On April 26, 2023 FORE Biotherapeutics reported the acceptance of two abstracts on new clinical data related to FORE8394, the company’s novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2023, in Chicago and virtually (Press release, Fore Biotherapeutics, APR 26, 2023, View Source [SID1234630575]). The datasets from the phase 1/2a clinical trial, evaluating the safety, tolerability, and efficacy of FORE8394 as a monotherapy will be presented.

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Details of the presentations are as follows:

Oral Presentation
Abstract number: 3006
Title: Safety and efficacy of the novel BRAF inhibitor FORE8394 in patients with advanced solid and CNS tumors: Results from a phase 1/2a study.
Presenter: Macarena de la Fuente, MD, University of Miami Sylvester Comprehensive Cancer Center
Presentation Session Date/Time: The oral presentation will take place on Monday, June 5, 2023, from 8:00 – 11:00 a.m. CDT, during the session titled "Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology."

Poster Presentation
Abstract number: 3106
Title: Dose optimization of novel BRAF inhibitor FORE8394 based on PK and efficacy results.
Presenter: Eric Sherman, MD, Memorial Sloan-Kettering Cancer Center
Presentation Session Date/Time: The poster will be presented on Friday, June 3, 2023, from 8:00 – 11:00 a.m. CDT, during the session titled "Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology."

About FORE8394

FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF. Preclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors but also disrupts constitutively active dimeric BRAF class 2 mutants, fusions, splice variants and others. Unlike first-generation RAF inhibitors, FORE8394 does not induce paradoxical activation of the RAF/MEK/ERK pathway. As a "paradox breaker," FORE8394 could therefore treat acquired resistance to current RAF inhibitors and, more generally, yield improved safety and more durable efficacy than first-generation RAF inhibitors. The company previously announced interim data from the ongoing Phase 1/2a clinical trial evaluating FORE8394 in advanced solid and CNS tumors with activating BRAF alterations, providing evidence of durable anti-tumor activity in patients with BRAF-mutated (V600+) cancers. The data were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) in September 2022.

On April 26, 2023 Novocure (NASDAQ: NVCR) reported the results of the LUNAR phase 3 clinical trial in metastatic, non-small cell lung cancer (NSCLC) will be presented for the first time at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, to be held from June 2 to June 6 (Press release, NovoCure, APR 26, 2023, View Source [SID1234630574]).

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The LUNAR study is a phase 3, open-label, randomized study evaluating the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with standard therapies including immunotherapies for metastatic NSCLC following progression while on or after treatment with platinum-based therapy.

"Novocure is pioneering an innovative therapeutic modality for the treatment of solid tumors targeting the electrical properties of cancer cells," said William Doyle, Novocure’s Executive Chairman. "LUNAR is the first randomized, phase 3 clinical trial to evaluate the application of TTFields outside of the brain and the first phase 3 clinical trial to evaluate the use of TTFields with immunotherapy. LUNAR enrolled a patient population with metastatic disease that has not seen significant improvement in outcomes since 2016. We are eager to share our groundbreaking data at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting and look forward to the opportunity to extend the survival of many more patients with aggressive cancers in the years to come."

Earlier this year, Novocure announced the LUNAR clinical trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival when TTFields therapy was added to standard pharmacological therapies compared to standard pharmacological therapies alone.

The LUNAR data will be presented on Tuesday, June 6 at 11:09 a.m. CDT in Hall D1 as a late-breaking abstract during ASCO (Free ASCO Whitepaper)’s metastatic, non-small cell lung cancer session. The presentation will be given by lead author Ticiana Leal, M.D., of Emory University.

The oral presentation of the LUNAR clinical trial data is one of 10 abstracts on TTFields therapy to be included at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting.

ASCO Investor Event

Novocure will host an investor event at 2 p.m. CDT on Tuesday, June 6, 2023. The event will include a presentation and discussion of the LUNAR clinical trial data, featuring leading thoracic oncologists, investigators, and Novocure leadership. A live webcast of the event will be available on the investor relations page of www.novocure.com. For more information or to request in-person attendance, please contact Novocure investor relations ([email protected]).

Industry Expert Theater

On June 3 at 9:30 a.m. CDT, Novocure’s Chief Science Officer Moshe Giladi will discuss future directions for TTFields in the meeting’s Industry Expert Theater.

