On February 22, 2022 PharmaMar (MSE: PHM) reported that it will host a key opinion leader (KOL) webinar addressed to investors and analysts, entitled "Small Cell Lung Cancer: Today, until Tomorrow, US & EU" on Wednesday, March 9th at 1pm EST/7pm CET (Press release, PharmaMar, FEB 22, 2022, View Source [SID1234608809]).

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The webinar will feature presentations by Key Opinion Leaders (KOLs) Professor Dr. Benjamin Besse from Institut Gustave Roussy, Villejuif, France and Dr. Jacob Sands from Dana Farber Cancer Institute, Boston. They will discuss the latest research in SCLC and the current landscape in various lines of treatment, including the first-line and relapsed settings. They will also discuss the various unmet medical needs of patients and physicians and present their view on the future treatment paradigm.

This event follows the initiation by PharmaMar of a global randomized phase III study of Zepzelca (lurbinectedin) monotherapy or in combination with irinotecan in relapsed Small Cell Lung Cancer (SCLC) (NCT05153239)1. This trial is expected to serve in a confirmatory capacity in the US following lurbinectedin’s accelerated FDA approval in 2020, as well as a registrational capacity for EMA and other regulatory bodies.

In addition, North America partner Jazz Pharmaceuticals along with its partner Roche Pharmaceuticals initiated a Phase III study assessing the safety and efficacy of lurbinectedin as a first-line maintenance treatment in Small Cell Lung Cancer (SCLC) (NCT05091567)2. If successful, the trial could support an FDA supplemental new drug application, and potentially allow PharmaMar to submit a dossier for registration to the European Medicines Agency. PharmaMar holds full commercial rights for lurbinectedin in Europe and most territories outside the United States and Canada.

The numbers to connect to the teleconference are +34 91 901 16 44 (from Spain), +1 646 664 1960 (from USA or Canada) or +44 20 3936 2999 (other countries). Participant access code: 620352.

The teleconference will be available on PharmaMar’s website by visiting the Events Calendar section of the company’s website at www.pharmamar.com

A recording of the webcast will be made available to accredited investors. To request a link, please feel free to reach out to [email protected].

About Professor Dr. Benjamin Besse

Dr. Benjamin Besse is Professor of Medical Oncology at Paris-Saclay University, Orsay, France and a full-time cancer specialist at Gustave Roussy Cancer Campus, Villejuif, France. Currently, Dr. Besse is Head of the Cancer Medicine Department at Gustave Roussy Cancer Campus and Chair of the EORTC Lung Group. He coordinates the French network for thymic malignancy. His main research interests are application of molecular abnormalities to personalize treatment, circulating biomarkers, early drug development in thoracic tumors and thymic malignancies. He has authored/co-authored more than 250 peer-reviewed papers.

About Dr. Jacob Sands

Dr. Jacob Sands received his MD from the University of Cincinnati in 2005. He completed his residency in internal medicine at the University of California, Davis and fellowship training in hematology/oncology also at the University of California, Davis. He joined the faculty in the Lowe Center for Thoracic Oncology at Dana-Farber in 2017. His research focuses on improved diagnostics and treatments for small cell lung cancer as well as improving lung screening and assisting in the development of lung screening programs throughout the country.

On February 22, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported it has entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals, Inc. ("CPP"), a private clinical stage company developing therapeutics to reduce the risk and recurrence of cancer and rare diseases, for a combination of stock and future milestone payments (Press release, Panbela Therapeutics, FEB 22, 2022, View Source;utm_medium=rss&utm_campaign=panbela-therapeutics-inc-to-acquire-cancer-prevention-pharmaceuticals-inc [SID1234608808]).

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Strategic Rationale and Benefits of the Transaction

The combined entity will have an expanded pipeline addressing an estimated aggregate $5 billion market opportunity for the areas of initial focus: familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs boast a steady cadence of catalysts with programs ranging from pre-clinical to registration studies, including CPP’s lead asset with a fully funded registration trial scheduled to begin this year. In addition, the transaction facilitates operational and commercial synergies, under the leadership of a highly experienced management team with a proven history of drug discovery, development, and commercialization expertise. "This transaction is an important step towards our goal of creating a diversified pipeline with an ability to hit multiple targets and thereby expanding the potential of the combined company," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "The combined platforms will be better positioned to treat more patients. This transaction is a tremendous strategic fit and we feel creates robust stockholder value."

