On March 28, 2023 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported it received $35 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. The investment will be used to advance and accelerate lead candidate JK07, including the planned initiation of the first Phase 2 study in HFrEF, the continuation of the ongoing Phase 1b clinical trial in heart failure with preserved ejection fraction (HFpEF), and the launch of the Company’s first neurology clinical trial with JK07. The financing will also support the ongoing Phase 1/2 trial of JK08 in solid tumors and advance JK06, a pre-clinical biparatopic antibody-drug conjugate, into an initial Phase 1/2 study.

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We’re thrilled about the progress we made in 2022, particularly completing enrollment in the Phase 1b study of JK07 in HFrEF. The study achieved its objective of characterizing the safety and activity of the molecule and defining the therapeutic window. We’re excited to now turn our focus towards initiating a Phase 2 study this year," said Sam Murphy, Chief Executive Officer of SalubrisBio. "We look forward to multiple additional milestones across our pipeline in the year ahead, including interim data readouts from JK07 in HFpEF and JK08 in solid tumors, and initiation of an initial clinical trial evaluating JK07 in neurodegenerative disease.

JK07 Advancing into Phase 2

Patient dosing has been completed in the Phase 1b clinical trial assessing the safety, tolerability, pharmacokinetics and exploratory efficacy of JK07 in HFrEF. This study demonstrated robust changes in biomarkers and exploratory efficacy parameters at dose levels that were safe and well tolerated. Topline results are planned to be presented at an upcoming medical meeting. The first Phase 2 study is expected to begin in 2H of 2023. A second Phase 1b study in HFpEF is actively enrolling, with interim results expected in the second half of 2023.

For more information on the JK07 clinical trial, please visit View Source and View Source

JK08 Phase 1/2 Study Progress

The fourth cohort in the ongoing Phase 1/2 study of JK08 as a monotherapy treatment for solid tumors is now recruiting. Through the first three cohorts, preliminary data indicate favorable safety and encouraging, dose-dependent pharmacodynamic activity. SalubrisBio expects to report preliminary findings later this year at a medical meeting.

For more information on the JK08 clinical trial, please visit View Source

About JK07

JK07 is a recombinant fusion protein consisting of a fully human immunoglobulin IgG1 monoclonal antibody and an active polypeptide fragment of the human growth factor neuregulin [NRG-1]. NRG-1 is a clinically validated growth factor that has shown promising activity in HFrEF, but also undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – HER3/ErbB3 and HER4/ErbB4. The HER4/ErbB4 pathway appears to be responsible for the regenerative effects in the heart, while the HER3/ErbB3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking HER3/ErbB3 signaling with an antibody fusion design, JK07 selectively stimulates the HER4/ErbB4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects.

About JK08

JK08 is a recombinant fusion protein consisting of a CTLA-4-specific antibody and a C-terminal IL-15/sushi domain. JK08 was designed based on clinical studies from both individual molecules, which together portend synergistic effects in an antibody fusion construct. The CTLA-4-specific antibody ipilimumab validated CTLA-4 as a target for cancer therapy, but response rates are limited. Analysis of clinical samples demonstrated that NK cell activity signatures and ADCC biomarkers correlate with ipilimumab responses. Recombinant IL-15 has demonstrated potent stimulation of NK cell expansion and activation in clinical studies. JK08 channels the potent immune stimulation of IL-15 through the CTLA-4 antibody domain towards T-regulatory cell depletion and reversing immunosuppression which may contribute to cancer progression.

On March 28, 2023 -Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, reported that it established a strategic research collaboration with the Sino-American Cancer Foundation (SACF) (Press release, Sino-American Cancer Foundation, MAR 28, 2023, View Source [SID1234629474]). This collaboration will leverage Simulations Plus’ staff and Artificial Intelligence-driven Drug Design (AIDD) technology in the ADMET Predictor software platform to support the discovery and design of novel inhibitors of methylenetetrahydrofolate dehydrogenase 2 (MTHFD2), an emerging cancer target.

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Per the terms of the collaboration, Simulations Plus will develop quantitative structure-activity relationship (QSAR) models for efficacy against MTHFD2, using information from SACF as well as academic and patent literature. The biologists, computational and medicinal chemists in the Early Drug Discovery Services team at Simulations Plus will work with the researchers at SACF to define the multi-objective parameters against which the lead molecule(s) will be optimized. The new AIDD Module in ADMET Predictor will then be employed to generate libraries of virtual compounds that are optimized for potency and other chosen parameters. The teams will select promising candidates for synthesis and testing, and ensuing rounds of QSAR model building and AIDD optimization will be performed until the milestone criteria in the collaboration agreement are achieved.

