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Onco360® Selected by Merck & Co., Inc. to Be in Specialty Pharmacy Network for WELIREG™ (belzutifan)

On August 19, 2021 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by Merck & Co., Inc. to be in the specialty pharmacy network for WELIREG (belzutifan), a hypoxia-inducible factor inhibitor indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery (Press release, Onco360, AUG 19, 2021, View Source [SID1234586762]).

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"Onco360 is honored to be included in the Merck specialty pharmacy network for WELIREG," said Benito Fernandez, Chief Commercial Officer, Onco360. "Onco360 is committed to supporting von Hippel-Lindau patients afflicted with certain associated tumors requiring treatment."

Biocept’s CNSide Assay Identifies Tumor Cells and Actionable Treatment Biomarkers from Cerebrospinal Fluid in Patients with Metastatic Non-Small Cell Lung Cancer

On August 19, 2021 Biocept (Nasdaq: BIOC), a leading provider of molecular diagnostic assays and services, reported that new data show the company’s cerebrospinal fluid assay, CNSide, detected tumor cells and identified actionable mutations in lung cancer patients with leptomeningeal carcinomatosis, allowing for targeted treatment decisions that may improve outcomes and extend life expectancy (Press release, Biocept, AUG 19, 2021, View Source [SID1234586761]). The study will be presented as a poster at the Third Annual Conference on Brain Metastases hosted by the Society for Neuro-Oncology (SNO), being held virtually Aug. 19-20, 2021.

More than 198,000 patients are diagnosed with non-small cell lung cancer (NSCLC) each year. An estimated 3-9% of those patients will develop leptomeningeal carcinomatosis (LMC), a complication in which the cancer spreads to the membranes surrounding the brain and spinal cord. LMC is typically diagnosed through clinical evaluation, imaging and cytology, which have limited sensitivity. When left untreated, the average patient life expectancy is just four to six weeks.

The retrospective study, conducted at the University of Utah Huntsman Cancer Institute, used Biocept’s CNSide assay to detect and analyze tumor cells in the cerebrospinal fluid of 15 unique patients. Of the samples analyzed, CNSide detected tumor cells in 100% of samples with LMC, while cytology detected tumor cells in just 40% of the samples. CNSide also identified actionable biomarkers in tumor cells, which allowed oncologists to make targeted treatment decisions that reduced debilitating symptoms and extended patient lives by more than three years in some cases. The study results suggest that CNSide is more sensitive than cytology, and survival of patients with LMC can be prolonged if an actionable target is identified and treated.

"LMC is a devastating diagnosis for patients and, quite often, hospice is the only recommended course of action," said Wallace Akerley, M.D., University of Utah Huntsman Cancer Institute, and lead study investigator. "However, we now have targeted therapies that can improve and dramatically extend the lives of patients with LMC who have a treatable mutation. This study shows that using CNSide to interrogate the cerebrospinal fluid for actionable mutations provides the information needed to determine the appropriate treatment for patients with LMC. With the right therapy, we have the ability to restore quality of life and extend life expectancy for many patients."

"Identifying actionable mutations is critical for treating patients with LMC," said Michael C. Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. "CNSide has demonstrated the ability to reliably detect and analyze tumor cells in the cerebrospinal fluid that may not be found in blood or tissue samples. The specific molecular targets identified in these tumor cells can help guide a physician’s choice of newer, more effective therapies and inform the response to therapy in a way that can really help these patients see an improvement of symptoms and live significantly longer lives."

The study, titled "Beyond Cytology – A Single Institution Experience Using CNSide for Diagnosing and Monitoring Treatment Response in Non-Small Cell Lung Cancer Patients with Leptomeningeal Carcinomatosis (LMC)," can be accessed here.

VYANT BIO AND CYCLICA ANNOUNCE A STRATEGIC COLLABORATION TO IDENTIFY COMPOUNDS TO TREAT CDKL5 DEFICIENCY DISORDER

On August 19, 2021 Vyant Bio, Inc., (Nasdaq: VYNT), a leading biotech company discovering new therapeutics for neurological diseases and hard-to-treat cancers, and Cyclica, Inc., the partner of choice for data driven drug discovery, reported a non-exclusive strategic collaboration combining Vyant Bio’s patient-derived complex organoid biology alongside Cyclica’s proteome-wide, Artificial Intelligence ("AI") enabled discovery platform to identify new treatments for CDKL5 Deficiency Disorder ("CDD"), a severe neurodevelopmental epilepsy disorder with no effective treatments or cure (Press release, Cyclica, AUG 19, 2021, View Source [SID1234586760]).

