On March 27, 2023 OncoVerity, a pioneer in applying advanced multiomic, data driven patient stratification to the development of human therapeutics in oncology, reported that it has secured worldwide licensing rights to cusatuzumab from argenx and received $30M in funding from argenx and a joint venture of UCHealth and University License Equity Holdings, Inc. on the University of Colorado Anschutz Medical Campus for its continued development (Press release, OncoVerity, MAR 27, 2023, View Source [SID1234629399]). Cusatuzumab is a first-in-class anti-CD70 antibody that has generated promising results in early acute myeloid leukemia (AML) human studies. OncoVerity will optimize cusatuzumab’s continued development in AML and explore its application in other cancers.

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OncoVerity is also announcing the appointment of Max Colao, MBA as Chief Executive Officer, and Dr. Clay Smith as Chief Medical Officer.

"We are thrilled to welcome Max and Clay to the OncoVerity leadership team. Together with Max’s extensive commercial leadership experience and Clay’s proven track record in research and development, we are confident that will drive growth and expansion as we enter the next phase of development," said Arjen Lemmen, Vice President, Corporate Development and Strategy at argenx, and OncoVerity Board Member.

Mr. Colao has over 30 years of biotechnology leadership experience. In his most recent position, he served as the Chief Commercial Officer of Aurinia, where he built out the commercial team through launch. Prior to that, Mr. Colao held senior roles of increasing responsibility at Alexion, where he led the US commercial operations and built out the new business units in launching several rare disease therapies. He also spent over 20 years at Amgen, where he launched multiple therapies in the areas of hematology, oncology, and autoimmune disorders supporting Amgen’s growth from small to large biotech.

Dr. Smith joins OncoVerity with more than 30 years of experience in oncology research, clinical care and clinical trials. He was previously Professor and Associate Chief of the Hematology Division at the University of Colorado. He was also the Director at UCHealth Blood Disorders and Cell Therapies Center. With the support of the University of Colorado Anschutz Medical Campus and UCHealth, Dr. Smith and his team pioneered the clinical and single cell multiomics infrastructure necessary to support, de-risk, and accelerate the development of this innovative therapy. Throughout his career, Dr. Smith has published over 150 scientific articles.

"I am excited to lead OncoVerity to its next phase of development and believe that the licensing of cusatuzumab and new funding demonstrate our commitment to advance novel cancer therapies in areas of high unmet need," said Max Colao. "OncoVerity’s differentiated approach and talented team put us in a strong position to answer unresolved disease and therapeutic questions in oncology. I’m grateful for the contributions of the University of Colorado and argenx in establishing OncoVerity and look forward to making significant progress on behalf of cancer patients around the world."

"OncoVerity is an example of a unique partnership that bridges the best in research, healthcare delivery, and the use of advanced multiomic data science-driven drug development to bring cutting edge treatments to patients in the areas of greatest unmet medical need," said Kimberly Muller, Executive Director, CU Innovations, Anschutz Medical Campus, General Partner, CU Healthcare Innovation Fund, and Board Member of OncoVerity.

"This is a very exciting time to be joining OncoVerity as we start this journey to advance cancer research and develop targeted therapies that can make a real difference in the lives of patients," said Dr. Clay Smith. "I am particularly enthusiastic about the potential for our work on cusatuzumab for the treatment of AML, a disease where despite many advances in the treatment paradigm there remains a significant opportunity to develop effective therapies that meaningfully prolong survival."

About Cusatuzumab

Cusatuzumab is a monoclonal antibody targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. Cusatuzumab is designed to: block CD70, kill cancer cells expressing CD70 through complement dependent cytotoxicity, enhanced antibody-dependent cell-mediated phagocytosis and enhanced antibody-dependent cell-mediated cytotoxicity, and restore immune surveillance against solid tumors (Silence K. et al. mAbs 2014; 6 (2):523-532). Cusatuzumab is currently being evaluated in patients with hematologic malignancies, including a Phase 2 trial in combination with azacitidine and a Phase 1b trial in combination with azacitidine and venetoclax in patients with newly diagnosed AML.

About Acute Myeloid Leukemia

Despite the advancements in medical research, there is still a significant lack of effective therapies to treat Acute Myeloid Leukemia (AML). The five-year survival rate for AML patients remains the lowest of all blood malignancies (5-20%), and relapse is common. AML is a heterogeneous disease, which means that it can differ in its genetic and molecular characteristics from one patient to another. This makes it difficult to develop effective treatments that can target all types of AML. Innovative therapies and targeted treatment approaches that can improve the survival rates, reduce toxicity, and target specific subtypes of AML are urgently needed to address this unmet need.

