On August 19, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Immunome, AUG 19, 2021, View Source [SID1234586763]).

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"We made strong progress during Q2 in the development of IMM-BCP-01, our antibody cocktail to combat SARS-CoV-2. We finalized the selection of antibodies for the cocktail, secured increased funding for the program from the Department of Defense, and demonstrated IMM-BCP-01’s potent neutralization activity against all SARS-CoV-2 variants of concern, including the Delta variant, in preclinical testing. We believe we are well-positioned for an IND filing for this program in the third quarter," said Purnanand Sarma, Ph.D., President and CEO of Immunome. "We have continued to strengthen the company through a number of executive and non-executive appointments, in addition to a successful fundraising. We believe these activities set us up for value-creating events in the near-term, including a planned IND filing for our IL-38 immuno-oncology program in the fourth quarter. I look forward to updating you further on our progress in the coming months."

Second Quarter and Subsequent Highlights

Demonstrated Potent Neutralization Activity of IMM-BCP-01 Against SARS-CoV-2 Delta Variant. In July 2021, Immunome announced that its three-antibody cocktail (IMM-BCP-01) has demonstrated potent neutralizing activity against the SARS-CoV-2 Delta variant in pre-clinical pseudovirus testing. An Investigational New Drug (IND) filing for IMM-BCP-001 is planned for 3Q 2021.
Selected Antibodies for IMM-BCP-001 Antibody Cocktail. In April 2021, the company announced antibody selection for its IMM-BCP-01 cocktail and shared data showing that IMM-BCP-01 neutralizes CDC SARS-CoV-2 "Variants of Concern" in preclinical testing. The cocktail was efficacious in Syrian hamsters infected with SARS-CoV-2 (USA-WA1/2020) in both prophylactic and treatment schedules. Further, the cocktail neutralized Alpha and Beta variants in live virus testing and Gamma and Epsilon variants in pseudovirus testing.
Completed a $27 million Private Placement. In April 2021, the company announced a private placement of its common stock for gross proceeds to Immunome of approximately $27 million, before deducting placement agent commissions and other offering expenses.
Awarded $4.3 million by the U.S. Department of Defense (DoD). In May 2021, Immunome announced that the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense had awarded the company $4.3 million. These funds were in addition to Immunome’s original $13.3 million award provided by the DoD in July 2020. (Contract number: W911QY2090019)
Appointed Corleen Roche as Chief Financial Officer. In April 2021, Immunome announced that it had appointed Corleen Roche as its Chief Financial Officer. Ms. Roche is a highly accomplished CFO with over 30 years of industry experience.
Appointed Franklyn G. Prendergast, M.D., Ph.D., to Board of Directors. In June 2021, the company announced that it had appointed Dr. Prendergast to its Board of Directors. Dr. Prendergast is a renowned medical and academic research professional who received the 2019 Mayo Distinguished Alumni award and has over 45 years of association with the Mayo Foundation. Over the past 20 years, Dr. Prendergast has served on the Board of Directors or Scientific Advisory Board of several biotechnology companies.
Appointed Andrew Badley, M.D., to COVID-19 Advisory Board. In June 2021, Immunome announced the appointment of Andrew D. Badley, M.D., to the company’s COVID-19 Advisory Board. Dr. Badley is a renowned infectious disease expert who has spent 19 years with the Mayo Clinic in various roles. He currently serves as the Chair of Mayo Clinic’s COVID-19 Research Taskforce.
Financial Highlights

Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2021 were $3.2 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2021 were $2.5 million.
Net loss: Net loss for the three months ended June 30, 2021 was $5.2 million.
Cash and cash equivalents: As of June 30, 2021, cash and cash equivalents totaled $59.8 million.

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."

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.

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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.

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]).

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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."

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.

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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.