On April 26, 2023 Avenge Bio, Inc. ("Avenge"), a clinical stage, oncology-focused biotechnology company developing the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported the successful completion of the first dose cohort in a Phase 1/2 clinical trial of AVB-001 in patients with refractory ovarian cancer (Press release, Avenge Bio, APR 26, 2023, View Source [SID1234630569]).

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The dose escalation trial evaluates the safety and tolerability, as well as preliminary efficacy, of AVB-001 administered intraperitoneally across a series of ascending dose-level cohorts. In the first cohort, the administration of AVB-001 has been well tolerated. No dose-limiting toxicities, on-target or off-target toxicities, or other unexpected events were observed. As such, investigators have initiated dosing in the second dose level cohort.

"We are pleased to complete the first dose cohort in this Phase 1/2 clinical trial. Although early, we are encouraged by the initial observations in this first dose level indicating the potential for this allogeneic cell-based immunotherapy. We look forward to announcing additional data on this program in the second half of 2023," said Claudio Dansky Ullmann, MD, Chief Medical Officer of Avenge Bio.

The Phase 1/2 clinical trial is a first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT05538624) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AVB-001 delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.

In addition to advancing the lead clinical trial in ovarian cancer, Avenge is also developing programs for additional conditions of high unmet needs in other peritoneal malignancies, and pleural cancers such as malignant pleural mesothelioma.

About LOCOcyte Platform

Our LOCOcyte allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverages three unique advantages:

Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy,

Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and

The immunomodulator trains the patient’s immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.

On April 26, 2023 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company reported a fundamental shift in the ongoing development and manufacture of its lead product TCB-008, an allogeneic gamma-delta T cell therapies for cancer, and the Company’s CAR modified gamma-delta T cell (Press release, TC Biopharm, APR 26, 2023, View Source [SID1234630568]).

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Following an analysis of current and emerging trends in the cell therapy landscape, the Company intends to pursue exclusive partnerships for test research and combination trial with complimentary therapies using allogeneic gamma delta t-cells, subvariant 2 ("GDT v2s"), the Company’s lead asset TCB-008. The Company’s current plans around the advancement of TCB-008 as a monotherapy for Acute Myeloid Leukemia and the ability to manufacture the product to GMP standards will continue with the FDA IND filing in Q3 of 2023 will continue as scheduled and as the final monotherapy trial for TCB-008.

A collaborative integration of TC BioPharm’s primary asset, TCB-008, will further enable the Company to expand operations into CAR Therapy with a focus on binder B7H3 for the treatment of ovarian cancer. The shift should enable the company to maximize the potential of its therapies and increase the value of the assets and the company. At present the Company has executed three research collaborations around TCB-008 in combination with complimentary approaches and expects to finalize a partnership from one of these collaborations in 2023 for trial in 2024.

"Our 2023 plan is rooted in enabling research teams to work together on preclinical and clinical studies to evaluate the potential for gamma-delta T cell therapies and better understand the behaviors of these cells in patients," said Bryan Kobel, CEO of TC BioPharm. "TCB-008 is an extremely promising therapeutic in cancer, and given its versatility, its mechanism of action, and the numerous arenas where other companies are attempting to activate, interact with or draw gamma delta t-cells to tumors, we believe TCB-008 will be a best-in-class asset for these companies to partner with in the future. This will give TCBP multiple shots on goal and maintain our leadership position as the de facto partner for companies looking to explore gamma delta t-cells sub variant 2 in combination with their asset. Our approach is already beginning to show signs of success, with multiple research collaborations and increasing interest from other potential strategic partners. In today’s capital markets environment, we firmly believe partnering will have an increased importance for development stage biotech companies and with TCB-008 as a best-in-class asset, we hope to leverage our success into non-dilutive capital and expanded data sets with partners. Having just completed a capital raise on the heels of extending our cash runway via corporate restructuring, I am confident we are better positioned for long-term growth."

TCBP will increase the focus on the CAR program, looking to shorten the timeline to completing a pre-clinical package and pursuing a US Phase I trial. The current target indication will be Ovarian cancer, with more than 313,000 new cases of ovarian cancer in 2020. The Five year Relative Survival rate is 49.7%

This approach should drive an increase in the company’s patent portfolio and IP, increasing the value of the Company in a potential acquisition scenario as well as increasing the competitive advantage of the Company with IP and patent protection.

