On October 27, 2022 Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, reported favorable preclinical data that support continued development of the company’s Targeted Protein Degrader (TPD), SP-3164 (Press release, Salarius Pharmaceuticals, OCT 27, 2022, View Source [SID1234622551]). The data were presented on October 26 at the 5th Annual Targeted Protein Degradation Conference by Daniela Santiesteban, Ph.D., Salarius’ director of targeted protein degradation development, in a presentation titled "Development of SP-3164, a Cereblon-Binding Molecular Glue." The presentation is available for viewing on the company’s website here.

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Dr. Santiesteban’s presentation included an overview of SP-3164 development and the therapeutic benefits of a stereoselective molecular glue. SP-3164 was developed to be the deuterium-stabilized, active S-enantiomer, or the preferred enantiomer, of avadomide or CC-122. Avadomide is a widely studied molecular glue with demonstrated clinical activity and established safety data. In in vitro studies, SP-3164 has shown potent cereblon binding, efficient degradation of neosubstrates and induction of cell death in both lymphoma and multiple myeloma cells. In in vivo studies, SP-3164 has shown minimal to no interconversion of the preferred S-enantiomer into the unwanted R-enantiomer, indicating successful stabilization.

In addition, SP-3164 showed significant tumor growth inhibition in in vivo studies including statistically significant improvement over the approved immunomodulatory drugs lenalidomide (Revlimid) and pomalidomide (Pomalyst) in a multiple myeloma NCI-H929 mouse model. Dr. Santiesteban concluded that by eliminating the unwanted R-enantiomer, SP-3164 may lead to improved activity and safety, as demonstrated by deuterated R-enantiomer’s lack of anticancer activity and its potential role in supporting tumor growth.

"We are delighted by the reception Dr. Santiesteban’s presentation received," said David Arthur, chief executive officer of Salarius. "These initial data explain why we believe SP-3164 is so exciting, with the potential to make a positive difference in the treatment of hematologic cancers. Our near-term plans for SP-3164 include research in multiple blood cancers, additional pharmacokinetic and pharmacodynamic work to better understand potential clinical dosing advantages and additional studies to explore immuno-oncology effects and potential combinations for SP-3164.

"We are looking forward to providing additional preclinical information at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting later this year, completing our Investigational New Drug (IND)-enabling studies, submitting the SP-3164 IND to the U.S. Food and Drug Administration in the first half of 2023 and beginning clinical trials shortly thereafter," Mr. Arthur added.

On October 27, 2022 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that the Company will host a conference call and webcast on November 3, 2022 at 4:30 pm ET (1:30 pm PT) to provide a business update and report third quarter 2022 financial results (Press release, Corvus Pharmaceuticals, OCT 27, 2022, View Source [SID1234622549]).

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The conference call can be accessed by dialing 1-844-825-9789 (toll-free domestic) or 1-412-317-5180 (international) and using the conference ID 10170960. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

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."