On March 27, 2023 CANbridge Pharmaceuticals, Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, reported that the CAN008 (asunercept) Phase 2 trial for the treatment of glioblastoma multiforme (GBM) in China is fully enrolled, with a total of 117 patients (Press release, CANbridge Life Sciences, MAR 27, 2023, View Source [SID1234629398]). The multi-center, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of CAN008 plus temozolomide (TMZ) during and after radiation therapy in newly diagnosed patients and is a potentially registrational trial. Five-year follow-up data from the CAN008 Phase 1 trial showed 67% overall survival in the high-dose group and a median 17.95 months of progression-free survival in newly diagnosed GBM patients. The data were presented at the ESMO (Free ESMO Whitepaper) Sarcoma and Rare Cancers Annual Meeting in March. Interim data from the CAN008 Phase 2 GBM China trial is expected in mid-2023.

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"Treatment with CAN008 significantly improved progression-free survival in the Phase 2 clinical trial of recurrent glioblastoma conducted by Apogenix in Germany," said Wenbin Li, Director of Comprehensive Treatment Ward of Neuro-Oncology, Beijing Tiantan Hospital, Capital Medical University, principal investigator of the study. "The recently published long-term follow up data from newly diagnosed GBM patients in the CAN008 Phase 1 clinical trial is also encouraging, with 4 of the 7 patients in the 400mg/week dose group still alive at 5 years. We are pleased to have completed enrollment in the Phase 2 trial of CAN008, which we believe is a promising treatment that could provide new hope to patients. Thank you to all of the researchers and staff who helped ensure that patients got their medications during the difficult COVID-19 prevention and control period and to the patients, who put their trust in us."

"We are delighted to have reached full enrollment in our Phase 2 glioblastoma trial for our first-in-class candidate, CAN008, in China, " said James Xue, Ph.D., founder, chairman and CEO of CANbridge Pharmaceuticals Inc. "In addition, we are greatly encouraged by the five-year overall survival data of 67% in the high-dose group from our Phase 1 trial and look forward to the furthering the clinical development of CAN008 for patients in China."

About CAN008

CAN008 (asunercept) is a CD95-Fc fusion protein that binds to the CD95 ligand to block the interaction between the ligand and the CD95 receptor. CAN008 has a unique dual mechanism of action. It inhibits both the invasive growth and migration of tumor cells, which could reduce the T-cell apoptosis, thereby enhancing immune recognition of the cancer. Earlier asunercept glioblastoma multiforme (GBM) clinical trial data showed favorable safety and tolerability, prolonged survival and improved quality-of-life.

Asunercept has been granted US FDA Orphan Drug Designation and Orphan Medicinal Product Designation by the European Medicines Agency (EMA) for GBM. It has also been accepted into the EMA’s PRIME (Priority Medicines) program, which provides support to medicines that could address unmet medical needs. In China, CAN008 has received a Class 1 New Drug Designation by the National Medical Products Administration. CANbridge holds the rights to develop CAN008 for any indication in Greater China and is currently conducting a CAN008 Phase 2 trial in GBM in China.

On March 27, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported 2022 annual results as of 31 December 2022 (Press release, InnoCare Pharma, MAR 27, 2023, View Source [SID1234629397]).

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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "The company achieved high-quality development in various fields in 2022: rapid growth of orelabrutinib sales after its inclusion in the National Reimbursement Drug List (NRDL), oralabrutinib’s approval in Singapore marking the commercialization go international, successful listing on the STAR Board of the Shanghai Stock Exchange, approval of tafasitamab in combination with lenalidomide in Hong Kong and first prescription in Boao, and 13 innovative drugs entering clinical trials… The Company has achieved many milestones in the 1.0 development stage. We are accelerating our concerted efforts towards the goal of Company 2.0, committing to building a leading franchise in Hema-Oncology, competitive drug portfolio for autoimmune diseases and solid tumor, so as to launch more drugs on the market, driving a substantial revenue increase year by year."

Financial Highlights

The revenue reached about RMB625 million in 2022, including about RMB566 million from orelabrutinib, a year-on-year increase of 163.6%, mainly due to the continuous growth of orelabrutinib after its inclusion in the NRDL;
The research and development expenses reached RMB639 million in 2022. Excluding the impact of the upfront payment to Incyte last year, the R&D expenses increased by 29.0% year-on-year;
The cash and cash equivalents1 rose to RMB9.56 billion, an increase of 37.4% year on year in 2022, mainly due to the fund raised from the STAR Board listing;
The total assets expanded to RMB10.32 billion in 2022, an increase of 39.5% compared with 2021;
Adjusted loss for 2022 as illustrated under Non-HKFRSs2 Measure reached RMB 474 million.
1 Cash and cash equivalents refer to cash, bank balance, investments measured at fair value investments and interest receivable.
2 Non-HKFRSs: Excluding foreign exchange and share-based compensation impact.

