On May 30, 2022 The board of directors of HBM Holdings Limited reported that the Company has commenced collaborations on antibody-drug conjugate ("ADC") projects with LegoChem Biosciences Inc. ("LegoChem Biosciences" or "LCB") and Duality Biotherapeutics ("Duality Biologics") as part of the Company’s ADC development and collaboration strategy (Press release, Harbour BioMed, MAY 30, 2022, View Source [SID1234628154]).

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In 2022, the Company entered into a collaboration agreement with Duality Biologics, pursuant to which the Company shall grant the exclusive rights of its monoclonal antibodies for specific tumor to Duality Biologics to develop the world’s first-in-class ADCs based on Duality Biologics’ Duality Immune Toxin Antibody Conjugate platform.

The Company also entered into a license agreement with LegoChem Biosciences in 2022, over an antibody for ADC. The agreement also contemplated that the contracting parties may collaborate in developing the ADC for therapeutic applications.

Pursuant to the license agreements and subject to the terms and conditions thereof, the Company shall receive upfront payments, milestone payments and sales-based royalties. The Company believes that the aforementioned collaborations will contribute further to the Harbour Mice platform’s ADC Ecosphere with the Company’s other industrial leading partners such as MediLink Therapeutics and Kelun-Biotech.

On May 30, 2022 Cureteq AG (Cureteq), a clinical stage company developing innovative medicines with the support of a sophisticated artificial intelligence (AI) platform, reported the company has in-licensed its first compound, and will develop it as a potential first-in-class treatment for multiple cancers, initially for brain and kidney cancer (Press release, Oncoteq, MAY 30, 2022, View Source [SID1234651596]). The development path is guided by AI and builds on strong preclinical and clinical data.

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The compound, M8891, is a small-molecule methionine aminopeptidase 2 (MetAP2) inhibitor licensed from global science and technology company Merck based in Darmstadt, Germany. This is the first of what is planned to be a series of acquisitions by Cureteq as the company looks to build a pipeline of novel and better potential medicines against a range of diseases. Cureteq sets out to pioneer a new standard for AI-supported drug development to the benefit of patients, doctors and society.

Cureteq leverages AI to identify the top potential indications of a given molecule and to devise optimized and de-risked clinical development plans. Such an approach provides for accelerated development of new medicines to treat the diseases for which they will be most effective and have the highest chance of becoming available to patients. The AI-platform differentiates from other AI approaches by its breadth and depth, connecting billions of data points according to the most relevant medical concept; this greatly enhances the quality and impact.

Mads Dalsgaard, Chief Executive Officer of Cureteq AG, commented:
"We are very excited to complete our first in-licensing deal and commence development, combining the AI-technology and our medical expertise. M8891 has the potential to be a first-inclass treatment for cancers, such as kidney and brain cancers, which both have a devastating impact on patients’ lives. We are pleased to collaborate with Merck by carrying forward this promising molecule and excited about proving the power of AI in drug development".

M8891, through a unique mechanism of action (MetAP2 inhibition), inhibits both the cancer cells and their ability to generate new blood vessels in vitro, which is necessary for tumor growth. It is thought that this can potentially suppress the progression of the malignant disease, shrink, or even eliminate the cancer, especially if M8891 is combined with other anti-tumor treatments. Preventing disease progression or shrinking the tumor with safe and tolerable drugs is usually associated with an improved quality of life and helps patients to minimize fatal complications from their disease or may even prolong an otherwise drastically shortened life expectancy.

In a recent phase 1, dose-escalation study in patients with solid tumors, M8891 as monotherapy was demonstrated to have acceptable safety and also showed preliminary signs of anti-tumor efficacy. Such data add to the robust preclinical data package supporting potential anti-tumor activity across a broad range of tumors. Cureteq plans to validate the AI generated hypotheses preclinically and in a multi-cohort, Phase 1b study of M8891 in combination with current standardof-care treatments for kidney and brain cancer; patient enrollment is expected to commence in 2023.

M8891 will be developed by Oncoteq AG, a newly established subsidiary of Cureteq.

On May 30, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the first patient has been dosed in the Phase I STAMINA-001 trial to evaluate ATG-037 as a monotherapy or in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors in Australia (Press release, Antengene, MAY 30, 2022, View Source [SID1234615231]).

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The primary objective of the study is to evaluate the safety, tolerability, recommended Phase II dose and preliminary antitumor efficacy of ATG-037 as a monotherapy and in combination with pembrolizumab. Secondary objectives include characterization of the pharmacology of ATG-037.

ATG-037 is an orally available, small molecule CD73 inhibitor. CD73 is an "immune checkpoint mediator"[1] that interferes with anti-tumor immune responses by generating adenosine, which leads to immunosuppression in the tumor microenvironment. ATG-037 can reverse adenosine-mediated immunosuppression[2]. It has demonstrated promising preclinical efficacy as a monotherapy and in combination with ICIs and chemotherapy agents. In preclinical studies, this compound overcomes the "hook effect" that is common in anti-CD73 antibodies. In addition, GLP toxicology studies indicate the compound has a potentially wide therapeutic window.

