On November 28, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported its first patients enrolled in Europe for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer (Press release, Panbela Therapeutics, NOV 28, 2022, View Source;utm_medium=rss&utm_campaign=panbela-announces-first-patients-enrolled-in-europe-for-aspire-trial [SID1234624506]). 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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"We’re really excited, after just recently announcing regulatory approval for the opening of trial sites in Europe, to have our first patients enrolled in Italy," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Having European enrollment underway is highly encouraging as we continue to ramp up the trial. We’re targeting the interim analysis in early 2024."

With approximately 95 sites planned throughout the United States, Europe, Australia, and South Korea, Panbela is 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. The Company expects that a significant number of global sites will be open by year-end with the full complement of sites open by early-mid 2023.

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 investigatorinitiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.

On November 28, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported its participation in the following investor conferences taking place November 29 – December 1, 2022 (Press release, Lexicon Pharmaceuticals, NOV 28, 2022, http://www.lexpharma.com/media-center/news/830-lexicon-pharmaceuticals-to-participate-in-the-34th-annual-piper-sandler-healthcare-conference-and-the-5th-annual-evercore-isi-healthconx-conference [SID1234624505]):

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34th Annual Piper Sandler Healthcare Conference
5th Annual Evercore ISI HealthCONx Conference
Lonnel Coats, Lexicon’s chief executive officer, Jeffrey L. Wade, Lexicon’s president and chief financial officer, and Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer, will participate in moderated discussions at the Piper Sandler conference on Tuesday, November 29th, at 11:00 am ET and at the Evercore ISI conference on Thursday, December 1st at 8:00 am ET.

A simultaneous webcast of both discussions will be available in the "Events" section of the Lexicon website at www.lexpharma.com/events, and a recording of the webcast will be available for two weeks following the original on-demand date.

On November 28, 2022 BT BeaMedical Technologies ("BeaMed"), a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals (OTC: IPIX) (the "Company") that it has received U.S. Food and Drug Administration (FDA) clearance (K222701) for its MANTA surgical laser family (Press release, Innovation Pharmaceuticals, NOV 28, 2022, View Source [SID1234624504]). The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022.

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BeaMed is the inventor and developer of the StingRay Laser System (the "StingRay System"), a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage.

The MANTA surgical laser family was cleared by the FDA including five different wavelengths (810nm, 980nm, 1064nm, 1470nm and 1940nm) and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery.

BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications.

"We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals.

"This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more," said Gil Shapira, co-founder of BeaMed.

BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation (View Source), a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology (MIT).

On November 28, 2022 Farma Mondo Group, a Swiss-based pharmaceutical group focused on providing market access and speciality distribution services through a unique infrastructure and geographical footprint across emerging and emerged markets, and Helsinn Group ("Helsinn"), a fully integrated global biopharma company with a track record of over forty years of commercial execution and a strong focus in oncology and rare diseases, reported the signing of an exclusive marketing and distribution agreement in the Baltic region for AKYNZEO hard capsules (combination of netupitant/palonosetron), for the treatment of chemotherapy-induced nausea and vomiting (CINV) in adults (Press release, Helsinn, NOV 28, 2022, View Source [SID1234624503]).

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Under the terms of the agreement, Farma Mondo will manage the commercialization of AKYNZEO in Estonia and Latvia.

Yaron Spigel, Group Chief Executive Officer of Farma Mondo, commented: "This agreement once again demonstrates the Farma Mondo’s mission to provide access to medicines where no one else can. We are proud to partner with Helsinn in the Baltic region as we continue to expand our infrastructure worldwide to further support patients’ unmet needs."

Giorgio Calderari, Helsinn Group CEO, commented: "It is a pleasure to welcome Farma Mondo to our expanding network of partners for AKYNZEO and we are thankful to be able to utilize their reach in the Baltic region to enable patient access to this much needed treatment. We look forward to working with them in order to enhance quality of life for patients undergoing chemotherapy in these countries."

On November 28, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences (NYSE: RCUS) reported a positive update from the fourth interim analysis of the randomized, open-label Phase 2 ARC-7 study in patients with first-line metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥50% without epidermal growth factor receptor or anaplastic lymphoma kinase (EGFR/ALK) mutations (Press release, Gilead Sciences, NOV 28, 2022, View Source [SID1234624498]). ARC-7 is evaluating the combinations of anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab (doublet), and domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine receptor antagonist (triplet), versus zimberelimab alone, and represents the first randomized Phase 2 study of an Fc-silent anti-TIGIT/anti-PD-1 combination. The protocol-specified fourth interim analysis was conducted when the trial reached full enrollment, with a clinical data cutoff date of August 31, 2022. A total of 150 patients have been randomized across the three study arms.