Orelabrutinib for the treatment of Multiple Sclerosis (MS)

The 12-week interim analysis data of the MS global phase II trial has met the primary endpoint. Orelabrutinib significantly reduced disease activity in RMS patients. The primary objective of detecting significant reduction in cumulative number of new gadolinium (Gd) + T1 lesions at week 12 compared to placebo was met in all three active treatment groups in a dose-dependent manner. The 50 mg QD, 50 mg BID and 80 mg QD group showed the reduction of 70.1% (P=0.0238), 80.8% (P=0.0032) and 92.1%(P=0.0006) respectively, supporting further development.

Developing B-Cell and T-Cell Pathways in Autoimmune Diseases

The Company has fortified powerful discovery engine in the global frontier targets for the development of autoimmune therapeutics through B-cell and T-cell pathways for the purpose of providing the first-in-class or best-in-class treatments to the massive unmet clinical needs with a promising market potential in global and/or regional markets.

Orelabrutinib

Phase IIa trial for systemic lupus erythematosus (SLE) delivered positive results, initiated the Phase IIb trial for a larger population clinical trial;
Phase II clinical trial for the treatment of primary immune thrombocytopenia purpura (ITP) achieved proof-of-concept (PoC). The data from 22 patients with previous response to glucocorticoids (GC) or intravenous immunoglobulin (IVIG) were analyzed as a sub-group: 75.0% patients at the 50mg arm achieved the primary endpoint.
Phase II clinical trial for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) undergoing in China.
ICP-488

The single ascending doses (SAD) part, two cohorts of multiple ascending doses (MAD) have been completed. ICP-488 is developed for the treatment of inflammatory diseases such as psoriasis, SLE and inflammatory bowel disease (IBD).
ICP-332

Developed for the treatment of various autoimmune disorders, the Company has completed the Phase I clinical trial of ICP-332. Based on the data of safety, PK/PD, and biomarkers with no significant decrease of platelet and hemoglobin, InnoCare initiated Phase II study in atopic dermatitis (AD).
Building A Leading Franchise in Hema-Oncology

With Orelabrutinib as a backbone therapy and the support of our abundant pipeline in hematology, such as Tafasitamab, ICP-248, ICP-490, ICP-B02 and potential future internal and external pipeline development, InnoCare aims to become a leading player in hematology in China and worldwide by covering multiple myeloma (MM), Non-Hodgkin Lymphoma (NHL), and Leukemia by single or combo therapy. A particular combination therapy toolkit is well designed and aims to position a full coverage of DLBCL.

Orelabrutinib (BTK inhibitor)

Orelabrutinib’s supplemental New Drug Application (sNDA) was under priority review by the China National Medical Products Administration (NMPA) for the treatment of patients with relapsed or refractory Marginal Zone Lymphoma (R/R MZL). So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and hope that orelabrutinib can fill the gap in this therapeutic area.
In the U.S., patient enrollment of a Phase II registrational trial for R/R Mantle Cell Lymphoma (MCL) was completed, and expect to submit NDA in 2024.
Orelabrutinib was approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with R/R MCL, which marks the commercialization of InnoCare go international.
Phase III registrational trial for the first-line treatment of Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) is conducted in China. Patient enrollment is expected to be completed this year.
Strengthen development in diffuse large B lymphoma (DLBCL)
A Phase III registrational study of orelabrutinib for the first-line treatment of MCD DLBCL was initiated.
The latest data of orelabrutinib in the treatment of DLBCL in a real-world analysis were released at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Orelabrutinib-containing regimens demonstrated encouraging efficacy and well-tolerated safety profile among patients with MCD DLBCL.
A comprehensive tool-kit including orelabrutinib, tafasitamab, ICP-B02 and ICP-490 offers a unique position to treat all stages of DLBCL patients with combination therapies.
ICP-B04 (Tafasitamab)

