On April 12, 2022 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer, fibrosis and inflammation, reported that the preclinical data poster of BBT-207 was unveiled at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 being held from April 8-13 (Press release, Bridge Biotherapeutics, APR 12, 2022, View Source [SID1234612098]).

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BBT-207, a novel fourth-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) currently under IND-enabling preclinical development, is the company’s first internally discovered drug candidate with potent activity and efficacy against a broad range of EGFR mutations in non-small cell lung cancer (NSCLC), including C797S double mutations which arise after third-generation EGFR TKI treatment.

During the poster presentation, the company highlighted the potent anti-tumor efficacy of BBT-207, observed through both in-vitro and in-vivo studies. Biochemical and cellular in-vitro efficacy data showed that BBT-207 is highly potent against EGFR C797S double mutations inclusive of Del19/C797S (DC) and L858R/C797S (LC) as well as driver mutations including Del19 and L858R. The results obtained from the in-vitro biochemical study demonstrated that the IC50 for EGFR tyrosine kinase inhibition activity was achieved at 0.8 nM against DC and LC double mutations, while Osimertinib showed 304.4 nM and 573.7 nM. Further, an in-vitro study utilizing Ba/F3 cell lines showed that BBT-207 is mutant selective and has minimal effect on wild-type EGFR.

The poster also highlighted the pharmacokinetics (PK) data of BBT-207 in animal models, which showed that the plasma concentrations of the drug candidate remained above the IC50 (0.7-11.8 ng/mL) and IC90 values (5.2-39.9 ng/mL, unpublished) for triple, double, and single mutations in Ba/F3 cell lines.

In addition, in-vivo efficacy studies have shown that BBT-207 boasts robust efficacy and induced tumor regressions over 14 days in both single (driver) mutations and C797S double mutations, when dosed at 40mg/kg QD. Further, BBT-207 demonstrated dose dependent tumor regression efficacy against T790M double mutations, which indicates the potential of BBT-207 as a broad-spectrum frontline treatment for NSCLC.

"We are highly encouraged that our data presented at the AACR (Free AACR Whitepaper) annual meeting strongly supports that BBT-207 has the potential to be positioned as the best-in-class fourth-generation EGFR TKI targeting C797S double mutations as well as an advanced frontline treatment for EGFR-driven NSCLC," and "while third-generation EGFR TKIs are emerging as early-stage treatments, unmet medical needs relating to C797S mutations still exist. We look forward to entering the Phase 1 clinical study in metastatic NSCLC patients who harbor C797S mutations, in order to bring a novel therapy in the advanced cancer disease area," stated Jimmy Jin M.D., Ph.D., the Head of Discovery Biology of Bridge Biotherapeutics.

Bridge Biotherapeutics is also developing BBT-176, a fourth-generation EGFR TKI candidate that is designed to inhibit C797S triple mutations. As third-generation EGFR TKIs, such as Osimertinib, have emerged as first-line treatments for EGFR-mutant NSCLC, Bridge Biotherapeutics has reinforced its oncology pipelines by nominating BBT-207 in November 2021, as the first internally-discovered EGFR TKI inhibiting C797S double mutations. Armed with BBT-176 and BBT-207, the company aims to offer NSCLC patients comprehensive treatment solutions.

A copy of the poster presented at the AACR (Free AACR Whitepaper) 2022 annual meeting is available at: https://bit.ly/3O4xOJp

The details of the presentation are as follows:

Presentation Title: BBT-207, a 4th Generation EGFR TKI With Broad-Spectrum Activity to Both Treatment-Emergent and Drug- naïve Mutants for the Treatment of NSCLC

Session Category: Experimental and Molecular Therapeutics

Session Title: Tyrosine Kinase and Phosphatase Inhibitors (PO.ET06.01)

Session Date & Time: Tuesday, April 12, 2022, 1:30 pm — 5:00 pm

Abstract Number: 3346

On April 12, 2022 Enzychem Lifesciences (KOSDAQ: 183490), a late-stage biopharmaceutical company, reported that the abstract has been accepted for an Oral Proffered Paper at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) 2022 annual meeting, which will be held in hybrid on June 23-25, 2022 in Toronto, Canada (Press release, Enzychem Lifesciences, APR 12, 2022, View Source [SID1234612096]).

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The abstract highlights the new clinical data from Enzychem’s Phase 2 US clinical trial evaluating EC-18 in head and neck cancer (HNC) patients with chemoradiation-induced oral mucositis (CRIOM). It will be presented by the highest enrolling site’s principal investigator, Christina Henson, M.D, a board-certified Radiation Oncologist and Residency Program Director for Radiation Oncology at the University of Oklahoma.

"I am honored to present Enzychem’s clinical data at the MASCC/ISOO 2022 annual meeting," said Dr. Christina Henson. "This compelling Phase 2 data shows that EC-18 will become an important treatment option for cancer patients undergoing chemoradiation therapy with currently no approved therapies."

The details of the presentation are as follows:

Title: Phase 2, Randomized, Double-Blind Trial of EC-18 to Alter the Severity and Course of Oral Mucositis Due to Chemoradiation for Head and Neck Cancer
Presenter: Christina Henson, M.D
Date: June 24th, 2022

On April 12, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, reported that the first patient has been dosed in the Company’s Phase 1 clinical trial of IO-202, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with advanced solid tumors (NCT05309187) (Press release, Immune-Onc Therapeutics, APR 12, 2022, View Source [SID1234612095]).

