On April 6, 2021 PlantForm Corporation, PlantPraxis Biotecnologia and Bio-Manguinhos/Fiocruz (Health Ministry of Brazil) reported a collaborative research and development agreement to develop a biosimilar pembrolizumab for the Brazilian market (Press release, PlantForm, APR 6, 2021, View Source [SID1234577647]).

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The original antibody drug, pembrolizumab, is widely used in immunotherapy to treat a variety of cancers including melanoma, lung cancer, head and neck cancer, and stomach cancer.

"This agreement advances PlantForm’s collaborations in Brazil to make affordable, effective cancer drugs available to millions of Brazilians," said Dr. Don Stewart, PlantForm’s President and CEO. "It also advances PlantForm’s global strategy for biosimilar drug development and manufacturing to increase affordability and access to a wide range of life-saving medications."

"Since 2015 when ANVISA approved the first biosimilar in Brazil it paved the way for more people to have access to advanced health treatments," said Germana Regazzi, PlantPraxis Director. "We want to make a difference in this market by transferring an innovative technology that will bring a low-cost biosimilar pembrolizumab to Brazil."

"Bio-Manguinhos, a pioneer institution in the development and production of vaccines, biopharmaceuticals and diagnostics and a protagonist in the production of biosimilars in Brazil, is now investing in plant-based technology. We strongly believe it can be an important option to bring high quality/low cost biopharmaceuticals and vaccines to the Brazilian Universal Health System (SUS). PlantForm holds one of the most promising technologies in the field, representing an ideal partner to pursue this goal," commented Sotiris Missailidis, Deputy Director of Technological Development of Bio-Manguinhos/Fiocruz.

The original drug (Keytruda by Merck) is a global market leader in oncology treatment and is on track to be the world’s best-selling drug by 2025 with annual projected sales of US $22.5 billion. It will lose exclusivity protection in the U.S., EU and Brazil in 2028.

PlantPraxis is a joint venture between PlantForm do Brasil (a wholly owned subsidiary of PlantForm Corporation) and Axis Biotec Brazil to develop and commercialize certain biosimilar and/or biobetter versions of key biologic drugs using the vivoXPRESS manufacturing platform for biopharmaceuticals. Bio-Manguinhos is a Brazilian government institution responsible for technology development and production of vaccines, reagents and biopharmaceuticals to meet public health needs.

With this partnership, the three-year research and development initiative will culminate in protocols for Phase 1 and Phase 3 clinical trials. Following successful completion of clinical trials and market entry in Brazil through Bio-Manguinhos/Fiocruz, PlantForm and PlantPraxis will take biosimilar pembrolizumab to world markets.

On April 6, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that a study recently published in BMC Gastroenterology shows that the Epigenomics new liver cancer panel represents a new and valuable alternative for the early detection of hepatocellular carcinoma (liver cancer, HCC) in cirrhotic patients (Press release, Epigenomics, APR 6, 2021, View Source [SID1234577597]).

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Greg Hamilton, CEO of Epigenomics AG, commented: "HCC is in the top 10 of most common cancers in both men and women worldwide, occurring in approximately 4.5 million U.S. adults. In addition, HCC is considered the second leading cause of cancer-related deaths world-wide with more than 780,000 deaths annually. However, early detection offers a good chance of curative treatment. The performance of the currently recommended surveillance methods, however, are suboptimal, as are the low participation rates in surveillance. In this respect, we are very pleased with the results of the study, as it demonstrates that our liver cancer panel can address the significant clinical need for novel minimally invasive testing to aid in the detection of HCC at an early stage, and thus save lives."

The study compared patients with cirrhosis who had early-stage treatable liver cancer with patients having cirrhosis but no cancer. As reported in the study, when combined with AFP (alpha-fetoprotein) measurement in an ad hoc analysis, the new Epigenomics Next Generation Sequencing (NGS) panel achieved a sensitivity of 68 % at a specificity of 97 %.

