On April 27, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported it has signed a definitive agreement to acquire all of the equity of Myriad myPath, LLC (Myriad myPath Laboratory), from Myriad Genetics (Press release, Castle Biosciences, APR 27, 2021, View Source [SID1234578578]). Myriad myPath Laboratory is a CLIA-certified laboratory in Salt Lake City, where the myPath Melanoma 23-gene expression profile (GEP) test was developed and is currently owned and offered. Castle is acquiring Myriad myPath Laboratory for $32.5 million. Castle will finance the acquisition price with cash and cash equivalents on hand. The transaction is expected to close approximately four weeks post signing, at which time Castle will be the successor owner of Myriad myPath Laboratory. The transaction is subject to customary conditions to closing.

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"With the acquisition of Myriad myPath Laboratory, Castle strategically expands its suite of genomic tests for skin cancer and expects to offer the most comprehensive testing solution for difficult-to-diagnose melanocytic lesions"

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myPath Melanoma is a clinically validated GEP test designed to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. Castle currently offers DecisionDx DiffDx-Melanoma, a 35-GEP test designed to characterize difficult-to-diagnose melanocytic lesions. myPath Melanoma is a distinct test, which Castle anticipates will complement its current offerings and enable Castle to provide the most comprehensive molecular testing solution for difficult-to-diagnose melanocytic lesions.

"With the acquisition of Myriad myPath Laboratory, Castle strategically expands its suite of genomic tests for skin cancer and expects to offer the most comprehensive testing solution for difficult-to-diagnose melanocytic lesions," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe this acquisition will add incremental value to both myPath Melanoma and DiffDx-Melanoma by leveraging the strengths of these two distinct, validated tests. Thus, through this acquisition, we believe that more patients will receive actionable results more of the time, enabling a more confident diagnosis and clearer treatment path."

DecisionDx DiffDx-Melanoma and myPath Melanoma are both commercially available and will remain available through Castle and Myriad, respectively, throughout the transaction period. As the successor owner, upon closing, Castle will be the sole provider of myPath Melanoma.

National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2021 state that ancillary tests, including GEP tests such as myPath Melanoma and DecisionDx DiffDx-Melanoma, may facilitate interpretation of cases (melanocytic neoplasms of uncertain biologic potential) that are diagnostically uncertain or controversial by histopathology. Additionally, myPath Melanoma is currently covered under a MolDX Local Coverage Determination policy through Noridian Healthcare Solutions, LLC, the Medicare Administrative Contractor that oversees laboratories in both Utah and Arizona.

Company management will host a conference call and webcast to discuss this transaction at 7:30 a.m. Eastern time today.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website (View Source). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until May 17, 2021.

To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 8479479.

There will be a brief Question & Answer session following management commentary.

About DecisionDx DiffDx-Melanoma

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

On April 27, 2021 Leading BioSciences, Inc. a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, reported the closing of its previously announced merger transaction with Seneca Biopharma, Inc. ("Seneca") (Press release, Neuralstem, APR 27, 2021, View Source [SID1234578595]). Seneca shareholders previously approved the transaction. The combined, publicly traded company will operate under the name Palisade Bio, Inc. ("Palisade Bio" or the "Company"), and its common stock is expected to commence trading on the Nasdaq Capital Market on April 28, 2021, under the ticker symbol "PALI."

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In addition, the Company has announced the closing of the previously announced private placement led by Altium Capital that included $20.0 million in cash plus the cancelation of outstanding principal and interest pursuant to the notes previously issued to the investor.

"This merger marks a tremendous milestone for all stakeholders in the newly formed Palisade Bio, a now publicly listed company with a promising pipeline of oral therapies for GI complications," said Tom Hallam, Ph.D., chief executive officer of Palisade Bio. "We are thrilled to have the added financial flexibility provided by Seneca and the private placement financing as we advance our drugs through clinical development. Our lead asset, LB1148, has already demonstrated efficacy signals in clinical trials that we believe may support a potential paradigm shift in the restoration of post-operative GI function following a wide range of common surgeries. There are more than six million of these procedures annually in the U.S. Now, as the combined company, Palisade Bio, we plan to build on this momentum with multiple clinical data readouts planned over the next 12 to 18 months."

