On November 28, 2022 Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies, reported the U.S. Patent Office has issued a key patent covering the company’s Shielded-Cell & Immunotherapy Pairs (SCIP) platform (Press release, Cimeio Therapeutics, NOV 28, 2022, https://www.cimeio.com/2022/11/28/cimeio-therapeutics-announces-issuance-of-key-patent-covering-cell-therapy-platform/?utm_source=rss&utm_medium=rss&utm_campaign=cimeio-therapeutics-announces-issuance-of-key-patent-covering-cell-therapy-platform [SID1234624489]).

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U.S. Patent No. 11,499,168 covers a method for in vivo selective depletion of edited primary hematopoietic cells or non-edited primary hematopoietic cells. This method was first discovered and developed in the lab of company founder Lukas Jeker, M.D., Ph.D., at the University of Basel, and is exclusively licensed to Cimeio.

"This comprehensive intellectual property provides broad protection for our platform," said Cimeio CEO Thomas Fuchs. "We believe this patent, along with those we’ve filed for our target antigen and immunotherapy portfolio, cements us as a leader in the emerging field of cell shielding and will enable the broad development of our SCIP platform."

Cimeio uses genome editing to insert novel protein variants into hematopoietic stem cells or other types of cells, allowing the cells to maintain their function while making them resistant to paired immunotherapy depletion. Cimeio’s platform has effectively shielded cells from depletion mediated by antibodies, T-cell engagers, ADCs, and CAR-T cells in preclinical studies.

The company is advancing its first programs towards clinical development for genetic and malignant hematologic diseases. As previously disclosed, two posters for the company’s pipeline programs will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2022 in New Orleans.

On November 28, 2022 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena"), a targeted oncology company forging new territory in patient-directed cancer treatment, reported a next-generation mitogen-activated protein kinase (MEK)-RAF complex inhibitor, IK-595, has been nominated as the company’s first development candidate in the RAS pathway (Press release, Ikena Oncology, NOV 28, 2022, View Source [SID1234624488]).

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The RAS pathway is implicated in at least half a million new cancer diagnosis each year in the United States alone. Ikena aims to target the pathway on multiple levels, including preventing known resistance mechanisms to achieve deep and sustained responses. Ikena’s new development candidate, IK-595, traps MEK and RAF in an inactive complex, more completely inhibiting RAS signals than existing inhibitors. IK-595’s ability to complex CRAF, in particular, prevents a well-recognized signaling bypass mechanism that cancer cells employ to drive therapeutic resistance to other drugs in this class. In addition, trapping CRAF in an inactive complex prevents the kinase independent anti-apoptotic function in RAS and RAF mutant cancers, a mechanism that cannot be addressed with first generation MEK inhibitors or pan-RAF inhibitors. IK-595 is being developed as an oral therapy, with a half-life enabling a pharmacokinetic profile potentially superior to other drugs, with the goal of developing an optimal therapeutic window for patients. The company plans to submit an investigational new drug application (IND) for IK-595 to the US Food & Drug Administration (FDA) in the second half of 2023.

"I am thrilled to announce this addition to our pipeline, one that adds to our holistic approach to the Hippo & RAS oncosignaling network. IK-595 inhibits multiple nodes of MEK-RAF signaling, including avoiding known mechanisms of resistance," said Mark Manfredi, PhD, Ikena’s Chief Executive Officer. "The industry’s excitement about MEK inhibition stems from its great potential as a target, but the challenges of CRAF bypass and achieving optimal target inhibition have kept first generation treatments from meeting the full potential of the target. We are hopeful that our MEK-RAF trapping approach with an optimized therapeutic window can make IK-595 a game-changing candidate for multiple indications in the RAS space."

