On June 1, 2021 Enlivex Therapeutics Ltd., (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, reported that the Canadian Intellectual Property Office has issued Canadian Patent No. 2,893,962 covering AllocetraTM, the Company’s immunotherapy product candidate (Press release, Enlivex Therapeutics, JUN 1, 2021, View Source [SID1234583308]). The new patent is expected to provide added intellectual property protection for pharmaceutical compositions, manufacturing methods and uses of AllocetraTM.

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Oren Hershkovitz, PhD, CEO of Enlivex, stated, "We are pleased to have this patent granted in Canada, which adds to existing AllocetraTM patents in various countries around the world. We currently continue to focus our clinical development efforts on life-threatening diseases with high mortality rates and no effective treatments such as sepsis, COVID-19, and solid tumors."

AllocetraTM is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, AllocetraTM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On June 1, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, and Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported the companies have entered into a collaboration and license agreement for adagrasib, a small-molecule KRASG12C inhibitor, in Greater China (mainland China, Hong Kong, Macau and Taiwan) (Press release, Zai Laboratory, JUN 1, 2021, View Source [SID1234583307]).

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"We believe Zai Lab is an ideal partner to enable us to expand and accelerate Mirati’s global adagrasib development," said Charles M. Baum, M.D., Ph.D., president and chief executive officer, Mirati Therapeutics, Inc. "Zai Lab has an established record of rapid and high quality development and commercialization of innovative oncology product candidates in China. Their capabilities position Mirati to further develop adagrasib for patients with cancer who harbor the KRASG12C mutation around the world."

"We are delighted to collaborate with Mirati to bring adagrasib to patients in need in Greater China as soon as possible," said Samantha Du, Ph.D., founder, chairperson, and chief executive officer of Zai Lab. "Lung cancer is the most common cancer in China, and we aim to make adagrasib an important product in our growing lung cancer franchise. We are also excited about the potential of adagrasib to treat colorectal, pancreatic and other cancers characterized by KRASG12C mutations."

Under the terms of the agreement, Zai Lab obtains the right to research, develop, manufacture and exclusively commercialize adagrasib in Greater China. Zai Lab will support accelerated enrollment in key global, registration-enabling clinical trials of adagrasib in patients with cancer who have a KRASG12C mutation.

Mirati has an option to co-commercialize in Greater China and retains full and exclusive rights to adagrasib in all countries outside of Greater China. Mirati will receive a $65 million upfront payment, with the potential to receive up to an additional $273 million in development, regulatory and sales-based milestone payments. Mirati is also eligible to receive high-teen- to low-twenties-percent tiered royalties based on annual net sales of adagrasib in Greater China.

About Adagrasib (MRTX849)

Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C mutated cancers, which regenerates every 24-48 hours. Studies of adagrasib have shown that the drug has a long half-life and extensive tissue distribution and is well tolerated. Adagrasib has shown single-agent responses in non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, and other solid tumors with KRASG12C mutations. Adagrasib is also being evaluated in several clinical trials in combination with other anticancer therapies with strong scientific rationale in patients with advanced solid tumors. Registration-enabling studies are ongoing in NSCLC and colorectal cancer. For more information visit Mirati.com/science.

About NSCLC and Colorectal Cancer in China

KRASG12C is the most common KRAS mutation in non-small cell lung cancer (NSCLC). The mutation is a biomarker of poor prognosis in Chinese patients with NSCLC. Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases. According to the World Health Organization, the incidence of lung cancer in China in 2020 was 815,563 cases, with 714,699 deaths.

Colorectal cancer (CRC) is the second most commonly diagnosed cancer type in China. According to the World Health Organization, the incidence of colorectal cancer in China in 2020 was 550,628 cases, with 283,751 deaths.

On June 1, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) reported that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L), with the NDA being granted Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is November 30, 2021 (Press release, CTI BioPharma, JUN 1, 2021, View Source [SID1234583306]). The FDA is not currently planning to hold an advisory committee meeting to discuss the NDA.

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"We are pleased that the FDA’s acceptance of our NDA brings us one step closer to our goal of providing myelofibrosis patients with severe thrombocytopenia a new treatment option," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "With commercial preparation underway, we believe we will be well positioned for a potential U.S. launch later this year. We look forward to working with the FDA during its review of our application."

The NDA was accepted based on the data from the Phase 3 PERSIST-2 and PERSIST-1 and the Phase 2 PAC203 clinical trials, with a focus on the severely thrombocytopenic (platelet counts less than 50 x 109/L) patients enrolled in these studies who received pacritinib 200 mg twice a day, including both frontline treatment-naive patients and patients with prior exposure to JAK2 inhibitors. In the PERSIST-2 study, in patients with severe thrombocytopenia who were treated with pacritinib 200 mg twice a day, 29% of patients had a reduction in spleen volume of at least 35%, compared to 3% of patients receiving the best available therapy, which included ruxolitinib.; 23% of patients had a reduction in total symptom scores of at least 50%, compared to 13% of patients receiving the best available therapy. In the same population of patients treated with pacritinib, adverse events were generally low grade, manageable with supportive care, and rarely led to discontinuation. Platelet counts and hemoglobin levels were also stabilized.

