Propella Therapeutics Granted U.S. Patent for New Treatment for Metastatic Prostate Cancer

On October 7, 2020 Propella Therapeutics Inc. (Propella), a leader in the development of innovative best-in-class prescription products, reported the issuance of a U.S. patent for a new drug treatment for metastatic prostate cancer (Press release, Propella Therapeutics, OCT 7, 2020, View Source [SID1234568209]). The patent covers new molecules that are designed to provide significant advantages over the current standard of care. The patent, titled Abiraterone Prodrugs, protects certain novel prodrugs. These are biologically inactive compounds that the body converts into the active pharmacological agent, abiraterone.

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"This patent protects our ability to develop and market safe, effective, and long-acting drugs for the treatment of metastatic prostate cancer and other conditions related to the overproduction of androgens," said Propella President and CEO William Moore, PhD. "This protection gives Propella and its investors further confidence to complete promising preclinical studies and file its Investigational New Drug (IND) application in the first quarter of 2021."

Abiraterone is a potent CYP 17 enzyme inhibitor that prevents the synthesis of testosterone and other androgens that fuel prostate cancer cells. The current treatment uses abiraterone acetate, which patients take by mouth, once a day. This produces varying blood concentrations of abiraterone, including high levels that can be toxic, and low blood levels that may not be effective against cancer tumors. Propella’s prodrug abiraterone decanoate has been shown to profoundly reduce testosterone levels for three months following a single injection.

Internationally recognized expert in systemic therapies for patients with advanced urologic cancers, Neal D. Shore, MD, FACS, from the Carolina Urologic Research Center stated, "The preclinical data in primates show that testosterone reductions that result from the abiraterone prodrug depot injection are consistent with those clinically observed with oral abiraterone acetate. I am enthusiastic for the potential of this new more ‘patient-friendly’ treatment option for some metastatic prostate cancer patients."

Biocare Medical Launches 3 Novel IVD Antibodies for Clinical Diagnostic and Cancer Research: BAP1, BCA-225 [Cu-18] and SMAD4 [EP618Y]

On October 7, 2020 Biocare Medical, a leading provider of innovative, automated immunohistochemistry (IHC) reagents and instrumentation, reported the launch of three novel IVD IHC antibody markers at the forefront of clinical diagnostic and research applications (Press release, Biocare Medical, OCT 7, 2020, View Source [SID1234568208]). These three markers SMAD4 [EP618Y], BAP1, and BCA-225 [Cu-18] may aid pathologists in critical prognostic and diagnostic decisions – impacting patient outcome. Each new marker is available as an IVD grade antibody in ready to use and concentrated formats, leveraging maximum flexibility for your laboratory.

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BAP1 Antibody – Biocare’s rabbit polyclonal BAP1 is an excellent biomarker that may aid in diagnosis of multiple types of cancers including uveal melanoma, malignant mesothelioma, cutaneous melanoma, and renal cell carcinoma. Protein expression of BAP1 using immunohistochemistry may serve as a rapid and cost-effective means of identifying uveal melanoma patients with aggressive disease.1 Loss of BAP1 staining is associated with higher risk for tumor growth and metastasis.2

BCA-225 [Cu-18] Antibody – Biocare’s mouse monoclonal offering of BCA-225 is a well known clinical marker for breast carcinomas. BCA-225 expression was found to be common in adenocarcinomas of the breast (98%).3 Adenocarcinoma that metastasizes from an unknown primary site is a significant oncologic problem. When used in a panel, BCA225 may serve as a predictive marker to identify tumors of unknown origin.4

SMAD4 [EP618Y] Antibody – Biocare’s rabbit monoclonal offering of SMAD4 [EP618Y] may aid prognosis through varying expression. Loss of SMAD4 correlated significantly with decreased survival in all colon cancer patients. High SMAD4 expression, however, was significantly associated with increased survival, especially in colon cancer patients. SMAD4 loss, and to a lesser extent weak expression, is strongly associated with poor survival regardless of stage.5,6

The launch of these antibodies continue Biocare Medical’s long-standing history of providing novel, high-quality reagents to customers looking to advance their research and diagnostic efficiency in the laboratory. These new markers will provide a cost-effective expansion to pathologists looking to elevate clinical utility and diagnostic clarity.

