On March 8, 2022 Eucure Biopharma, a wholly owned subsidiary of Biocytogen, reported the first patient dosing for a phase I multi-regional clinical trial (MRCT) of YH002 (anti-OX40 monoclonal antibody, mAb) in combination with YH001 (anti-CTLA-4 mAb) (No. YH002004) in Australia (Press release, Biocytogen, MAR 8, 2022, View Source [SID1234609975]). This phase I MRCT will be conducted in Australia and China.

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The clinical trial is an open-label, dose-escalation phase I study designed to evaluate the safety, tolerability and preliminary efficacy of YH002 in combination with YH001 in patients with advanced solid tumors. Pharmacokinetics and immunogenicity of YH001 and YH002 will also be evaluated.

Eucure Biopharma has previously completed mono-dose-escalation studies for YH001 and YH002. The results show that both YH001 and YH002 have good tolerance and safety.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said, "Both YH001 and YH002 are developed from Biocytogen’s evidence-based in vivo efficacy screening platform. Using animal models, we found for the first time, that combination of YH002 and YH001 has very good antitumor activity. We expect the results from animal models can be verified in patients. We are hopeful that these platforms will continue to drive the discovery and development of novel therapeutic antibodies, ADCs and bispecific ADCs for future clinical benefit."

About YH002

YH002 is a recombinant anti-OX40 humanized IgG1 antibody. Targeting OX40 enhances anti-tumor responses both by activating effector T cells and inhibiting or exhausting regulatory T cells (Treg). In preclinical studies, YH002 demonstrated excellent specificity, affinity and safety. In vivo studies using Biocytogen’s humanized mouse models demonstrated improved therapeutic potential of YH002 compared to benchmark antibodies, and indicated promising potential for combination therapy.

About YH001

YH001 is an anti-CTLA-4 monoclonal antibody that aims to enhance the anti-tumor immune response through removal of Treg from the tumor microenvironment. Combination therapies that block multiple inhibitory immune checkpoints (including CTLA-4 and PD-1) are currently considered to be promising treatments for multiple types of tumors, due to their potential to influence the activity of multiple populations of T cells.

On March 8, 2022 Johnson & Johnson reported that it is currently talking with two China biopharmas about forming partnerships, though it did not name either company (Press release, Johnson & Johnson, MAR 8, 2022, View Source [SID1234609974]). J&J has a very good reason for being interested in China . Four years ago, its subsidiary, Janssen Pharma, formed a $1 billion partnership for Nanjing Legend Bio’s CAR-T multiple myeloma therapy. At the time Legend wasn’t particularly well known, but its CAR-T posted very high efficacy rates in a early trial. One week ago, Carvykti (cilta-cel) was approved for a US launch.

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On March 8, 2022 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that the Company will present a poster and three oral presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place between April 8-13, 2022 in New Orleans, Louisiana and virtually (Press release, C4 Therapeutics, MAR 8, 2022, View Source [SID1234609972]).

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Presentations at AACR (Free AACR Whitepaper) Annual Meeting 2022:

Title: CFT7455: Pharmacokinetic (PK) Profile of a Novel IKZF1/3 Degrader, CFT7455, Enables Significant Potency Advantage over Other IKZF1/3 Degraders in Models of Multiple Myeloma (MM) and the Results of the Initial Treatment Cohort from a First-in-Human (FIH) Phase 1/2 Study of CFT7455 in MM
Abstract Number: CT186, Poster
Time: Tuesday, April 12, 2022, 9:00 AM – 12:30 PM CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 33
Presenter: Sagar Lonial, M.D., FACP, chief medical officer, Winship Cancer Institute of Emory University; professor and chair, department of hematology and medical oncology, Emory University School of Medicine

Title: The discovery and characterization of CFT7455: A Potent and Selective Degrader of IKZF1/3 for the Treatment of Relapsed/Refractory Multiple Myeloma
Abstract Number: 7922, Oral
Time: Monday, April 11, 2022, 10:15 AM -11:45 AM CT
Location: New Orleans Convention Center, La Nouvelle Orleans A-B
Session: New Drugs on the Horizon: Part 3
Presenter: Jim Henderson, Ph.D., vice president of chemistry, C4 Therapeutics

