On May 1, 2023 Marker Therapeutics, Inc, a clinical-stage company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that it has entered into a comprehensive agreement with CellReady, a newly formed Contract Development and Manufacturing Organization (CDMO) founded by John Wilson, founder and CEO of Wilson Wolf Corporation and Marker Co-Founder and Board Member (Filing, Marker Therapeutics, MAY 1, 2023, View Source [SID1234630805]).

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Under the terms of the non-dilutive agreement, CellReady will purchase certain cell manufacturing assets from Marker for approximately $19 million in cash and reduce Marker’s overhead by about $11 million annually by employing Marker’s manufacturing, development, quality, and regulatory affairs personnel, and assuming the leases for Marker’s Houston-based manufacturing and research and development facilities. The parties anticipate the transaction will close on June 26, 2023.

CellReady also agreed to enter into a long-term contract with Marker wherein CellReady will perform a wide variety of services for Marker including research and development, manufacturing, and regulatory activity in support of Marker’s clinical trials.

This agreement allows Marker to concentrate solely on the clinical advancement of its unique form of T cell therapy, which has demonstrated the ability to recognize and kill cancer cells even as the cancer cells evolve to escape detection. Currently approved genetically engineered CAR T and TCR therapies cannot recognize evolving cancer cells, and this limitation can lead to relapse.

Juan Vera, M.D., formerly Marker’s COO and Chief Scientific Officer, has assumed the role of Chief Executive Officer of Marker Therapeutics effective May 1, 2023. Dr. Vera commented, "Marker’s management and impartial members of the board worked with John Wilson and CellReady to develop a very creative and non-dilutive plan that provides Marker with the financial runway to pursue its clinical priorities through the end of 2025. At the same time, through CellReady, Marker will maintain full access to its industry-leading operational, quality, development, and regulatory team and facilities whenever it needs them. I look forward to working with the Marker clinical team to advance the development of MT-601 in our ongoing non-Hodgkin’s lymphoma trial and eventual pancreatic cancer trial, in addition to MT-401 for our post-transplant AML trail. Additionally, I am spearheading a strategic review process of our clinical programs with the Marker management team as part of our restructuring efforts."

Mr. John Wilson, founder and CEO of Wilson Wolf Corporation and Marker Co-Founder and Board Member, stated, "I continue to believe that Marker’s unique therapies can make a positive impact in the cancer field. This is why I co-founded Marker, made investments along the way, and have remained a longtime shareholder. Advancing these therapies would not be possible without the institutional and retail investors who have joined our mission. The reality is that Marker has not yet met our investors’ expectations. Therefore, extending Marker’s clinical runway without investor dilution is the right thing to do. Paying Marker approximately $19 million in cash and simultaneously eliminating about $11 million of Marker’s annual costs related to its personnel and facilities, greatly reduces Marker’s cash needs as it pursues clinical development of its lead programs. Meanwhile, CellReady will provide Marker with all resources required to advance its clinical program, including people, facilities, and cell manufacturing capabilities. I estimate the net benefit to Marker to be approximately $42 million through the end of 2025."

Marker’s Clinical Strategy Update
Marker’s MT-601, a multi-tumor-associated antigen (multi-TAA) specific T cell product targeting six cancer antigens, is in an ongoing clinical trial for the treatment of patients with relapsed/refractory non-Hodgkin’s lymphoma who have failed, or are ineligible to receive, an anti-CD19 CAR T cell treatment.

The MT-601 study is based on the results that were observed in the Phase I/II TACTAL study that enrolled patients with Hodgkin’s and non-Hodgkin’s lymphoma. The TACTAL study, which used a multi-TAA specific T cell product targeting five lymphoma antigens, reported long-term complete response (CR) rates that were comparable to recently approved anti-CD19 CAR-T cell therapies, even at very low cell doses.

Marker is also continuing the clinical development of MT-401, its multi-TAA specific T cell product for the treatment of pediatric and adult patients with acute myeloid leukemia (AML) after receiving allogeneic transplant. AML is a very challenging form of cancer and, in September 2022, Marker indicated that it had observed promising early clinical results which suggested that MT-401 can potentially rescue post-transplant AML patients with measurable residual disease. Should data continue to demonstrate the potential to stop AML from progressing into the dire condition of Frank Relapse, Marker believes this will be a significant advance in AML treatment.

Through extensive scientific review, Marker believes the magnitude of a patient’s tumor burden may correlate with MT-401 and MT-601 clinical outcomes. Marker is now updating clinical protocols to potentially improve patient outcomes by assessing tumor burden. Data availability is expected toward the latter half of 2024.