Edwards Lifesciences To Host Earnings Conference Call On October 21, 2020

On October 7, 2020 Edwards Lifesciences (NYSE: EW), reported its operating results for the quarter ended September 30, 2020 after the market closes on Wednesday, October 21, 2020, and will host a conference call at 5:00 p.m. ET that day to discuss those results (Press release, Edwards Lifesciences, OCT 7, 2020, View Source [SID1234568207]).

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To participate in the conference call, dial (877) 704-2848 or (201) 389-0893. For 72 hours following the call, an audio replay can be accessed by dialing (877) 660-6853 or (201) 612-7415 and using conference number 13710472. The call will also be available via live or archived webcast on the "Investor Relations" section of the Edwards web site at ir.edwards.com.

Phenomic AI Launches with $6 Million Financing and an AI/ML Platform for Targeting the Tumor Stroma

On October 7, 2020 Phenomic AI, a biotech using AI/ML to reveal drug targets that emerge from cell-cell interactions and drive novel antibody drug discovery for challenging diseases, reported the official launch of the company with US$6 million seed financing (Press release, Phenomic AI, OCT 7, 2020, View Source [SID1234568205]). The financing was led by CTI Life Sciences Fund and joined by AV8 Ventures, Luminous Ventures, and Viva BioInnovator. Current investors, Garage Capital, Hike Ventures, and Cantos Ventures, also joined the round. The proceeds of the financing will support preclinical studies for two validated cancer drug targets discovered with the company’s platform as well as discover and advance additional drug targets into the company’s pipeline. Phenomic AI also announced the appointments of Dr. Michael (Mike) Briskin, as Chief Scientific Officer (CSO), and Nobel Laureate James (Jim) P. Allison, Ph.D. and Padmanee (Pam) Sharma, M.D., Ph.D., to the company’s Scientific Advisory Board (SAB), bringing significant expertise in immunotherapy discovery and development.

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"Cells do not exist in isolation in the human body, and the interactions between different cell types in disease states carries significant information that Phenomic has unlocked for drug discovery," said Shermaine Tilley, Ph.D., Managing Partner, CTI Life Sciences Fund. Ruchita Sinha, General Partner at AV8, further commented, "In two years, the Phenomic team has made impressive progress in building their platform and using it to find new drug targets in the tumor stroma. The appointments of Mike, Jim, and Pam, leaders in immuno-oncology, further highlight the exceptional advancements of Phenomic."

The tumor stroma has been increasingly recognized as a complex barrier, composed of many different cell types and other factors, such as fibroblasts and the extracellular matrix, that prevent immune therapies from working effectively. A major challenge in discovering drugs for the tumor stroma has been screening targets against more physiologically relevant models, such as organoids that incorporate the many cell-types needed to simulate the stroma. To address this challenge, Phenomic’s platform uses deep-learning tools for image and genetic analysis to deconvolute effects of target inhibition in multi-cell assays. By factoring in multi-omics analysis of tissue data and reverse translation of clinical datasets, Phenomic’s approach seeks to ensure model and mechanism relevance early in the drug discovery process.

"Building on our foundational machine-learning tools, we can now process and extract information from the interactions between different cell types at the scale and speed necessary to power drug discovery," said Sam Cooper, CEO of Phenomic AI. "We’ve rapidly identified novel targets in the tumor stroma and have confirmed that they are heavily upregulated in specific solid tumors. With the support of our new and current investors and the addition of Mike, who brings deep drug discovery expertise, we are launching the company with significant momentum to advance novel antibodies into preclinical studies that could improve the effectiveness of cancer treatment."

Dr. Briskin has more than 25 years of industry experience, including founding and running discovery research at Jounce Therapeutics, leading translational studies for inflammation and oncology at Merrimack Pharmaceuticals, and performing early discovery work for Entyvio (vedolizumab) at LeukoSite (acquired by Millennium Pharmaceuticals). He currently serves as chairperson of the SAB of Obsidian Therapeutics.

