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Positive Pre-IND meeting with US FDA for Phase I CAR-T Study

On March 20, 2023 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical stage cell therapy company and an Australian leader in cell therapy, reported that it has successfully completed a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) and has received positive feedback on the development plan for CHM 2101 (Press release, Chimeric Therapeutics, MAR 20, 2023, View Source [SID1234629156]).

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This is a significant milestone towards an Investigational New Drug (IND) Application and Phase 1 clinical trial for CHM 2101. The objective of the meeting was to facilitate FDA regulatory communication and guidance through the IND submission process for CHM 2101. The pre-IND meeting package included details and specific questions regarding the clinical development plan and technical operations, including drug product manufacturing and quality release plan for CHM 2101.

The company received positive written responses from the FDA that provide a clear path to an IND submission for CHM 2101 and validates the team’s efforts and accomplishments in preparing CHM 2101 for clinic.

"The positive feedback we received from the FDA was encouraging and aligns clearly with our development plan for CHM 2101," said Jennifer Chow, Chimeric’s Chief Executive Officer and Managing Director. "We are highly appreciative of the FDA’s support and guidance as this brings us closer to potentially transforming the lives of patients with gastrointestinal and neuroendocrine tumours."

CHM 2101 is a first in class, 3rd generation autologous CAR T cell therapy invented at the worldrenowned cell therapy centre, the University of Pennsylvania. Preclinical evidence for CHM For personal use only 2101 was published in March 2022 in Nature Cancer, with the data demonstrating strong evidence of efficacy with complete eradication of eight different types of gastrointestinal cancers with no relapse or toxicity. Chimeric is focused on advancing CHM 2101 towards a phase 1A clinical trial in gastrointestinal and neuroendocrine tumours.

Evotec SE to announce preliminary financial results for fiscal year 2022 on 28 March 2023

On March 20, 2023 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported its preliminary financial results for 2022 on Tuesday, 28 March 2023 (Press release, Evotec, MAR 20, 2023, View Source [SID1234629096]).

The Company is going to hold a conference call to discuss the results as well as provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Tuesday, 28 March 2023

Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

To join via phone, please pre-register via the following link: View Source;linkSecurityString=94e63fcfc

You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage www.evotec.com shortly before the event.

The on-demand version of the webcast will be available on our website: View Source

Eterna Therapeutics Reports Financial Results for Fourth Quarter and Full Year 2022 and Recent Business Highlights

On March 20, 2023 Eterna Therapeutics Inc. (Nasdaq: ERNA) ("Eterna" or the "Company"), a life science company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new medicines, reported financial results for the quarter and year ended December 31, 2022 and provided a business update (Press release, Eterna Therapeutics, MAR 20, 2023, View Source [SID1234629092]).

"2022 was a transformational year for Eterna, and we believe that we made significant progress executing on our core strategy of unlocking the potential of mRNA cell engineering through strategic collaboration," said Matt Angel, Ph.D., Chief Executive Officer of Eterna. "We remained focused on expanding our capabilities to support the development of next-generation mRNA-based therapeutic products, and deploying our extensive portfolio of in-licensed mRNA cell engineering patents through strategic partnerships. We believe that our accomplishments have positioned us to drive value for shareholders, partners, and patients, and for continued growth across our business."

Significant milestones in 2022 and year-to-date 2023 include:

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In February 2023, Eterna entered into an income generating, exclusive cell line customization and license agreement with Lineage Cell Therapeutics, Inc. ("Lineage") under which Eterna has agreed to develop novel gene-edited pluripotent stem cell (iPSC) lines, which Lineage may evaluate for development into cell transplant therapies for the treatment of certain central nervous system (CNS) disorders and other neurology indications. Eterna is the exclusive licensee of the key intellectual property underlying this partnership. This is Eterna’s first income generating agreement, leveraging its extensive patent portfolio in-licensed from its partner, Factor Bioscience Limited ("Factor").

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In January 2023, Eterna appointed Matt Angel, Ph.D. as CEO and President of Eterna. Dr. Angel had previously served as Interim CEO and President of Eterna since May 2022, and he has continued to serve on the Company’s Board of Directors.

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In November 2022, Eterna entered into an amended license agreement with Factor under which Eterna obtained expanded rights to sublicense Factor’s entire portfolio of more than 100 patents related to mRNA-based cell engineering technologies to third parties.

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In October 2022, Eterna entered into a sublease agreement with Bristol Myers Squibb ("BMS") for the entire top floor (approximately 45,000 square feet) of 250 Water Street, a new approximately 450,000 square feet building located at the new Cambridge Crossing development in the heart of the greater Boston biotech community. BMS has agreed to provide $8.6 million for Eterna to build out the space into a state-of-the-art lab and office.

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In October 2022, the Company completed its name change from Brooklyn ImmunoTherapeutics, Inc. to Eterna Therapeutics Inc. to reflect the Company’s focus on deploying its extensively patented in-licensed mRNA cell engineering technologies.

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In September 2022, Eterna entered into a Master Services Agreement ("MSA") and first work order under the MSA with Factor, giving Eterna access to Factor’s research laboratory facilities, scientific equipment, training in mRNA, iPSC and gene-editing technology, protocols related to the development of mRNA cell engineering products, and in vitro transcription templates, mRNA constructs, and iPS cells.

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In August 2022, Eterna entered into a sponsored research agreement with Michael Andreeff, M.D., Ph.D., Professor of Leukemia at The University of Texas MD Anderson Cancer Center. Under the agreement, Dr. Andreeff will evaluate the capacity of Eterna’s gene-edited iPSC-derived therapeutic candidates to stimulate enhanced immune responses, including their effects on various aspects of T-cell mediated immunity, and to promote multilineage differentiation and hematopoietic regeneration in vivo.