Title: The Discovery and Characterization of CFT8634: A Potent and Selective Degrader of BRD9 for the Treatment of SMARCB1-perturbed Cancers
Abstract Number: 7756, Oral
Time: Sunday, April 10, 2022, 3:00 PM – 4:30 PM CT
Location: New Orleans Convention Center, La Nouvelle Orleans A-B
Session: New Drugs on the Horizon: Part 2
Presenter: Kate Jackson, Ph.D., senior director of chemistry, C4 Therapeutics
Title: Preclinical Evaluation of CFT1946 as a Selective Degrader of Mutant BRAF for the Treatment of BRAF Driven Cancers
Abstract Number: 2158, Oral
Time: Monday, April 11 2:30 PM – 4:30 PM CT
Location: New Orleans Convention Center, Great Hall AD
Session: Emerging New Anticancer Agents
Presenter: Mathew Sowa, Ph.D., senior director, proteomics and ubiquitin proteasome system biology, C4 Therapeutics
In addition to these data presentations, Chris Nasveschuk, senior vice president, chemistry, will be participating in the Targeted Protein Degradation: Access to New Medicines by Drugging Challenging Targets educational session on Friday, April 8, 2022 from 5:30 PM to 5:50 PM CT.

Investor Webcast Information
C4T will host an investor webcast on Friday, April 8, 2022 at 2 PM ET to discuss the CFT7455 Cohort A clinical data that will be presented at the AACR (Free AACR Whitepaper) Annual Meeting. The webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.c4therapeutics.com. A replay of the webcast will be available on C4T’s website for 30 days following the event.

On March 8, 2022 Orbit Discovery (Orbit), a ground-breaking peptide discovery company reported the commencement of a partnership with WuXi AppTec, a leading global provider of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry (Press release, WuXi AppTec, MAR 8, 2022, View Source [SID1234609952]).

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Orbit will combine its leading peptide discovery platform and experience with WuXi AppTec’s downstream capabilities. Specifically, Orbit gains access to WuXi AppTec’s expertise in peptide optimisation, peptide production and manufacturing to help its Partners obtain clinically relevant data packs and materials in a rapid timeframe. Orbit will also utilise other capabilities within WuXi AppTec, in particular their expertise in cell line and assay development and biophysical analysis.

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Incorporating these capabilities into the Orbit platform will enable functional assays to be developed against a wider range of targets, facilitating direct functional screens using novel bead-based technologies and microfluidics.

This is the first strategic technology link Orbit has penned since its formation in 2016. The partnership underlines the commitment of the new management team to deliver ground-breaking technology and broader capabilities to the Partners engaged in applying the Company’s technology for the discovery of peptide therapeutic leads.

"We aim to move Orbit to the forefront of peptide discovery, and relationships such as this help us leverage expertise that would take far longer to grow organically. We see the partnership with WuXi AppTec as being a key relationship and a great asset to our current Partners, and Partners of the future." He added: "We see particular value in the development and manufacturing platform of WuXi AppTec, that will enable us to generate peptides at small or large scale that incorporate chemical modifications to facilitate peptide optimisations and the journey towards a therapeutic candidate."

Dr Neil Butt, Chief Executive Officer of Orbit Discovery

"We are very pleased to have the opportunity to support Orbit Discovery and its research partners" commented Dr Dave Madge, VP Discovery Services at WuXi AppTec. "We see substantial synergies between the Orbit technology for peptide discovery and our platform for optimisation, characterisation and manufacture of novel peptide therapeutics."

On March 8, 2022 Orum Therapeutics, a biotechnology company pioneering the development of tumor-directed targeted protein degraders, reported that the Company will present preclinical data for ORM-5029 at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 taking place April 8-13 virtually and in-person at the Ernest N. Morial Convention Center in New Orleans (Press release, Orum Therapeutics, MAR 8, 2022, View Source [SID1234609842]). Orum is developing ORM-5029 as a potential first-in-class targeted protein degrader therapy for HER2-expressing breast cancer.

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Presentation Details

Poster Title: ORM-5029: A first-in-class targeted protein degradation therapy using antibody neodegrader conjugate (AnDC) for HER2-expressing breast cancer
Date and Time: Wednesday, April 13, 9:00 AM – 12:30 PM EDT
Virtual E-Poster Viewing: April 8 to July 13
Session Category: Experimental and Molecular Therapeutics
Session Title: Emerging New Anticancer Agents
Session Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 22
Poster Board Number: 7
Abstract number: 3933

About Orum’s AnDC Platform

Orum’s Antibody neoDegrader Conjugate (AnDC) platform is built on novel targeted protein degrader (TPD) combined with the precise tumor cell delivery mechanisms of antibodies to generate innovative, first-in-class cell-specific TPD for the treatment of cancer. The company has developed new molecular glue degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, neoDegraders are designed to be delivered specifically to cancer cells and degrade the intracellular target protein and cause tumor cell death.