Vyant Bio’s human-first approach to novel drug discovery incorporates patient biology into the earliest steps of the process with highly functional, disease-based neural organoids, while Cyclica’s proprietary machine learning platforms marry knowledge and structure-based approaches to find novel targets, uncover new uses for existing drugs, and design new molecules with therapeutic potential. Combined, the technologies aim to identify, validate, and progress new targets as well as new and existing compounds for streamlined and de-risked CDD-based drug discovery.

Vyant Bio has deep experience in using human-based disease biology to ensure that early findings are directly related to the patients destined to receive treatments. They have incorporated CDD-based neural organoids into their platforms and are using initial findings to build a robust drug discovery pipeline.

"Last quarter we had launched commercial stage, novel disease models for CDD," stated Jay Roberts, CEO of Vyant Bio. "With this strategic collaboration we have the advantage of leveraging Cyclica’s demonstrated ability to identify unique relationships between compounds, proteins, cellular pathways, and diseases, as well as their AI-based drug discovery. These complementary technologies, combined with our additional pre-clinical expertise, will accelerate the identification of potential medicines and therapies to help children with this devastating disease. We continue to be focused on rapidly identifying small and large molecule therapeutics to treat central nervous system and oncology-related diseases. "

Naheed Kurji, Co-Founder, CEO, and President of Cyclica, shares his enthusiasm for the partnership adding "Cyclica is building the biotech pipeline of the future, and partnerships with leading organizations like Vyant Bio are key to streamline the discovery of better medicines. Given the unique synergy of Vyant Bio’s in vitro screening approach to human disease and Cyclica’s multi-targeted and multi-objective drug discovery platform, we aim to bring novel therapeutics to patients suffering from CDD."

Lantern Pharma Announces Positive Preclinical Data in Glioblastoma (GBM) with Drug Candidate LP-184 and Expands GBM Research Collaboration

On August 19, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company, reported that a successful preclinical study has shown its drug candidate LP-184 is able to inhibit tumor growth and improve survival in animal models of glioblastoma (GBM) (Press release, Lantern Pharma, AUG 19, 2021, View Source [SID1234586759]). This study was conducted in collaboration with the research group of John Laterra, M.D., Ph.D., at Kennedy Krieger Institute, which is affiliated with Johns Hopkins University. Lantern had previously announced the initiation of this GBM focused collaboration with Dr. Laterra in December of 2020.

Recent in vitro and in vivo data from this collaboration on the efficacy of LP-184 in GBM cell lines, patient-derived neurospheres and mice models validated in-silico predictions generated by RADR on the efficacy of the drug candidate. RADR is Lantern’s proprietary machine learning-based artificial intelligence platform that integrates data analytics, experimental biology and large-scale genomic analysis to transform the cost, pace and timeline of oncology drug discovery and development.

In the research done with Johns Hopkins, LP-184 treatment induced tumor regression evidenced by greater than 106% tumor growth inhibition in two subcutaneous xenograft models of GBM (U87 and M1123). LP-184 also prolonged survival in mice bearing an intracranially implanted tumor model of GBM (U87), as compared with those that did not receive any drug substance. Intravenous administration of LP-184 over two cycles reduced subcutaneous xenograft tumor volume in mice by greater than 85% within the treatment group. In the orthotopic GBM xenograft tumor model in mice, a single cycle of LP-184 resulted in a statistically significant (p < 0.0001) extension of median overall survival in the LP-184-treated group (42 days) versus the control group (33 days). Lantern expects to further refine the dosing regimen and cycle in the next phase of work with the expectation that additional improvements in survival can be translated into human clinical trials.

Results from this ongoing translational research program highlight the promising in vivo anti-tumor effect of LP-184 in multiple GBM xenograft models and are expected to help guide the clinical application and focus of the drug candidate. Data from this study will be used to power future insights and analyses provided by RADR, in addition to further enhancing the signature of response for LP-184 in genomically-defined GBM. Additionally, these findings are expected to support Lantern Pharma’s orphan drug designation application to the FDA for the use of LP-184 in the treatment of glioblastoma. The study’s observations and detailed results are being prepared for peer-reviewed publications and scientific conferences.

GBM is a rare disease with an overall five-year survival rate of 5%. This means that only approximately 5 in 100 people survive GBM for five years and beyond. In 2020, 12,000 new GBM cases were diagnosed in the U.S. and more than 154,000 new cases were diagnosed worldwide. LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1. RADR-driven analyses have identified, in clinical databases, GBMs with elevated PTGR1 expression and harboring defects in DNA damage repair pathways as a targeted subset of genetically defined patients who could potentially benefit from LP-184-based therapy.

