On September 29, 2022 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported that data at the 2022 International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (CICON) in New York City, NY (Press release, Imvax, SEP 29, 2022, View Source;utm_medium=rss&utm_campaign=imvax-presents-new-data-on-personalized-whole-tumor-derived-immunotherapeutic-platform-at-2022-international-cancer-immunotherapy-conference [SID1234621548]).

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This new data provides additional evidence for the generation of an immune response in the role of dendritic cell maturation, CD4 and CD8 T cell activation and increases in both central and effector memory T cells in the anti-tumor immunostimulatory activity of Imvax’s platform. Following favorable clinical results obtained in glioblastoma study using IGV-001, the data support the development of IEC-001 for the treatment of endometrial cancer.

"This work further details the multi-layered and durable immune activation induced by our immunotherapeutic platform and its performance in multiple tumor types," said Mark A. Exley, Ph.D., Chief Scientific Officer. "Our robust preclinical data gives us confidence as we continue to develop our platform of personalized, whole tumor-derived treatments beyond glioblastoma to additional solid tumors."

The study was executed using IEC-001 (loaded with patient-derived endometrial cancer cells) or IGV-001 (loaded with patient-derived glioblastoma cells). Immunological effects were evaluated over several weeks via nine IEC-001 and three IGV-001 patient-matched peripheral blood mononuclear cells (PBMC) co-culture assays. Results indicated that co-culture of PBMCs with the relevant Imvax candidate resulted in increased immunological activity of various types. These included, at various timepoints, increased dendritic cell maturation, elevated percentages of activated CD4+ and CD8+ T cells, increased effector memory CD4+ T cells, and T cell activation, responses that were further stimulated upon rechallenge. In summary, these results support the potential of Imvax’s immunotherapeutic platform and further development of IEC-001 for the treatment of endometrial cancer.

On September 29, 2022 Micronoma In the largest analysis of its kind, Pan-cancer analyses reveal cancer type-specific fungal ecologies and bacteriome, reported in the September 29 issue of Cell, an international collaboration between the Weizmann Institute of Science, University of California San Diego, and Micronoma has systematically profiled fungal communities—the mycobiome—in 35 types of cancer (Press release, Micronoma, SEP 29, 2022, View Source [SID1234621547]).

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The study was led by the first co-authors, Lian Narunsky-Haziza, Gregory Sepich-Poore, and Ilana Livyatan, with many other collaborators from Israel and the U.S. Drawing from more than 17,000 tissue and blood samples among four independent cohorts, with hundreds of contamination controls, the effort comprehensively shows the ubiquitous existence and cancer type-specificity of the mycobiome. The findings are a significant advance with profound implications for early-stage cancer detection.

Outside the laboratory, microorganisms almost never exist in isolation. In fact, the study of microbes on and within the human body, known as the microbiome, has revealed ecosystems teeming with bacteria, viruses, archaea, and fungi that cohesively work together to aid digestion, build immunity, and even shape our behaviors.

From the standpoint of cancer, however, the presence and role of microbes in tumors was mostly ignored until recently. Indeed, knowledge was significantly advanced by two recent papers that characterized microbes among more than 30 cancer types (Poore et al., 2020. Nature, Nejman et al., 2020. Science), yet, no study had focused so deeply on a major player: fungi.

"The existence of fungi in most human cancers is both a surprise and to be expected," said Rob Knight, Ph.D., professor of Bioengineering, Pediatrics and Computer Science and Engineering at UC San Diego, Wolfe Family Endowed Chair in Microbiome Research at Rady Children’s Hospital-San Diego, and co-founder of Micronoma. "It is surprising because we don’t know how fungi could get into tumors throughout the body. But it is also expected, because it fits the pattern of healthy microbiome throughout the body, including the gut, mouth, and skin, where bacteria and fungi interact as part of a complex community."

Although the existence of live, often intracellular microbes within the tumors of most cancer types has been documented in the past five years, attention has been heavily focused on detailing bacteria without characterizing what other kinds of microbes are present, like fungi.

The study explains the complexities of analyzing fungi caused by the fact that, despite their ubiquity, cancer-associated fungi usually have extremely low abundances. While that limitation made the project a challenge, the fruitful international collaboration of the laboratories of Ravid Straussman and Yitzhak Pilpel at the Weizmann Institute of Science, Knight, and Sepich-Poore, now chief analytic officer at Micronoma, was uniquely positioned to carry out the work of systematically analyzing publicly available cohorts as well as their own patient samples.

"The finding that fungi are commonly present in human tumors should drive us to better explore their potential effects and re-examine almost everything we know about cancer through a ‘microbiome lens.’ I believe that this novel perspective would help us to better understand cancer, and consequently to better treat it," emphasized Straussman.

"These findings validate the view that the microbiome in its entirety is a key component of cancer biology and may present significant translational opportunities, not only in cancer detection, but also in other biotech applications related to drug development, cancer evolution, minimal residual disease, relapse, and companion diagnostics," added Sepich-Poore.

On September 29, 2022 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, reported that the Company will participate in the Ladenburg Thalmann Healthcare Conference on September 29, 2022 (Press release, Palatin Technologies, SEP 29, 2022, View Source [SID1234621546]).

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Carl Spana, Ph.D., President and Chief Executive Officer will present an update on the Company’s pipeline and participate in an Analyst led Fireside Chat.

On September 29, 2022 Scilex Holding Company ("Scilex"), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, reported that it pre-emptively paid off and eliminated all of its remaining Notes in an aggregate principal amount of $67.7 million for a cash payment of approximately $39.7 million (Press release, Sorrento Therapeutics, SEP 29, 2022, View Source [SID1234621544]). Scilex is a nearly 100% (or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento").

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Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) ("Vickers"), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, have entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the "Combined Company") will be renamed Scilex Holding Company, and its common stock and warrants to purchase common stock are expected to be listed on Nasdaq under the ticker symbol "SCLX" and "SCLXW", respectively. The boards of directors of each of Vickers, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur in the fourth quarter of 2022, is subject to the approval of Vickers’s and Scilex’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

On September 29, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported Regulatory approval for the opening of trial sites in Spain, France and Italy for Panbela’s clinical trial in the first-line treatment of metastatic pancreatic cancer (Press release, Panbela Therapeutics, SEP 29, 2022, View Source;utm_medium=rss&utm_campaign=panbela-receives-approvals-to-open-trial-sites-in-spain-france-and-italy-for-aspire-trial-studying-ivospemin-sbp-101-in-combination-with-gemcitabine-and-nab-paclitaxel-in-patients-with-metastatic-p [SID1234621542]). ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. Detailed information on the trial can be located at View Source

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With approximately 95 sites planned throughout the United States, Europe, Australia, and South Korea, we are continuing to focus on site initiation and enrollment in order to ultimately deliver a more effective treatment for pancreatic cancer, a deadly disease with few treatment options. Site initiation can now accelerate, and we are pleased with the current momentum of the ASPIRE trial. We expect that a significant number of global sites will be open by year-end with the full complement of sites open by the first quarter 2023. "We’re excited to have these recent approvals as we move forward towards the interim analysis which is expected to be completed in early 2024," commented Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela.

About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101 Ivospemin

Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. For more information, please visit View Source .

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.