The first prescription of tafasitamab in combination with lenalidomide was filed at the Ruijin Hainan Hospital at Bo’ao, who achieved complete response (CR) after 2 cycles of treatment;
The Company is advancing the registrational trial of tafasitamab in combination with lenalidomide, as well as the exploratory clinical trial of orelabrutinib in Combination with tafasitamab + lenalidomide in China;
Tafasitamab in combination with lenalidomide was approved by the Department of Health, the Hong Kong Special Administrative Region, China, which will benefit the DLBCL patients in greater bay area;
Tafasitamab has been included in the overseas Special Drug list of commercial insurance in more than 10 provinces and cities, which improves the access of DLBCL patients in these regions.
ICP-B02 (CM355)

ICP-B02 is a CD20xCD3 bispecific antibody. First patient for the treatment of lymphoma was dosed in January 2022 and Phase I dose escalation is progressing. So far, the almost complete B-cell depletion was observed in patients treated with low dose of ICP-B02. The IND application for ICP-B02 subcutaneous (SC) formulation was approved for clinical trial by the CDE in March 2023.
ICP-490

Novel targeted protein degrader ICP-490 has entered clinical trial in China for the treatment of R/R multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). ICP-490 is much more potent, which can overcome acquired resistance against earlier-generation of CRBN modulators.
ICP-248

First subject has been dosed in the clinical trials of BCL2 inhibitor ICP-248, which is developed to treat malignant hematological tumors such as NHL and acute lymphoblastic leukemia (ALL) as single drug or in combination with other drugs such as BTK inhibitor. ICP-248 is expected to have extraordinary blockbuster potential.
Building a competitive drug portfolio for solid tumor in China and worldwide

To benefit patients more, the Company strived to expanding the breadth of the pipeline covering solid tumors through the precision medicine philosophy and intend to provide the right medicine to the right patient at the right time. InnoCare believes the potential best-in-class molecules ICP-192 and ICP-723 will enable the Company to establish a solid initial presence in the field of solid tumor treatment.

ICP-192 (Gunagratinib)

In January 2023, the latest data of gunagratinib in patients with cholangiocarcinoma (CCA) was presented at 2023 ASCO (Free ASCO Whitepaper)-GI. Gunagratinib is safe and well-tolerated with high response rate (52.9%) compared to other approved FGFR inhibitors in previously treated patients with locally advanced or metastatic CCA harboring FGR2 gene fusions or rearrangements. Currently, patient enrollment for ICP-192 registrational trial in CCA is ongoing.
ICP-723 (Zurletrectinib)

Phase II dose expansion study is going with recommended phase II dose (RP2D) at 8 mg, 75% ORR observed in various types of solid tumors carrying NTRK fusion in different dosage. Based on the Proof-of-Concept (PoC) data obtained, InnoCare will promote a registration clinical study of ICP-723 in China.
The first adolescent patient (12 to 18 years old) has been dosed in clinical trial with ICP-723. This is also the first time that ICP-723 will be evaluated in the clinical study of adolescent patients after showing good safety and efficacy in adult patients. The IND submission for additional pediatric population (<12 years old) was accepted by CDE in January 2023.
ICP-B05 (CM369)

The first subject has been dosed in the clinical trial of monoclonal antibody ICP-B05 targeting CCR8 jointly developed by InnoCare and Keymed Biosciences. As the potential first-in-class, the drug is developed as a monotherapy or combined with other therapies to treat advanced solid tumors, including lung cancer, digestive tract cancer, etc.
ICP-189

The clinical trials of Novel SHP2 allosteric inhibitor ICP-189 are conducted in China and the U.S., developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. As of 8 February 2023, dosage has been escalated up to 40 mg with no DLT observed and demonstrated favorable PK profile and long half-life. Preliminary efficacy was observed in ICP-189 monotherapy. One patient with cervical cancer in 20 mg dose cohort achieved confirmed PR.
Other Corporate Development

STAR Board Listing
On September 21, 2022, InnoCare got listed on the STAR Board of the Shanghai Stock Exchange. The listing on the STAR Board will further enhance InnoCare’s innovative advantages in blood tumors, solid tumors and autoimmune diseases, and contribute to achieving its strategic goal of benefiting global patients with its self-developed innovative drugs.
Manufacturing
Guangzhou: Guangzhou InnoCare has been approved for commercial production of orelabrutinib, and provided this innovative drug to patients in 30 provinces (autonomous regions and municipalities).
Beijing: InnoCare’s Beijing Innovative Drug Base has started construction for the R&D center and large molecule production facility, and is expected to be completed in 2025.
To know more about the detailed financial data and business update of InnoCare 2022 annual results, please log in View Source

Conference Call Information

InnoCare will host a conference call at 9:30 a.m. Beijing time in Chinese and at 8:00 p.m. Beijing time in English on March 28, 2023. Participants must register in advance of the conference call. Details are as follows:

For Chinese conference call, please register through the below link:
View Source

For English conference call, please register through the below link:
View Source

On March 27, 2023 BJ Bioscience, Inc. BJ Bioscience, a biotech company focusing on discovery and development of novel biologics for cancer immunotherapy, reported that it entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) (Press release, BJ Bioscience, MAR 27, 2023, View Source [SID1234629396]). The collaboration will allow for the evaluation of safety and efficacy of BJ-001, a tumor-targeting IL-15 fusion protein, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in an ongoing Phase 1 clinical trial.

