GoldenBiotech's New Drug Antroquinonol Receives FDA Approval on COVID-19 Phase 2 Clinical Trial in USA

Golden Biotechnology Corp. | July 02, 2020

Golden Biotechnology Corp. (GoldenBiotech, 4132.TWO), a leading Taiwanese biopharmaceutical company, announced that the FDA approved its investigational new drug (IND) application for a Phase II clinical trial of Antroquinonol (Hocena®) on COVID-19 patients in USA. GoldenBiotech has also applied for the US BARDA (Biomedical Advanced Research and Development Administration) CoronaWatch meeting. Future developmental planning of Antroquinonol in COVID-19 include joining the COVID-19 Candidate and Technologies Portal of the National Institutes of Health (NIH) and applying for the US emergency authorization (EUA) once it exhibits significant clinical results, all to expedite the meeting of the urgent market demand. The Phase II trial will be a randomized, double-blinded, placebo-controlled study of Antroquinonol as a potential treatment option for mild-to-moderate pneumonia in COVID-19 patients, as measured by the proportion of patients alive and free of respiratory failure (i.e., need for invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or extracorporeal membrane oxygenation [ECMO]) on Day 14. Dr. Today Su, Chief Executive Officer at GoldenBiotech, stated, "At present, physician can only provide supportive care such as oxygen supplementation, mechanical ventilation, and/or extracorporeal membrane oxygenator (ECMO) based on the clinical symptoms of the patients or enroll them in available clinical trials. Clearly, new and more effective drugs are still in need to fight the pandemic. Thus, it is imperative to provide immediate and ample supply to the world should our study improve the efficacy of any newly authorized treatments recommended as standard of care (SoC) for COVID-19." Currently there is no drug in development for treating Covid-19 that can effectively improve the severe inflammatory response induced by the virus nor the overall survival rate. We can see that by far there is no single drug that can simultaneously fight against the COVID-19 virus (SARS-CoV2) and the symptoms induced. Combination therapies adopted by other clinical trials may solve the shortcomings of single-drug therapies with slightly better efficacy, but the higher risk of adverse effects is inevitable.

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In the future we will be able to produce customized microbial organisms living factories that will make possible novel therapies and applications in biotech. Beat Christen explains the current state of work at ETH Zurich’s Institute of Molecular Systems Biology: an algorithm can write the genome of a new organism, though further work is needed to create the organism itself.

Spotlight

In the future we will be able to produce customized microbial organisms living factories that will make possible novel therapies and applications in biotech. Beat Christen explains the current state of work at ETH Zurich’s Institute of Molecular Systems Biology: an algorithm can write the genome of a new organism, though further work is needed to create the organism itself.

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MEDTECH

Pfizer to Acquire Trillium Therapeutics Inc.

