On December 22, 2021 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (Nasdaq: ALLR) reported the submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) seeking marketing approval for dovitinib for the third-line treatment of renal cell carcinoma (RCC) patients (Press release, Allarity Therapeutics, DEC 22, 2021, View Source;U.S.-FDA-for-Dovitinib-for-Third-Line-Treatment-of-Renal-Cell-Carcinoma-RCC/default.aspx [SID1234597618]).

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The Company’s NDA filing is supported by its prior PMA submission with the FDA for use of Dovitinib-DRP, the Company’s validated companion diagnostic for the drug, to select and treat RCC patients most likely to respond to dovitinib.

Allarity’s CEO Steve Carchedi noted, "This NDA submission for dovitinib, in connection with the Dovitinib-DRP companion diagnostic, is a historic milestone for our Company and an important step for late-stage renal cell carcinoma patients awaiting new treatment options. Over the past decade, we have worked diligently to advance our novel oncology therapeutics pipeline together with our unique DRP diagnostic technology to realize the promise of personalized cancer care for patients. We greatly look forward to the approval of dovitinib and to introducing the clinical value of DRP companion diagnostics to oncologists and their patients."

Dovitinib is a small molecule, pan-tyrosine kinase inhibitor in-licensed from Novartis, and is Allarity’s most advanced clinical therapeutic candidate. The drug has previously shown clinical activity in a number of cancer indications, including RCC, gastrointestinal stromal tumors (GIST), endometrial cancer, metastatic breast cancer, and hepatocellular carcinoma (HCC). The Company expects to further evaluate the therapeutic benefit of dovitinib in one or more of these additional indications, either as a monotherapy or in combination with other oncology therapeutics.

"As a clinical oncologist looking for new therapies for my RCC patients, I am enthusiastic about Allarity’s NDA filing together with its Dovitinib-DRP(R) companion diagnostic," stated Professor Roberto Pili, M.D., Associate Dean for Cancer Research and Integrative Oncology at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences. "These patients, and their treating oncologists, are greatly in need of new precision medicines, coupled with validated companion diagnostics, to help select and treat the most likely responders. I look forward to working with Allarity to advance this new personalized cancer care approach for RCC patients."

Allarity’s unique and clinically-validated DRP companion diagnostics platform enables the prediction of whether a particular cancer patient is likely to respond to treatment with dovitinib, in addition to a broad range of anti-cancer drugs. DRP drug response assessments for an individual patient are made based on a biopsy from the patient’s tumor. The Dovitinib-DRP companion diagnostic is intended to be used to identify patients with later-stage renal cell carcinoma (RCC) who, by the gene expression signature of their tumor, are identified as having a high likelihood of responding to dovitinib. By identifying and treating only those RCC patients most likely to respond to dovitinib, and avoiding treatment of those RCC patients likely to not respond to the drug, Allarity aims to improve treatment options for patients and their treating oncologist to improve therapeutic benefit.

On December 22, 2021 Novartis reported that it entered into a definitive agreement to acquire all of the outstanding share capital of the UK-based ocular gene therapy company Gyroscope Therapeutics (Press release, Novartis, DEC 22, 2021, View Source [SID1234597617]).

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Geographic atrophy (GA) is an advanced form of dry age-related macular degeneration (AMD) that leads to progressive and irreversible vision loss1. There are no approved treatments for GA, making it one of the most significant unmet needs remaining in retinal diseases2.

GT005 is designed as an AAV2-based, one-time investigational gene therapy for GA secondary to AMD that is delivered under the retina. GT005 aims to restore balance to an overactive complement system, a part of the immune system, by increasing production of the CFI protein. Complement overactivation can lead to inflammation that damages healthy tissues, and it has been strongly correlated with the development and progression of AMD3. The CFI protein regulates the activity of the complement system. It is believed that increasing CFI production could reduce inflammation, with the goal of preserving a person’s eyesight.

The safety and efficacy of GT005 for the treatment of GA secondary to AMD is currently being evaluated in a Phase 1/2 clinical trial and two Phase 2 clinical trials4,5,6. GT005 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of people with GA.

Gyroscope also has several additional assets in its pipeline in early discovery for retinal diseases.

"With our own pioneering research in ocular gene therapies and our experience gained from bringing Luxturna to inherited retinal dystrophy patients outside of the US, Novartis has a well-established expertise in ocular gene therapies that will position us well to continue developing this promising one-time treatment" said Marie-France Tschudin, President, Novartis Pharmaceuticals. "This acquisition is one more step forward in our commitment to delivering innovation in ophthalmology to treat and prevent blindness worldwide."

Novartis will make an upfront payment of $800 million and potential additional milestone payments of up to $700 million. Closing of the transaction is subject to customary closing conditions including regulatory approvals. Until closing, Novartis and Gyroscope Therapeutics will continue to operate as separate and independent companies.

About geographic atrophy (GA)
Dry AMD is a leading cause of permanent vision loss in people over the age of 55 and is a devastating diagnosis2,7. As dry AMD advances, it leads to GA, an irreversible degeneration of retinal cells, causing a gradual and permanent loss of central vision. This disease can severely impact a person’s daily life as they lose the ability to drive, read and even see faces7.

On December 22, 2021 Sandoz, a global leader in generic and biosimilar medicines, reported that it has submitted a Marketing Authorization Application for a proposed biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix, Inc. to the European Medicines Agency (EMA) (Press release, Sandoz, DEC 22, 2021, View Source [SID1234597614]).