Clinical development to-date has enabled the company to pivot to logical, more agile clinical strategy towards U.S. FDA trials for TCB-008 for AML. Completing dosing of the safety cohort was another step in TCBP’s efforts and firmly plant TCBP as the leader in the allogeneic gamma delta space.

TCBP will review external assets with pre-clinical packages/early data Cell therapies across the spectrum including TCR/CAR/Other immunotherapy opportunities and other areas where TCB-008 might be effective. Potential near-term collaborations could include fungal infection therapies in Rare Disease indications and combination research to assist private companies seeking capital where it can leverage equity capital to stockpile assets.

"Prioritizing partnerships as we head towards US trials realigns us with our long-term goal of becoming a leading commercial stage company," Kobel said. "These partnerships will expand the data set on TCB-008, give us more knowledge around both our product and GDTs and provide investors with multiple shots on goal and additional inflection points at a lower cash expenditure. We firmly believe in the potential of TCB-008 and we continue to position the Company to be more economically efficient."

On April 26, 2023 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that a poster featuring the latest clinical data of uliledlimab, the Company’s proprietary and highly differentiated CD73 antibody, in combination with PD-1 therapy in non-small-cell lung cancer (NSCLC), will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6 in Chicago, Illinois (Press release, I-Mab Biopharma, APR 26, 2023, View Source [SID1234630567]).

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Presentation details:

Abstract Title:

Uliledlimab and Toripalimab Combination Therapy in Treatment Naïve Advanced
NSCLC: Phase 1b/2 Clinical Trial Results Using CD73 as a Potential Predictive Biomarker

Abstract Number:

2570

Presenting Author:

Prof. Qing Zhou, Guangdong Provincial People’s Hospital

Session:

Developmental Therapeutics – Immunotherapy

Location:

Hall A, McCormick Place Convention Center, Chicago, Illinois

Presentation Date/Time:

June 3, 2023, 8:00 am – 11:00 am E.T.

About Uliledlimab

Uliledlimab (also known as TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine, in turn, binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in the tumor microenvironment. Uliledlimab is expected to offer clinical benefits by suppressing tumor growth in concert with checkpoint therapies such as PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties, as evident in preclinical studies.

On April 26, 2023 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development, and commercialization of transformative targeted therapies, reported that initial dose escalation data from the ongoing phase 1/2 study of THE-630 in advanced gastrointestinal stromal tumors (GIST) were accepted for online publication at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, in Chicago, Illinois (Press release, Theseus Pharmaceuticals, APR 26, 2023, View Source [SID1234630566]).

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The abstract selected for online publication was submitted on February 14, 2023. On May 25, 2023, Theseus plans to host a virtual investor event to present data with an updated cutoff date. The data to be presented from the ongoing dose escalation study are expected to include preliminary safety, pharmacokinetic (PK), and clinical activity data through cohort 6, as well as an analysis of circulating tumor DNA (ctDNA) data through cohort 5.

THE-630 is a pan-variant tyrosine kinase inhibitor (TKI) of the receptor tyrosine kinase KIT, designed for patients with GIST that have developed resistance to earlier lines of therapy. The primary objectives of the phase 1 dose escalation portion of the study are to evaluate the safety profile of THE-630, including the determination of a recommended phase 2 dose (RP2D) in GIST patients who have received imatinib and at least one other TKI. Secondary objectives include determining the PK profile of THE-630, and to characterize preliminary evidence of antitumor activity.

Virtual Investor Event

Theseus will host a virtual investor event to review these new data on Thursday, May 25, 2023, beginning at 5:30pm ET. The event will be webcast live and can be accessed in the Events section of the Company’s investor relations website at ir.theseusrx.com. A replay of the webcast will be archived and available for 30 days following the event.