Leading BioSciences Inc.’s management team will lead the merged company, Palisade Bio, following completion of the merger transaction. Palisade Bio will focus on developing therapeutics for broad GI disorders and complications. The Company’s lead asset, LB1148, is a patent-protected oral formulation of a protease inhibitor that neutralizes the activity of digestive proteases released from the gut during surgery. LB1148 has demonstrated the potential to improve restoration of normal GI function following major surgery and reduce certain postoperative complications such as abdominal adhesions. The FDA has granted LB1148 Fast Track Designation for treating postoperative GI dysfunction in pediatric patients who undergo open-heart surgery based on its potential to treat this serious condition, positioning LB1148 for potential accelerated approval and priority review. Palisade expects to initiate a Phase 2/3 study of LB1148 for the treatment of postoperative GI dysfunction associated with pediatric cardiovascular surgery and report Phase 2 data read-outs in GI surgery by year-end 2021.

Conference Call and Webcast Details:

Management will host a conference call and webcast with slides at 11:00 AM Eastern Time on Wednesday, April 28, 2021, for investors regarding this announcement with details as follows:

About LB1148

LB1148 is an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and formation of postoperative adhesions. By inhibiting the activity of these digestive proteases, LB1148 has the potential to prevent damage to GI tissues, accelerate the time to return of normal GI function, and shorten the duration of costly post-surgery hospital stays

On April 27, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") and its development partners reported that they have advanced into clinical development (Phase 1b through Phase 3 clinical trials) a number of fully human monoclonal antibodies (mAbs) for the treatment of COVID-19 and various cancers (Press release, Sorrento Therapeutics, APR 27, 2021, View Source [SID1234578547]). This demonstrates the potential of the deep pipeline generated from Sorrento’s proprietary G-MAB library, invented by Dr. Henry Ji, the Chairman and CEO of Sorrento. This G-MAB library is based on the use of RNA transcription for amplification of the antibody variable domains from over 600 donors. These donors were from both sexes and of multiple ethnicities, leading to a broad diversity of antibodies. In-depth analysis of deep sequencing DNA data showed that the G-MAB library contains more than 20 quadrillion (1016) distinct antibody sequences. The G-MAB library has fostered the development of several early and late-stage oncology programs that are currently in Phase 2 and Phase 3 clinical trials and neutralizing mAbs currently in a Phase 2 clinical trial directed against the spike protein of COVID-19 viruses.

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Two independent anti-PD-L1 mAbs are now in Phase 2 and Phase 3 clinical studies. A PD-L1 mAb (STI-3031, also known as IMC-001) was licensed to ImmuneOncia Therapeutics, Inc. ("ImmuneOncia"), a joint venture between Sorrento and Seoul-based Yuhan Corporation. IMC-001 has completed a Phase 1b study in patients with metastatic or locally-advanced solid tumors and is nearing completion of a Phase 2, open-label, "Neo-Chance" study in patients with resectable gastric cancer, esophageal cancer and liver cancer. ImmuneOncia has also started to enroll patients in a Phase 2 study in relapsed or refractory extranodal NK/T cell lymphoma, nasal type. Sorrento has filed an IND in the U.S. and received clearance from the FDA to proceed with a Phase 2a study for STI-3031 for advanced urothelial carcinoma.

A second antibody, Socazolimab, is licensed to Lee’s Pharmaceutical Holdings Limited in the Greater China territory, and has been cleared to begin a multicenter Phase 3 trial as a potential first-line treatment for patients with extensive-stage small-cell lung cancer. Professor Shun Lu (Shanghai Chest Hospital) is the Principal Investigator. Additionally, Phase 1b studies in several other indications have been completed for this product candidate, including: recurrent metastatic cervical cancer, advanced urothelial carcinoma, and high-grade osteosarcoma after adjuvant chemotherapy for maintenance. In addition, a Phase 1b/2 study has been initiated as a potential neoadjuvant treatment option for esophageal carcinoma. For cervical cancer, a pivotal study has been completed with a breakthrough therapy designation granted by the National Medical Products Administration (NMPA) in China. Sorrento intends to open an IND in the U.S. with the intent to have an end-of-phase 3 meeting or pre-NDA discussion with the FDA for various cancer indications.

