Cue Biopharma’s Therapeutic Immuno-STAT Biologics to be Featured in Oxford University Presentation at the Biophysical Society 2022 Annual Meeting

On February 15, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported that the company’s therapeutic Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are scheduled to be featured in an Oxford University poster presentation at the Biophysical Society Annual Meeting taking place on February 19-23, 2022 at the Moscone Center in San Francisco, California (Press release, Cue Biopharma, FEB 15, 2022, View Source [SID1234608264]). Cue Biopharma entered into a strategic research collaboration with Dr. Michael Dustin and the University of Oxford in May 2020 to determine the molecular mechanisms underlying the activity of its IL-2 based CUE-100 series biologics.

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Presentation Details
Title: Integration of IL-2 Signaling at the Immunological Synapse
Presenter: Dr. Jesusa Capera Aragones of the Kennedy Institute at the University of Oxford
Poster Session: Membrane Receptors and Signal Transduction
Poster #: 414/B238
Poster Location: Exhibit Hall ABC
Date & Time: February 20, 2022 at 1:45 p.m. PST or 4:45 p.m. EST

"It has traditionally been the view that cytokine signaling follows T cell receptor signaling, however this study demonstrates that antigen-T cell receptor signaling and cytokine signaling can work side-by-side to impact T cell responses through the immunological synapse," said Dr. Dustin, professor of immunology and Wellcome Trust Principal Research Fellow, director of research of the Kennedy Institute at the University of Oxford.

Dr. Anish Suri, president and chief scientific officer of Cue Biopharma commented, "The mechanistic insights provided by the elegant work conducted by Dr. Aragones and Dr. Dustin supports the central hypothesis of Immuno-STATs specifically – that concurrent delivery of antigen and interleukin 2 (IL-2) signals results in robust synapse formation, providing for selective T cell activation, a supposition now being clinically validated through the development of CUE-101, our lead and representative IL-2 based drug product candidate from the CUE-100 series."

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a pMHC to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

Entry into a Material Definitive Agreement

On February 15, 2022, Cannabics Pharmaceuticals Inc. (the "Company") reported that entered into a forbearance agreement (the "Agreement") with an institutional investor (the "Investor") relating to that certain Senior Secured Promissory Note in the original principal amount of $1,375,000 due on December 21, 2021 (the "Note") (Filing, 8-K, Cannabics Pharmaceuticals, FEB 15, 2022, View Source [SID1234608223]). The Note was issued by the Company to the Investor in connection with that certain Securities Purchase Agreement dated as of December 16, 2020, and amended as of February 22, 2021.

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Pursuant to the Agreement, the Investor, through March 7, 2022 (the "Forbearance Period"), agreed to forbear from exercising any rights and remedies against the Company related to the outstanding payments under the Note and to waive certain other defaults under the Note and related rights pursuant to the Registration Rights Agreement entered into in December 2020 between the Company and the Investor. This description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the form of Forbearance Agreement filed as Exhibit 10.1 to this report and is incorporated herein by reference.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Corcept Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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Evotec SE Invests In Data-Driven Biotechnology Company IMIDomics, Inc.

On February 15, 2022 Evotec SE (FSE: EVT; MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that has made an equity investment in IMIDomics, Inc., a privately held global biotechnology company focused on the discovery and development of new targets and medicines for the treatment of patients with immune-mediated inflammatory diseases ("IMIDs") (Press release, Evotec, FEB 15, 2022, View Source [SID1234608174]).

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IMIDs affect nearly one in ten people – limiting quality of life and creating significant challenges to physical and mental well-being. The complexity of these diseases means even getting a diagnosis can be a long-term struggle for patients, and then finding a treatment that works can be a frustrating, time-consuming trial and error process.

"Evotec and IMIDomics are perfectly aligned on their goal to leverage data to discover and develop precise-acting, effective medicines of the future," said Dr Werner Lanthaler, Chief Executive Officer of Evotec. "By joining IMIDomics as a minority shareholder, we are excited to further grow our EVOequity portfolio of highly promising companies with complementary technologies and assets."

In conjunction with the investment, an Evotec representative will join the IMIDomics board of directors. No financial details were disclosed.

Celularity Receives Orphan Drug Designation from U.S. FDA for its NK Cell Therapy CYNK-101 in Development for the First-Line Treatment of Advanced HER2/neu Positive Gastric and Gastroesophageal Junction Cancers

On February 15, 2022 Celularity Inc. (Nasdaq: CELU) (Celularity), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, reported the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its investigational natural killer (NK) cell therapy, CYNK-101, for treatment of gastric/gastroesophageal junction cancer (Press release, Celularity, FEB 15, 2022, View Source [SID1234608167]). CYNK-101 is being developed as a first-line treatment in combination with standard chemotherapy, trastuzumab and pembrolizumab in patients with locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. CYNK-101 is an investigational genetically modified NK cell therapy designed to synergize with approved antibody therapeutics through enhanced antibody-dependent cellular cytotoxicity (ADCC).

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"This designation underscores the significant unmet need for these patients and CYNK-101’s potential in a new first-line treatment strategy," said Robert Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. "We are grateful for the FDA’s recognition of this potential treatment paradigm through Orphan Drug Designation and Fast Track designation, which we received earlier this year. At Celularity, we are committed to forging new treatment strategies that leverage the unique properties of placental-derived cellular therapies to improve the lives of patients with this difficult-to-treat cancer."

Andrew Pecora, M.D., President of Celularity, added, "The addition of cleavage-resistant CD16 significantly augments the antibody-dependent activity of our natural killer cell therapy. To date, we have seen promising clinical data from our unmodified NK cellular therapies and believe this genetically modified construct has significant potential in a range of indications. In our Phase 1/2a clinical trial of CYNK-101, we are excited to explore a multipronged strategy of our NK cells and activated T cells through check point inhibition to potentially enhance overall outcomes achieved with traditional chemotherapy and Traztuzumab in HER2/neu positive G/GEJ adenocarcinoma."

This is the fifth designation received by Celularity from the FDA in the past 12 months and follows fast track designations for CYNK-101, in development for the first-line treatment of advanced HER2/neu positive G/GEJ cancers, and CYNK-001, an unmodified investigational NK cell therapy in development for the treatment of acute myeloid leukemia and in development for the treatment of recurrent glioblastoma multiforme, as well as orphan drug designation for CYNK-001 for the treatment of malignant gliomas.

About Orphan Drug Designation

The Orphan Drug Act (ODA) provides incentives to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases and conditions. To qualify for orphan designation, both the drug and the condition must meet criteria specified in the ODA and FDA’s implementing regulations. Orphan designation qualifies the drug sponsor for development incentives including tax credits for qualified expenses, exemption from the FDA user fee, and the potential for seven years of exclusivity for a drug that obtains approval.

About Gastric Cancer

Gastric cancer is the fifth most common cancer worldwide. Despite recent improvements in treatment quality and options, advanced gastric cancer remains one of the hardest to cure cancers, with a median overall survival (OS) of 10–12 months and a five-year OS of approximately 5–20%.

About CYNK-101

Celularity’s lead therapeutic candidate based on its placental-derived genetically modified NK cell type is CYNK-101, an allogeneic, off-the-shelf human placental CD34+-derived NK cell product genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. Currently CYNK-101 is being developed as a treatment in combination with standard chemotherapy, trastuzumab and pembrolizumab for HER2 positive overexpressing gastric or gastroesophageal junction adenocarcinoma. The safety and efficacy of CYNK-101 have not been established, and CYNK-101 has not been approved for any use by the FDA or any other analogous regulatory authority.