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"We are very pleased to announce the initiation of our Phase 1 study of IO-202 in solid tumors, a significant achievement in our development strategy targeting the LILRB family of myeloid checkpoints to overcome immune suppression in the tumor microenvironment," said Paul Woodard, M.D., chief medical officer of Immune-Onc. "We believe by targeting the LILRB4 checkpoint, IO-202 may reverse the immunosuppressive effects of tumor associated monocytic myeloid cells, enhance dendritic cell function, and promote T cell activation – thereby, unleashing the antitumor activities of the immune system and increasing the therapeutic benefit of T cell checkpoint inhibitors. We look forward to conducting this study and assessing the potential of IO-202 as a monotherapy and in combination with pembrolizumab across multiple solid tumor types."

This study consists of two parts: a dose escalation portion to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-202 alone and in combination with pembrolizumab, an anti-PD-1; and a dose expansion portion using the recommended Phase 2 dose of IO-202 in combination with pembrolizumab in multiple solid tumor types. Various biomarkers will be explored to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals for IO-202 as a monotherapy and as a combination with a PD-1 inhibitor in patients with advanced solid tumors.

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune inhibitory transmembrane receptor expressed by monocytic myeloid cells, including dendritic cells, monocytes, monocytic myeloid-derived suppressor cells and tumor-associated macrophages. LILRB4 inhibits antigen-presenting cell function, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells. Immune-Onc and The University of Texas published pioneering research in Nature illuminating the role of LILRB4 in immune suppression and tumor infiltration in acute myeloid leukemia (AML) and presented the rationale for targeting LILRB4 in solid tumors at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

ABOUT IO-202

IO-202 is a first-in-class LILRB4 antagonist antibody with broad potential as an immunotherapy in both blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical studies showed that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.

IO-202 has two ongoing clinical studies: Its first Phase 1 trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as a monotherapy and in combination with azacitidine (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020 and Fast Track designation for relapsed or refractory AML in 2022. The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).

On April 12, 2022 Lysogene (FR0013233475 – LYS) (Paris:LYS), a phase 3 gene therapy platform Company targeting central nervous system (CNS) diseases, reported that it has exercised its option to enter into an exclusive worldwide license agreement with Yeda Research and Development Co Ltd, the commercial arm of the Weizmann Institute of Science, for the development and commercialization of a gene therapy candidate for the treatment of neuronopathic Gaucher disease and Parkinson disease (PD) with GBA1 mutations (Press release, Lysogene, APR 12, 2022, View Source [SID1234612094]).

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Since 2020, Lysogene has been collaborating with Prof. Anthony Futerman at the Weizmann Institute of Science with the aim of developing a novel AAV gene therapy approach for neuronopathic Gaucher disease, Parkinson disease, and other diseases associated with mutations of the GBA1 gene. Lysogene has provided expertise in AAV vector design and production, while Prof. Futerman’s lab provided glucocerebrosidase variants with enhanced biological properties. After approximately 20 months of successful collaboration, Lysogene decided to exercise its option to license the program on the basis of positive preliminary biological proof of principle studies.

Under the terms of the agreement, Lysogene will be responsible for the preclinical and clinical development, manufacturing, regulatory activities, and commercialization of the drug candidate, globally. Yeda Research and Development Co Ltd will be eligible for royalties and other payments.

Ralph Laufer, CSO of Lysogene, commented: "We are thrilled to add to our R&D pipeline a new promising gene therapy asset, which addresses high unmet medical needs in Gaucher disease, as well as broader indications, such as PD-GBA. The first results obtained by Prof. Anthony Futerman’s team are promising and we look forward to expanding them in additional preclinical studies. The cost of these preclinical studies will not affect our cash runway. We continue to replenish our early-stage pipeline to position Lysogene as a key player in the field of gene therapy translational science."

"We are excited to expand our successful research collaboration with Lysogene based on the novel research by Prof. Futerman and his colleagues," said Elik Chapnik, Sr. Director of Business Development at Yeda. "We are confident that this new licensing deal has the potential to bring transformative therapeutic options to patients suffering from genetically-defined CNS diseases with significant unmet need, such as neuronopathic Gaucher disease."

On April 12, 2022 Chimeron Bio, an RNA company developing self-amplifying RNA (saRNA) vaccines and therapeutics designed on its proprietary ChaESAR RNA delivery platform, reported it has entered into a manufacturing agreement with FUJIFILM Diosynth Biotechnologies (FDB), a leading Contract Development and Manufacturing Organization (CDMO) with experience in the development and manufacture of recombinant biopharmaceuticals and viral gene therapies, to advance the Company’s Oncology portfolio to the clinic (Press release, Chimeron Bio, APR 12, 2022, View Source [SID1234612092]).

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Chimeron Bio selected FUJIFILM Diosynth Biotechnologies as its partner for the transfer and scale up of their drug substance manufacturing process. Drug substance manufacturing will be carried out in FUJIFILM Diosynth Biotechnologies’ state-of-the-art cGMP manufacturing facility in College Station, Texas. Materials from this partnership will help facilitate Chimeron’s IND-enabling work and entry into the clinic.

"We selected FUJIFILM Diosynth Biotechnologies as our manufacturing partner because of their proven track record in the advanced therapies space," said Jolly Mazumdar, chief executive officer, Chimeron Bio. "FDB really understands our ChaESAR platform and pipeline potential, making them the best partner to scale up our processes and help bring our ground-breaking approach for the treatment of underserved patients closer to reality."

"Chimeron’s ChaESAR platform has the potential to impact how we bring treatments and therapies to patients," said Gerry Farrell, chief operating officer, FUJIFILM Diosynth Biotechnologies, Texas site. "We are delighted to be the partner of choice to bring their technology into our GMP facility and produce Bulk Drug Substance to support their clinical trials."

About Chimeron’s ChaESAR platform

The ChaESAR platform is a self-assembling biosynthetic non-lipid nanoparticle (NLNP) comprising a self-amplifying RNA genome encased within a capsid with a surface ligand of choice.