Abstract Titles

Ten abstract titles from Novocure-sponsored and partner programs include:

Tumor Treating Fields (TTFields; 150 kHz) with standard of care (SOC) systemic therapy in metastatic non-small cell lung cancer (mNSCLC) following platinum failure: Randomized, phase 3 LUNAR (EF-24) study
Real-world experience with Tumor Treating Fields (TTFields) in newly diagnosed glioblastoma: A survival meta-analysis with systematic review
Post-marketing surveillance safety analysis of patients with CNS malignancies treated with Tumor Treating Fields (TTFields) therapy between 2011–2022
Phase 3 PANOVA-3 study: Tumor Treating Fields (TTFields) therapy concomitant with gemcitabine and nab-paclitaxel (GnP) for front-line treatment of locally advanced pancreatic cancer
Phase 3 TRIDENT study (EF-32): Tumor Treating Fields (TTFields; 200 kHz) concomitant with chemoradiation, and maintenance TTFields therapy/temozolomide in newly diagnosed glioblastoma
Safety and efficacy of Tumor Treating Fields (TTFields) prior and concomitant to radiotherapy in patients with newly diagnosed glioblastoma: Results from PriCoTTF
The association between body mass index and distribution intensity of Tumor Treating Fields (TTFields) in the lungs (online only)
Management of Tumor Treating Fields (TTFields) therapy-related skin adverse events in pleural mesothelioma: A single center experience of TTFields therapy concomitant with chemotherapy (online only)
Tumor Treating Fields (TTFields) therapy skin safety and prevention strategy: Fractionated schema protocol (3-day on/1-day off) improves usage and minimizes skin adverse events (online only)
Outcomes of stage IV non-small cell lung cancer patients after failure of platinum-based chemotherapy in clinical trials and real-world settings: A literature review (online only)
About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On April 26, 2023 Agenus (Nasdaq: AGEN), a leading immuno-oncology company specializing in immunological agents for cancer and infectious diseases, reported plans to present clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting, to be held June 2-6 in Chicago, IL (Press release, Agenus, APR 26, 2023, View Source [SID1234630573]).

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Data from a single-arm, open-label Phase 2 study of balstilimab (PD-1 antagonist) and zalifrelimab (first generation CTLA-4 antagonist) plus doxorubicin in patients with advanced sarcomas will be presented at an oral session on Monday, June 5 from 11:30am – 2:30pm CDT.

Complete results from the monotherapy arm of the first-in-human dose escalation study of AGEN2373 (CD137 agonist) in patients with advanced solid tumors will be presented at a poster discussion on Saturday, June 3rd from 3:00pm – 4:30pm CDT.

Presentation Details:

Abstract Title: A single-arm, open-label phase 2 trial of doxorubicin plus zalifrelimab, a CTLA-4 inhibitor, with balstilimab, a PD-1 inhibitor, in patients with advanced/metastatic soft tissue sarcomas
Abstract #: 403784
Presenting Author: Dr. Breelyn Wilky, MD, Director of Sarcoma Medical Oncology, Deputy Associate Director for Clinical Research, University of Colorado Medicine
Session Title: Oral Abstract Session – Sarcoma
Session Date and Time: 6/5/2023, 11:30am – 2:30pm CDT

Abstract Title: A Phase 1 Study of AGEN2373, a Novel CD137 Agonist Antibody Designed to Avoid Hepatoxicity, in Patients with Advanced Solid Tumors (NCT 04121676)
Abstract #: 2524
Poster Board #: 366
Presenting Author: Dr. Minal Barve, MD, Executive Medical Director and Chief Medical Officer, Mary Crowley Cancer Research
Poster Discussion Session: Developmental Therapeutics – Immunotherapy
Poster Session Display Date and Time: 6/3/2023, 8:00am – 11:00am CDT
Poster Discussion Session Date and Time: 6/3/2023, 3:00pm – 4:30pm CDT

The complete abstracts will be available on May 25th, 2023, at 5:00pm ET. Data presented at the conference will be available to view in the Publications section of the Agenus website (View Source) following the ASCO (Free ASCO Whitepaper) Conference.

About Balstilimab
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Agenus is developing balstilimab as a backbone agent for combination trials within its portfolio, as well as supplying drug to collaborators to enable novel combinations with external agents.

About Zalifrelimab
Zalifrelimab is a novel, fully human monoclonal immunoglobulin G1 (IgG1) designed to block CTLA-4 (cytotoxic T-lymphocyte associated antigen 4) from interacting with its ligands CD80 and CD86. Clinical trials have shown its efficacy in multiple indications, including a Phase 2 study in cervical cancer where it demonstrated robust activity in combination with balstilimab (O’Malley et al. JCO 2022).

