On October 9, 2020 Creative Biosciences, a Guangzhou oncology testing company, reported that it raised $90 million in a Series C funding led by Tsing Song Capital (Press release, Creative Biosciences, OCT 9, 2020, View Source [SID1234568282]). In 2018, Creative Bio was approved by China’s NMPA to market Colosafe, a stool-based diagnostic test for colon cancer. The company says Colosafe costs less than half the US competition but has a higher detection specificity. Creative was founded by the research team led by Professor Hongzhi Zou at Sun Yat-sen University. It will use the proceeds to develop early screening and point-of-care testing products for lung, bladder, liver and cervical cancers.

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On October 9, 2020 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly",NYSE: LLY), reported that HALPRYZA (rituximab injection), a recombinant human/murine chimeric monoclonal antibody drug co-developed by Innovent and Lilly, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with diffuse large b cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL) in China (Press release, Innovent Biologics, OCT 9, 2020, View Source [SID1234568276]). HALPRYZA (rituximab injection) is Innovent’s fourth monoclonal antibody drug approved by the NMPA following TYVYT (sintilimab injection), BYVASDA (bevacizumab injection) and SULINNO (adalimumab injection). It is also the second monoclonal antibody approved by NMPA that was co-developed by Innovent and Lilly after the approval of TYVYT.

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The clinical efficacy and safety of rituximab in CD20-positive non-Hodgkin’s lymphoma have been confirmed in several large-scale clinical trials. Rituximab injection, approved by FDA in 1997, is approved for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA)，granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and moderate to severe pemphigus vulgaris (PV). The efficacy and safety of rituximab have been well recognized worldwide. HALPRYZA (rituximab injection) is a recombinant human/murine chimeric monoclonal antibody drug co-developed by Innovent and Eli Lilly. The launch of HALPRYZA (rituximab injection) will provide Chinese patients with high-quality and relatively more affordable rituximab injection.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "HALPRYZA (rituximab injection) is another example of our success with the National Major New Drug Innovation and Development Projects and the fourth monoclonal antibody drug approved by the NMPA following TYVYT (sintilimab injection)，BYVASDA (bevacizumab injection), and SULINNO (adalimumab injection). We hope to bring this high-quality drugs to more patients in need in China as soon as possible."

Dr. Li WANG, Senior VP of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center, stated: "We’re excited that Lilly and Innovent strategic collaboration has reached another success. Lymphoma is one of the malignant tumors with rapid growing incidence. However, the survival rate is also relatively higher than other tumor types when having appropriate treatment. The approval of HALPRYZA (rituximab injection) will bring a new option to Chinese Lymphoma patients, help them to improve quality of life & prolong their survivals."

About Malignant Lymphoma

Malignant lymphoma is one of the most common hematological malignancies in China. It is one of the top ten malignant tumors with high morbidity and mortality. In recent years, the incidence of malignant lymphoma has been rising. According to histopathology, lymphoma can be divided into Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL), of which NHL accounts for the majority. NHL is a general term for a series of related but different lymphoid malignant tumors. Most (80-85%) originates from B cells. The rest originate from T cells or NK cells. More than 95% of B-cell non-Hodgkin’s lymphoma cells express CD20. The incidence of NHL increases with age. The most common type of NHL in China is diffuse large B-cell lymphoma (DLBCL), accounting for 40-50% (about 30-40% in Western countries). DLBCL is a moderately malignant to highly malignant invasive lymphoma that progresses rapidly and leads to the death of patients within a few months without treatment.

About HALPRYZA (rituximab injection)

HALPRYZA is rituximab injection and a recombinant human/murine chimeric monoclonal antibody drug. Rituximab binds to the CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). Normal and malignant B cells are targeted for destruction by the antibody, thereby achieving anti-tumor and immunosuppressive therapeutic effects.

On October 9, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer, reported that Athenex Oncology, a U.S. based division of Athenex, launched Your Guide to Facing Metastatic Breast Cancer — a free, first-of-its-kind resource offering comprehensive lifestyle guidance to people living with metastatic breast cancer (MBC) (Press release, Athenex, OCT 9, 2020, View Source [SID1234568275]). The Guide provides evidence-based recommendations for increasing resilience, reducing stress, maintaining good dietary and sleep habits, managing inflammation, and other tips to improve quality of life while living with MBC. The Guide can be ordered at www.AthenexOncology.com/patient-resources.

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The launch of Your Guide to Facing Metastatic Breast Cancer is timed to coincide with MBC Awareness Day on October 13. The Guide, which is created by health and wellness company Viver Health, complements Facing MBC Together, a public education and patient support program that Athenex Oncology launched in June 2020 to provide practical and emotional support to people living with MBC.

"Introducing Your Guide to Facing Metastatic Breast Cancer during National Breast Cancer Awareness Month underscores Athenex Oncology’s commitment to meeting the needs of the metastatic breast cancer community," noted Timothy Cook, senior vice president, global oncology at Athenex. "Our continued provision of practical resources that promote health and wellness reflects our view of individuals as whole people, not as ‘patients.’ While the lifestyle tips in the Guide can be useful to anyone, they are designed to be especially helpful to those who are living with metastatic breast cancer."

