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 [SID1234568267]). 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.

Entry into a Material Definitive Agreement

On October 7, 2020, Cumberland Pharmaceuticals Inc. (the "Company" or "Cumberland") reported that it entered into a Third Amendment to the Revolving Credit Note and Fourth Amendment ("Fourth Amendment") to the Revolving Credit Loan Agreement with Pinnacle Bank (the "Pinnacle Agreement") (Filing, 8-K, Cumberland Pharmaceuticals, OCT 7, 2020, View Source [SID1234568266]). The original Pinnacle Agreement was dated July 31, 2017. The Fourth Amendment provides for a principal available for borrowing of up to $15 million and Cumberland has the ability to request an increase of up to an additional $5 million, upon the satisfaction of certain conditions and approval by Pinnacle Bank. If fully expanded, the Fourth Amendment would provide a maximum principal available for borrowing of up to $20 million, which was also the maximum aggregate principal available for borrowing under the previously amended Pinnacle Agreement.

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The Fourth Amendment extends the maturity date of the Pinnacle Agreement through October 1, 2022.
The interest rate on the Pinnacle Agreement, as amended, is based on LIBOR plus an interest rate spread. The pricing provides for an interest rate spread of 1.75% to 2.75% above LIBOR with a minimum LIBOR of 0.90%. Cumberland is subject to a financial covenant, maintenance of either the Funded Debt Ratio or a Tangible Capital Ratio, as defined, determined on a quarterly basis. Borrowings under the line of credit are collateralized by substantially all of the Company’s assets.

Genor Completes $371 Million Hong Kong IPO; Market Cap Reaches $1.8 Billion

On October 7, 2020 Genor Biopharma of Shanghai reported that it raised $371 million in its Hong Kong IPO, pricing the offering at the top of the range (Press release, Genor Biopharma, OCT 7, 2020, View Source [SID1234568220]). In early trading, Genor rose 22%, giving the company a market capitalization of $1.8 billion. Founded in 2007, Genor has a portfolio of 15 mAbs and recombinant fusion proteins, comprising novel drugs and biosimilars that target indications in cancer, metabolic and autoimmune diseases. Hillhouse, which led a $160 million Series B financing in Genor earlier this year, owns 30% of the company’s shares post-IPO.

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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.