"While ICIs are widely used in the treatment of various cancers, many patients have resistant or refractory disease, which has created a large unmet need," said Dr. Ganessan Kichenadasse, principal investigator, Southern Oncology Clinical Research Unit in Adelaide, Australia. "Mounting evidence suggests that adenosine plays a critical role in suppressing anti-tumor immunoactivity. CD73 can convert adenosine monophosphate (AMP) to adenosine. ATG-037, an orally available, small molecule CD73 inhibitor, can block the generation of adenosine. We are excited to be a part of the STAMINA-001 Trial. This Phase I study brings together a group of highly experienced Australian investigators to collaborate with Antengene. We are excited to assess the therapeutic potential of ATG-037 for patients with solid tumors as a single agent as well the exploring the opportunity for benefit with the addition of an ICIs."

"Developing agents that can act in the tumor microenvironment to reverse immunosuppression is one of the key focus areas for Antengene, " said Dr. Kevin Lynch, Antengene’s Chief Medical Officer. "Preclinical data presented at the 2022 American Association of Cancer Research Annual Meeting (AACR 2022) showed that ATG-037 had a stronger ability to restore T-cell function in higher-AMP environments compared with anti-CD73 monoclonal antibodies. These data highlighted the potential therapeutic advantages of small molecule inhibitors of CD73 over blocking antibodies, either as a monotherapy, or in combination with other immune-oncological treatments. We have been very pleased with the drug’s performance in preclinical studies and are hopeful that in this Phase I study ATG-037 can demonstrate the tolerability and signals of activity that will allow us to move forward into a broader development program. We are very excited about the start of this first in human clinical trial and look forward to next steps with ATG-037."

About the STAMINA-001 Trial

The STAMINA-001 trial is a Phase I multi-center, open-label, dose finding study of ATG-037 monotherapy or combination therapy with pembrolizumab in patients with locally advanced and metastatic solid tumors. Subjects will begin with two monotherapy cycles and then be allowed to receive the addition of pembrolizumab. The primary objective of the study is to evaluate the safety and tolerability of ATG-037 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and/or optimal biological dose of ATG-037 monotherapy and preliminary efficacy. Secondary objectives include characterization of the pharmacology of ATG-037. As a Phase I study, there will be intensive safety monitoring throughout the trial.

About ATG-037

ATG-037 is an orally-available, highly selective small molecule that completely blocks the activity of CD73. CD73, an ecto-5′-nucleotidase, catalyzes the conversion of adenosine monophosphate (AMP) to adenosine. Adenosine production leads to significant immunosuppression in the tumor microenvironment, now recognized as one of the most important immunomodulatory pathways in the tumor microenvironment.

Many human tumors overexpress CD73 and this expression is frequently associated with poor prognosis. Blocking CD73 has been shown to be effective in controlling tumor growth and metastases and CD73 inhibitors may increase the therapeutic activity of ICIs and chemotherapy agents. Clinical data so far indicate that CD73 inhibitors add little additional toxicity to standard of care treatments.

On May 30, 2022 Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported the launch of a Phase I clinical trial of the Company’s siRNA (small interfering RNA) drug candidate, STP705, in adults undergoing abdominoplasty for submental fat reduction (Press release, Sirnaomics, MAY 30, 2022, View Source [SID1234615232]). This study is the first application for Sirnaomics to apply an RNAi therapeutic candidate for medical cosmetology treatment.

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The global non-invasive fat reduction market size was valued at USD1.1 billion in 2021 and is anticipated to register a compound annual growth rate (CAGR) of 16.1% from 2022 to 2030, up to approximately USD4.0 billion (Grand View Research). Non-invasive fat reduction is a procedure that is done to decrease or eliminate stubborn fat pockets in specific areas of the body by using methods like cryolipolysis, radio frequency, and laser lipolysis. Non-invasive devices that are used in these procedures to permanently abolish fat cells are approved by the U.S. Food and Drug Administration (FDA) as their efficiency and safety have been tested and the results have been proven to show significant results. However, the market is currently dominated by devices that have mild therapeutic effects and require multiple treatment sessions. Sirnaomics will initially focus on the use of STP705 for submental fat reduction.

The dose-ranging, randomized, double-blind, vehicle-controlled study will enroll 10 patients to evaluate the safety and tolerability of STP705, which will be delivered via subcutaneous injection. The primary endpoints are to assess injection comfort, characterize local and systemic safety, and evaluate histological changes of subcutaneous doses of STP705, and to compare the safety and tolerability of three different concentrations of STP705 to select dosages for future studies.