Development Highlights, Corporate Updates, and Upcoming Milestones

Advancing new development candidate, IK-595, through IND-enabling studies, targeting MEK-RAF through novel mechanisms aiming to address existing gaps in the MEK inhibitor space
Preclinical differentiation data planned for presentation in the first half of 2023
IND targeted in the second half of 2023
Progressing novel, paralog-selective transcriptional enhanced associate domain (TEAD) inhibitor, IK-930, in the clinic and further defining differentiation profile from panTEAD inhibition
Monotherapy program progressing as planned, advanced through multiple dose escalation cohorts
Preclinical data on differentiation and advantages of paralog selectivity planned for presentation in first half of 2023
Initiation of osimertinib combination cohort clinical program expected in first half of 2023
Initial clinical data from IK-930 monotherapy program expected in second half of 2023
Following a portfolio review, discontinuing the internal clinical development of the EP4 antagonist IK-007 and exploring strategic alternatives for this program
Clinical data from IK-007 in microsatellite stable colorectal cancer (MSS-CRC) will be presented in a poster at 2022 European Society for Medical Oncology Immuno-Oncology Congress
Portfolio reprioritization and streamlining of discovery and clinical activities contribute to extension of cash runway into 2025
Runway does not include any potential licensing revenue from the aryl hydrocarbon receptor (AHR) antagonist IK-175 program, currently in development in collaboration with Bristol Myers Squibb and eligible for opt-in through early 2024
"Ikena has a strong track record of internal drug discovery and development that has built our robust clinical and early-stage pipeline," said Jotin Marango, MD, PhD, Chief Financial Officer and Head of Corporate Development of Ikena. "Our goal is to continue our leadership in targeted oncology by discovering and advancing best-in-class candidates like IK-930 and IK-595, therapies designed to address the needs of specific patient populations while at the same time building value for our shareholders."

On November 28, 2022 Evotec’s partner Exscientia plc (Nasdaq: EXAI) reported clinical trial application ("CTA") approval of a Phase I/II trial of EXS-21546, an A2a receptor antagonist, co-invented and developed through a collaboration between Exscientia and Evotec (Press release, Evotec, NOV 28, 2022, View Source [SID1234624487]). The approval enables site activation in the first European country.

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The Phase I/II trial will evaluate safety, efficacy, pharmacokinetics and pharmacodynamics of EXS-21546 in combination with anti-PD-1 therapy in up to 110 patients with immunotherapy relapsed or refractory renal cell carcinoma ("RCC") and non-small cell lung cancer ("NSCLC"). The molecule was identified in 9 months after testing 163 compounds and is one of the first AI designed drugs in the industry to enter the clinic. In June 2022, Exscientia reported topline data from a healthy volunteer study which confirmed Exscientia’s target product profile design, including potency, high receptor selectivity and expected low brain exposure with no CNS adverse events reported.

Exscientia intends to expand to additional tumour types, including breast cancer, in future trials after assessment of EXS-21546 activity and validation of its selection biomarkers.

Exscientia will lead further clinical development of the molecule and Evotec will retain co-ownership rights throughout clinical development.

On November 27, 2022 Lyvgen Biopharma, a leading innovative global biotech company dedicated to discovering, developing and commercializing first-in-class and best-in-class biotherapeutics for cancer, reported an open label, phase 2, multicenter, randomized trial of LVGN7409 plus docetaxel or, in collaboration with Bristol Myers Squibb, nivolumab in patients with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) (Press release, Lyvgen Biopharma, NOV 27, 2022, View Source [SID1234624463]).

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"Lyvgen clinical collaboration with Bristol Myers Squibb underscores our commitment to exploring combination regimens from our portfolio with complementary mechanisms of action that may transform cancer care", said Jieyi Wang, Ph.D., Founder and CEO of Lyvgen. "We are excited to enter this clinical collaboration with Bristol Myers Squibb and look forward to initiating enrollment in these combination regimens for patients who cannot benefit from existing therapy worldwide."

LVGN7409, a recombinant monoclonal antibody that targets CD40 for activation optimally in tumor microenvironment, which is a member of the tumor necrosis factor (TNF) receptor family (TNFRSF5) and modulates immune responses by activating antigen presenting cells and reprograming the immuno-suppressive tumor microenvironment.

Bristol Myers Squibb’s nivolumab is a human monoclonal antibody that binds to the PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Docetaxel is an anti-tubulin chemotherapy agent used to treat a number of types of cancer, including non-small-cell lung cancer, breast cancer, head and neck cancer, stomach cancer, and prostate cancer.

