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.

On June 22, 2023 CEL-SCI Corporation (NYSE American: CVM) reported that it will present the new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN), at the American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer on July 8-12, 2023 in Montreal, Canada (Press release, Cel-Sci, JUN 22, 2023, View Source [SID1234632859]).

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"This data to be presented at AHNS, in our view and also in the view of our clinical consultants, is quite remarkable and has the potential to help many more people than just the study population in our recently concluded Phase 3 clinical trial," stated CEL-SCI CEO, Geert Kersten. "In fact, these findings are so novel that we are currently preparing to file a new patent application. Details will be announced once the presentation has been given."

CEL-SCI’s IT-MATTERS pivotal Phase 3 study reported a statistically significant 14.1% absolute 5-year overall survival (OS) benefit in the intent to treat (ITT) subjects who received Multikine followed by surgery and radiotherapy, as compared to control subjects who received only standard of care (SOC) (surgery plus radiotherapy). The Company is pursuing marketing approval for Multikine in the treatment of head and neck cancer in the U.S., Canada and the European Union.

On June 22, 2023 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported a first reported case of a uveal melanoma (UM) patient who was treated with single agent darovasertib as neoadjuvant therapy and was spared enucleation in an Investigator Sponsored Trial (IST) (Press release, Ideaya Biosciences, JUN 22, 2023, View Source [SID1234632858]).

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"We are very excited to explore the potential of darovasertib as neoadjuvant and adjuvant therapy for patients with ocular melanoma. This case suggests that treatment with darovasertib as monotherapy can preserve the eye and may have vision-sparing utility as well as quality of life benefits," said Professor Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent’s Hospital in Sydney, a principal investigator in the IST. The IST, captioned as "Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma" (NADOM), also includes participating sites of Alfred Health and the Royal Victorian Eye and Ear Hospital in Melbourne.

"Avoiding enucleations with darovasertib is a very promising development in the field of ocular oncology. We are looking forward to further research and trials using this approach," said Dr. William Glasson, MBBS, FRANZCO, Terrace Eye Center, Brisbane, Australia, who was the treating ophthalmologist for the first reported case of spared enucleation on darovasertib monotherapy.

In the reported case, the UM patient observed a 24% reduction in tumor size following four months of neoadjuvant treatment with darovasertib as monotherapy. The reduction in tumor size enabled plaque brachytherapy as a primary interventional treatment rather than originally planned enucleation. This UM patient shared his experience in an exclusive interview and report by medical reporter Gabriella Rogers of Television 9 News Channel station in Sydney Australia on June 21, 2023. See link: View Source

The eye preservation was observed in the first UM patient treated under the amended protocol of the NADOM study. Pursuant to the protocol, uveal melanoma patients who would otherwise undergo enucleation are instead treated with single agent darovasertib as neoadjuvant treatment for up to six months or maximum benefit – reflecting an increase in potential treatment duration versus the initial approach of one month neoadjuvant therapy. Multiple additional UM patients are also enrolled in the Phase 1 NADOM study under the amended protocol.

IDEAYA is initiating clinical sites to support a company-sponsored Phase 2 clinical trial, designated as IDE196-009 (NCT05907954), to evaluate darovasertib as monotherapy in (neo)adjuvant uveal melanoma with potential near-term clinical endpoints such as organ preservation (avoiding enucleation) for large ocular tumors and reduction in radiation dose and/or vision preservation for small or medium ocular tumors. The Phase 2 clinical trial plans to enroll patients in U.S., Europe and Australia.

IDEAYA previously reported preliminary clinical activity observed in primary uveal melanoma, including tumor shrinkage in 9 of 9 patients following therapy with darovasertib as monotherapy or in combination with crizotinib, and an initial reported patient who was spared an enucleation following neoadjuvant treatment with the combination under a compassionate use protocol.

Uveal melanoma is a rare, lethal form of melanoma that arises from melanocytes of the iris, the ciliary body, or most commonly the choroid, with an annual potential incidence of approximately 8,700 patients aggregate and an estimated prevalence of ~100,000 patients aggregate in the U.S. and Europe. UM has no approved systemic neoadjuvant or adjuvant therapies. Current approaches for treatment of primary UM includes radiotherapy (plaque brachytherapy or stereotactic radiosurgery) and, for larger tumors, enucleation of the eye, with consequential patient impact including reduced vision, decreased depth perception, diminished social functioning and unsatisfactory cosmesis.

Darovasertib (IDE196) is a potent, selective small molecule inhibitor of protein kinase C (PKC). The FDA has designated darovasertib as an Orphan Drug in Uveal Melanoma, including primary and metastatic disease under 21 C.F.R Part 316. IDEAYA owns or controls all commercial rights in darovasertib in UM, subject to certain economic obligations pursuant to its exclusive, worldwide license with Novartis.

