On June 22, 2023 Parthenon Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), reported that the Journal for ImmunoTherapy of Cancer (JITC) has published results from a collaboration between Parthenon Therapeutics, The University of Texas Health Center at Houston (UTHealth Houston) and George Washington University, demonstrating that PRTH-101 potently inhibits the adhesion of collagen receptor discoid in domain receptor-1 (DDR1)-expressing cancer cells to collagen substrates and DDR1 autophosphorylation induced by collagen (Press release, Parthenon Therapeutics, JUN 22, 2023, View Source [SID1234632864]).

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The article entitled, "A highly selective humanized DDR1 mAb reverses immune exclusion by disrupting collagen fiber alignment in breast cancer," describes the humanization of PRTH-101 and the mechanism by which the drug candidate binds to its target to inhibit DDR1. The publication is now available online on the JITC website.

Key Publication Highlights

Structural studies, including a PRTH-101/DDR1 co-crystal structure, identified the PRTH-101 epitope on DDR1
Culturing DDR1-expressing human cancer cells with PRTH-101 inhibited DDR1 autophosphorylation induced by collagen and the shedding of DDR1 fragments from the cell surface
PRTH-101 demonstrated the ability to potently inhibit the adhesion of DDR1-expressing cancer cells to collagen substrates, disrupting the physical barrier formed by aligned collagen fibers in tumors
The ability of PRTH-101 to inhibit functions of the extracellular component of DDR1 differentiates PRTH-101 from DDR1 kinase inhibitors
"Our collaboration with UTHealth Houston and George Washington University has yielded great insight into the capabilities of PRTH-101 as well as demonstrated the role of DDR1 in promoting immune exclusion in cancers," said J. Paul Eder, MD, Chief Medical Officer of Parthenon Therapeutics. "This study reinforces the development of PRTH-101 as a cancer therapeutic, and also sheds light on a new therapeutic strategy to modulate collagen alignment in the tumor ECM for enhancing antitumor immunity."

Parthenon recently initiated a Phase 1 first-in-human clinical trial for its lead candidate PRTH-101 in patients with advanced solid tumors (NCT05753722).

About PRTH-101

PRTH-101 is a therapeutic antibody that specifically binds to and blocks DDR1, a protein expressed on tumor cells that binds collagen to make a minimally permeable physical barrier blocking immune cells from interacting with and attacking tumor cells. Thus, these "immune cell-excluded" solid tumors are resistant to attack by the immune system (as well as other existing therapies). By disabling DDR1, the collagen fibers lose alignment and loosen, creating gaps in the tumor barrier, thus allowing T cells to enter and attack the tumor. The creation of DDR1-directed collagen alignment does not appear to have a normal physiological surrogate and may therefore be unique to pathologies such as neoplasia, potentially allowing for relatively safe interventions. Thus, blockade of DDR1 represents a unique and "orthogonal" approach to stimulating the immune-based antitumor activity, and such blockade shows both single agent anti-tumor activity as well as marked augmentation of immunity enhanced by PD-1 blockade.

Tumor types which show particularly high levels of DDR1-associated collagen barriers include colorectal, ovarian, and non-small cell lung cancer. Currently, there are no approved drugs that target DDR1.

On June 22, 2023 Palleon Pharmaceuticals, a clinical-stage company pioneering glyco-immunology drug development to treat cancer and inflammatory diseases, reported that the first patient has been dosed in the combination therapy cohort of the Phase 1/2 clinical trial for E-602, its lead candidate from the EAGLE (Enzyme Antibody Glyco-Ligand Editing) oncology platform (Press release, Palleon Pharmaceuticals, JUN 22, 2023, View Source [SID1234632863]). The GLIMMER-01 (Glycan-Mediated Immune Regulation) trial is designed to study E-602 as a monotherapy and in combination with cemiplimab (anti-PD-1) in patients with advanced cancers.

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"With E-602, we are investigating an entirely new approach to oncology, one that we feel has potential benefits both as a monotherapy and in combination with other anti-cancer agents," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "We are pleased to work with Regeneron to evaluate E-602 in combination with cemiplimab. We expect this trial to provide valuable information as we look to understand the benefits that targeting sialoglycans can bring to advancing the field of oncology and ultimately improving the outlook for patients."

E-602 is a first-in-class glyco-immune checkpoint inhibitor developed by Palleon and designed to enzymatically degrade immunosuppressive cell-surface sugars on tumors and immune cells. GLIMMER-01 is an open-label, single-arm, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic, and antitumor activity of E-602. Regeneron is providing cemiplimab for the trial as part of a clinical supply agreement initiated earlier this year.