"Lyvgen believes that the combination therapy targeting co-stimulatory checkpoint CD40 and co-inhibitory checkpoint PD-1, may offer the greatest chance to increase immunotherapy effectiveness in patients with resistant or refractory diseases, further validating the synergy observed in our pre-clinical studies for the combination of LVGN7409 and an immune check-point inhibitors." said Hubert Chan, M.D., Ph.D., Chief Medical Officer. " We also believe LVGN7409 may be useful in combination with immune-modulating chemotherapy agents such as docetaxel. Through this phase 2 study, we are enthusiastic to demonstrate that the stimulation of CD40 has the potential to reverse an immune-suppressed tumor microenvironment characterized by drug resistance and to improve anti-tumor efficacy when added to the current ‘standard of care’ therapy. There is a significant unmet medical need for the refractory NSCLC patients, and we hope this study will bring promising results to those cancer patients." continued Dr. Chan.

Clinical benefits for patients must be proven through rigorous clinical studies. There are no shortcuts. Lyvgen’s focus on immune agonists is widely applicable for most cancer indications. Our xLinkAb platform helps achieve a balance between safety and efficacy, which can greatly increase the chances of success. The advantages of agonistic antibodies have been validated in several preclinical and clinical studies. At present, the agonistic antibody field is still young, but developing rapidly with huge potential as a hot field of cancer immunotherapy. Our strength and long-term engagement in immune-oncology agonistic antibodies are returning primary promising clinical results. The Lyvgen pipeline of biologics may be benefit-cost effective drugs for a large panel of cancer indications.

Under the terms of the Agreement, Lyvgen will sponsor the study and Bristol Myers Squibb will provide nivolumab for the combination trial. Lyvgen has global commercial and development rights to LVGN7409.

About LVGN7409

LVGN7409 is a next generation CD40 agonistic monoclonal antibody developed on Lyvgen xLinkAb platform, which activates CD40 to promote tumor antigen presentation and induction of cancer-fighting T cells, and "warms up" the immune-"cold" tumor microenvironment. Unique structure and functionality of LVGN7409 permits its higher tolerable dosage and broader clinical utility.

On November 27, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that clinical data from multiple trials in relation to TYVYT (sintilimab injection), olverembatinib (BCL-ABL TIK), IBI188(anti-CD47 monoclonal antibody), IBI110 (anti-LAG-3 monoclonal antibody) and IBI939 (anti-TIGIT monoclonal antibody) will be presented at the upcoming international medical conferences (Press release, Innovent Biologics, NOV 27, 2022, View Source [SID1234624462]). A brief summary of the presentations is as follows:

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EUROPEAN SOCIETY OF MEDICAL ONCOLOGY IMMUNO-ONCOLOGY CONGRESS 2022 (Dec 7-9)

Topic: Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with sintilimab (anti-PD-1 mAb) in advanced squamous non-small cell lung cancer (sqNSCLC): updated results of the Phase Ib study
Presentation Type: Poster
Poster Number: 86P
Main Researchers: Professor Caicun Zhou, Shanghai Pulmonary Hospital; Professor Nong Xu, The First Affiliated Hospital, School of Medicine, Zhejiang University.

Topic: A Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer (NSCLC)
Presentation Type: Poster
Poster Number: 77P
Main Researcher: Professor Ying Cheng, Jilin Cancer Hospital.

64TH AMERICAN SOCIETY OF HEMATOLOGY ANNUAL MEETING & EXPOSITION (Dec 10-13)

Topic: A phase 1b study to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome
Presentation Type: Poster
Poster Number: 1759
Main Researchers: Professor Zhijian Xiao, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Professor Miao Miao, The First Affiliated Hospital of Suzhou University.

Topic: Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP) with T315I Mutation
Presentation Type: Oral Presentation
Abstract Number: 170698
Main Researcher: Professor Qian Jiang, Peking University Institute of Hematology, Peking University People’s Hospital.

Topic: A Five-Year Follow-up on Safety and Efficacy of Olverembatinib (HQP1351), a Novel Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI）, in Patients with TKI-Resistant Chronic Myeloid Leukemia (CML) in China with T315I Mutation
Presentation Type: Oral Presentation
Abstract Number: 170868
Main Researcher: Professor Qian Jiang, Peking University Institute of Hematology, Peking University People’s Hospital.