Marker’s pancreatic trial is awaiting news on grant funding and Marker is analyzing the relationship between starting cellular material and manufactured cell quantity to ensure optimal conditions for its pancreatic trial outcomes. Marker will be following up to keep investors informed about the status of its pancreatic trial as information becomes available.

Key Transaction Terms

In connection with this transaction, Marker’s board of directors established a special transactions committee of impartial directors to review the terms of the transaction, as well as other strategic alternatives, and to issue a recommendation to the board of directors. The impartial members of the board of directors unanimously approved entry into the transaction based on the special transactions committee’s recommendation.

Pursuant to the agreement, Marker has made certain representations and warranties on the transferred assets and has agreed to certain customary covenants and restrictions with respect to assets and liabilities comprising the transaction consistent with a transaction of this nature.

The parties will also enter into a long-term supply agreement for the manufacture and supply of Marker’s clinical product candidates.

On May 1, 2023 SIRPant Immunotherapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for the Company’s lead product candidate, SIRPant-M, an autologous SIRPαlow activated macrophage therapy for the treatment of aggressive tumors SIRPant Immunotherapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for the Company’s lead product candidate, SIRPant-M, an autologous SIRPαlow activated macrophage therapy for the treatment of aggressive tumors (Press release, SIRPant Immunotherapeutics, MAY 1, 2023, View Source [SID1234630802]). Under this IND, SIRPant intends to initiate its Phase 1, first-in-human, multi-center study in patients with relapsed refractory non-Hodgkin lymphoma in Q3.

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"This is a major accomplishment for the company and an important step forward in the clinical evaluation of SIRPant-M for the treatment of multiple tumor types," said Robert Towarnicki, President & CEO. "This initial study will enroll relapsed refractory non-Hodgkin lymphoma patients who are ineligible for or previously failed approved therapeutic regimens. There remains a significant unmet need in this setting, and we are excited to try and fill this need by treating with SIRPant-M."

SIRPant anticipates following this initial IND with a second IND for SIRPant-M focused on solid tumor treatments, initially targeting head & neck cancers. In preclinical testing, SIRPant-M has shown effectiveness against a wide variety of solid tumors in vivo, in addition to compelling positive data in hematological tumors.

"Leveraging recent findings in macrophage biology, we developed a first-in-class cell therapy, SIRPant-M, to initiate adaptive immune responses against cancerous cells without requiring prior cancer-associated antigen identification" notes Nathanael McCurley, PhD, Vice President, R&D. "SIRPant-M employs a proprietary cocktail, PhagoAct, to license macrophages to drive tumor neo-antigen-specific polyclonal T cell and antibody responses, thus targeting cancer cells through multiple avenues simultaneously." By mobilizing both the cellular and humoral arms of the immune system, SIRPant-M yields long-lasting polyclonal immune memory against cancer.

The company anticipates conducting the planned clinical trial at five sites across the United States. Register for company updates regarding initiation and recruiting as the sites come online at View Source." target="_blank" title="View Source." rel="nofollow">View Source Under this IND, SIRPant intends to initiate its Phase 1, first-in-human, multi-center study in patients with relapsed refractory non-Hodgkin lymphoma in Q3.

"This is a major accomplishment for the company and an important step forward in the clinical evaluation of SIRPant-M for the treatment of multiple tumor types," said Robert Towarnicki, President & CEO. "This initial study will enroll relapsed refractory non-Hodgkin lymphoma patients who are ineligible for or previously failed approved therapeutic regimens. There remains a significant unmet need in this setting, and we are excited to try and fill this need by treating with SIRPant-M."

SIRPant anticipates following this initial IND with a second IND for SIRPant-M focused on solid tumor treatments, initially targeting head & neck cancers. In preclinical testing, SIRPant-M has shown effectiveness against a wide variety of solid tumors in vivo, in addition to compelling positive data in hematological tumors.

"Leveraging recent findings in macrophage biology, we developed a first-in-class cell therapy, SIRPant-M, to initiate adaptive immune responses against cancerous cells without requiring prior cancer-associated antigen identification" notes Nathanael McCurley, PhD, Vice President, R&D. "SIRPant-M employs a proprietary cocktail, PhagoAct, to license macrophages to drive tumor neo-antigen-specific polyclonal T cell and antibody responses, thus targeting cancer cells through multiple avenues simultaneously." By mobilizing both the cellular and humoral arms of the immune system, SIRPant-M yields long-lasting polyclonal immune memory against cancer.

The company anticipates conducting the planned clinical trial at five sites across the United States. Register for company updates regarding initiation and recruiting as the sites come online at View Source

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.