On March 28, 2023 Morphogenesis Inc., a Phase 3 clinical stage biopharmaceutical company developing novel personalized cancer vaccines, reported that it has entered into a definitive asset purchase agreement, in a stock for stock transaction, to acquire TυHURA’s novel ADCs targeting MDSCs to modulate tumor microenvironment immunosuppression (Press release, Morphogenesis, MAR 28, 2023, View Source [SID1234637063]). The technologies were developed by researchers at Moffitt Cancer Center, West Virginia Research Corporation and TυHURA. Through this acquisition, Morphogenesis now has exclusive worldwide license rights to TυHURA’s patents and patented technologies related to the ADC platform.

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"Tumor-associated MDSCs are a major obstacle to immunotherapy, being responsible for acquired resistance to checkpoint inhibitors, and contribute to T cell and NK cell exhaustion, preventing cellular therapies from being more effective in attacking cancer. TυHURA’s technology represents a new paradigm. Unlike conventional ADCs where an antibody is used as a targeting agent and a cellular toxin is the payload, TuHURA’s ADCs are bi-functional, where a small molecule inhibitor of MDSC function is the targeting agent, and an immune effector like a checkpoint inhibitor is the payload. These bi-functional ADCs block MDSC’s immune suppressing effects, while localizing an immune effector in the tumor microenvironment. Through this technology represents a promising new approach to overcoming resistance to cancer immunotherapy," commented James A. Bianco, M.D., Chief Executive Officer of Morphogenesis. "We believe through this strategic acquisition, TυHURA’s novel technology will be complementary to our IFx personalized cancer vaccine technology in addressing obstacles to overcoming resistance to immunotherapies."

"TυHURA and Moffitt researchers are the first to identify a novel Delta receptor on MDSCs that controls many of MDSC immune suppressing functions, representing a major advance in the ability to increase a tumor’s susceptibility to immune attack, with the promise of increasing the effectiveness and safety profile of immunotherapy," added Alan F. List, M.D., former President and CEO of Moffitt Cancer Center, a noted expert on the central role of MDSCs contribution to tumorigenesis and resistance to immunotherapy, and member of the independent committee of the Morphogenesis Board of Director’s who evaluated and negotiated the TυHURA asset purchase.

"Modulating the tumor microenvironment is an area of intense research and development among large pharmaceutical companies given its importance in preventing the effective use of immunotherapies like checkpoint inhibitors. This acquisition not only provides Morphogenesis a truly novel approach to block MDSC induced immunosuppression, but also significantly de-risks and bolsters our development pipeline. We look forward to further elucidating the unique characteristics of the Delta receptor and advancing a new generation of bi-functional ADCs toward first-in-human clinical trials," concluded Dr. Bianco.

On March 28, 2023 Athebio AG, an innovation leader in the discovery and design of designed ankyrin repeat proteins (DARPins), reported that it has entered a Development and License Agreement with Acuitas Therapeutics, a company focused on the development of delivery systems for nucleic acid therapeutics based on lipid nanoparticles (LNP) (Press release, AtheBio, MAR 28, 2023, View Source [SID1234631625]). Under the agreement, Athebio provides Acuitas with exclusive access to its Athebody DARPin technology to explore the potential of combining Athebio’s Athebody DARPins and Acuitas’ LNP technology for targeted nucleic acid delivery using DARPin-LNP and make it accessible to Acuitas’ partners.

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"We are excited to be working with the leader in the LNP field in order to tackle one of the most pressing issues for nucleic acid therapeutics – its target-specific delivery," said Patrik Forrer, one of the inventors of the DARPin technology and CEO and Chairman of Athebio. "The corona crisis has proven the huge potential of nucleic acid therapeutics, but without the possibility to deliver nucleic acids target-specifically, its application fields will remain limited. Our Athebody DARPins have ideal properties to potentially close this gap and take the mRNA technology to the next level. In particular, the highly stable Athebody DARPins should allow for simple site-specific conjugation to LNP and confer highly specific target binding. The combination of superior manufacturability and tailored target binding would have game-changing potential and we are looking forward to exploring this together with Acuitas."

On March 28, 2023 Genor Biopharma (Stock code: 6998.HK) reported that the China National Medical Products Administration (NMPA) has officially accepted the new drug application for GB491 (Lerociclib cyclin-dependent kinase 4/6 inhibitor) in combination with Fluvestran as the treatment of HR+/HER2- locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy (Press release, Genor Biopharma, MAR 28, 2023, View Source [SID1234629908]).

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About GB491 (Lerociclib)

GB491 (Lerociclib) is a highly selective oral CDK4/6 inhibitor for the treatment of breast cancer. It was developed by Genor Biopharma and G1 Therapeutics. The company in-licensed exclusive rights of GB491 (Lerociclib) from G1 Therapeutics, Inc. (Nasdaq: GTHX) in certain APAC countries excluding Japan in June 2020.

On March 28, 2023 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported that the Company will be presenting three posters at two upcoming scientific conferences: ESMO (Free ESMO Whitepaper)’s European Lung Cancer Congress (ELCC) 2023 and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 (Press release, BerGenBio, MAR 28, 2023, View Source [SID1234629649]).

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European Lung Cancer Conference 2023

March 29 – April 1, 2023

Bella Center – Copenhagen, Denmark

Poster Title: Phase 1b/2a safety and tolerability study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced or metastatic non-squamous NSCLC with/without STK11 mutations

Session Title: Poster Display session (ID 51)

Session Date & Time: Friday March 31, 2023, 12:00 PM – 12:45 PM

Location: Exhibition and Poster area

Presentation Number: 78TiP

American Association for Cancer Research Annual Meeting 2023

April 14 – 19, 2023

Orlando County Convention Center – Orlando, Florida

Poster Title: AXL as a Therapeutic Target in STK11 mutant NSCLC
Session Title: Combination Immunotherapies 1
Session Date and Time: Monday Apr 17, 2023, 1:30 PM – 5:00 PM
Location: Section 39
Poster Board Number: 18
Abstract Presentation Number: 3245

Poster Title:  Combined inhibition of AXL and ATR enhances replication stress, cell death and immune response in small cell lung cancer
Session Title:  DNA Repair / Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes
Session Date and Time: Wednesday Apr 19, 2023, 9:00 AM – 12:30 PM
Location: Section 18
Poster Board Number: 8
Abstract Presentation Number: 6206

The posters from both conferences will be available on the Company’s website in the Scientific Presentations portion of the Investors section following their presentations.

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 (Press release, Salubris Biotherapeutics, MAR 28, 2023, View Source [SID1234629613]). 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 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."

"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.