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Trastuzumab is a monoclonal antibody used for the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers2. Sandoz is seeking approval for the same indications as the reference medicine, based on a comprehensive package that includes analytical, preclinical, and clinical data.

"In 2020, breast cancer accounted for 28.7% of all new cancer cases diagnosed, making it the most frequently occurring cancer and first cause of cancer death among women in Europe1", said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. "Biosimilars have enormous potential to improve cancer care. Today’s submission is an encouraging step forward in our mission to expand access to advanced biologics treatments to address the evolving needs of patients, healthcare professionals and healthcare systems."

As part of the license agreement signed in April 2019, EirGenix, Inc. is responsible for development and manufacturing and Sandoz will have the right to commercialize the medicine upon approval in all markets excluding China and Taiwan. On December 20, 2021, Sandoz announced submission of a Biologics License Application for a proposed biosimilar trastuzumab (150 mg) to the US Food and Drug Administration.

Sandoz has been developing and providing oncology medicines for over 30 years. Today, it has more than 50 such medicines, including chemotherapeutics, biologics, hormones and supportive care treatments, for the treatment of a wide range of cancers. The collaboration with EirGenix, Inc. will enable Sandoz to build on its leading generic and biosimilar oncology portfolio to further expand patient access, while contributing to the sustainability of healthcare systems.

On December 22, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, reported the promotion of Harald Reinhart, M.D., from his current role as Chief Medical Officer (CMO) to President and Head of Global Development for Neuroscience, Autoimmune and Infectious Diseases (Press release, Zai Laboratory, DEC 22, 2021, View Source [SID1234597609]). Dr. Reinhart has been with the company since inception, first as an advisor and since 2017, as Chief Medical Officer responsible for the autoimmune and infectious diseases portfolio.

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"Harald has played a pivotal role in building Zai Lab’s broad and deep pipeline in autoimmune, infectious diseases and neuroscience," said Dr. Samantha Du, Founder, Chairperson and CEO at Zai Lab. "This promotion not only recognizes Harald’s tremendous contributions but will also empower him to further build a leading clinical team across these therapeutic areas."

Prior to joining Zai Lab, Dr. Reinhart served at Shionogi U.S. as Senior Vice President and Head of Clinical Development and Medical Affairs directing a broad portfolio of antibiotics, diabetes, allergy, and pain medications. Between 2003 and 2011, he was with Novartis as Vice President and Therapeutic Area Head, Clinical Development and Medical Affairs, where he oversaw successful regulatory filings for Coartem, Famvir, Sebivo, and Cubicin, and managed clinical development teams for infectious disease, immunity, transplantation, and renal disease. At Bayer Corp, he was international clinical project lead for ciprofloxacin and acarbose, and managed various other compounds.

Dr. Reinhart holds a doctorate in medicine from the University of Würzburg in Germany where he trained in surgery, anesthesiology, and internal medicine. He completed his medical and subspecialty training in the U.S. with board-certifications in internal medicine and infectious diseases. He is currently on faculty at Yale School of Medicine as Adjunct Clinical Professor of infectious diseases.

"It has been a phenomenal experience working at Zai Lab for the last seven years helping to bring transformative medicines to patients. I’m grateful for Samantha’s support and look forward to developing more medicines that truly make a difference in the lives of patients," said Dr. Reinhart. "I feel privileged to work every day with world-class colleagues at Zai Lab who share a unified vision for innovative drug development."

On December 22, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that the European Commission has granted Orphan Drug Designation to SNDX-5613, the Company’s highly selective oral menin inhibitor, for the treatment of acute myeloid leukemia (AML) (Press release, Syndax, DEC 22, 2021, View Source [SID1234597607]).

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"Supported by a growing body of clinical data, we firmly believe that SNDX-5613 is ideally positioned to serve as a best-in-class, meaningful intervention for patients with NPM1 and MLLr acute leukemias," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Receipt of Orphan Drug Designation from the European Commission further validates the important role that SNDX-5613 could play in the treatment of this highly underserved patient population, and we are fully committed to ensuring that it is able to reach as many of these patients as possible."

The European Commission grants Orphan Drug Designation for medicinal products intended to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union (EU) and when no satisfactory method of diagnosis, prevention, or treatment of the condition can be authorized. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.

SNDX-5613 was previously granted Orphan Drug Designation for the treatment of adult and pediatric AML by the U.S. Food and Drug Administration.

About SNDX-5613

SNDX-5613 is a potent, selective, small molecule inhibitor of the menin-MLL binding interaction that is being developed for the treatment of mixed lineage leukemia rearranged (MLLr) acute leukemias including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), and NPM1 mutant AML. In preclinical models of MLLr acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit. Menin-MLL interaction inhibitors have also demonstrated robust treatment benefit in multiple preclinical models of NPM1 mutant AML, which represents the most frequent genetic abnormality in adult AML. SNDX-5613 is currently being evaluated in the Company’s AUGMENT-101 Phase 1/2 open-label clinical trial for the treatment of relapsed/refractory (R/R) acute leukemias. SNDX-5613 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and European Commission for the treatment of patients with AML, and Fast Track designation by the U.S. FDA for the treatment of adult and pediatric patients with R/R acute leukemias harboring a mixed lineage leukemia rearranged MLLr or NPM1 mutation.