On October 27, 2022 Sporos BioDiscovery, Inc. (a wholly owned affiliate of Sporos Bioventures, "Sporos" or the "Company"), a precision oncology company developing a diversified pipeline of small molecule therapeutic programs targeting cancer vulnerabilities in the tumor and tumor microenvironment, reported its poster presentation highlighting preclinical data on the Company’s lead program, SPR1, a differentiated, novel TEAD inhibitor at 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place October 26-28, 2022, in Barcelona, Spain (Press release, Sporos Bioventures, OCT 27, 2022, View Source [SID1234622541]).

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"We were excited to present preclinical data from SPR1, a next-generation, finely tuned TEAD inhibitor program, with a unique TEAD isoform selectivity that we believe sets it apart from other TEAD inhibitors and offers a potential best-in-class profile. These preclinical data sets demonstrate compound safety and superior in vivo single-agent activity in large-volume tumor models and in combination with KRAS, MEK, and RTK inhibitors," said Dr. Stephen Rubino, Chief Executive Officer of Sporos. "Our data supports our initiative to move SPR1 into clinical development with a goal of filing an IND before the end of 2023."

The Hippo pathway (effected by the YAP/TAZ-TEAD transcriptional complex) is a major oncogenic pathway and hyperactivation of YAP/TAZ-TEAD transcription has been demonstrated as a key mechanism of resistance to MAPK pathway inhibition, as well as inhibition of its upstream inputs, such as EGFR and other receptor tyrosine kinases. The poster presents the first disclosure of SPR1, Sporos TEAD inhibitor program. Highlights of the poster, titled "A Family of Novel TEAD Palmitoylation Site Inhibitors with Exceptional Pre-clinical Anti-neoplastic Activity as a Monotherapy and in Combination with MAPK Inhibitors," include:

The synthesis of a series of small molecule inhibitors of TEAD transcription factors with nM activity in a broad range of cancer cell lines, coupled with favorable pharmacokinetic and safety profiles.
Fine-tuning of TEAD isoform specificity yielded exceptional TEAD inhibitors with low toxicity (MTD >300 mg/kg, >20X efficacious dose) coupled with high anti-tumor efficacy.
Sporos’ TEAD inhibitors yield rapid regression even in very large pre-clinical tumors, a first in the TEAD-inhibitor space.
Sporos’ TEAD inhibitors show strong synergy with precision oncology drugs targeting the MAPK pathway and its upstream inputs, including Sotorasib, Trametinib, and Osimertinib.
Differentiated activity profile of SPR1 TEAD inhibitors may derive from favorable TEAD isoform inhibitory specificity.

On October 27, 2022 Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and systemic targeted radiation therapy of certain hard-to-treat cancers, and AmbioPharm, a global peptide contract development and manufacturing organization, reported that they have entered into a strategic partnership for the manufacture and supply of peptide conjugates to be used by Ariceum in future clinical studies (Press release, Ariceum Therapeutics, OCT 27, 2022, View Source [SID1234622540]).

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AmbioPharm is supporting Ariceum with cGMP manufacturing and supply of peptide conjugates that will be radio-labelled as the radiopharmaceutical end-product used in upcoming clinical trials. Radio-labelled receptor-binding peptides are an important class of radiopharmaceuticals for targeted tumor diagnosis and therapy and will be used in clinical trials of Ariceum’s lead radiopharmaceutical product, satoreotide, for the treatment of neuroendocrine cancers and certain other aggressive, hard-to-treat cancers, currently in Phase I/II. Satoreotide is being developed as a ‘theranostic’ pair for the combined diagnosis and targeted radionuclide treatment of these tumours.

As a peptide contract development and manufacturing organization (CDMO) providing cGMP peptide APIs with capabilities ranging from research to commercial scales, AmbioPharm actively engages with innovative biopharmaceutical companies in developing first-in-class, best-in-class, and breakthrough peptide technologies that utilize AmbioPharm’s peptide manufacturing expertise and in-depth scientific experience in novel and conventional peptide chemistry.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "Ariceum is very pleased to be partnering with AmbioPharm. As we build our platform and continue to advance our lead product, satoreotide, towards clinical trials, we are delighted to be supported by such a well-established and reliable manufacturer of high-quality, FDA-inspected peptide APIs."

Michael W. Pennington, PhD, Chief Scientific Officer at AmbioPharm, added: "We are delighted to play a role in the synthesis of this peptide ‘theranostic’ that will be a valuable resource for the treatment and diagnosis of certain hard-to-treat neuroendocrine cancers."

On October 27, 2022 Therapeutic Solutions International (TSOI) reported that formation of a Spin-Off Company, Res Nova Bio, Inc., dedicated to the development of cancer inhibiting anti-angiogenesis immunotherapies (Press release, Therapeutics Solutions International, OCT 27, 2022, View Source [SID1234622539]).

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Res Nova Bio has licensed from Therapeutic Solutions International intellectual property covering StemVacs-V which is an iPSC derived platform technology announced in May of 20211 and discussed with potential corporate partners in September 20212.

The technology utilizes pluripotent stem cells called iPSCs in order to generate new cells which resemble tumor blood vessels that are made to act as a "therapeutic vaccine". Specifically, the administration of StemVacs-V stimulates the immune system to selectively kill blood vessels that feed the tumor but not healthy blood vessels. It is believed that for every 1 tumor blood vessel cell that is killed, 200-300 tumor cells are also killed as a result.