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BJ Bioscience will evaluate BJ-001 plus KEYTRUDA as part of the company’s ongoing trial in patients with locally advanced/metastatic solid tumors. In this trial, BJ-001 is studied as monotherapy or in combination with KEYTRUDA, for safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity.

In monotherapy dose escalation cohorts, BJ-001 has demonstrated tolerable safety profiles, favorable PK/PD profiles, and encouraging preliminary efficacy results.

"BJ Bioscience is excited to collaborate with MSD, one of the world’s leading multinational pharmaceutical companies," said Joe Zhang, MD, PhD, cofounder and CEO of BJ Bioscience. "Many consider KEYTRUDA to be one of the gold-standard medicines in the cancer immunotherapy arena. We believe BJ-001 may be a promising addition to this area. Our preclinical studies demonstrated that the combination of BJ-001 and an anti-PD-1 antibody was well-tolerated and showed promising early antitumor activity compared to either drug alone as monotherapy. With its tumor-targeting properties, we’re looking forward to evaluating BJ-001 in combination with KEYTRUDA as a potential new treatment option to benefit more cancer patients. This investigational combination is a key component of our BJ-001 development program."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About BJ-001
BJ-001 is a tumor-targeting IL-15 fusion protein, designed to expand and activate cancer-fighting natural killer (NK) cells and CD8+ T cells, and to have selected distribution in tumors with high integrin-expression. Preclinical data have demonstrated the ability of BJ-001 to accumulate in integrin-expressing tumors. Clinical data to date have shown Best-in-Class properties of BJ-001, including tolerable safety, dose-dependent and encouraging magnitude of stimulation and expansion of NK cells and CD8+ T cells with no impact on immunosuppressive regulatory T cells.

On March 27, 2023 Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique antibody-cell conjugation (ACC) technology to address gaps in cancer care, reported the upcoming poster presentation of new preclinical data for ACE2016, a gamma delta-2 T cell therapy designed to target EGFR expressing solid tumors (Press release, Acepodia, MAR 27, 2023, View Source [SID1234629395]). The company will present this data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Orlando, Florida, April 14-19, 2023.

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The poster presentation will showcase data demonstrating the in vitro and in vivo efficacy of ACE2016 against EGFR-expressing cancer cells which warrant investigation of potential clinical application in EGFR-expressing tumors.

Details on the presentation and session are provided below:

Presentation details

Presentation Title: ACE2016: an off-the-shelf EGFR-targeting γδ2 T cell therapy against EGFR-expressing solid tumors
Session Title: Late-Breaking Research: Immunology 1
Session Date and Time: Monday Apr 17, 2023 9:00 AM – 12:30 PM
Location: Poster Section 35
Poster Board Number: 5
Abstract Presentation Number: LB089

"The poster presentation at this year’s AACR (Free AACR Whitepaper) is an exciting opportunity for Acepodia to showcase preclinical data for ACE2016 as a potential off-the-shelf cell therapy which exploits the ability of gamma delta T cells to recognize and engage solid tumors expressing EGFR by ACC technology unlocking multiple receptor signaling," said Sonny Hsiao, Ph.D., chief executive officer and co-founder of Acepodia. "We look forward to presenting the preclinical data in more details in the poster session at AACR (Free AACR Whitepaper), and to further evaluating this exciting modality for solid tumor patients."

About Gamma-Delta T Cells
Acepodia’s gamma delta T cell program harnesses the unique properties of gamma delta T cells to develop a new class of off-the-shelf cell therapies for the treatment of cancer. Gamma delta T cells have characteristics of both the innate and adaptive immune systems that make them an ideal chassis for the development of cell therapies. This cell type can recognize and attack cancerous cells as well as coordinate a broad antitumor immune response by recruiting other immune factors and cells to the site of disease. Gamma delta T cells have also been shown to preferentially traffic to distinct tissues and could be ideally suited for more targeted treatment of certain types of cancers.