On November 22, 2021 EpicentRx, Inc., a clinical-stage biotechnology company at the forefront of oncolytic viruses and small molecules for the treatment of cancer and other inflammatory-driven diseases, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,906,957 entitled "Immunomodulatory Fusion Proteins (Press release, EpicentRx, NOV 22, 2021, View Source [SID1234595935])."

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This composition of matter patent is directed to novel therapeutic proteins, including a TGF-ß Trap Fusion Protein, both alone and in combination with viral expression and delivery vectors. The patent, which contains eight claims and expires no earlier than 2037, strengthens EpicentRx’s intellectual property position and coverage for its lead therapeutic product candidate, AdAPT-001, currently under investigation in a Phase 1 clinical trial for solid tumors. AdAPT-001 is a modified replicating type 5 adenovirus vector ‘armed’ with a TGF-ß trap, which is designed to selectively replicate in and destroy tumor cells.

The purpose of the TGF-ß trap is to sequester the powerful signaling molecule, TGF-ß, short for "transforming growth factor," which is overproduced in many disease states including cancer where TGF-ß is known to suppress the immune system. TGF-ß is also one of the main drivers of fibrotic disorders such as liver cirrhosis, Crohn’s disease, scleroderma, arteriosclerosis, non-alcoholic steatohepatitis (NASH), diabetic nephropathy, idiopathic pulmonary fibrosis, chronic graft vs. host disease, keloid formation and a host of other conditions where excessive scarring replaces healthy tissue.

"We are extremely pleased with the issuance of this foundational patent, which not only expands the breadth of our oncolytic adenovirus intellectual property portfolio but also, and perhaps, more importantly, covers the TGF-ß trap protein as a standalone therapeutic, independent of the oncolytic virus, to treat a range of disease relevant processes for which TGF-β is a key driver from immune system evasion by cancer cells to fibrosis," said Tony R. Reid, M.D., Ph.D., Chief Executive Officer of EpicentRx.

About AdAPT-001

AdAPT-001 is an oncolytic virus which is part of the company’s proprietary AdAPT Immunotherapy Platform, a platform developed on a genetically modified version of the human adenovirus that has been uniquely designed to preferentially infect and kill cancer cells. Currently in an ongoing Phase 1 trial for solid tumors, AdAPT-001 encodes a ligand trap comprised of the ligand-binding domain of the TGF-β receptor, which is fused to the portion of the human antibody known as the Fc domain.

On November 22, 2021 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported that Chief Executive Officer, Dr. Ian Walters, will participate in the Piper Sandler 33rd Annual Virtual Healthcare Conference being held on November 29-December 2, 2021 (Press release, Portage Biotech, NOV 22, 2021, View Source [SID1234595957]). Dr. Walters will give an overview of Portage’s pipeline and status of current programs, including the company’s lead invariant natural killer T cell (iNKT) agonists, PORT-2 and PORT-3.

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The pre-recorded presentation is available now through the following link (here) as well as on the Investor section of the company’s website at View Source Management will also be hosting 1×1 meetings on November 30 and December 1.

On November 22, 2021 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and biologic cancer therapeutics, reported that CEO Masoud Tavazoie, M.D., Ph.D., will present at the Piper Sandler 33rd Annual Virtual Healthcare Conference at 10:00 A.M. EST on November 22, 2021 (Press release, Inspirna, NOV 22, 2021, View Source [SID1234596758]).

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A pre-recorded webcast of the presentation will be available at the time of the presentation and will be available on Inspirna’s website within the News section.

On November 22, 2021 Apollomics Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, reported that the first patient has been successfully dosed in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) in China (Press release, Apollomics, NOV 22, 2021, View Source [SID1234595902]). Apollomics licensed the Greater China rights for uproleselan from GlycoMimetics.

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"As our first Phase 3 clinical trial, dosing of the first patient with APL-106 is a major inflection point for Apollomics as we now become a company in late-stage development," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor. APL-106 acts via an innovative mechanism that drives cancer cells out of the bone marrow, making them a prime target to be killed by chemotherapy. This combined treatment approach could have a meaningful impact on the lives of patients living with relapsed or refractory AML."

The Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study. The Phase 3 clinical trial is a randomized, double-blind, placebo controlled, bridging study that will evaluate the efficacy of uproleselan in combination with chemotherapy, compared to chemotherapy alone, for treating relapsed/refractory AML, in Chinese patients. The trial will enroll approximately 140 adult patients with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy.

The primary endpoint for the trial is overall survival. Secondary outcome measures include the rate and duration of remission, and whether uproleselan could reduce the rate of oral mucositis, a chemotherapy-related side effect. Apollomics expects to conduct this study at approximately 20 blood cancer clinical research centers across China. Additional information on the Phase 3 trial can be found on clinicaltrials.gov (NCT05054543)

About APL-106 (uproleselan injection)

APL-106 (uproleselan injection) is an innovative drug discovered and developed by GlycoMimetics. Uproleselan (yoo’ pro le’ sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells, thereby disrupting the mechanism of leukemic cell resistance within the bone marrow microenvironment. Apollomics licensed uproleselan from GlycoMimetics, and Apollomics has the rights to clinical development, production and commercial sales in the Greater China market (Mainland China, Hong Kong, Macau and Taiwan). The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia. APL-106 has also been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

About Acute Myeloid Leukemia (AML)

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. It is an aggressive disease that causes the bone marrow to produce immature cells that are unable to carry out their normal function and develop into leukemia cells. In the U.S., there are approximately 20,000 new cases of AML each year, and the 5-year survival rate is 28.7%1. The annual incidence of AML in China in 2019 is approximately 26,9002, and relapsed/refractory AML has an extremely poor prognosis.