CPP co-founder and CEO, Jeff Jacob, stated, "I strongly believe Panbela is the right choice to carry our efforts forward and continue the outstanding work our team has done to build our clinical stage orphan and oncology pipeline into what it is today and to continue the development of Flynpovi, our lead asset. Flynpovi, a combination of CPP-1X (eflornithine) and sulindac has a dual mechanism both inhibiting polyamine synthesis and increased polyamine export and catabolism. By leveraging the established infrastructure of Panbela, we expect to continue to expand our pipeline. After a full assessment of strategic alternatives, our Board of Directors believes the transactions signifies the best value opportunity for CPP stakeholders."

CPP is developing therapeutics designed to reduce the risk of cancer and other diseases. In addition to the fully funded FAP registration trial scheduled to begin by year-end, a phase 3 trial in colon cancer survivors is currently underway and is sponsored by the Southwest Oncology Group (SWOG). Additionally, clinical trials in neuroblastoma, gastric cancer, and early-onset type-1 diabetes are underway in collaboration with various nonprofit groups.

Transaction Details

Under the terms of the agreement and plan of merger, the holders of CPP’s outstanding capital stock immediately prior to the merger will receive shares of common stock of Panbela upon closing of the mergers. On a pro forma and fully diluted basis, holders of Panbela common stock are expected to own approximately 59% of the post-merger holding company and holders of CPP securities, including converted indebtedness, are expected to beneficially own approximately 41% of post-merger holding company. CPP stockholders will be eligible to receive contingent payments totaling a maximum of $60 million from milestone and royalty payments associated with the potential approval and commercialization of the lead asset.

The proposed mergers have been unanimously approved by the boards of directors of each company and the stockholders of CPP. A closing is expected to occur by the second quarter of 2022, subject to approval of the issuance of securities in the transactions by Panbela’s stockholders, and satisfaction of other customary closing conditions.

Additional Information

The combined company will be led by Jennifer Simpson, Chief Executive Officer of Panbela and will remain headquartered in Waconia, Minnesota. The board of the combined company is expected to optimize the value of this transaction and beyond and will include at least two members initially designated by CPP, CPP Chief Executive Officer, Jeff Jacob, and CPP Director, Dan Donovan.

Canaccord Genuity LLC is acting as the exclusive financial advisor to Panbela, and Faegre Drinker Biddle & Reath LLP is acting as its legal counsel. The Sage Group is acting as the exclusive financial advisor to CPP, and Blank Rome LLP is acting as its legal counsel.

About: SBP-101
SBP-101 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. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.0 months which is not yet final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with 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, SBP-101 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 current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

On February 22, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported the promotion of John Goldberg, M.D. to Chief Medical Officer (Press release, Oncorus, FEB 22, 2022, View Source [SID1234608807]). Dr. Goldberg joined Oncorus in October 2018 as Senior Vice President of Clinical Development with responsibilities including oversight of all clinical studies, drug development and regulatory strategies.

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"We are delighted to announce John’s promotion to Chief Medical Officer as he has been an integral part of our company’s progress thus far. His first-hand experience as a practicing oncologist with over 15 years of experience enrolling patients into clinical trials, coupled with expertise across a range of immunotherapies, have been crucial to our pipeline progress and we are incredibly pleased to have his continued guidance in this new role," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We look forward to John’s leadership as we continue to advance our viral immunotherapy candidate, ONCR-177, through the clinic with additional data from multiple cohorts expected later this year, in addition to progressing our ONCR-GBM program and selectively self-amplifying viral RNA (vRNA) product candidates ONCR-021 and ONCR-788."

"It’s an honor to take on the role of Chief Medical Officer at Oncorus, and I’m incredibly excited and motivated by the unique opportunity that Oncorus has to make a meaningful difference in cancer patients’ lives via its dual platform approach to unleashing the full potential of viral immunotherapies," said Dr. Goldberg. "Both the HSV and selectively self-amplifying vRNA platforms create a uniquely diverse pipeline rooted in compelling science and promising future growth. I believe that Oncorus has the potential to meaningfully impact the current standard of care in oncology, and, in partnership with the rest of the executive team, I look forward to advancing this innovative technology."