"Cancer and fibrotic diseases are driven by the dysregulation of local cellular environments, where multiple cell types are engaged in complicated, uncontrolled interactions, and teasing apart each cell type’s contribution has previously been a tremendous challenge," said Dr. Briskin, CSO of Phenomic AI. "By combining insights from Phenomic’s proprietary platform, along with additional technologies based on primary human cell data, we anticipate that we will be able to quickly build out a meaningful pipeline of new antibody drugs targeting the tumor stroma and other diseases driven by multi-cellular pathologies. Furthermore, having the expertise from Jim and Pam, who are translational researchers at the frontline of immuno-oncology drug development, will provide tremendous insights into the biology and clinical strategies for our targets of interest."

Dr. Allison was awarded the Nobel Prize in 2018 for his pioneering and unrelenting research in cancer immunotherapy, which led to the U.S. FDA approval in 2011 of ipilimumab, a significant life-extending therapy for late-stage metastatic melanoma. His current work is focused on identifying new targets to further unleash the immune system and eradicate cancer. Dr. Sharma is a leader in immuno-oncology clinical trials and drug development, with translational research focused on identifying mechanisms of response and resistance to immunotherapy. Dr. Sharma is currently exploring combinations of immunological therapies and other drugs in preclinical models as well as early-stage clinical trials to potentially overcome specific resistance pathways and improve clinical outcomes for cancer patients.

Sensei Biotherapeutics Announces $28.5 Million Financing To Advance Clinical Pipeline and Immunophage™ Platform Targeting Multiple Cancers

On October 7, 2020 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing personalized yet off the shelf immunotherapies for cancer and infectious diseases, reported the completion of a $28.5 million equity financing (Press release, Sensei Biotherapeutics, OCT 7, 2020, View Source [SID1234568204]). The financing was co-led by Cambrian Biopharma and H&S Ventures, along with participation from new investors Future Ventures, Christian Angermayer’s Apeiron Investment Group, and Presight Ventures, Apeiron’s U.S. arm.

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Sensei is currently advancing multiple clinical and pre-clinical studies with their lead Immunophage program, SNS-301, a bacteriophage engineered to express aspartate β-hydroxylase (ASPH), a tumor associated antigen. The proceeds from the Series AA financing will enable the further development of SNS-301 and enable the advancement of Sensei’s pipeline of novel immunotherapies based on its Immunophage platform, which combines a vaccine’s ability to generate antigen-specific B- and T-cells with payloads of immunomodulatory nanobodies. Sensei Bio is building an extensive R&D infrastructure for the discovery of Immunophage, including GMP manufacturing, and is creating libraries of Immunophage that will be combined to create personalized yet off the shelf cocktails based on the genetic profile of each patient’s tumor.

"With this new funding, we advance our vision for establishing a new and disruptive class of immunotherapies called Immunophage, based on engineered bacteriophage," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We are poised for significant progress as this funding enables us to expand our clinical programs for SNS-301 and operate our Immunophage platform at scale. We are grateful for the support from both new and existing investors and I look forward to further realizing Sensei’s potential and building out this new class of immunotherapies."

"Sensei’s phage platform represents a transformative leap in immuno-oncology, with a cancer vaccine that can induce all the elements of a robust anti-tumor immune response. With experienced management and scientific teams, Sensei is well positioned to become a leader in next generation of immune-oncology therapeutics," said James Peyer, CEO of Cambrian Biopharma. "We are pleased to support their highly unique platform approach and advance these therapies clinically."

In its next stage of growth, Sensei Bio will employ its proprietary platform to discover novel classes of cancer immunotherapies and advance lead candidates toward the clinic. These approaches include the following:

The development of select immunomodulatory nanobodies, camelid-based antibodies, that can be deployed as Immunophage payloads or stand-alone therapeutics.
The expansion of Sensei’s library based approach by engineering Immunophage targeting additional tumor associated antigens.
The deployment of customized yet off-the-shelf Immunophage cocktail therapies targeting tumor associated antigens, neoantigens, and virally-based cancer antigens.
A novel antibody-based approach to novel checkpoint inhibition and other methods of altering the tumor microenvironment toward anti-tumor immunity.
Potential expansion of its therapeutic area focus into infectious diseases based on partnerships with Pharma companies and government entities.