About AGEN2373
AGEN2373 is a novel anti-CD137 agonist that has been designed to activate T and NK cells while mitigating liver toxicities common to the CD137 target class. CD137 (4-1BB) is an activating receptor expressed on T and NK cells. Upon binding to CD137, AGEN2373 is designed to stimulate the growth and activation of cytotoxic T and NK cells, triggering a lasting memory response to cancer. AGEN2373 binds to a unique epitope designed to achieve this response specifically within the tumor microenvironment. This selective binding is designed to avoid serious side effects associated with CD137 activation in the liver that have been reported by competitor molecules. AGEN2373 has demonstrated preliminary clinical activity and has been well tolerated by patients without signs of liver toxicity (Tolcher et al. ASCO (Free ASCO Whitepaper) 2021).

On April 26, 2023 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the year ended December 31, 2022, and provided an update on key highlights for 2022 (Press release, CASI Pharmaceuticals, APR 26, 2023, View Source [SID1234630571]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are pleased to report $10.2 million in EVOMELA revenues for the fourth quarter, $38 million for the full-year 2022. We have achieved our goal for our full-year 2022 revenue growth to exceed 2021 revenues, with a 26.7% increase in year on year sales revenue. Our team in China delivered strong performance despite the adverse impact of COVID-19 including of a Q3-4 rapid national spread of the pandemic and lockdowns in several major cities in China. Through the efforts of the CASI team and our commercial group of hematology sales and medical marketing specialists in China, we have built a strong foundation for our commercial franchise. We plan to continue building our commercial franchise throughout 2023 and beyond."

Dr. He continued, "Advancement, development, and commercialization of the portfolio remains our strategic focus. 2022 marks a major milestone for CASI and our partner Juventas; the CNCT-19 New Drug Application (NDA) was accepted by National Medical Products Administration (NMPA) in December 2022. We are now diligently preparing for the anticipated CNCT-19 launch in China, as we continue the development of the regulatory framework for BI-1206 in China. We completed dosing the first patient in the BI-1206 phase I trial in China. CB-5339 also received Clinical Trial Application approval from the NMPA in January 2023. The Phase 1 dose escalation and expansion study of CID-103, in patients with previously treated, relapsed or refractory multiple myeloma is closed to further accrual in France and the UK. We plan to build on the momentum to drive our portfolio forward by executing on several milestones in the quarters ahead."

Key Highlights for 2022

EVOMELA (melphalan for injection)

Prior to EVOMELA’s entry into the Chinese market, an average of 800 stem cell transplants per year were conducted in the multiple myeloma (MM) treatment setting. Following EVOMELA’s launch in August of 2019, CASI worked closely with KOLs to drive market awareness and expedite adoption in the Chinese market. In 2022, nearly 10,000 patients were treated with EVOMELA. CASI continues to pursue a similar strategy with respect to marketing efforts and physician visits to further the adoption of stem cell transplantation as a standard of care in the MM treatment setting and will continue working to address the persistent high unmet need in this patient population.

CNCT19 (CD19 targeted CAR-T)

Our partner, Juventas Cell Therapy Ltd ("Juventas"), continues the development of CNCT19, an autologous CD19 CAR-T investigative product for which CASI has co-commercial and profit-sharing rights. CNCT19 is being developed as a potential treatment for patients with hematological malignancies which express CD19 including, B-cell acute lymphoblastic leukemia ("B-ALL") and B-cell non-Hodgkin lymphoma ("B-NHL"). The Phase 1 studies in B-ALL and B-NHL in China have been completed by Juventas. The Phase 2 B-ALL and B-NHL registration studies are both currently enrolling. In December 2020, CNCT19 received Breakthrough Therapy Designation based on initial data from the ongoing single-arm, open-label, non-randomized, dose-escalation, Phase 1 study designed to determine the safety and efficacy of CNCT19 in B-ALL. Since then, the National Medical Products Administration (NMPA) granted CTA approval for CNCT19 in two indications (relapsed/refractory B-All and B-NHL) in Nov. 2019. Additionally, earlier this year, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Juventas, for CNCT19, for the treatment of patients with Acute Lymphoblastic Leukemia (ALL). Currently, there are no domestically developed CD-19 CAR-T therapy marketed in China. CASI intends for CNCT (CD19 CAR-T) to be locally developed and manufactured to be more affordable and widely accessible to patients. Dec. 15, 2022, China National Medical Products Administration (NMPA) has accepted the new drug application (NDA) from Juventas Cell Therapy, Ltd., (Juventas) for CNCT19.

