1stOncology™: Cancer Intelligence Service – Page 6403 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Quest Diagnostics Completes Acquisition of Outreach Lab Services Business of Summa Health

On November 28, 2022 Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services, reported it has completed its previously announced acquisition of select assets of LabCare Plus, the outreach laboratory services business of Summa Health, a large integrated health system. Additional financial terms were not disclosed (Press release, Quest Diagnostics, NOV 28, 2022, View Source [SID1234624507]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

With the acquisition, Quest broadens access to diagnostic innovation and insights empowering better health for more communities in Northeastern Ohio. Physicians and patients will benefit from access to Quest’s industry-leading and highly innovative test menu, network of patient access sites throughout the state, broad health plan coverage and lower out-of-pocket costs for many services. Quest’s laboratories in Twinsburg, Ohio and Pittsburgh, Pennsylvania will provide testing for physicians and patients previously served by LabCare Plus.

Panbela Announces First Patients Enrolled in Europe for ASPIRE Trial Studying Ivospemin (SBP-101) in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

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

"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.

Lexicon Pharmaceuticals to Participate in the 34th Annual Piper Sandler Healthcare Conference and the 5th Annual Evercore ISI HealthCONx Conference

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]):

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.

Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

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.

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).

Farma Mondo Group and Helsinn sign exclusive partnership to commercialize AKYNZEO® in the Baltic region

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]).

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."