Sorrento previously announced FDA clearance to commence a Phase 1b study in various relapsed or refractory solid tumors with an anti-CD47 antibody (STI-6643) (a CD-47 checkpoint inhibitor interacting with SIRPα). In preclinical studies, STI-6643 appears to have a beneficial toxicity profile (e.g., reduced hemolysis) without a priming mechanism while maintaining potent anti-tumor activity. Additionally, Sorrento licensed a separate promising anti-CD47 antibody (IMC-002) to ImmuneOncia, which has initiated a Phase 1b study in patients with metastatic or locally-advanced solid tumors and relapsed or refractory lymphomas.

Sorrento previously announced the formation of its subsidiary company – Adnab, Inc.,– which is focused on developing and commercializing ADNAB platform products for hematological malignancies and solid tumors based on an exclusive license from the Mayo Clinic. Sorrento intends to combine a variety of its proprietary mAbs in conjunction with the ADNAB technology platform, which was developed by Dr. Svetomir Markovic, M.D., Ph.D., and his research team at Mayo Clinic. This effort will potentially result in multiple next-generation ADNAB products. Since ADNABs can be designed to have one or two mAbs on the external surface, in addition to a chemotherapeutic payload, the cytotoxic payload can potentially be delivered preferentially to targeted cancer cell types. Sorrento expects to develop a number of innovative ADNABs in anticipation of filing INDs for clinical trials later in 2021.

"These are very exciting times for Sorrento," said Dr. Ji. "These therapeutic antibody examples demonstrate that we are leveraging the G-MAB library to bring product candidates rapidly from preclinical development through the IND process and into clinic trials."

On April 27, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report business results for the first quarter of 2021 after the market closes on Wednesday, May 5, 2021 (Press release, Supernus, APR 27, 2021, View Source [SID1234578563]).

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Jack Khattar, President and CEO, and Jim Kelly, Executive Vice President and CFO, will host a conference call to present the first quarter 2021 financial and business results on Wednesday, May 5, 2021 at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be available at www.supernus.com.

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

On April 27, 2021 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) Platform, reported that it has been awarded a $2 million Direct-to-Phase-2 Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) (Press release, Shasqi, APR 27, 2021, View Source [SID1234578579]). These non-dilutive funds will support immune biomarker analysis of patient samples from Shasqi’s Phase 1 clinical trial of lead candidate SQ3370 as well as manufacturing process development.

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"We are thrilled the NCI sees the potential of SQ3370 as a novel therapy that could meaningfully impact outcomes for patients with solid tumors," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "Our goal at Shasqi is to improve the safety and efficacy of novel and existing standard of care cancer drugs by directly activating them at the tumor. Our approach is designed to improve the therapeutic window of a drug by maximizing the exposure of the drug to the tumor."

Wayne Saville, M.D., Chief Medical Officer of Shasqi commented, "We appreciate the NCI’s support to evaluate the immune signatures in patient samples from our ongoing Phase 1 trial of SQ3370. This information will provide mechanistic insight about the interplay between SQ3370 and changes to local and systemic immune responses observed in our preclinical tumor studies. In addition, funds from this grant will also allow us to fine-tune our current manufacturing process as we continue to advance SQ3370 through clinical studies."

CAPAC and SQ3370:

SQ3370 utilizes Shasqi’s proprietary CAPAC platform, a click chemistry-based approach that activates cancer drugs at a tumor with decreased systemic toxicity. The platform is based on the chemical reaction between an attenuated trans-cyclooctene-modified protodrug and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Unlike traditional targeted therapies, the CAPAC platform is agnostic to tumor characteristics that can vary from patient to patient, such as biomarker expression and enzymatic activity.