CB-5339 (VCP/p97 inhibitor)

CB-5339 CTA application for the Multiple Myeloma indication is in preparation after receiving an acceptance letter for the CB-5339 IND package from the China Center of Drug Evaluation. Cleave Therapeutics is responsible for the ex-China development of CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, and is evaluating the molecule in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

BI-1206 (Anti-FcyRIIB antibody)

Along with our partner, BioInvent, we continue to progress the development and regulatory framework for BI-1206 in China. The National Medical Products Administration (NMPA) granted BI-1206 Clinical Trial Application (CTA) approval in December 2021. EC approval from a leading investigational site was granted in January 2022. BI-1206 is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin lymphoma, which includes patients with FL, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumors. Earlier this year the U.S. FDA granted orphan drug designation, for BI-1206, for the treatment of follicular lymphoma (FL), the most common form of slow-growing non-Hodgkin lymphoma (NHL).

CID-103 (Anti-CD38 Mab)

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. CASI maintains exclusive global rights and is developing CID-103 for the treatment of patients with multiple myeloma. The Phase 1 dose escalation and expansion study of CID-103 in patients with previously treated relapsed or refractory multiple myeloma is closed to further accrual in France and the UK. Future multiple myeloma development activities will be focused on China. In May 2022, CASI entered into a sublicense agreement with Precision Autoimmune Therapeutics, who will carry out the development activities for the autoimmune indications for CID-103.

Fourth Quarter & Full-Year 2022 Financial Results

Revenues mainly consist of product sales of EVOMELA. Total revenue was $43.1 million for the year ended December 31, 2022, including EVOMELA sales of $38.0 million, compared to $30 million for the year ended December 31, 2021.
Costs of revenues were $15.8 million for the year ended December 31, 2022 compared to $12.6 million for the year ended December 31, 2021.
General and administrative expenses for the year ended December 31, 2022 were $23.4 million, compared with $23.8 million for the year ended December 31, 2021.
Selling and marketing expenses for the year ended December 31, 2022, were $14.3 million, compared with $14.7 million for the year ended December 31, 2021.
Research and development expenses for the year ended December 31, 2022 were $16.0 million, compared with $14.4 million for the year ended December 31, 2021.
Net loss for the year ended December 31, 2022 was $40.3 million compared to $35.8 million for the year ended December 31, 2021. As of December 31, 2022, CASI had cash and cash equivalents of $47.1 million compared to $38.7 million as of December 31, 2021.

Further information regarding the Company, including its Annual Report on Form 20-F for the year ended December 31, 2022, can be found at www.casipharmaceuticals.com.

On April 26, 2023 Compugen Ltd. (Nasdaq: CGEN) (TASE:CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that it will present pre-clinical data on its lead pre-clinical asset COM503 in an oral presentation at the 20th CIMT (Free CIMT Whitepaper) annual meeting, Europe’s Cancer Immunotherapy Meeting, on May 3-5, 2023, in Mainz, Germany (Press release, Compugen, APR 26, 2023, https://www.prnewswire.com/news-releases/compugen-to-present-data-on-its-lead-pre-clinical-asset-com503-in-an-oral-presentation-at-the-20th-cimt-annual-meeting-301805591.html [SID1234630570]).

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"We are very excited to be presenting our pre-clinical data on COM503, a novel approach to harness cytokine biology to treat cancer, discovered using our proprietary computational discovery platform," said Eran Ophir, Ph.D., SVP Research and Drug Discovery at Compugen. "The inflammasome derived cytokine IL-18 is abundantly expressed in the tumor microenvironment (TME) but is blocked naturally by IL-18 binding protein, thereby preventing IL-18 from activating NK and T cells and its resulting anti-tumor activity. During our oral presentation at CIMT (Free CIMT Whitepaper) we will present pre-clinical data showing that COM503 binds with high affinity to IL-18 binding protein, freeing IL-18 and restoring NK and T cell activity. We will also show that blocking IL-18 binding protein prevents tumor growth and releases IL-18 to activate immunity in the TME without affecting peripheral immunity in murine tumor models. This is a differentiated approach to harness cytokine biology for cancer therapeutics. IL-18 is one of the rare cytokines which is naturally blocked by an endogenous binding protein, presenting a potentially unique opportunity to use a blocking antibody to release IL-18 at the site where it is needed to fight cancer, thereby potentially overcoming the limitations of systemically administered cytokines."

Presentation details:

Abstract number: 213
Title: Unleashing natural IL18 activity using an anti-IL18BP blocker antibody induces potent immune stimulation and anti-tumor activity
First Author: Menachem, A
Poster presentation: Thursday, May 4, 2023
Oral presentation: Friday, May 5, 2023
Presenter: Ophir, E

The abstract is available on the publication section of Compugen’s website at www.cgen.com. The poster and presentation will be made available on the publication section of Compugen’s website at www.cgen.com following presentation.