Entry into a Material Definitive Agreement

On April 26, 2023 (the "Closing Date"), Eterna Therapeutics Inc., a Delaware corporation (the "Company"), reported to have entered into an asset purchase agreement (the "Purchase Agreement"), together with Exacis Biotherapeutics Inc. ("Exacis"), the stockholders party thereto (the "Stockholders") and, with respect to specified provisions therein, Factor Bioscience Limited ("Factor") (Filing, 8-K, Brooklyn ImmunoTherapeutics, APR 26, 2023, View Source [SID1234630829]). Pursuant to the Purchase Agreement, the Company acquired from Exacis substantially all of Exacis’ intellectual property assets (the "Purchased Assets"), including all of Exacis’ right, title and interest in and to an exclusive license agreement by and between Exacis and Factor (the "Purchased License"). The Company assumed none of Exacis’ liabilities, other than liabilities under the Purchased License that accrue subsequent to the Closing Date.

In consideration for the Purchased Assets, on the Closing Date, the Company issued to Exacis an aggregate of 69,343 shares of the Company’s common stock, par value $0.005 per share ("Common Stock"), which shares are subject to a 12-month lockup, pursuant to which Exacis may not sell or otherwise transfer such shares. The Company additionally agreed to make the following contingent payments: (i) if, at any time during the three-year period commencing on the Closing Date and ending on the three-year anniversary of the Closing Date, the Company’s market capitalization equals or exceeds $100.0 million for at least ten consecutive trading days, then the Company will issue to Exacis a number of shares of Common Stock equal to (x) $2.0 million divided by (y) the quotient of $100.00 million divided by the number of the Company’s then issued and outstanding shares of Common Stock; (ii) if, at any time during the three-year period commencing on the Closing Date and ending on the three-year anniversary of the Closing Date, the Company’s market capitalization equals or exceeds $200.0 million for at least ten consecutive trading days, then the Company will issue to Exacis a number of additional shares of Common Stock equal to (x) $2.0 million divided by (y) the quotient of $200.00 million divided by the number of the Company’s then issued and outstanding shares of Common Stock; and (iii) during the five-year period commencing on the Closing Date and ending on the five-year anniversary of the Closing Date (the "Five-Year Period"), the Company will pay or deliver to Exacis 20% of all cash or other consideration (collectively, "License Consideration") actually received by the Company during the Five-Year Period from (i) third-party licensees or sublicensees of the intellectual property rights acquired by the Company from Exacis pursuant to the Purchase Agreement, or (ii) subject to certain exceptions, the sale of such intellectual property rights; provided, that the License Consideration shall not in any event exceed $45.0 million.

The Purchase Agreement contains customary representations and warranties of the parties thereto, and Exacis and the Stockholders have agreed to five-year non-competition and non-solicitation covenants in favor of the Company.

In the Purchase Agreement, Exacis represented to the Company that it is an "accredited investor", as defined in Rule 501 promulgated under the Securities Act of 1933, as amended (the "Securities Act"), and the Company’s offer and sale of the shares of Common Stock described above have been made in reliance upon the exemptions from the registration requirements of the Securities Act pursuant to Section 4(a)(2) thereof and Rule 506(b) of Regulation D promulgated thereunder.

Dr. Matthew Angel, the Company’s President and Chief Executive Officer, is the co-founder, President, CEO, and a director of Factor Bioscience Inc., which is the parent of Factor and a wholly owned subsidiary of Factor Bioscience LLC, the latter of which is the majority stockholder of Exacis. Dr. Gregory Fiore, one of the Company’s directors, is the Chief Executive Officer and a 10% stockholder of Exacis. The Purchase Agreement and the transactions contemplated thereby were approved by the audit committee of the Company’s board of directors (the "Board"), as well as by all of the Company’s disinterested directors, comprising a majority of the Board.

The foregoing description of the Purchase Agreement is only a summary and is qualified in its entirety by reference to the full text of the Purchase Agreement, a copy of which is filed herewith as Exhibit 10.1 and incorporated herein by reference.

The Purchase Agreement is filed with this Current Report on Form 8-K to provide securityholders with information regarding its terms. It is not intended to provide any other factual information about the Company, Exacis or any other party thereto. The representations, warranties and covenants contained in the Purchase Agreement were made solely for purposes of such agreement and as of specific dates, are solely for the benefit of the parties to the Purchase Agreement, may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures made for the purpose of allocating contractual risk between the parties to the Purchase Agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to securityholders. Securityholders should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company, Exacis or any other party thereto. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Purchase Agreement, which subsequent information may or may not be fully reflected in the Company’s public disclosures, except to the extent required by law.

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IN8bio Announces Oral Presentation of New INB-200 Phase 1 Data in Glioblastoma (GBM) to be Presented at 2023 ASCO Annual Meeting

On April 26, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported an oral presentation at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago from June 2-6, 2023 (Press release, In8bio, APR 26, 2023, View Source [SID1234630670]). The oral presentation will highlight new Phase 1 study results evaluating the safety, tolerability and efficacy of INB-200, a potentially promising treatment for newly diagnosed glioblastoma multiforme (GBM).

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"We are excited that the Phase I trial of INB-200 in GBM has been selected for an oral presentation at ASCO (Free ASCO Whitepaper)," said William Ho, CEO and co-founder of IN8bio. "GBM is a highly aggressive and difficult-to-treat brain cancer, where treatment options have remained largely unchanged for almost two decades. The current median progression-free survival with the standard of care for GBM is 6-7 months and overall survival is only 14-16 months. We believe that our unique approach to solid tumor cancers targeting the DNA damage response with our genetically engineered gamma-delta T cells may eliminate more cancer cells and potentially prolong the time to relapse or death."

Details of the oral presentation are as follows:

Abstract Title: INB-200 Phase I Study of Gene Modified Autologous Gamma-Delta (γδ) T Cells in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM) Receiving Maintenance Temozolomide (TMZ)
Abstract #: 2007
Session: S100a – Central Nervous System Tumors
Date and Time: Friday, June 2, 2023, 2:45 PM CDT (3:45 PM EDT)

The abstract will be available on Thursday, May 25 at 5:00 PM EDT on ASCO (Free ASCO Whitepaper).org.

About INB-200

INB-200 is a genetically modified autologous drug resistant immunotherapy (DRI) product candidate for the treatment of solid tumors. This novel platform utilizes genetic engineering to generate chemotherapy resistant gamma delta T cells which can be administered concurrently with standard-of-care treatment in solid tumors. This is a powerful, synergistic treatment approach enabling gamma-delta T cells to persist in the presence of chemotherapy, and maintain their natural ability to recognize, engage and kill cancer cells.

INB-200 is the first genetically engineered gamma-delta T cell therapy to be administered to patients with solid tumors and our initial indication is in GBM.

FORE Biotherapeutics Announces Two Abstracts Accepted for Presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

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.

Novocure Announces Presentation of Results of the LUNAR Phase 3 Clinical Trial in Non-Small Cell Lung Cancer at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

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.

Agenus to Present at the American Society of Clinical Oncology 2023 Annual Meeting

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).