"We value the trust and confidence SACF has in our team and AI technology to complement and accelerate conventional drug design and lead optimization processes," said Dr. Jeremy Jones, Principal Scientist at Simulations Plus and project lead. "By combining their drug discovery expertise with our algorithmic and data science know-how, we are confident we will successfully support their hit-to-lead target development activities."

As part of this agreement, SACF will provide upfront funding to Simulations Plus to design a set number of compounds for efficacy against MTHFD2 which will be exclusive to SACF. Subsequent milestone payments will be made as key research and development goals are met.

"SACF has had an active interest in AI for de novo design for some time, and we have found a trusted partner in Simulations Plus to help us integrate this into our research," added Dr. Frank Luh, CEO of SACF. "Scientists from the two organizations will work side-by-side to combine SACF’s data with all that Simulations Plus offers to identify the next generation of compounds that could help in the treatment of cancer."

John DiBella, SLP Division President, said, "The Early Drug Discovery Services offering at Simulations Plus is tailor made for this type of partnership, where our team of experts, including computational, medicinal, and cheminformatics specialists, provide end-to-end AI-driven drug discovery and optimization support to complement the SACF team. Simulations Plus continues to invite future collaborations which benefit organizations and, most importantly, the global communities we serve.

On March 28, 2023 Biocom California, the association representing the life science industry of California, reported the following statement regarding their application to intervene in support of Illumina’s challenge to the European Commission’s jurisdiction over the acquisition of GRAIL (Press release, Illumina, MAR 28, 2023, View Source [SID1234629473]). The statement can be attributed to Joe Panetta, Biocom California’s president and CEO:

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"The European Court of Justice has granted Biocom California’s application to intervene in support of Illumina’s challenge to the European Commission’s jurisdiction over the acquisition of GRAIL. As the court recognized, Biocom California has a ‘direct, existing interest in the outcome’ of the case. The EU’s expanded approach to reviewing mergers, if upheld by the court, will make it more difficult for small, new and growing businesses to find investors, due to the unpredictability inherent in the new interpretation. Innovation in the life sciences will suffer as a result. The acquisition of GRAIL will allow Illumina to accelerate the availability and affordability of GRAIL’s multi-cancer early detection test, transforming the landscape of cancer detection on a global scale and ultimately save lives. As a leader and advocate for more than 1,700 life science companies, Biocom California strongly believes enabling this acquisition would ensure the growth and development of our innovation ecosystem, and ultimately improve the lives of patients.

On March 28, 2023 iOnctura, a clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer, reported that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, for the treatment of metastatic uveal melanoma by the Medicines & Healthcare products Regulatory Agency (MHRA) (Press release, iOnctura, MAR 28, 2023, View Source [SID1234629472]).

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The Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP) which aims to accelerate time to market and thereby patient access to novel treatments in the UK. Reserved for innovative therapies for life-threatening or seriously debilitating conditions, ILAP provides applicants with a toolkit to support all stages of the design, development, and approval process.

Roginolisib is a first-in-class, non-ATP-competitive, allosteric modulator of PI3Kd which prevents tumor proliferation and breaks immune tolerance in patients with solid and hematological tumors.

Catherine Pickering, Chief Executive Officer of iOnctura, said: "The Innovation Passport is an exciting step in the clinical development programme for roginolisib, a drug with a game-changing clinical safety and activity profile. Being awarded this passport will allow us to work closely with the MHRA and its partner agencies to chart out a roadmap for regulatory and key development milestones with the primary goal of achieving early patient access to roginolisib."

PI3Kδ inhibition in solid tumors has recently emerged as a novel approach to treating cancer because of its potential in targeting multiple tumor survival pathways. First-generation PI3Kδ inhibitors are used to treat hematological tumors, but safety concerns and limited target selectivity have curbed their clinical usefulness. These concerns are even more aggravated in patients with solid malignancies where rapid onset of toxicities have been observed. In contrast, roginolisib has a favorable toxicity profile with less than 5% Grade 3/4 toxicities at the biologically effective dose in clinical studies. Importantly, these toxicities have to-date been transient in nature without the need for dose reductions.

Clinical activity, including partial and complete responses, are being seen in patients with both solid and hematologic malignancies. Further details on clinical responses will be released at a future international clinical conference in 2023. Fourteen of 43 patients (including 12 of 28 uveal melanoma patients) are still on treatment, with two patients having been on treatment for more than two years. The one-year OS rate is currently 70%; median OS has not been reached.

