On April 6, 2021 Umoja Biopharma, a biotechnology company pioneering an integrated, in vivo immunotherapy platform, reported the appointment of Nushmia Khokhar, M.D., as Chief Medical Officer (Press release, Umoja Biopharma, APR 6, 2021, View Source [SID1234577649]).

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"We are excited to welcome Dr. Khokhar to the Umoja team. Nushmia is an accomplished oncologist who has spent a significant portion of her career overseeing the transition of novel cancer therapeutics from discovery to clinical development," said Andy Scharenberg, M.D., co-founder and CEO of Umoja. "Her expertise across early and late-stage clinical development will be invaluable to the company during a milestone year."

Prior to joining Umoja, Dr. Khokhar was the Senior Vice President, Head of Clinical Development at Autolus where she played a critical role in advancing the company’s autologous T-cell products and clinical programs. She also held numerous roles at Janssen Oncology, leading several successful clinical trials, directing the Phase 3 registration trial of Yondelis in soft tissue sarcomas, and serving as the Global Clinical Leader for the breakthrough therapy daratumumab (Darzalex) for hematologic cancers. Dr. Khokhar received her medical training from the Aga Khan University in Pakistan before completing a post-doctoral fellowship at Memorial Sloan-Kettering Cancer Center with a focus on pharmacology and molecular therapeutics. She completed a residency in internal medicine at Washington Hospital Center in Washington, D.C. prior to completing a Hematology/Oncology Fellowship at the Northwestern University Feinberg School of Medicine.

"Umoja’s innovative and integrated in vivo approach, along with its TumorTag technology platform has the potential to overcome serious barriers that have held back the CAR-T cell therapeutic space," said Dr. Khokhar, CMO of Umoja Biopharma. "Now is our time to make CAR-T cell treatments better, more efficient, and applicable for maximum patient impact, not only in heme malignancies but also in solid tumors. I’m looking forward to joining the Umoja team in the hopes of making this promise a reality."

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.

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 Bioniz Therapeutics, Inc., ("Bioniz"), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, reported the European Commission (EC) has granted orphan designation to BNZ-1 for the treatment of cutaneous T-cell lymphoma (CTCL), a rare skin cancer (Press release, Bioniz Therapeutics, APR 6, 2021, View Source [SID1234577646]). BNZ-1 has previously been granted orphan drug designation by the U.S. Food and Drug Administration (FDA). Bioniz recently completed a phase 2 study of BNZ-1 in CTCL in the United States and intends to initiate a phase 3 clinical trial of BNZ-1 for the treatment of patients with relapsed or refractory CTCL (rCTCL). Bioniz expects the phase 3 to begin enrolling the second half of 2021.

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"The currently approved therapies to treat CTCL are not ideal given the limited efficacy and safety concerns and are typically tolerated by patients only for a limited time due to many side effects that are associated with these treatments," said Nazli Azimi, Pharm.D., Ph.D., Founder, President, and CEO of Bioniz Therapeutics. "With our lead product candidate, BNZ-1, we have completed several significant milestones, including positive efficacy data from our phase 2 study, guidance from the FDA on our phase 3 trial design, and now orphan designation in the U.S. and EU. BNZ-1 has the potential to be a significant treatment for CTCL."

Orphan designation from the EC provides incentives for companies to develop medicines intended for the treatment, prevention, or diagnosis of a disease that is life-threatening or chronically debilitating and where no satisfactory treatment is currently authorized. The prevalence of the condition must not exceed more than five in 10,000 people in the European Union (EU). In addition to being eligible for a 10-year period of marketing exclusivity in the EU upon product approval, orphan designation provides fee waivers, protocol assistance, and eligibility for marketing authorization under the centralized procedure granting approval in all EU countries.

About Refractory Cutaneous T-cell Lymphoma (rCTCL)
Cutaneous T-cell lymphomas (CTCLs) are a rare, aggressive, heterogeneous group of non-Hodgkin’s lymphomas that manifest primarily in the skin. Although a wide array of therapeutic options are available for early-stage CTCL, not all patients respond, resulting in refractory CTCL (rCTCL) with limited treatment options and a poor prognosis.

About BNZ-1
The company’s lead product candidate, BNZ-1, is a selective inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in CTCL and autoimmune diseases. Bioniz is also planning a phase 2 study of BNZ-1 for the treatment of alopecia areata, which is also driven by unregulated T-cell biology.

On April 6, 2021 Shanghai Genechem Co., Ltd. (Genechem), a discovery company dedicated to novel drug target discovery and development of novel therapeutics, reported the execution of a global collaboration with I-Mab (Nasdaq: IMAB), a Nasdaq-listed global biopharmaceutical company, to develop and commercialize multiple bi-specific antibodies (BsAb) based on monoclonal antibody developed by Genechem and antibodies selected by I-MAB (Press release, Shanghai GeneChem, APR 6, 2021, View Source [SID1234577645]).

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"This collaboration is the first of many that will leverage Genechem’s Good Research Practice (GRP) and CHAMP antibody discovery platform, strong bioinformatic database, as well as strong development expertise of synergistic partners, to deliver globally competitive assets based on innovative targets. We are excited to collaborate with I-Mab, a global leader in Oncology and antibody development, to bring more products to address clinical unmet needs for patients in China and globally", commented Yueqiong Cao, Founder and CEO of Genechem.