Pfizer Inc | August 24, 2021

Pfizer Inc. and Trillium Therapeutics Inc. today announced that the companies have entered into a definitive agreement under which Pfizer will acquire Trillium, a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. Under the terms of the agreement, Pfizer will acquire all outstanding shares of Trillium not already owned by Pfizer for an implied equity value of $2.26 billion, or $18.50 per share, in cash. This represents a 118% premium to the 60-day weighted average price for Trillium. Trillium’s portfolio includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells. Its two lead molecules, TTI-622 and TTI-621, block the signal-regulatory protein α (SIRPα)–CD47 axis, which is emerging as a key immune checkpoint in hematological malignancies. TTI-622 and TTI-621 are novel, potentially best-in-class SIRPα-Fc fusion proteins that are currently in Phase 1b/2 development across several indications, with a focus on hematological malignancies. “Today’s announcement reinforces our commitment to pursue scientific breakthroughs with the addition of potentially best-in-class molecules to our innovative pipeline,” said Andy Schmeltz, Global President & General Manager, Pfizer Oncology. “The proposed acquisition of Trillium builds on our strong track record of leadership in Oncology, enhancing our hematology portfolio as we strive to improve outcomes for people living with blood cancers around the globe. Our deep experience in understanding the science of blood cancers, along with the diverse knowledge base we have developed across our growing hematology portfolio of eight approved and investigational therapies, provide us with a foundation to advance these important potential medicines to patients who need them.” Hematological malignancies are cancers that affect the blood, bone marrow, and lymph nodes. This classification includes various types of leukemia, multiple myeloma, and lymphoma. More than 1 million people worldwide were diagnosed with a blood cancer in 2020, representing almost 6% of all cancer diagnoses globally. In 2020, more than 700,000 people worldwide died from a form of blood cancer. “We’re delighted to announce Pfizer’s proposed acquisition of Trillium. Today’s announcement reflects Trillium’s potentially best in class SIRPα–CD47 status and contribution to immuno-oncology,” said Dr. Jan Skvarka, Chief Executive Officer of Trillium. “Trillium has the only known SIRPα–CD47 targeting molecules with clinically meaningful monotherapy responses as well as a strong basis for combination therapies, which is supported by preclinical evidence with a diverse set of therapeutic agents. With Pfizer’s global reach and deep capabilities, we believe our programs will advance more quickly to the patients we’ve always aspired to serve. We believe this is a good outcome for patients and our shareholders.” In clinical studies to-date, TTI-622 and TTI-621 have demonstrated activity as monotherapy in relapsed or refractory lymphoid malignancies, including Diffuse Large B-cell Lymphoma (DLBCL), Peripheral T-cell lymphoma (PTCL), Follicular Lymphoma (FL), and other lymphoid malignancies. As of July 26, 2021, Phase 1 data for TTI-622 in 30 response-evaluable patients have shown deep and durable responses in heavily pretreated patients, including two complete responses (CRs), one lasting over 114 weeks, with responses ongoing. TTI-622 and TTI-621 are currently the only known CD47-targeted molecules that have demonstrated meaningful single agent activity and CRs in multiple hematological malignancies. Thus far, adverse events (AEs) reported with TTI-622 and TTI-621 have been manageable. Related Grade 3 and 4 AEs with TTI-622 were rare and limited to transient cytopenias. In particular, the molecules demonstrate minimal red blood cell binding and few reported cases of anemia, an observed risk with other CD47-targeted approaches. Further data are expected to be shared at a forthcoming medical conference. “We are encouraged by the early clinical data for TTI-622 and TTI-621 monotherapy for patients with heavily pretreated lymphoid malignancies and early encouraging activity for TTI-622 in patients with multiple myeloma. Just as PD-1 and PD-L1 blockers have proven to be effective immuno-therapeutics for many solid tumors, the SIRPα-CD47 interaction defines a second key immune checkpoint for which disrupting agents are expected to become another important backbone immunotherapy for multiple types of cancer, especially hematological cancers,” said Chris Boshoff, MD, PhD, Chief Development Officer, Oncology, Pfizer Global Product Development. “Utilizing Pfizer’s leading research and global development capabilities, we plan to accelerate the clinical development of SIRPα fusion proteins as a potential new scientific breakthrough and explore combinations within our own portfolio and with innovative next-generation medicines for hematological malignancies.” In September 2020, as part of the Pfizer Breakthrough Growth Initiative (PBGI), Pfizer invested $25 million in Trillium and Jeff Settleman, Senior Vice President and Chief Scientific Officer of Pfizer’s Oncology Research & Development Group, was named to Trillium’s Scientific Advisory Board. Established in June 2020, PBGI’s goal is to provide funding for scientific research as well as access to Pfizer’s experts to ensure the continuity of clinical programs that could be of potential strategic interest for Pfizer. Pfizer has committed to providing up to $500 million in total funding to the PBGI. Additional Transaction Details The proposed acquisition of Trillium is to be completed by way of a statutory plan of arrangement under the Business Corporations Act (British Columbia) and subject to customary closing conditions, including approval of 66⅔% of the votes cast by Trillium shareholders, voting together as one class, at a special meeting of Trillium and approval of 66⅔% of the votes cast by Trillium shareholders and warrant holders, voting together as one class, at a special meeting of Trillium. Completion of the acquisition is also subject to court and regulatory approval, as well as certain other closing conditions customary for transactions of this nature. Pfizer’s financial advisors for the transaction are BofA Securities, Inc., with Ropes & Gray LLP and Norton Rose Fulbright Canada LLP acting as its legal advisors. Centerview Partners LLC served as Trillium’s financial advisor, while Goodwin Procter LLP and Baker McKenzie LLP (Canada) served as its legal advisors. About SIRPα/CD47 Accumulating data suggest that the SIRPα–CD47 axis is a key immune checkpoint in hematologic malignancies, similar to the PD-L1 / PD-1 checkpoint for solid tumors. CD47 is a protein that is overexpressed in numerous cancer cells, and in general, high CD47 expression correlates with more aggressive disease and poorer clinical outcomes. SIRPα is an inhibitory receptor expressed on myeloid cells that binds to CD47, preventing the immune system from destroying cancer cells. Disruption of the CD47-SIRPα interaction has been proven to elicit tumor destruction through triggering of an innate immune response. About Pfizer Oncology At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma. About Pfizer: At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. About Trillium Therapeutics Trillium is an immuno-oncology company developing innovative therapies for the treatment of cancer. The company’s two clinical programs, TTI-622 and TTI-621, target CD47, a “don’t eat me” signal that cancer cells frequently use to evade the immune system.

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NCCN Oncology Research Program and Puma Biotechnology, Inc. Collaborate to Research on Neratinib in Various Cancers

National Comprehensive Cancer Network | October 16, 2020

The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced plans to evaluate neratinib, a type of tyrosine kinase inhibitor (TKI) that works as a dual inhibitor of the epidermal growth factor receptor 1 (EGFR) and human epidermal growth factor receptor 2 (HER2). The research funding is supported by a $2-million grant from Puma Biotechnology, Inc. Projects may include pre-clinical, translational and clinical trials. They will focus on treatment of: Pediatric tumors(including neurofibromatosis Type 2 and progressive Vestibular Schwannoma). Early-stage and metastatic breast cancer, including those with HER2+ brain metastases. Other HER2-amplified tumors. EGFR-mutated glioblastoma multiforme. Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team.

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CELL AND GENE THERAPY

Enara Bio Relocates to The Oxford Science Park's Newest Facility to Expand R&D Capabilities

Enara Bio | December 09, 2020

Enara Bio, a biotechnology organization utilizing its proprietary T-cell/T-cell receptor (TCR) discovery and Dark Antigen™ platforms to deliver focused on cancer immunotherapies, announces its extension and move to the new Bellhouse Building at The Oxford Science Park. Enara Bio's move from the Oxford BioEscalator to one of the UK's biggest biomedical advancement habitats is in anticipation of its future development and desire to change malignancy care. The devoted exploration office will empower the organization to quicken the preclinical improvement of its lead MR1-targeting on T-cell therapy program while continuing to drive the disclosure of novel disease antigens and TCRs for immunotherapy. The move, which will see the organization possess more than 5,000 sq. ft of office and laboratory space in the Bellhouse Building, is a key milestone in Enara Bio's development and improvement. The reason fabricated office will empower Enara Bio to unite key faculty with world-driving abilities in bioinformatics, immunopeptidomics, cell therapy measure development, and immunology to discover and develop novel TCR-based immunotherapies.

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