On May 16, 2022 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2022, as well as key clinical and corporate developments (Press release, Cel-Sci, MAY 16, 2022, View Source [SID1234614676]).

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Clinical and Corporate Developments include:

The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has accepted two abstracts related to CEL-SCI’s pivotal Phase 3 Multikine (Leukocyte Interleukin, Injection)* head and neck cancer clinical trial for presentation at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting to be held June 3-7, 2022 in Chicago, Illinois. The abstract titles are:
"Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only."
"Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study."
Head and neck cancer patients who are scheduled to receive surgery and radiation as their first treatments have not seen a marked improvement in their treatment outcome in decades. CEL-SCI’s Phase 3 study showed great improvement in survival with no toxicity issues for these patients with a statistically significant, robust, and durable survival benefit of 14.1% at 5 years. This is clearly an unmet medical need for an estimated 211,000 people globally.
Additional results from the Phase 3 study of Multikine in advanced primary head and neck cancer have been submitted to the U.S. government clinical trial website www.clinicaltrials.gov. That data is expected to be released to the public in the near future.
CEL-SCI’s dedicated current Good Manufacturing Practice (cGMP) facility in which it manufactures Multikine is now undergoing validation following the completion of its commercial scale build out during the first quarter of 2022. The construction is designed to ensure the facility will be compliant with all U.S. Food and Drug Administration’s (FDA) and European cGMP regulations.
As of March 31, 2022, CEL-SCI had $34.3 million in cash and cash equivalents.
"ASCO’s annual meeting in June, with over 40,000 oncology professionals from over 100 countries expected, is one of the largest and most prominent oncology conferences. Our scientific team looks forward to presenting two abstracts there, and we expect a high level of interest based on Multikine’s results and the fact that outcomes have not improved for the head and neck cancer population in decades," stated CEL-SCI CEO, Geert Kersten. "The conference is well timed to inform oncologists from around the world about Multikine ahead of our planned regulatory filing for approval."

CEL-SCI reported an operating loss of $18.4 million for the six months ended March 31, 2022 versus an operating loss of $17.3 million for the six months ended March 31, 2021. CEL-SCI reported an operating loss of $9.6 million for the three months ended March 31, 2022 versus an operating loss of $8.5 million for the three months ended March 31, 2021. Net cash used in operating activities was $7.5 million for the six months ended March 31, 2022 which represents a decrease of $1.2 million compared to the six months ended March 31, 2021.

On MAY 16, 2022 CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, reported that interim results from the global Phase 2 study (CORE1) of CG0070 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (Press release, CG Oncology, MAY 16, 2022, View Source [SID1234614675]).

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The results (Session MP54-03) were presented at the 2022 American Urological Association (AUA) Annual Meeting. The preliminary data adds to that presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) earlier this year and continues to show both promising early anti-tumor activity and tolerability of CG0070 in combination with pembrolizumab for patients with BCG unresponsive NMIBC.

Summary of Interim Clinical Results

As of the interim analysis, based on a data cutoff on April 28, 2022, 22 patients were evaluable for efficacy with a minimum of 3 months follow up.
91% of patients evaluable for efficacy (n=20/22) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients evaluable for CR at additional timepoints, 87% (n=15) have also maintained a CR through 6 months, 80% (n=10) through 9 months and 75% (n=8) at the 12-month assessment.
Treatment related adverse events were generally limited to transient grade 1-2 local genitourinary symptoms including pollakiuria, bladder spasm, dysuria, fatigue, nocturia, hematuria, chills, and immune-related adverse events including hyperglycemia and hypothyroidism.
About the CORE1 Study

Under a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which will enroll up to 35 patients, is to evaluate the safety and efficacy of CG0070 plus pembrolizumab for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About CG0700

CG0070, a selective oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective retinoblastoma (Rb) pathway. CG0070 was designed to replicate inside tumor cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. The rupture of cancer cells releases tumor-derived antigens and GM-CSF, which stimulates a systemic anti-tumor immune response. In advanced clinical trials, CG0070 is a safe and efficacious agent in NMIBC following BCG failure. CG0070 is currently in late-stage clinical trials across a variety of solid cancers, as a monotherapy or in combination with immune checkpoint inhibitors.

On 16, 2022 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported the appointment of Meredith Manning to President of the Americas, effective immediately (Press release, PharmaEssentia, MAY 16, 2022, View Source [SID1234614674]).

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"PharmaEssentia has continued to build momentum with our strong pipeline and partnerships around the world. Now, with a world-class foundation built in the U.S. and launch underway, we are expanding our growth ambition across the American continents to address the clear gaps today in therapeutic options for the treatment of myeloproliferative neoplasms (MPNs)," said Ko-Chung Lin, PhD, co-founder and chief executive officer. "Meredith has built an incredible team of expert leaders and has established a strong infrastructure already in Boston, so they are well poised to build our presence with communities in both North and South America."

In this new scope, Ms. Manning will be supported by her U.S. leadership team to evaluate potential commercial strategies and partnerships to reach MPN patient communities throughout the American continents, with a near-term focus on Canada and Latin America. The company’s ongoing clinical trial SURPASS-ET, evaluating a potential therapy in the treatment of essential thrombocythemia (ET) has recently expanded into sites in Canada.

"The progress we’ve made in the last two years has been transformative for our mission and has established the right foundation to enable strong and sustainable growth as we expand into new markets," said Ms. Manning. "Together with our seasoned leadership team here in the U.S., I am optimistic that we can introduce our portfolio in areas that remain underserved today to help advance care of people with MPNs around the world."