"Submental fullness is a common condition that is resistant to diet and exercise and is influenced by multiple factors including aging and genetics," said Sirnaomics Executive Director and Chief Medical Officer Michael Molyneaux M.D. "Our goal in expanding our applications of STP705 with this study is to examine the safety and efficacy of this treatment in patients who are undergoing abdominoplasty. We hope to use the information from this study to expand into the treatment of submental fat reduction and other areas of non-invasive fat sculpting. This Phase I study will serve as a blueprint for future studies of STP705 in the medical aesthetics category."

"The current devices and procedures for non-invasive fat reduction have mild therapeutic effects, and require multiple and sometimes challenging treatment sessions, which are costly for patients and don’t always achieve the desired results," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "Based on a discovery from our previous clinical study and a series of preclinical evaluations with animal models, we decided to expand STP705 therapeutic application into medical aesthetics with this Phase I study."

About STP705

Sirnaomics’ leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in five clinical trials for different indications: a Phase IIa for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), and a Phase I for liver cancer (basket).

On May 29, 2022 InxMed Co., Ltd, a clinical-stage biotechnology company dedicates on developing innovative therapies targeting stroma microenvironment and drug resistance for hard-to-treat solid tumors, reported that the clinical data from an open-label phase Ib trial evaluating the efficacy and safety of IN10018, a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), in combination with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant recurrent ovarian cancer (PROC), will be presented in the form of poster at the upcoming 2022 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) from June 3, 2022 to June 7, 2022 (Press release, InxMed, MAY 29, 2022, View Source [SID1234615222]). Abstract was published on the ASCO (Free ASCO Whitepaper)’s website（Abstract #：5567）. The data showed that patients receiving combination of IN10018 with PLD demonstrated promising antitumor activities and manageable safety profile in PROC patients, with a high overall response rate (ORR) of 56.7%（Poster #：445）.

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This phase Ib study is to evaluate the safety, tolerability, and antitumor activities of IN10018 in combination with PLD in patients with platinum-resistant recurrent ovarian cancer. The primary endpoint for the study is objective response rate (ORR), and key secondary endpoint include disease control rate (DCR), duration of response (DOR) and progress-free survival (PFS).

As of cutoff data of December 31, 2021, a total of 42 patients were enrolled. Antitumor response was evaluated in 30 efficacy evaluable patients who had at least one post-baseline tumor assessments per investigator’s assessment. 17 PRs and 9 SDs were reported and none of the patients had CR. The ORR was 56.7%, the DCR was 86.7%, and the median DOR was 4.5 months (95% confidence interval [CI]: 2.7 months – NA) and still maturing. The ORR and DCR were 65.0% (13/20) and 90.0% (18/20), respectively, in 20 efficacy evaluable patients who had at least 6 months follow-up. In all 42 enrolled patients, the median PFS were 6.2 months (95% CI: 6.2 months – NA) and still maturing.

The safety profile of the combination is comparable to these single agents alone without additive toxicities. No IN10018 related death observed and only 9.5% (4/42) patients reported SAEs which were related to both IN10018 and PLD. The most frequently reported IN10018 related AEs were proteinuria, decreased appetite, fatigue, and AEs of gastrointestinal origin such as nausea, diarrhea, vomiting. Majority of these drug related AEs were CTCAE grade 1 and 2, no drug related grade 4 or 5 AE reported. Proteinuria was noted asymptomatic, reversible and could be managed with appropriate dose interruption/reduction and only one proteinuria event resulted in IN10018 dose reduction.

"We are extremely pleased with the data as it demonstrates the superior efficacy and safety of our IN10018, as well as confirming the proof of mechanism of IN10018 regimen. We are excited by this outcome and are working hard on completing this study and determining the further design for a subsequent pivotal study," said Dr Zaiqi Wang, CEO of InxMed. FAK is a non-receptor tyrosine kinase that plays an important role in cell adhesion, migration, and regulation. It exhibits expression upregulation in multiple tumor types. Researchers have found that inhibiting the FAK signaling pathway can effectively reverse previously failed chemotherapy and targeted therapy caused by drug resistance and enhance the response and efficacy of immunotherapy for solid tumors.

InxMed set up a global clinical development program for IN10018, as one of the most advanced FAK inhibitors. Clinical trials currently underway in the US and China are designed for platinum-resistant ovarian cancer, NRAS mutant metastatic melanoma, triple-negative breast cancer, head and neck cancer, pancreatic cancer, and other solid tumors that are still lacking effective treatment. IN10018 received fast track designation from the U.S. Food and Drug Administration (FDA) in August 2021, and breakthrough designation from China National Medical Products Administration (NMPA) for the treatment of patients with platinum-resistant ovarian cancer.

InxMed has the exclusive global development and commercial operation rights of IN10018 and is planning to initiate a pivotal trial in the second half of the year.