On June 22, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported presentations from the Company’s investigational prostate (prostate specific-membrane antigen, or PSMA-targeting) and renal (carbonic anhydrase IX, or CAIX-targeting) diagnostic and therapeutic programs at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting being held in Chicago from June 24 – 27 (Press release, Telix Pharmaceuticals, JUN 22, 2023, View Source [SID1234632857]).

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Further data from Telix’s completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) will be delivered by Jeremie Calais, MD in an oral presentation.

In addition, Andrew M. Scott, MD will present a preclinical evaluation of Telix’s CAIX-targeting radionuclide therapy candidate TLX250 (177Lu-DOTA-girentuximab) in combination with a Merck KGaA DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib.

SNMMI 2023 will also feature presentations on Telix’s lutetium-based, antibody-directed prostate cancer therapy program, ProstACT, and the Company’s FDA-approved, gallium-based prostate cancer imaging agent, Illuccix, where PSMA imaging with positron emission tomography (PSMA-PET) continues to be a focus for the nuclear medicine and molecular imaging community.

Telix Chief Medical Officer, Dr. Colin Hayward said, "It is fantastic to have such broad representation at this year’s SNMMI annual meeting, the premier educational, scientific, research, and networking event in nuclear medicine and molecular imaging worldwide. Alongside further data from the highly successful Phase III ZIRCON study in kidney cancer imaging, we are excited to present latest updates from our ProstACT SELECT and TARGET studies as this program builds momentum into the ProstACT GLOBAL study.

"Preclinical data from a study of Telix’s CAIX-targeting therapy candidate TLX250 with an investigational DNA damage response inhibitor will also be presented as this combination prepares to move into the clinic. And last – but by no means least – our approved prostate cancer imaging agent, Illuccix, will feature on the program as part of lifecycle management. Drop by our booth number 4015 to meet with the team, to learn about Telix’s deep theranostic pipeline, and to discuss how recent guideline updates for prostate cancer imaging could impact clinical decision making and patient management."

SNMMI oral presentation details are as follows:

Session: Focus on Clinical Studies – New Insights
Title: 177Lu-TLX591 safety, biodistribution and dosimetry study (ProstACT SELECT)
Date and Time: 24-Jun-2023, 3:45 – 3:55 PM
Presenter: Nat Lenzo, MD (GenesisCare)
Abstract ID: P1145

Session: Urologic Malignancies – Integrated Session
Title: 89Zr-DFO-girentuximab PET/CT imaging can accurately detect clear cell renal cell carcinoma (ccRCC) primary and secondary lesions in patients with renal masses at conventional imaging, results from ZIRCON Phase III study
Date and Time: 26-Jun-2023, 10:55 – 11:05 AM
Presenter: Jeremie Calais, MD (UCLA)
Abstract ID: P1113

Session: Imaging and Therapy in Preclinical Oncology Models – Session 2
Title: Addition of DNA dependent protein kinase (DNA-PK) inhibitor peposertib enhances efficacy of 177Lu-based radioimmunotherapy in pre-clinical models of prostate and renal cell carcinoma
Date and Time: 26-Jun-2023, 11:05 – 11:15 AM
Presenter: Andrew M. Scott, MD (Olivia Newton-John Cancer Research Institute, and La Trobe University)
Abstract ID: P1271

SNMMI poster presentations:

Session: Meet the Author: Oncology: Clinical Therapy & Diagnosis – Group A
Title: Analysis of bone lesions on 68Ga-PSMA-11 PET/CT in a randomized controlled trial of men with biochemical recurrence of prostate cancer post prostatectomy
Date and Time: 26-Jun-2023, 11:15 – 11:45 AM
Presenter: David Schuster, MD (Emory University)
Abstract ID: P968

Session: Meet the Author: Oncology: Clinical Therapy & Diagnosis – Group A
Title: External beam therapy with theranostic radioligand therapy for oligometastatic prostate cancer (ProstACT TARGET)
Date and Time: 26-Jun-2023, 11:15 – 11:45 AM
Presenter: Nat Lenzo, MD (GenesisCare)
Abstract ID: P1178

Session: Meet the Author: Oncology: Clinical Therapy & Diagnosis – Group A
Title: 30-second acquisition for Ga-68 PSMA-11 total-body PET/CT impacts prostate cancer management
Date and Time: 26-Jun-2023, 11:15 – 11:45 AM
Presenter: Harshad Kulkarni, MD (BAMF Health)
Abstract ID: P1408