Palleon recently announced Phase 1 results from the GLIMMER-01 trial of E-602 as a monotherapy at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 in Orlando, Florida. The study demonstrated proof of mechanism for E-602, including dose dependent desialylation and dose dependent immune system activation. Additionally, E-602 was found to be well tolerated across the entire dose range evaluated with no dose limiting toxicities.

On June 22, 2023 Aptorum Group Limited (Nasdaq: APM) ("Aptorum Group" or "Aptorum"), a clinical stage biopharmaceutical company focused on novel technologies including the targeting of oncological diseases, reported that the group has submitted the relevant Phase 1b/2a clinical trial protocol of SACT-1, an orally administered repurposed small molecule drug for the treatment of neuroblastoma to US FDA (Press release, Aptorum, JUN 22, 2023, View Source [SID1234632862]). The Phase 1b/2a study of SACT-1 submitted is for the combination with chemotherapy for first relapse or refractory high risk neuroblastoma.

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Mr. Darren Lui, Chief Executive Officer of Aptorum Group, commented, "Pursuant to an IND opened in September 2021, we have recently submitted a clinical protocol for a Phase 1b/2a trial of SACT-1 (in combination with chemotherapy) to the US FDA and no further comments have been received from the agency in the past 30 days. As a result, we are ready to advance the relevant Phase 1b/2a trials for SACT-1 in neuroblastoma patients subject to patient recruitment.

This Phase 1b/2a trial represents another key milestone for the company and one of the targeted strategic goals for the year of 2023. Neuroblastoma is a solid tumor arising in the nervous system outside of the brain predominantly in pediatric patients. The clinical behavior of neuroblastoma is highly variable with majority cases being highly aggressive. SACT-1 has the potential to effectively target this disease and address the unmet demands of such."

The targeted objectives of the Phase 1b part of the study based on neuroblastoma patients to be enrolled is to determine the recommended phase 2 dose (RP2D) based on safety, pharmacokinetics and efficacy and the Phase 2a part of the study based on neuroblastoma patients to be enrolled will be used to assess the preliminary efficacy of SACT-1. We will work closely with the regulatory agency in our journey towards the approval of our drug.

About SACT-1

SACT-1 is an orally administered repurposed small molecule drug to target neuroblastoma. SACT-1’s mechanism has been investigated in our preclinical studies to enhance tumor cell death and suppress MYCN expression (a common clinical diagnosis in high-risk or relapsed neuroblastoma patients where an amplification of MYCN is usually observed). SACT-1 is designed to be used especially in combination with standard-of-care chemotherapy.

On June 22, 2023 Lunaphore Technologies SA, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, reported that it has reached an agreement to be acquired by Bio-Techne Corporation (NASDAQ:TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities (Press release, Bio-Techne, JUN 22, 2023, View Source [SID1234632861]). The acquisition is anticipated to close in Q3.

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Founded in 2014 and headquartered in Tolochenaz, Switzerland, Lunaphore is a leading developer of fully automated spatial biology solutions using precision microfluidic technology capable of revealing hyperplex proteomic and transcriptomic biomarkers in tumors and other tissues at single-cell and subcellular resolution. Providing ultimate flexibility in panel design, Lunaphore’s technology and instrumentation empower researchers in immunology, immune-oncology, and neuroscience to push the boundaries of scientific discovery and accelerate therapeutic development. Lunaphore’s spatial biology technology enables the identification of biomarker "signatures" with clinical relevance, providing data necessary to support the development of diagnostic tools and streamline clinical trials, and ultimately improve patient outcomes.

Lunaphore’s instrument portfolio includes COMET, an end-to-end spatial biology platform, with staining, imaging, and image preprocessing steps integrated into a fully automated, high-throughput instrument, that delivers true walk-away automation with unmatched scalability, reproducibility, and tissue morphology. Eliminating the need to conjugate antibodies, researchers can leverage their existing antibody libraries and decades of know-how on Lunaphore’s platforms to scale assays into endless multiplexing possibilities. Designed for use with standard pathology slides, COMET’s superior tissue profiling capabilities enable the analysis of 40 different spatial biomarkers per sample in each automated run, allowing for virtually unlimited plex. The product portfolio is complemented by SPYRE antibody panel kits and HORIZON image analysis software. Lunaphore also offers LabSat, an automated tissue staining instrument that offers a 30-minute turn-around time, delivering a much faster and hands-off staining solution compared to manual methods where turnaround times can take several days.