Dr. Goldberg has served as Senior Vice President of Clinical Development since he joined Oncorus in 2018. Prior to joining Oncorus, Dr. Goldberg served as Senior Medical Director of H3 Biomedicine, a developer of genomics-based cancer therapies. While at H3 Biomedicine, he supervised the clinical development of H3B-8800, the first-in-human spliceosome modulator. Previously, Dr. Goldberg held clinical roles in cancer drug development, leading the pediatric oncology Phase 1 program at the University of Miami and working as Medical Director for Agenus. His immunotherapy experience includes first-in-human neo-antigen vaccines, dendritic cell vaccine and GVAX trials, as well as check point inhibitors and costimulatory agonists. Dr. Goldberg is also a pediatric oncologist with 15 years of experience treating children with cancer and enrolling patients in clinical trials. He received his pediatric hematology oncology training from the Dana-Farber Cancer Institute and Children’s Hospital Boston and his general pediatrics training from the University of Rochester. Dr. Goldberg holds an M.D. from the University of Massachusetts Medical School and a A.B. in Biological Sciences from the University of Chicago. In addition to his current role at Oncorus, Dr. Goldberg is a Medical Advisory Board Member for the Sarcoma Foundation of America and a member of the Advisory Group at MassBio.

On February 22, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Thursday, March 3, 2022, at 5:00 p.m. ET to discuss a corporate update and financial results for the fourth quarter and full year 2021 (Press release, Oncolytics Biotech, FEB 22, 2022, View Source [SID1234608806]).

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Conference Call & Webcast

A webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 507-590#.

On February 22, 2022 NuCana plc (NASDAQ: NCNA) reported it has completed enrollment of the number of patients in the ongoing Phase III NuTide:121 study required to conduct the second interim analysis, which is expected to occur in the second half of 2022 after the 644th patient has completed 28 weeks of follow-up (Press release, Nucana BioPharmaceuticals, FEB 22, 2022, View Source [SID1234608805]). The NuTide:121 study is comparing Acelarin combined with cisplatin to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer. As previously announced, NuCana expects to conduct the first interim analysis after the 418th patient has completed 28 weeks of follow-up, which is expected to occur in the first half of 2022.

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NuCana believes that a statistically significant improvement in the Objective Response Rate (ORR) at either of the first two interim analysis, accompanied by positive trends in other endpoints, has the potential to allow for accelerated approval of a new drug application (NDA) for Acelarin in the United States. At the first interim analysis, an improvement in ORR of approximately 14% or more in the Acelarin plus cisplatin arm compared to the gemcitabine plus cisplatin arm would be statistically significant. Due to the larger number of patients included in the second interim analysis, an improvement in ORR of approximately 9% or more would be statistically significant. Recruitment in the NuTide:121 study, which is intended to enroll up to 828 patients, is ongoing and NuCana believes subsequent analyses could provide the confirmatory data to support full (regular) approval.

"We are delighted with the pace of enrollment in the NuTide:121 study especially against the backdrop of the Covid pandemic," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "With the enrollment of the 644th evaluable patient, we are now in position to complete two pre-specified interim analyses in 2022."

Mr. Griffith continued: "In the ABC-08 study of first-line patients with biliary tract cancer, Acelarin plus cisplatin achieved an ORR of 44% among the evaluable population. This compared favorably to the ORR of 26% achieved among evaluable patients treated with gemcitabine plus cisplatin in the ABC-02 study, which established this regimen as the global standard of care. Biliary tract cancer is a devastating disease and we believe Acelarin could represent a new option to help address the significant unmet need for more effective medicines."

About NuTide:121

NuTide:121 is a global, multi-center, 1:1 randomized Phase 3 study comparing Acelarin, a ProTide transformation of gemcitabine, in combination with cisplatin, to gemcitabine in combination with cisplatin in up to 828 patients with advanced biliary tract cancer who have not previously received treatment for advanced disease. The primary endpoints of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR) and the FDA-approved protocol includes three interim analyses. Based on the statistical analysis plan, and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, accompanied by positive trends in other endpoints, has the potential to allow for an accelerated approval of a new drug application (NDA) for Acelarin in the United States. Under this scenario, the NuTide:121 study would continue and the Company believes it could use the data from subsequent analyses as the confirmatory data required to support full (regular) approval. There are currently no agents approved for the first-line treatment of patients with biliary tract cancer.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, are a group of cancers originating in the biliary tract. The biliary tract is comprised of the gallbladder and interconnecting ducts responsible for the transport of bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 16,000 of those diagnoses in the United States. There are currently no agents approved for the first-line treatment of patients with advanced biliary tract cancer; however, the worldwide standard of care in these patients is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.