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In March and December 2022, Eterna announced the completion of two private placements yielding combined gross proceeds of approximately $20 million.

Fourth Quarter and Full Year 2022 Financial Results

Research and development expenses were $2.0 million for the fourth quarter of 2022, which included $0.2 million of non-cash stock-based compensation expense. For the full year of 2022, research and development expenses were $10.4 million, which included $1.2 million of non-cash stock-based compensation expense. General and administrative expenses were $2.8 million for the fourth quarter of 2022, which included $0.2 million of non-cash stock-based compensation expense. For the full year of 2022, general and administrative expenses were $16.8 million, which included $1.7 million of non-cash stock-based compensation expense. The impairment of in-process research and development was approximately $6.0 million for the full year of 2022 and related to the Company’s decision to not further develop the IRX-2 product candidate associated with its legacy immunotherapy business. There was no such charge in the fourth quarter of 2022. The change in the fair value of warrant liabilities was a credit of $0.3 million for the fourth quarter of 2022 and a credit of $10.8 million for the full year of 2022.

Net loss for the fourth quarter of 2022 was $4.5 million, or $1.24 per share. For the full year of 2022, net loss was $24.6 million, or $8.06 per share. As of December 31, 2022, Eterna had cash of approximately $15.5 million, of which approximately $4.1 million was restricted cash, collateralizing a letter of credit with respect to our BMS sublease.

Earlier today, Eterna filed its Annual Report on Form 10-K for the year ended December 31, 2022 with the Securities and Exchange Commission.

CoImmune Obtains License to IL-18 Armored CAR Technology

On March 20, 2023 CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, reported it has exercised its option to obtain an exclusive license in the CD19-targeted, allogeneic cell therapy field to IL-18 Armored Chimeric Antigen Receptor (CAR) technology under a prior agreement with Memorial Sloan Kettering Cancer Center (MSK) (Press release, CoImmune, MAR 20, 2023, View Source [SID1234629075]). The company plans to couple the technology with allogeneic Cytokine Induced Killer (CIK) cells to launch the clinical development of CMN-008 (Armored CAR-CIK cells) with CD19 as the initial target in B-cell malignancies.

"We are pleased to obtain an exclusive license in the CD19-targeted, allogeneic cell therapy field to IL-18 Armored CAR technology developed by the renowned researchers at MSK that significantly strengthens our position as a leader in the field of immuno-oncology," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "As we advance towards the clinical development of a new investigational product with this technology in combination with our proprietary CIK cells, it is important to note that this is not simply another CD19 program. We are preparing to launch the first corporate-sponsored Armored CAR-CIK trial for a B-cell malignancy, and we believe this is an opportunity to dramatically change the therapeutic model to a potential outpatient procedure."

CoImmune designed CMN-008 using a highly potent proprietary CAR-CD19/IL-18 construct co-developed with MSK scientists. The CIK cells are genetically modified using a non-viral bicistronic vector encoding both CAR-CD19 and IL-18 that ensures all CAR+ cells are IL-18+. CMN-008 is manufactured from healthy donor cells requiring minimal tissue match to the patient and is more cost effective to produce than autologous CAR-T therapies.

"Traditional CAR-T therapies require preconditioning lymphodepletion prior to administration which frequently results in infection complications requiring hospitalization," said Renier J. Brentjens, M.D., Ph.D., Deputy Director and Chair of Medicine, Roswell Park Comprehensive Cancer Center, who previously developed the IL-18 Armored CAR technology at MSK. "In animal models evaluating IL-18 Armored CAR technology, there was an increase in durability of responses and anti-tumor activity without requiring lymphodepletion, which could be a real game changer and warrants further evaluation."

CoImmune intends to file an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) for CMN-008 in mid-2023 followed by the initiation of a Phase 1 clinical trial.

Phanes Therapeutics Announces First Patient Dosed in Phase 1 Study of PT886 for Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinomas

On March 20, 2023 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, reported that the first patient has been dosed in the phase 1 clinical study (NCT05482893) of PT886, a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47 for the treatment of gastric, gastroesophageal junction and pancreatic adenocarcinomas (Press release, Phanes Therapeutics, MAR 20, 2023, View Source [SID1234629074]). PT886 was assembled using Phanes’ proprietary bispecific antibody platforms PACbody and SPECpair and was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA last year.

PT886 directly kills tumor cells via both the ADCP activity of macrophages and ADCC activity of NK cells, and by targeting both claudin 18.2 and CD47 overexpressed on the surface of tumor cells, it broadens the tumor killing spectrum. Additionally, PT886 is expected to induce the presentation of tumor neoantigens by channeling tumor cells into phagocytotic antigen presenting cells (APCs) and stimulate adaptive immune system by indirectly activating T cell killing of claudin 18.2 low or negative tumor cells through recognition of tumor neoantigens. The anti-CD47 arm of PT886 is highly differentiated and has demonstrated minimum binding to human red blood cells while maintains strong binding activity to CD47 on tumor cells. "PT886 targets a validated tumor associated antigen in claudin 18.2 with enhanced anti-tumor activity and broadened tumor killing spectrum through a best-in-class anti-CD47 arm. It is a product of Phanes’ ingenious innovation in creative design of both novel therapeutic approaches and practical technologies," said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics.

The multi-center Phase I clinical trial of PT886 is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate. Enrollment in the trial is open to individuals aged 18 years and older who have measurable disease with at least 1 lesion amenable to response assessment per RECIST 1.1 criteria, adequate organ function, and an ECOG performance status of 0 to 1.

For more information on the study please visit ClinicalTrials.gov (NCT05482893).