Bio-Techne and Lunaphore recently announced a strategic partnership to develop the first fully automated spatial multiomic workflow. This fully automated multiomics solution will utilize Lunaphore’s COMET instrument and SPYRE antibody panels as well as Bio-Techne’s RNAscope HiPlex technology to enable simultaneous hyperplex detection of protein and RNA biomarkers on the same slide at single-cell resolution.

"Lunaphore is very complementary to Bio-Techne’s leading spatial biology franchise, as COMET delivers an automation platform for our RNAscope assays, and we leverage our global commercial team to penetrate this rapidly growing market. We also see additional synergies with our leading portfolio of antibodies and other products," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "Lunaphore is seeing strong initial traction with its COMET instrument, as this fully integrated, fully automated spatial biology system delivers the end-to-end automation that is in high demand from translational researchers. We anticipate COMET to play an important role as spatial biology gains traction in clinical applications. We are excited to welcome Lunaphore’s talented team, instrument portfolio, and technology to Bio-Techne."

"We are truly excited to be joining Bio-Techne and combining capabilities to lead the Spatial Biology market." said Dr. Ata Tuna Ciftlik, Chief Executive Officer of Lunaphore. "Our shared vision of tackling the translational and clinical research market, while using our complementary best-in-class spatial proteomics and transcriptomics products is going to make a great impact on our customers in advancing research. In addition, Bio-Techne’s global reach, and commercial and operational excellence will enable Lunaphore to accelerate its penetration into the high growth spatial biology market. We’re now joining forces to be the largest spatial biology player."

Wenger Plattner is serving as Bio-Techne’s legal counsel. Bourgeois Avocats SA is serving as legal counsel to Lunaphore. UBS Investment Bank served as financial advisor to Lunaphore.

On June 22, 2023 Stanford University’s Innovative Medicines Accelerator (IMA) and Intonation Research Laboratories (Intonation) reported to have formed a collaboration to develop treatments that target cancerous neuroendocrine tumors, or tumors that form from hormone-releasing cells (Press release, Stanford University, JUN 22, 2023, View Source [SID1234632860]).

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The goal of the collaboration is to reduce the time and resources it takes to translate a biomedical breakthrough into a clinically and commercially viable medicine.

"I’m excited about this collaboration with Intonation Research Laboratories, which has the potential to speed the translation of promising research into urgently needed new treatments and therapies," said Marc Tessier-Lavigne, president of Stanford University. "This type of partnership goes to the heart of why we created the Innovative Medicines Accelerator — to connect biomedical researchers with partners so that we can more efficiently translate Stanford discoveries into real impact for society."

Lloyd Minor, MD, dean of the Stanford School of Medicine, said that the goal of the collaboration, IMA’s second in recent months, is to rapidly improve patient care. "We hope to greatly accelerate our drug development program and deliver transformative treatments to patients burdened with neuroendocrine tumors," he said.

Over the next two years, Intonation, led by founder and chairman Suresh K. Jain, PhD, will collaborate on a project that originated in the laboratory of Justin Annes, MD, PhD, associate professor of endocrinology, and advanced in partnership with Mark Smith, PhD, head of medicinal chemistry at Sarafan ChEM-H.

"We have found a unique aspect of neuroendocrine tumor biology that can be leveraged to develop targeted and effective medications," Annes said.

The agreement calls for a close collaboration where the Annes laboratory and Intonation, with the IMA’s help, contribute expertise and resources to strengthen foundational intellectual property created at Stanford University. "We want to find partners where we don’t just hand it over and be done," said Chaitan Khosla, PhD, the Innovative Medicines Accelerator director and a professor of chemistry and of chemical engineering at Stanford University. "We want to assist the partner so they can run the next leg of the journey."

"Joining forces with Stanford University’s IMA is a prime opportunity to collaboratively create innovative treatments for neuroendocrine tumors in an efficient and cost-effective way," Jain said. "Our partnership with a renowned academic institution such as Stanford will reinvigorate and enhance the ecosystem of drug discovery in India."

Khosla said this additional relationship will allow the university to explore new external collaboration models as it attempts to fulfill its stated mission concerning accelerators: to be a more purposeful university. The IMA is evaluating and fine-tuning several additional home-grown projects from Stanford University’s principal investigator labs with potential for prototyping highly differentiated new medicines, Khosla said.

"The IMA continues to seek high-quality partners in our mission as an accelerator," said Khosla, the Marc and Jennifer Lipschultz Director of the Stanford Innovative Medicines Accelerator. "And we are excited about engaging diverse partners in helping us scale Stanford-grown solutions."

The collaboration with Intonation follows on the heels of January’s announcement that the IMA is initiating a similar agreement with investment firm The Invus Group around another form of cancer, glioblastoma.