Ms. Manning has served as General Manager for the U.S. subsidiary of PharmaEssentia since February 2020, expanding the team nearly three-fold since her arrival and leading the organization through the U.S. regulatory approval and commercial launch of the Company’s first product, BESREMi. With a sharp focus on data-driven market insights and commercial strategy, Ms. Manning’s career has been focused on introducing transformative therapies into underserved communities. She was previously Chief Commercial Officer at resTORbio, and prior to that served as a vice president of marketing for a seven-brand hemophilia portfolio at Baxter BioScience (now Takeda). Earlier in her career, Meredith built and managed successful commercial teams for Vertex and Pfizer.

On May 16, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that it will host a scientific symposium on precision oncology titled "Targeted Radionuclide Therapy – present and future prospects" held as an ancillary event in parallel to the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, ITM Isotopen Technologien Munchen, MAY 16, 2022, View Source [SID1234614673]). The symposium will feature key opinion leaders in the field and will be held in a hybrid format on June 03, 2022 from 11:00 am – 12:30 pm CST in the Hyatt Regency McCormick Place, in Chicago, USA and online.

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Targeted Radionuclide Therapy is an approach to treating a variety of cancer types. As new areas of interest and advancing approaches to implementing this uniquely selective therapeutic modality continue to be highlighted, the session will offer an overview of the key topics. The panel will focus on the clinical application of Targeted Radionuclide Therapy in the treatment of neuroendocrine tumors, prostate cancer and potential future prospects. They will also spotlight the benefits and risks of this therapeutic approach, address any challenges that may be encountered, and provide valuable insights to their patient management experiences. Participants will be able to interact with the speakers in a Q&A session at the end of the event.

Scientific Program and Speakers:

Welcome and Introduction
Pamela Kunz, MD
Smilow Cancer Hospital and Yale Cancer Center

Clinical Application of Targeted Radionuclide Therapy in Neuroendocrine Tumors
Pamela Kunz, MD (20min)
Smilow Cancer Hospital and Yale Cancer Center, New Haven

Clinical Application of Targeted Radionuclide Therapy in Prostate Cancer
Michael Morris, MD (20 min)
Memorial Sloan Kettering Cancer Center, New York

Personalizing the Targeted Radionuclide Therapy, Advancements and Challenges
Thomas Hope, MD (20min)
University of California, San Francisco

The Future of Targeted Radionuclide Therapy
Wolfgang Weber, MD, PhD (20min)
Klinikum rechts der Isar (the University Hospital of the Technical University of Munich)

Discussion & Closing Remarks
Pamela Kunz, MD

For the full scientific program and registration form please click here:
View Source

The symposium will be recorded, and available on demand for 6 months after the event.

The event is not sponsored, endorsed, or accredited by ASCO (Free ASCO Whitepaper), CancerLinQ, or Conquer Cancer the ASCO (Free ASCO Whitepaper) Foundation.

About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, like receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue.

On May 16, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported details of the initial clinical trial in the Company’s pan-cancer Fibroblast Activation Protein-α (FAP-α) targeted program PNT2004, FRONTIER (Press release, Point Biopharma, MAY 16, 2022, View Source [SID1234614672]).

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FRONTIER stands for "FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients with Select Solid Tumors".

The Phase 1 clinical trial is expected to commence in summer 2022 in Canada and will use a gallium-68 (68Ga)-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) lutetium-177 (177Lu)-based PNT6555 therapeutic agent. The Phase 1 clinical protocol will evaluate PNT6555 in ~30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.

Dosing will start at 4 GBq with each subsequent dose level increasing by 4 GBq and 2 GBq dose de-escalations. Each 177Lu PNT6555 dose will be followed by a 6-week interval. 68Ga-PNT6555 PET/CT imaging will be conducted approximately 90 minutes post injection, and dosimetry will be completed at the time of first 177Lu-PNT6555 dose and each subsequent cycle. The primary objective of the study is to determine the maximum tolerated dose (MTD), and the Recommended Phase II Dose (RP2D). The company expects to present initial imaging and dosimetry data in early 2023.

"We believe radiopharmaceuticals are on the verge of a revolution," said Dr. Joe McCann, CEO of POINT Biopharma. "For most of their existence, therapeutic radio-pharmaceuticals have been limited to small, orphan indications. Drug candidates like PNT6555 could exponentially increase the number of patients which could benefit from this treatment modality. FAP-α is an extremely exciting target for therapeutics. It is present in greater than 90% of epithelial tumors, which include many of the highest prevalence forms of cancer. Not only would better imaging to detect metastatic dis-ease enable more cancers to be treated earlier, but the capability of delivering radiation directly to a wide variety of cancers could also revolutionize treatment paradigms."

FRONTIER will be the first in-human trial of PNT6555, while additional preclinical studies are in development and include other therapeutic isotopes such as actinium-225 (225Ac). A summary of the pre-clinical data for the program can be found in a poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting last month, titled "Pre-clinical characterization of the novel Fibroblast Activation Protein (FAP) targeting ligand PNT6555 for the imaging and therapy of cancer" (Abstract ID: 3554, Session: Preclinical Radiotherapeutics). The presented data conclude:

• In pre-clinical xenograft models: 68Ga-PNT6555 is an effective imaging agent, with strong tumor targeting, low background in normal tissues and rapid clearance via urinary excretion, and 177Lu-PNT6555 shows prolonged tumor retention out to 168 hours post-injection.

• Efficacy studies with 177Lu-PNT6555 or 225Ac-PNT6555 demonstrate compelling and dose-responsive inhibition of HEK-mFAP tumor growth.

A link to the poster can be found on the Investor Presentations section of the Company’s website: View Source