1National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program
2CIC Report

On November 22, 2021 ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) reported that it has completed the previously announced acquisition of Novitium Pharma, a privately held, New Jersey-based pharmaceutical company with development, manufacturing, and commercialization capabilities (Press release, ANI Pharmaceuticals, NOV 22, 2021, View Source [SID1234595919]).

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"Today marks a major milestone for ANI and the many patients who rely on our high-quality, cost-effective medications. With the completion of this acquisition, we bring on board a world-class R&D engine in the generic and 505 (b)(2) sectors, and a highly-compliant U.S. based manufacturing facility, positioning us well for sustainable long-term growth. Novitium has continued to perform in-line or above our investment thesis since deal signing on March 9th with thirteen new product approvals, strong quarter-on-quarter EBITDA growth and a successful FDA GMP inspection completed in July 2021," stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

"ANI is thrilled to welcome the expertise and leadership of Novitium’s founders, Samy Shanmugam, Chad Gassert and Vijay Thorappadi, along with over 100 talented and dedicated employees, who have joined the ANI team. Our robust product pipeline includes several more CGT and 505 (b)(2) candidates and will be further expanded to maximize the value of our bolstered R&D engine," concluded Lalwani.

Samy Shanmugam, co-founder of Novitium and ANI’s new Head of Research & Development and Chief Operating Officer of New Jersey Operations added, "Today is an exciting day for all of our employees, as we combine the complementary strengths of our two platforms. We are energized by today’s events and look forward to strong contributions in driving the future success of an united ANI."

"ANI’s new capital structure, comprised of the recently completed $75 million equity raise and the closure of a new $300 million Term Loan-B, $40 million revolver and $25 million PIPE, gives the Company significant flexibility in supporting the integration of Novitium into ANI, ensuring a strong Purified CortrophinTM Gel commercial launch and will propel the next phase of growth for ANI," stated Stephen Carey, Senior Vice President and Chief Financial Officer of ANI.

Compelling Investment Thesis

Proven R&D Engine Fuels Sustainable Growth
Novitium has a strong pipeline with 20+ new product launches planned in the next 18 months, including products with U.S. Food and Drug Administration (FDA) Competitive Generic Therapy designation. Novitium received thirteen approvals since March 2021, several of which were limited competition launches. Novitium’s proven R&D leadership team of Samy Shanmugam, Chad Gassert and Vijay Thorapaddi will drive the combined company’s R&D engine.

Expands ANI’s R&D Pipeline Focused on Niche Opportunities
Novitium has expanded the 505 (b)(2) portfolio beyond the three initial 505(b)(2) candidates in Oncology and Hypertension. The combined company has also expanded dosage forms to include injectables and gels.

Enhances scale of CDMO Business & U.S. Based Manufacturing Capacity.
Novitium adds nine new customers to ANI’s growing CDMO business. Additionally, Novitium brings a U.S. based, state-of-the-art manufacturing facility enhancing manufacturing capabilities and CDMO opportunities.

Compelling Financial Profile
Immediately accretive to Adjusted non-GAAP earnings per share. The acquisition diversifies ANI’s revenue base by contributing to each of its reporting segments: Generics, Contract Manufacturing, Royalties/Other and, following the launch of Novitium’s 505(b)(2) pipeline products, the Brand segment.

The Transaction has satisfied customary closing conditions, and received approval from shareholders and relevant regulatory agencies, including clearance under the Hart-Scott Rodino Antitrust Improvements Act. As previously announced, the U.S. Federal Trade Commission (the FTC) has accepted the proposed consent order in connection with ANI’s definitive agreement to acquire Novitium Pharma. The divestitures required by the FTC of development rights to one generic drug and assets with respect to another generic drug are immaterial to the Company’s business and have been completed. The acceptance by the FTC satisfies all required antitrust clearances needed to be obtained for the acquisition.

Terms of the Transaction and Debt Re-Financing

Under the terms of the transaction, the Purchase Price is comprised of (i) a cash payment of $89.5 million and (ii) the issuance of 2,466,654 common shares of ANI equity. Novitium is also eligible to receive (i) $25 million in contingent payments upon the achievement of financial targets related to Generics products and filing of certain ANDAs and (ii) $21.5 million in contingent payments upon the achievement of financial targets from the 505(b)(2) products.

Commensurate with the completion of the transaction, ANI retired its existing Term Loan-A credit facility (including the repayment of $200.1 million of face value outstanding) and closed a new $300 million Term Loan-B and a $25 million PIPE investment with Ampersand Capital Partners. The new credit facility also includes a $40 million revolver that is un-drawn at this time. The new debt financing is secured by substantially all the assets of ANI and its subsidiaries.

Advisors

Bourne Partners, Truist Securities and Houlihan Lokey acted as financial advisors to ANI Pharmaceuticals. SVB Leerink acted as financial advisor to Novitium Pharma and its shareholders. Hughes Hubbard & Reed LLP were ANI’s legal advisors and Orrick, Herrington & Sutcliffe LLP acted as legal advisors to Novitium and its shareholders.