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For the current interim analysis, efficacy was evaluated in study patients who had at least 13 weeks of potential follow-up and were eligible for at least two imaging scans (n=133). Both domvanalimab combinations continued to show clinically meaningful differentiation compared to zimberelimab monotherapy across multiple efficacy measures, including objective response rates (ORR), progression-free survival (PFS) and six-month landmark PFS.

"The efficacy measures observed, including PFS, reinforce confidence in the TIGIT pathway. The interim results show that combining two checkpoint inhibitors – an anti-TIGIT and an anti-PD-1 – delivered added benefit beyond anti-PD-1 monotherapy in this setting," said Melissa L. Johnson, M.D., Director Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, and Lead Investigator for the ARC-7 study. "These data are important for the lung cancer research field, and I look forward to presenting the dataset at the upcoming virtual ASCO (Free ASCO Whitepaper) Monthly Plenary on December 20th."

At time of data cutoff, no unexpected safety signals were observed across the three study arms. Both domvanalimab-containing arms were generally well tolerated and showed an overall safety profile consistent with the known safety profiles for each individual molecule to date.

"We are thrilled that Dr. Melissa Johnson will present the full results for the current interim analysis of ARC-7, including ORR, PFS and disease control rate, in the coming weeks, given the importance of these data for the immuno-oncology field," said Dimitry S.A. Nuyten, M.D., Ph.D., Chief Medical Officer of Arcus Biosciences. "The consistency of the efficacy and safety data from both of the domvanalimab-containing arms observed at this interim analysis support our continued strong conviction in the domvanalimab program."

"These results strengthen our belief in the potential of domvanalimab and the promise of our anti-TIGIT approach to meaningfully impact the outlook for people with metastatic lung cancer," said Bill Grossman, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Gilead Oncology. "We will continue to accelerate our TIGIT development program with Arcus, with four ongoing registrational studies in NSCLC and upper GI malignancies."

Detailed results from this fourth interim analysis and an exploratory analysis on 12 patients who crossed over from zimberelimab monotherapy arm to triplet therapy will be presented on December 20, 2022, at the Monthly Plenary Series, a new virtual forum for presentation and discussion of the latest cancer research. According to ASCO (Free ASCO Whitepaper), live presentations are accessible to virtual attendees and available on-demand, and abstract presentations are accompanied by a discussant presentation and followed by a live Q&A session. Abstracts accepted for the Monthly Plenary Session are also placed at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2023. During the ASCO (Free ASCO Whitepaper) Annual Meeting, additional results from further analysis of the ARC-7 dataset will be presented.

Domvanalimab, zimberelimab and etrumadenant are investigational molecules and neither Arcus or Gilead have received approval from any regulatory authority for any use globally, including for the treatment of lung cancer. Their efficacy and safety for the treatment of lung cancer have not been established.

About the ARC-7 Study

The ARC-7 study is a Phase 2, multicenter, 3-arm, randomized open-label study evaluating the safety and efficacy of anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab (doublet) versus domvanalimab plus zimberelimab and etrumadenant (triplet), an A2a/b adenosine receptor antagonist, versus zimberelimab alone in 150 patients with first-line metastatic non-small cell lung cancer with PD-L1 TPS ≥50% and no EGFR or ALK mutations. Patients are randomized 1:1:1 across the three study arms, and patients who progress on zimberelimab monotherapy may cross over to receive the triplet. At the time of the fourth interim analysis, 133 patients had at least 13 weeks of potential follow-up (eligible for at least two tumor assessments). The co-primary endpoints are objective response rate and progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Secondary endpoints include duration of response, disease control rate, overall survival and safety. More information about ARC-7 is available at View Source

About Domvanalimab

Domvanalimab is an Fc-silent investigational monoclonal antibody that is designed to bind to TIGIT, a protein receptor on immune cells that acts as a brake on the immune response. Cancer cells can exploit TIGIT to avoid detection by the immune system. By binding to TIGIT, domvanalimab is expected to free up immune activating pathways and activate immune cells to attack and kill targeted cells. Domvanalimab is being evaluated in four registrational Phase 3 studies across lung and gastrointestinal cancers, including: (1) ARC-10, evaluating domvanalimab plus zimberelimab versus pembrolizumab in first-line locally advanced or metastatic PD-L1 ≥50% NSCLC; (2) PACIFIC-8, being operationalized by AstraZeneca, evaluating domvanalimab plus durvalumab in unresectable Stage 3 NSCLC; (3) STAR-121, evaluating domvanalimab plus zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy in first-line PD-L1 unselected NSCLC; and (4) STAR-221, evaluating domvanalimab plus zimberelimab and chemotherapy versus nivolumab plus chemotherapy in first-line locally advanced, unresectable or metastatic gastric, esophageal and gastro-esophageal junction adenocarcinomas.