About Myelofibrosis and Severe Thrombocytopenia
Myelofibrosis is a type of bone marrow cancer that results in formation of fibrous scar tissue and can lead to severe thrombocytopenia and anemia, weakness, fatigue and enlarged spleen and liver. Patients with severe thrombocytopenia are estimated to make up one-third of patients treated for myelofibrosis, or approximately 17,000 people in the United States and Europe. Severe thrombocytopenia, defined as blood platelet counts of less than 50 x 109/L, has been shown to result in overall survival rates of just 15 months. Thrombocytopenia in patients with myelofibrosis is associated with the underlying disease but has also been shown to result from treatment with ruxolitinib, which can lead to dose reductions, and as a result, may potentially reduce clinical benefit. Survival in patients who have discontinued ruxolitinib therapy is further compromised, with an average overall survival of seven to 14 months. Myelofibrosis patients with severe thrombocytopenia have limited treatment options, and represent an area of significant area of unmet medical need.

About Pacritinib
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1, and CSF1R, but not JAK1. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia, and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT.

On June 1, 2021 Cellestia Biotech, specialized in targeting Transcription Factors (TFs) involved in human diseases reported that it will present updated clinical data of its ongoing Phase 1 trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021 underscoring the ambition to become a leader in the field of TFs (Press release, Cellestia Biotech, JUN 1, 2021, View Source [SID1234583304]).

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Dr. Florian Vogl, CMO of Cellestia Biotech said: "Our clinical data at ASCO (Free ASCO Whitepaper) this year validate our transformative scientific approach and open the path for CB-103 to become a new treatment option for patients with NOTCH-driven cancers and non-oncology conditions such as autoimmune and inflammatory diseases."

Dr. Michael Bauer, CEO of Cellestia stated: "Cellestia is shifting the boundaries of biomedical research: the outstanding clinical data on CB-103 confirm Cellestia´s ability to develop novel therapies targeting Transcription Factors that historically have been considered difficult or impossible to target. We have shown we can do it and we will further expand our pipeline to address currently unmet medical needs."

Presentation details:

Title: Phase 1 study of CB-103, a novel first-in-class inhibitor of the CSL-NICD gene transcription factor complex in human cancers

Abstract Number: 3020

Session: Poster Discussion Session, Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology ]]Presenting Author: Elena López-Miranda, MD, Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain

Date / Time: (Virtual) Friday, June 4th, poster and recording available on demand at ASCO (Free ASCO Whitepaper).org from 9:00 AM EST A copy of the poster can be accessed on www.cellestia.com after the presentation concludes, and the recorded oral presentation will be hosted on the online ASCO (Free ASCO Whitepaper) Meeting Library. Cellestia Biotech AG Hochbergerstr. 60C www.cellestia.com CH-4057 Basel

About Cellestia’s clinical Phase 1 trial
CB103-C-101 is a Phase 1/2a multicenter, open-label, dose-escalation study with expansion arms of CB-103 in adult patients with locally advanced or metastatic solid tumors and hematological malignancies characterized by alterations of the Notch signaling pathway. The study is open for enrollment at sites in Europe and Switzerland, the US, and Asia (China, Korea).

About Transcription Factors (TF)
Transcription refers to the first step of gene expression where an RNA is created from a DNA template. Transcription factors (TF) are DNA-binding proteins that play a key role in gene transcription. Through their ability to initiate or repress site-specific transcription, each cell in our bodies can differentiate into a different cell type despite containing the same exact genetic code. Transcription factors also make genetic fine-tuning possible. Modulating the activity and the amount of transcription factor can increase or decrease the rates of the chosen gene’s transcription. Ultimately, transcription factors can be thought of as the "gatekeepers" that determine if a gene is expressed or not.

On June 1, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the U.S. Food and Drug Administration (FDA) is "on site" for the ROLONTIS (eflapegrastim) manufacturing facility inspection (Press release, Spectrum Pharmaceuticals, JUN 1, 2021, View Source [SID1234583302]). Spectrum previously received notification from the agency that it would defer its decision on the BLA for ROLONTIS because an inspection of the Hanmi Bioplant in South Korea could not be conducted due to restrictions on travel related to the COVID-19 pandemic.

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"I would like to confirm that the FDA has initiated its inspection of the ROLONTIS manufacturing facility," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals.

About ROLONTIS

ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.