and carboplatin had graduated in the triple-negative subgroup of high-risk early-stage breast cancer. Further findings of this study with complete regimen details will be included in the full abstract in June at ASCO (Free ASCO Whitepaper).

"As we continue to improve response to therapy, we have the opportunity to find less toxic, more tolerable regimens that will be as good or better than standard chemotherapy. Our goal for this study was to test a promising PD1 inhibitor in combination with the Athenex oral taxane which was shown to be more effective than paclitaxel in a phase 3 trial in the metastatic setting. Working with companies like Athenex and GSK allows us to test combinations that could improve our ability to deliver combined therapies the world over, and find the best possible outcome for the patients. We are looking forward to sharing our results at this year’s ASCO (Free ASCO Whitepaper)," said Laura Esserman, MD, the leader of the I-SPY 2 study and co-founder of Quantum Leap.

The I-SPY 2 TRIAL, sponsored by Quantum Leap, is a standing Phase 2 randomized, controlled, multicenter platform with an innovative Bayesian adaptive randomization design aimed to rapidly screen and identify promising new treatments in specific subgroups of adults with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage 2/3). GSK provided dostarlimab. Athenex provided oral paclitaxel and encequidar.

On May 1, 2023 Verastem Oncology, (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that the Company will participate in the following upcoming investor conferences (Press release, Verastem, MAY 1, 2023, View Source [SID1234630795]):

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!

JMP Securities Life Sciences Conference; podium presentation on Tuesday, May 16, 2023 at 1:00 p.m. ET
RBC Capital Markets Global Healthcare Conference; fireside chat on Wednesday, May 17, 2023 at 2:05 p.m. ET

A live webcast of the presentation and fireside chat will be available on the investors section of the Company’s website at www.verastem.com. An archived replay of the presentation and fireside chat will be made available on the same website for approximately 90 days following each event.