The current standard of care for HCC surveillance is ultrasound plus AFP with a sensitivity of 63% and a specificity of 84%. Consequently, the Epigenomics’ blood-based panel provides a very simple and affordable method that may improve clinical performance and could be particularly applicable in settings where resources for surveillance by imaging may be limited. Such a blood test can help detect HCC at an early stage and thus prevent cancer-related deaths, because after all, patients’ chances of survival decrease rapidly if the disease is detected late.

On April 6, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its first quarter 2021 financial and operating results on Thursday, May 6, 2021, before the U.S. financial markets open (Press release, Regeneron, APR 6, 2021, View Source [SID1234577616]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 7794757. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On April 6, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that Dr. Jennifer Buell, President and COO, Dr. Steven O’Day, Chief Medical Officer, and Dr. Dhan Chand, Scientific Director, Head of Drug Discovery, at Agenus, will participate in a webcast hosted by Dr. Matt Phipps of William Blair on Saturday, April 10, 2021 at 10:30 a.m. ET (Press release, Agenus, APR 6, 2021, View Source [SID1234577631]).

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Dr. Steven O’Day will review abstracts presented at AACR (Free AACR Whitepaper) 2021 featuring AGEN1181 and balstilimab, including objective responses observed in the ongoing Phase 1/2 trial, clinical benefits seen in underserved patient populations, and how they may inform the path forward for continued development.

Dr. Jennifer Buell and Dr. Dhan Chand will also be available to discuss the Fc-engineering driving AGEN1181’s enhanced activity, and how the AACR (Free AACR Whitepaper) presentations support AGEN1181’s place in the Agenus pipeline, alone and in combination with other immune-focused anti-cancer mechanisms.

Registration for the webinar can be done in advance at View Source

A replay will be available after the call on the Events & Presentations page of the Agenus website at View Source

On April 6, 2021 MitoImmune Therapeutics Inc. reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for MIT-001, an innovative new drug candidate for the treatment of oral mucositis (Press release, MitoImmune Therapeutics, APR 6, 2021, View Source [SID1234577648]).

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MitoImmune plans to initiate a randomized, double–blind, placebo–controlled, multi–center trial in the first half of this year to evaluate the safety and efficacy of three different doses of MIT-001 compared to the placebo in prevention of OM in 60 patients with head and neck squamous cell carcinoma (HNSCC) who are undergoing concurrent chemoradiotherapy (CCRT) in the US and South Korea.

CCRT as a standard therapy for the treatment of a number of cancers can cause various side effects during the patient’s treatment process. One of the most serious side effects, oral mucositis, accompanied by intensive inflammation and necrosis in the oral cavity, leads to large restrictions on the patient’s dietary intake, increases the risk of severe infection, and even acts as a serious obstacle to CCRT. The unmet medical needs in developed countries remain very high, but there is no effective medical treatment for oral mucositis.

"We are very pleased to be advancing our therapy of anti-inflammatory and anti-necrotic agent based on the novel action mechanism of mitochondria-targeted reactive oxygen species (ROS) scavenger into the clinical development in our quest to bring an innovative, better treatment to the patients who need them," said Soon-Ha Kim, Ph.D., chief executive officer of MitoImmune.

In addition to phase 2 clinical trial for the patients with HNSCC in the United States and Korea, Mitoimune has recently received the IND approval from the Ministry of Food and Drug Safety (MFDS) in Korea for a phase 2 clinical trial, to verify the safety and efficacy for OM in the lymphoma/ multiple myeloma patients with chemotherapy (CT) undergoing hematopoietic stem cell transplantation (HSCT). The first HSCT patient administration is planned for the 2nd quarter of this year.

MIT-001 is a novel class of anti-inflammatory and anti-necrotic agent, specifically scavenging ROS in the mitochondria. This action mechanism of MIT-001 is expected to effectively suppress massive inflammation like oral mucositis occurring in the necrotic ulcers of oral mucous via removing excessive mitochondrial ROS, a major contributing factor in the CCRT-induced inflammation and necrosis.

MitoImmune is a leading biotech company focusing on the development of mitochondrial therapeutics providing a breakthrough for life-threatening diseases based on its proprietary structural platform technology, which was scientifically verified through more than 40 published papers. MitoImmune is seeking to expand its R&D pipelines to chronic inflammatory disorders and neurodegenerative diseases.