On May 1, 2023 CG Oncology, Inc. announced updated data from the CORE-001 study, an ongoing Phase 2 clinical trial of cretostimogene grenadenorepvec (CG0070) in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (Press release, CG Oncology, MAY 1, 2023, View Source [SID1234630801]).

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The results were presented by Roger Li, MD, lead study investigator and urologic oncologist at Moffitt Cancer Center in an oral presentation at the American Urological Association (AUA) 2023 Annual Meeting in Chicago, IL.

"The latest results from the CORE-001 trial continue to demonstrate strong efficacy and a favorable safety profile for cretostimogene grenadenorepvec in BCG-Unresponsive NMIBC, a difficult-to-treat patient population," said Arthur Kuan, Chief Executive Officer, CG Oncology. "We hope that the clinical evidence from our combination study with KEYTRUDA will demonstrate cretostimogene grenadenorepvec’s potential to become a foundational bladder-sparing therapy for patients who have limited options."

Summary of New Clinical Results

Abstract #23-5631 – CORE-001: Phase 2 Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin (BCG)

The new data for CORE-001 adds to data previously presented and shows anti-tumor activity, tolerability and durability of cretostimogene grenadenorepvec in combination with pembrolizumab for patients with BCG unresponsive NMIBC.

Based on a preliminary data cutoff on March 3, 2023, 34 patients were evaluable for efficacy with a minimum of 3-month follow up.
85% of patients evaluable for efficacy (n=29/34) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients evaluable for CR at additional timepoints, 82% (n=27/33) have also maintained a CR through 6 months, 81% (n=25/31) through 9 months and 68% (n=17/25) at the 12-month assessment.
The combination of cretostimogene grenadenorepvec and pembrolizumab has been generally well tolerated with the adverse event profile consistent with that observed in prior studies of each agent alone. The most common treatment-related adverse events reported include transient grade 1-2 local genitourinary symptoms.
"We are excited to see the responses at 12 months for the majority of the trial patients," said Roger Li, MD, lead study investigator and urologic oncologist at Moffitt Cancer Center. "We plan to follow the patients in complete remission beyond this time point to ascertain longer-term response to cretostimogene grenadenorepvec and pembrolizumab."

About the CORE-001 Study

Under a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of cretostimogene grenadenorepvec in combination with pembrolizumab, CORE-001, which has completed enrollment of 35 total patients, evaluates the safety and efficacy of cretostimogene grenadenorepvec plus pembrolizumab for the treatment of BCG-Unresponsive NMIBC.

More information about the study, CORE-001 (NCT04387461), along with other studies sponsored by CG Oncology, can be found at www.clinicaltrials.gov or www.cgoncology.com.

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec (CG0070) is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with cretostimogene grenadenorepvec in combination with OPDIVO (nivolumab).

On May 1, 2023 Guided Therapeutics, Inc. or the "Company" (OTCQB: GTHP), the maker of LuViva, a rapid and painless cervical cancer detection system based on the Company’s patented biophotonic technology, reported an update regarding the start of its pivotal clinical trial (Press release, Guided Therapeutics, MAY 1, 2023, View Source [SID1234630800]). The results of this clinical study will be used to support the Company’s application for U.S. FDA approval. The clinics involved in the study represent a mix of academic and community practices as well as representative population demographics. The first of the two academic centers opened for study recruitment in April and expects enrollment and testing to commence on their next colposcopy clinic scheduled for May 5th. At the second academic center, all internal scientific and institutional review boards have approved the study and final preparations are being made to begin training there. The two community-based clinics have approved the study, signed clinical trial agreements, and are preparing to start the study. It is estimated that approximately 400 women will be tested. Additional information regarding the study can be found at Clinicaltrials.gov.

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"We are extremely pleased to have four excellent clinical centers planning to enroll patients for our study," said Mark Faupel, CEO of Guided Therapeutics. "We believe the addition of the two community clinics will shorten the timeline to completion of the study and provide us with a well-balanced and representative sample of the U.S. female population."

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.

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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.

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"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]).

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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