On October 24, 2023 Novartis reported a very strong quarter, with double-digit sales and core operating income growth leading to a further upgrade to 2023 guidance (Press release, Novartis, OCT 20, 2023, View Source [SID1234636263]). We have successfully executed the spin-off of Sandoz, allowing us to fully focus on high-value innovative medicines. Our growth drivers, including Kesimpta, Entresto, Kisqali and Pluvicto, continue to perform well in the market. Our robust pipeline also continues to deliver, and we have achieved important innovation milestones for Pluvicto, iptacopan, remibrutinib and Lutathera. We are confident in our mid-term growth outlook and remain committed to creating value for our shareholders."

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On October 12, 2023 Scientists at the Translational Genomics Research Institute (TGen), part of City of Hope, in collaboration with SIWA Therapeutics Inc., reported results from a preclinical study that highlights the potential of SIWA318H, an advanced glycation end product (AGE)-targeting antibody, in the fight against pancreatic cancer (Press release, SIWA Therapeutics, OCT 12, 2023, View Source [SID1234636200]). The results appear in Scientific Reports, a Nature publication.

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Pancreatic cancer, especially pancreatic ductal adenocarcinoma (PDAC), has long been known for its aggressive nature and resistance to current treatment options. SIWA318H’s ability to selectively target senescent cells represents a new approach to treating the disease. Senescent cells within the tumor microenvironment have been identified as major contributors to tumor development, growth and therapy resistance. SIWA318H, an antibody specifically designed to target AGEs, offers a novel approach to eliminate these senescent cells and reshape the tumor microenvironment.

"These pre-clinical results suggest that SIWA318H is a promising new therapeutic against pancreatic cancer," said Lewis S. Gruber, CEO and co-founder of SIWA Therapeutics. "By reshaping the tumor microenvironment, our goal is to improve the efficacy of cancer treatments and potentially lead to better patient outcomes."

The study’s key findings reveal that SIWA318H has a remarkable ability to specifically attach itself to modified proteins associated with aging and cancer progression. It targets senescent cells, which are linked to these health issues, both in vitro and within living organisms. This ability to target senescent cells is an important part of how the drug works. Additionally, SIWA318H can trigger a process called antibody-dependent cell-mediated cytotoxicity (ADCC), which helps the immune system eliminate cancer cells.

In a study involving mice with pancreatic cancer, those treated with SIWA318H saw a significant reduction in tumor growth, increased survival, and an increased rate of complete remission compared to mice treated with a control antibody. Furthermore, the tumors treated with SIWA318H showed fewer senescent cells and less profibrotic cells, indicating a positive impact on the tumor’s surrounding environment.

"SIWA318H’s ability to selectively target senescent cells, coupled with its demonstrated efficacy in preclinical models, offers a glimmer of hope for a new approach to tackling this formidable disease," said Haiyong Han, Ph.D., a professor in the Molecular Medicine Division at TGen and the study’s senior author.

These findings also suggest that SIWA318H holds promise for potential use in combating aging-related issues and cancer.

On October 20, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that another patient has reached the 18-month survival mark after start of therapy increasing overall survival at 18 months (OS-18) to 67% in the GLORIA expansion arm for newly diagnosed glioblastoma patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy (Press release, TME Pharma, OCT 20, 2023, View Source [SID1234636199]).

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This announcement provides an update to a recent disclosure by the company (October 10, 2023) at time of which the last patient had not yet passed the 18-month survival mark. The percentage of patients alive 18 months after the start of their therapy has thus increased from 50% to 67% (4 of 6 patients). Thus, the survival rate at 18 months of patients treated with NOX-A12 + bevacizumab (anti-VEGF) + radiotherapy outperforms by 13-fold the 18-month survival of 5% observed in the matched group of reference patients receiving standard of care1.

Median overall survival also continues to improve further and has already exceeded 18 months as the remaining patients in the GLORIA clinical trial continue to receive treatment or follow-up care2. For comparison, the matched standard of care reference cohort achieved a median overall survival of 10.5 months.

"We have reached a decisive moment in the development of our lead asset NOX-A12 in aggressive adult brain cancer with the achievement of an unprecedented 18-month survival rate of 67 percent in patients with chemotherapy refractory tumors not amenable to complete surgical resection," said Aram Mangasarian, CEO of TME Pharma. "We have been steadily building this compelling body of clinical evidence month by month to the point where NOX-A12-based therapies now have the potential to be the best available treatment for glioblastoma patients. It has been highly encouraging to see the data reach meaningful maturity enabling us to have a constructive discussion with regulators before the end of the year on the next steps in development and potential for access to an expedited regulatory pathway for approval of NOX-A12. We target having an IND in place and access to an expedited pathway by the end of Q1 2024, which we expect will attract significant interest from investors and potential partners."