A research paper recently published in Cancer Research Communications highlights that roginolisib has immune-modulatory properties that can be exploited in solid tumors and further reinforced the conclusion that roginolisib inhibits regulatory T cell proliferation while having limited anti-proliferative effects on conventional CD4+ T cells and no effect on CD8+ T cells; both immune cell types key to a robust immune response to tumors. You can access the link to the paper here.

On March 28, 2023 OncoVent Co., Ltd. ("OncoVent"), a majority-controlled subsidiary of Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (the "Company"), yesterday entered into a license agreement with Orient EuroPharma Co., Ltd. ("OEP") (Press release, Quest PharmaTech, MAR 28, 2023, View Source [SID1234629471]).

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According to the terms of the agreement, OncoVent agreed to grant exclusive rights to OEP, which will be responsible for the commercialization of oregovomab, an immunotherapy drug candidate, in Taiwan, including related regulatory applications and necessary clinical trials. OncoVent is entitled to a number of payments from OEP under the license agreement, including a one-off non-refundable upfront payment upon the effective date of the license agreement, multiple regulatory milestone payments, and multiple commercial milestone payments, in a total transaction amount of up to US$11.2 million. OEP also agreed to purchase oregovomab from OncoVent at a price equal to an agreed percentage to the average sale price of oregovomab in Taiwan.

In addition, OncoVent granted OEP the right of first refusal for the exclusive sales, marketing, and distribution right in Hong Kong and Macau.

Oregovomab, a murine monoclonal antibody and a first-in-class anti-CA125 immunotherapy drug candidate, is currently being evaluated in a global Phase III trial using study drugs produced by Cytovance Biologics Inc, a wholly-owned subsidiary of the Company and a leading contract development and manufacturing organization (CDMO) serving the biopharmaceutical industry.

Prior to this, a Phase II clinical study of oregovomab in combination with standard chemotherapy for the first-line treatment of patients with advanced primary ovarian cancer was already completed. Results from the Phase II clinical trial showed that the safety and efficacy of the combination in patients with advanced primary ovarian cancer were in line with expectations, with the median progression-free-survival (PFS) of the oregovomab plus chemotherapy cohort significantly improved to 41.8 months, compared with 12.2 months with the chemotherapy-only regimen, with a hazard ratio (HR) of 0.46 (95% confidence interval [CI]: 0.28, 0.77). It also showed a significant improvement in overall survival (OS) with an HR of 0.35 (95% Cl: 0.16, 0.76).

Ovarian cancer is ranked the eighth most common cancer in women globally and the first-line treatment for this disease has not changed for many years. Oregovomab has obtained Orphan Drug Designations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The first patient in a Phase III clinical trial of oregovomab was dosed in the U.S. in 2020. This global pivotal trial is expected to enroll 602 patients from 190 clinical sites in 17 countries and regions. As of the date of the announcement, the Phase III clinical trial of oregovomab has enrolled 534 subjects globally, of which 21 subjects are from Taiwan.

Mr. Calvin Tsai, Chief Executive Officer of OEP, said, "we have been actively expanding our oncology portfolio through R&D collaborations and in-licensing, in order to address unmet medical needs in a broad range of tumor types and bring renewed hope to cancer patients in the Asia Pacific region. Hepalink is a leading multinational biopharmaceutical company dual-listed in Hong Kong and mainland China. Its subsidiary, OncoVent, possesses a monoclonal antibody (mAb) technology platform and advanced biotechnologies for the development of oncotherapeutic vaccines and immuno-oncologic combination therapies. It is our pleasure to enter into this collaboration with Hepalink. We believe oregovomab can potentially improve the treatment outcomes for patients with advanced primary ovarian cancer. This collaboration with OncoVent not only strengthens our oncology portfolio, but also serves our overarching objective of advancing oncologic therapeutics."

Ms. Tao Han, Chief Business Officer of Shenzhen Hepalink Pharmaceutical Group Co., Ltd. and Chief Executive Officer of OncoVent Co., Ltd, commented, "having established itself in the oncology field for over 20 years, OEP is a multinational pharmaceutical company with integrated capabilities in R&D, manufacturing and commercialization, as well as a highly experienced team in the Asia Pacific region. We are glad to have entered into this strategic agreement with OEP as it will allow us to jointly develop and commercialize oregovomab, a candidate drug with promising therapeutic potential, and explore the drug’s additional therapeutic utility for a broader population of cancer patients. Moving forward, Hepalink will continue to seek partnering opportunities to accelerate the expansion of its innovative drug business and develop a diverse range of commercial capabilities.