On April 26, 2023 Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that it will present updated clinical data on GC012F, the Company’s FasTCAR-enabled autologous CAR-T cell therapy dual-targeting B-cell maturation antigen (BCMA) and CD19, from ongoing investigator-initiated trials (IIT) in relapsed-refractory multiple myeloma (RRMM) and B-cell non-Hodgkin’s lymphoma (B-NHL) at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 2-6, 2023, in Chicago and online (Press release, Gracell Biotechnologies, APR 26, 2023, View Source [SID1234630565]).

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"We are looking forward to sharing updated results from our ongoing studies evaluating GC012F in relapsed/refractory multiple myeloma and B-cell non-Hodgkin’s lymphoma. We are particularly encouraged by the recognition of our long-term follow-up data of GC012F in RRMM, which will be presented at an oral session. We believe for these hematological cancers, there is critical need for transformational treatment options with strong efficacy, favorable safety profiles and rapid manufacturing," said Dr. Wendy Li, Gracell’s Chief Medical Officer. "With plans to commence clinical trials in the U.S. and China following the receipt of regulatory clearance of Investigational New Drug applications, 2023 is a critical year for both GC012F and Gracell. We plan to showcase the latest data to our peers in cancer research at the ASCO (Free ASCO Whitepaper) Annual Meeting that augments the clinical validation of the FasTCAR platform in a wide array of indications, emphasizing the importance of the dual-targeted approach and the potential benefits of enhanced T cell quality and accelerated delivery of the therapy to patients thanks to Gracell’s FasTCAR next-day manufacturing technology."

BCMA/CD19 Dual-Targeting FasTCAR-T GC012F for the Treatment of RRMM

Longer-term follow-up data from a multicenter investigator-initiated trial evaluating GC012F for the treatment of RRMM in heavily pretreated patients will be presented as an oral abstract session.

Oral presentation details are as follows:

Abstract title: Updated results of a phase I, open-label study of BCMA/CD19 dual-targeting fast CAR-T GC012F for patients with relapsed/refractory multiple myeloma (RRMM)
Abstract number: 8005
Session title: Hematologic Malignancies – Plasma Cell Dyscrasia
Session type: Oral Abstract Session
Presentation time: Saturday, June 3 at 1:15 PM – 4:15 PM CDT
BCMA/CD19 Dual-Targeting FasTCAR-T GC012F for the Treatment of B-NHL

A separate poster presentation will highlight updated clinical results from an ongoing IIT evaluating GC012F for the treatment of relapsed/refractory B-NHL. While CD19-directed CAR-T has proven effective for the treatment of NHL[i],[ii], the CD19/BCMA dual-targeting approach is novel for this indication. Additionally, this study further validates the FasTCAR platform.

Poster presentation details are as follows:

Abstract title: Updated clinical results of first-in-human study of CD19/BCMA dual-targeting fast CAR-T GC012F for patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma

Abstract number: 7562
Session title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session type: Poster Abstract Session
Session date & time: Monday, June 5 at 8:00 – 11:00 AM CDT
Full abstracts will be released on May 25, 2023 at 5 PM EDT. Additional information about the presentation and the ASCO (Free ASCO Whitepaper) Annual Meeting is available on the ASCO (Free ASCO Whitepaper) website.

About GC012F

GC012F is Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer treatment by driving fast, deep and durable responses with improved safety profile. GC102F is currently being evaluated in investigator-initiated trials in multiple myeloma and B-cell non-Hodgkin’s lymphoma (B-NHL), and has demonstrated a consistently strong efficacy and safety profile. In February 2023, Gracell announced regulatory clearance of Investigational New Drug applications in the U.S. and China to commence clinical trials evaluating GC012F for the treatment of relapsed/refractory multiple myeloma.

About FasTCAR

Introduced in 2017, FasTCAR is Gracell’s revolutionary next-day autologous CAR-T cell manufacturing platform. FasTCAR is designed to lead the next generation of cancer therapy and improve outcomes for patients by enhancing efficacy, reducing costs, and enabling more patients to access critical CAR-T treatment. FasTCAR drastically shortens cell production from weeks to overnight, potentially reducing patient wait times and probability for their disease to progress. Furthermore, FasTCAR T-cells appear younger and are more robust than traditional CAR-T cells, making them more proliferative and effective at killing cancer cells. In November 2022, FasTCAR was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards for its ability to address major industry obstacles.