On October 20, 2023 Foundation Medicine Inc. and Roche reported that they will present the results from a randomized, global precision oncology study designed to prospectively assess the efficacy and safety of molecularly-guided therapy for patients with unfavorable subset cancer of unknown primary (CUP) (Press release, Foundation Medicine, OCT 20, 2023, View Source [SID1234636198]). The results will be presented as a late breaking abstract on Saturday, October 21 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in Madrid, Spain.

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People with CUP typically have a group of heterogeneous tumors. These patients have a high unmet medical need due to the lack of a definitive diagnosis of a primary tumor site. Because the cancer’s tumor of origin is unknown, targeted treatment has historically been challenging. As a result, there has been little progress in improving the poor outcomes for patients with CUP. The CUPISCO study investigated how comprehensive genomic profiling (CGP), using Foundation Medicine’s U.S. Food and Drug Administration (FDA)-approved and CE-marked FoundationOneCDx and FoundationOneLiquid CDx diagnostic tests, could impact progression-free and overall survival in patients with CUP.

"Patients with CUP do not have many treatment options, so we set out to investigate how implementing comprehensive genomic profiling could impact outcomes," said Dr. Jeffrey Ross, Medical Director at Foundation Medicine. "The increases we saw in progression-free survival are promising, and we look forward to conducting continued research to reinforce the value of genomic profiling for patients with CUP."

The global multicenter CUPISCO trial spanned 159 sites in 34 countries and included over 400 patients with CUP who were not amenable to resection and/or radiation with curative intent. During induction therapy, patients received three cycles of standard platinum-based chemotherapy. Patients achieving disease control were randomized 3:1 to targeted therapy informed by comprehensive genomic profiling versus chemotherapy continuation for at least three further cycles. The median progression-free survival in the patients who received molecularly guided therapy was 6.1 months (95% confidence interval [CI] 4.7–6.5) versus 4.4 months (4.1–5.6) for chemotherapy (hazard ratio [HR] 0.72; 95% CI 0.56–0.92; p=0.0079). The median overall survival was 14.7 months (95% CI 13.3–17.3) versus 11.0 months (9.7–15.4), respectively (HR 0.82; 95% CI 0.62–1.09; p=0.1779), though overall survival data were immature at cutoff.

"Collaborative research is core to our work at Foundation Medicine and is a pivotal element of making continued progress for cancer patients," said Mia Levy, MD, PhD, Chief Medical Officer at Foundation Medicine. "Our high-quality tests played an important role in demonstrating the value of molecularly guided therapy for this patient population and we hope that these findings will lead to increased treatment options for their care."

On October 20, 2023 Therapeutic Solutions International, Inc. (TSOI), reported the successful first treatment of a patient with FloraStilbene, a patent pending formulation of the abortion pill’s active ingredient, RU486, and pterostilbene (Press release, Therapeutics Solutions International, OCT 20, 2023, View Source [SID1234636197]).

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The Company has been utilizing pterostilbene, a naturally occurring analog of resveratrol, found in blueberries, for the treatment of cancer and immune modulation for several years, including being granted a patent on synergies with conventional immunotherapies1. In May of this year, Res Nova signed a collaborative agreement with compounding pharmacy Cure Stat Rx for developing a compounded formulation of FloraStilbene2.

"I have worked with Dr. Ramesh Chigurupati, President, and CEO of Cure Stat Rx for many years and have always been impressed by the efficiency and excellence in ability to provide compounded drugs and formulations," said Dr. James Veltmeyer, Chief Medical Officer of Res Nova Bio. "We look forward to offering FloraStilbene to all patients taking immunotherapy, chemotherapy, or radiation therapy that can benefit from immune stimulation of NK cells, T cells, and dendritic cells."

FloraStilbene has previously been shown to enhance immunotherapy of various tumors3, as well as chemotherapy efficacy4.

"The strategic objective of Therapeutic Solutions International is to develop intellectual property, use it to seed a subsidiary company, and let the subsidiaries grow and flourish," stated Timothy Dixon, President, and CEO of Therapeutic Solutions International. "I am extremely proud of the leadership role of Ms. Ramos who in the period of less than a year was able to take FloraStilbene from concept to patient. This is literally unheard of in traditional biotechnology development models."

In addition to Res Nova, Therapeutic Solutions International has multiple subsidiaries including a) Campbell Neurosciences, focused on the identification of suicidal propensities using a proprietary test and various interventions5; b) Breath Biologics, which is in discussions with the FDA for its filed Phase I/II trial in COPD6; c) CTE Biologics, which is advancing its clinical stage technology for treating Chronic Traumatic Encephalopathy7; and d) VasoSome Vascular, which is in preclinical development of mesenchymal stem cell derived exosomes for treatment of aortic aneurysms8.

"I am thankful for our translational medicine team that has worked closely with Drs Veltmeyer and Chigurupati for making this first patient treatment a reality," said Famela Ramos, President, and CEO of Res Nova Bio. "Although we plan on performing clinical trials to formally establish a level of efficacy, we believe it is imperative to get this drug into the hands of physicians as soon as possible, and we are thankful for having the opportunity to do this today."