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.

On April 27, 2021 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 biologic therapies, reported that it has closed a $105 million Series C financing co-led by Eventide Asset Management, Cowen Healthcare Investments and current investor 3×5 Partners, who were joined by new investors Adage Capital Management, Point72 Asset Management, Avego Healthcare Capital, FMB Research and Broadfin Holdings (Press release, Arch Oncology, APR 27, 2021, View Source [SID1234578597]). Arch Oncology’s existing investors, including Roche Venture Fund, RiverVest Venture Partners, and Lightchain, also participated in the round. In connection with the financing, Joy Ghosh, Ph.D., Senior Research Analyst at Eventide Asset Management, Eric Pham, Ph.D., Associate at Cowen Healthcare Investments, and Joe Biller, Managing Director at 3×5 Partners, will join the Company’s Board of Directors.

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"This financing enables the clinical progress of our differentiated anti-CD47 product candidate AO-176, currently in Phase 1/2 clinical trials for solid tumors, both as a monotherapy and in combination with paclitaxel, and multiple myeloma. Looking forward, we plan to expand the AO-176 clinical program to include a combination trial with pembrolizumab (KEYTRUDA) in solid tumors, and a combination trial with standard therapies in multiple myeloma. We will also explore other indications and combinations consistent with our novel mechanisms of action," said Laurence Blumberg, M.D., President and Chief Executive Officer of Arch Oncology. "The quality of our new and existing investors is a testament to this pipeline and our mission on behalf of patients with cancer who need better therapeutic options."

AO-176 is an anti-CD47 IgG2 antibody in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and with hematologic malignancies, both as monotherapy and in combination with standard therapies. AO-176 works by blocking the "don’t eat me" signal enabled by CD47’s interaction with SIRPa and inducing phagocytosis. It has a unique combination of features, positioning it to improve upon the safety and efficacy profile among anti-CD47 antibody therapies including: lower binding to normal cells in general and negligible binding to red blood cells; enhanced binding to CD47 in acidic environments found in tumors; and induction of programmed and immunogenic cell death.

"Arch Oncology’s highly differentiated approach to the development of anti-CD47 agents is a promising development in the immuno-oncology space," said John McKearn, Ph.D., Managing Director, RiverVest Venture Partners and Chairman of the Board of Arch Oncology. "We look forward to continuing to support the Company as it develops and advances its robust pipeline of promising drug candidates, including a broad clinical program for AO-176."

On April 27, 2021 Advaxis, Inc. (NASDAQ: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that the Company has achieved the second milestone under its licensing agreement for ADXS31-164, also known as ADXS-HER2, to OS Therapies for evaluation in the treatment of osteosarcoma in humans (Press release, Advaxis, APR 27, 2021, View Source [SID1234578521]).

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Under the terms of the license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG), is responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. OS Therapies recently completed a financing, triggering the second milestone payment. Under the agreement, Advaxis has the opportunity to receive additional clinical, regulatory, and sales-based milestone payments as well as royalties on future product sales. Additional details of the financial terms have not been disclosed.

"This funding milestone for OS Therapies brings OST-HER2, originally ADXS-HER2, one step closer to the clinic," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We are confident in the potential of OST-HER2, which had been approved in the U.S. for the adjuvant treatment of osteosarcoma in canines, and are proud to have played a role in the development of this important new candidate for osteosarcoma patients. We look forward to the team at OST advancing the program, building upon our early Phase 1 data evaluating ADXS-HER2."

Mr. Berlin continued, "This milestone payment will provide Advaxis additional capital as we build momentum across our growing ADXS-HOT neoantigen-directed off-the-shelf clinical programs. To date, we have assembled a robust clinical and translational data set which suggests our unique approach has the potential to enhance and/or restore responses to checkpoint inhibitors in lung cancer. We look forward to leveraging these resources as we advance ADXS-503, currently being evaluated in our Phase 1/2 study in NSCLC, and ADXS-504 for early-stage prostate cancer, which is on-track to enter the clinic in Q2 2021."