"This new data reinforces that LP-184 may have clinical utility for the treatment of primary and metastatic brain cancers," says Panna Sharma, Lantern Pharma’s chief executive officer. "We believe that LP-184’s molecular features and distinct mechanism of action, anti-tumor efficacy and strong correlation with specific biomarkers have the potential to provide a unique and powerful approach aimed at addressing high unmet needs in GBM and other aggressive CNS tumors. With this exciting data, we look forward to continuing our work with Dr. Laterra evaluating the potential of LP-184 as a new, potent treatment option for GBM, especially in areas not adequately addressed today, including MGMT-unmethylated, TMZ-resistant, EGFR-aberrant and recurrent GBMs associated with poor prognosis."

Based on these observations, Lantern recently extended and expanded its collaborative agreement with Kennedy Krieger Institute and Johns Hopkins. The objectives of the expanded agreement include further validation of in-silico and other experimental results that support the observation that LP-184 can be an effective treatment in GBM regardless of MGMT (a DNA repair enzyme) status of the cancer. This has significant potential to provide a much-needed alternative to the standard-of-care drug, temozolomide (TMZ), especially in GBMs that over-express MGMT — which can be up to 50% of GBM cancers. These patients that have GBMs that over-express MGMT are generally unresponsive to TMZ and need new therapy options that can exploit other molecular pathways and mechanisms. Development of an agent with efficacy in GBM, regardless of its MGMT methylation status, would be an important advance towards addressing a critical gap in the current standard of care.

Lantern’s RADR platform has also identified a subset of GBM with a low expression of nucleotide excision repair (NER) genes as being responsive to LP-184. Since NER is a critical mechanism for the repair of DNA damage induced by LP-184, the collaboration will further examine the enhanced sensitivity of this subset of GBM cancers to LP-184. In parallel, Lantern is also engaging in an additional study with Johns Hopkins to determine the pharmacokinetics and pharmacodynamics of LP-184 as it relates to the central nervous system (CNS) which has the potential to help uncover additional CNS cancers where LP-184 can play a key therapeutic role.

This research at the Kennedy Krieger Institute is being conducted in collaboration with Dr. Laterra, a professor in the Departments of Neurology, Neuroscience and Oncology at The Johns Hopkins University School of Medicine and a research scientist at Kennedy Krieger Institute. He is the director of the Division of Neuro-Oncology in the Department of Neurology at Johns Hopkins. Dr. Laterra’s laboratory focuses on the cellular and molecular biology of primary brain tumor malignancy, with the combined goals of defining basic mechanisms and translating these discoveries into experimental therapeutics. He is particularly interested in the molecular mechanisms, as well as the potential therapeutic interventions, to reverse glioma cell growth and survival pathways, and in the functioning of the blood-brain and blood-tumor barriers.

PharmaCyte Biotech Announces $70 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On August 19, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has entered into definitive agreements with institutional investors for the purchase and sale, in a registered direct offering priced at-the-marked under Nasdaq rules, of 14,000,000 shares of the Company’s common stock (or common stock equivalents) at an effective purchase price of $5.00 per share for gross proceeds of $70 million (Press release, PharmaCyte Biotech, AUG 19, 2021, View Source [SID1234586758]). PharmaCyte has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate 7,000,000 shares of common stock. The closing of the offering is expected to occur on or about August 23, 2021, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price equal to $5.00 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

PharmaCyte intends to use the net proceeds of this offering to (i) complete activities requested by the U.S. Food and Drug Administration (FDA) in order to address the FDA’s clinical hold on its Investigational New Drug application (IND) with respect to the Company’s planned Phase 2b clinical trial in locally advanced, inoperable, pancreatic cancer (LAPC), including conducting several additional preclinical studies and assays and providing the FDA with the additional information it requested, (ii) fully fund and conduct the Phase 2b clinical trial in LAPC, if and when the clinical hold on the IND is lifted, and (iii) for general working capital purposes.

The shares of common stock (and common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the U.S. Securities and Exchange Commission (SEC) on April 14, 2021, and an additional registration statement on Form S-3 filed on August 19, 2021, pursuant to Rule 462(b), which became effective automatically upon filing. The offering of the shares of common stock (or common stock equivalents) is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the shares of common stock (or common stock equivalents) being offered in the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. (Press release, PharmaCyte Biotech, AUG 19, 2021, View Source [SID1234586758])