"I have previously been involved in the original studies using placental cells to stimulate immunity to cancer endothelium (blood vessels), using a product called "ValloVax". Having administered ValloVax to cancer patients I have seen the potency of this product firsthand. Unfortunately, despite receiving FDA clearance, commercial development of ValloVax ceased, therefore, in collaboration with scientists at Therapeutic Solutions International we developed a second generation ValloVax called StemVacs-V," said Dr. James Veltmeyer, co-inventor and Chief Medical Officer of Therapeutic Solutions International. "In contrast to previous approaches, StemVacs-V allows for creating all doses from one standardized cell type, which alleviates the need for multiple placentas, avoiding variability in production. Additionally, because StemVacs-V is derived from iPSC, gene editing can be performed in order to increase therapeutic efficacy."

"Therapeutic Solutions International can be seen as an ‘innovation factory’ containing multiple assets at different stages of development," said Timothy Dixon, co-inventor, President, and CEO of the Company. "We believe that spinning off separate companies allows for hyper-accelerated development of the various technologies in our pipeline. We are confident that Res Nova Bio, Inc., will commercialize this radically new approach to cancer that combines the two most promising treatment approaches, suppression of angiogenesis and immunotherapy."

On October 27, 2022 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported that the company will release its financial results for the third quarter ended September 30, 2022, including a corporate update, on Thursday, November 3, 2022, before the opening of the U.S. financial markets. A webcast will follow at 8:00 am ET (Press release, Immunic, OCT 27, 2022, View Source [SID1234622538]).

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To participate in the webcast, please register in advance at: View Source or on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.

An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations.

On October 27, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that the final primary endpoint results from the phase III randomized single-center MIRAGE trial were presented at the 64th Annual Meeting of the American Society for Radiation Oncology (ASTRO) being held October 23-26, 2022, at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, ViewRay, OCT 27, 2022, View Source [SID1234622537]). The trial was independently conducted by investigators at UCLA and compared MRIdian MRI-guided SBRT vs. CT-guided SBRT for localized prostate cancer.

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Final outcomes of the phase III randomized trial comparing acute grade ≥2 genitourinary (GU) toxicity following MRIdian MRI-guided vs. CT-guided prostate SBRT determined that MRI-guidance significantly reduced acute grade ≥2 GU and gastrointestinal (GI) toxicity. In the trial, 156 patients were randomized and received MRIdian MRI-guided SBRT or CT-guided SBRT (40 Gy in five fractions). Acute grade ≥2 GU toxicity rates were significantly lower with MRI-guidance vs. CT-guidance (24.4% in the MRI group vs. 43.4% in the CT group). Rates of acute grade ≥2 GI toxicity were also significantly lower with MRI-guidance (0.0% in the MRI group vs. 10.5% in the CT group). On multivariable analysis, which controls for differences in the use of hydrogel spacer, prostate size, and baseline urinary symptoms, the MRI-guidance arm was associated with a 60% reduction in odds of grade ≥2 GU toxicity.

Perhaps even more notably, there were improvements in multiple patient-reported outcomes. Significantly more patients receiving CT-guided SBRT experienced large increases in urinary symptoms, as measured by a >15 points increase in International Prostate Symptom Score (IPSS) (6.8% in the MRI group vs. 19.4% in the CT group). Similarly, a significantly greater percentage of patients experienced a clinically notable decrease in bowel-related quality of life with CT-guided, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC-26) survey (25.0% in the MRI group vs. 50.0% in the CT group). Finally, though it is too early to draw final conclusions as more than 2/3rds of men on the trial received hormonal therapy, exploratory analysis in men who did not receive hormonal therapy showed that patient-reported, sexual-function scores (by EPIC-26) decreased more in men receiving CT-guided SBRT.

"A major consideration with prostate SBRT is the margin of normal tissue around the target that is exposed to high-dose radiation. The highly positive final results of our phase III MIRAGE trial show that when MRI-guidance is used to shrink this margin, there are significant improvements in both physician-scored and patient-reported toxicity in terms of urinary and bowel side effects," said Amar Kishan, MD., Associate Professor and Chief of the Genitourinary Oncology Service at UCLA. "UCLA has had a robust, leading SBRT program since 2010, and we have long offered this to our patients using a CT-guided platform. With the positive results of our trial, we have shifted to almost exclusively offering MRI-guided SBRT. Though differences in late toxicity will take years to manifest, in the interim, these data provide strong support for the use of this advanced technology to treat with unprecedented tight margins."

The MRIdian system provides oncologists outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and organs-at-risk, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins. This allows for delivery of the prescribed dose to the target, while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy.

To date, nearly 27,000 patients have been treated with MRIdian. Currently, 54 MRIdian systems are installed at hospitals around the world where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts, and presentations. For a list of treatment centers, please visit: View Source

Conflicts of Interest: Amar Kishan, M.D. discloses research funding from the Department of Defense, the National Institutes of Health, the Jonsson Comprehensive Cancer Foundation, the Prostate Cancer Foundation, and the American Society for Radiation Oncology. He also discloses research support, not related to this study, from ViewRay, Inc. He discloses consulting fees from ViewRay, Inc. and Varian Medical Systems, Inc. Dr. Kishan also discloses low-value stock held in ViewRay Inc.