The recommendations in the Guide are based on extensive research showing that a health-oriented lifestyle – one that encompasses a healthy diet and nutrition, exercise, stress reduction, inflammation management, and adopting coping mechanisms to become more physically and emotionally resilient – may improve overall survival and quality of life following a breast cancer diagnosis.1-6 The Guide has distilled and translated those research findings into simple and easily understandable information that people living with MBC can adopt and implement on their own.

"Living with metastatic breast cancer is about more than just taking your medicine and keeping all your doctor’s appointments," commented Beth Baughman DuPree, M.D., a board-certified general surgeon specializing in diseases of the breast, and a medical advisor to the development of the Guide. "It’s about being mindful and taking an active role in your own care, while also finding ways to bring meaning to your life, whether through connecting with friends, creating art, communing with nature, or relieving stress through yoga, tai chi, quigong, reiki, or just plain laughter. Your Guide to Facing Metastatic Breast Cancer is designed to help you find your own path to health, wellness, optimism, and inner strength."

Dr. DuPree, who is the medical director of the oncology service line at Northern Arizona Healthcare, vice president, health at Holy Redeemer Health System in Pennsylvania, as well as founder and president of the Healing Consciousness Foundation added, "While the Guide was created before the global COVID-19 pandemic struck, its recommendations can be particularly useful during these difficult times, when people with metastatic breast cancer feel even more isolated than usual."

On October 9, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that the Company’s European manufacturer, BSP Pharmaceuticals S.p.A. ("BSP"), has begun the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable (Press release, CNS Pharmaceuticals, OCT 9, 2020, View Source [SID1234568274]).

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"Our preparations for filing an IND for Berubicin require continued execution in both our clinical and manufacturing initiatives," stated John Climaco, CEO of CNS Pharmaceuticals. "With the manufacturing of our Berubicin Drug Product in Europe, we continue to advance closer toward an IND filing for Berubicin, which we expect to submit later this quarter. We have also made significant progress on the clinical front and recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group ("IAG") as the imaging partner, and Berry Consultants as a biostatistical advisor for our Phase 2 trial design. We have also added Dr. Patrick Wen, a renowned neuro-oncologist, to our Scientific Advisory Board. Our laser focus remains on initiating a U.S. Phase 2 trial for Berubicin in Q1 of 2021 and we continue to demonstrate our ability to execute our operational and clinical plans toward that goal."

As part of the Company’s plan to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin, the Company implemented a dual-track drug product manufacturing strategy. Under this dual-track strategy, it engaged two separate manufacturers for Berubicin on different continents, both U.S.-based Pharmaceutics International, Inc. ("Pii") and Italy-based BSP. As previously announced, CNS completed synthesis of Berubicin active pharmaceutical ingredient (API) and shipped API to both Pii and BSP to prepare an injectable form of Berubicin for clinical use. BSP and Pii have now begun manufacturing of Berubicin and the Company expects to complete manufacturing at both locations early in the fourth quarter.

The FDA recently granted the Company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product’s development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug’s approval for that use.

On October 9, 2020 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported that the first patient has been dosed with TP-1454, an investigational small-molecule pyruvate kinase M2 isoform (PKM2) activator, administered alone and in combination with ipilimumab and nivolumab, in a Phase 1/1b study in patients with advanced metastatic or progressive solid tumors (Press release, Sumitomo Dainippon Pharma, OCT 9, 2020, View Source [SID1234568273]).

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"Dosing the first patient in this study marks an important milestone, as TP-1454 is the first PKM2 activator to be evaluated in patients with cancer," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "The novel mechanism of action for TP-1454 aims to target the underlying drivers of tumor growth and tumor-driven immune suppression. We look forward to further understanding the safety and efficacy of TP-1454 alone and in combination in patients with solid tumors and applying these learnings to advance the compound."

The primary objectives of the first-in-human, open-label study are to assess the safety of oral TP-1454 administered once daily as monotherapy in patients with advanced metastatic or progressive solid tumors and as combination therapy with ipilimumab and nivolumab. The study will also establish the dose of TP-1454 alone and in combination with ipilimumab and nivolumab for future studies in select advanced solid tumors. Secondary objectives include assessing the pharmacokinetic (PK) profile and preliminary antitumor activity of TP-1454 alone and in combination with ipilimumab and nivolumab and evaluating pharmacodynamics of TP-1454.

The trial is being conducted in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT04328740).

About TP-1454

TP-1454 is an investigational oral pyruvate kinase M2 isoform (PKM2) activator, that is currently being evaluated in a Phase 1/1b study in patients with advanced metastatic or progressive solid tumors (NCT04328740). TP-1454 is the first PKM2 activator to be evaluated in cancer patients. Pyruvate kinase is the enzyme responsible for catalyzing the last step of glycolysis. PKM2 plays a critical role in the metabolic changes observed in cancer and immune cells and establishes a metabolic advantage for tumor cells over the tumor immune microenvironment.1