On December 3, 2021 Global pharma major, Lupin Limited (Lupin) reported that they have entered into an exclusive distribution and marketing agreement with Biomm SA in Brazil (Press release, Lupin, DEC 3, 2021, View Source [SID1234596434]). Under the terms of agreement, Biomm will distribute and market biosimilar Pegfilgrastim in Brazil.

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Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.

Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.

On December 3, 2021 AQILION AB (publ) reported that it has strengthened its pipeline with an innovative development program in the field of chronic inflammation (Press release, Aqilion, DEC 3, 2021, View Source [SID1234596433]). With this acquisition, Aqilion is taking over all rights to the program, now under the name Regulus, from LEO Pharma. The project is ready for clinical trials and Aqilion plans to begin clinical development in 2022.

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Aqilion has acquired all rights to Regulus from LEO Pharma, who developed the project from early internal discovery research. Under the terms of the agreement, Aqilion will make an upfront payment that is a combination of cash and equity and LEO Pharma will become a shareholder of Aqilion. Furthermore, Aqilion will make additional payments from either product sales or through out-licensing revenues.

Regulus is a novel next-generation selective JAK1 inhibitor previously developed as LEO 142397, now AQ280. Drugs with a similar mechanism of action have shown clinical efficacy in autoimmune and inflammatory diseases. Aqilion will initially investigate AQ280 as a potential therapy for eosinophilic esophagitis (EoE), an inflammatory disease of the esophagus. To date, no drugs with the same mechanism of action have been developed for EoE and there is a high unmet medical need. Aqilion will conduct the Regulus project in-house with the aim of starting a Phase 1 safety study in healthy volunteers in 2022, followed by a Phase 2a study in patients.

"It is both gratifying and inspiring for us at Aqilion to be able to expand our chronic inflammation pipeline with such an innovative, high quality and exciting program as Regulus. Expanding our pipeline with a project in early clinical development has been a priority and we now look forward to advancing Regulus, while benefiting from synergies with our pipeline of preclinical projects," says Sarah Fredriksson, CEO of Aqilion.

"We are always excited to see our R&D operations bring forward new compounds that has the potential to help patients in any indication. In this case EoE where Aqilion is the right partner to pursue the potential of LEO 142397 – now Regulus. LEO Pharma will continue our dedication to bringing forward new innovative treatments that are either first or best in class and changing the standards of care within medical dermatology," says Thorsten Thormann, VP Research and Early Development in LEO Pharma.

About eosinophilic esophagitis
Eosinophilic esophagitis (EoE) is a rare chronic disease involving inflammation of the esophageal mucosa; its main symptom is swallowing difficulties. EoE is a relatively new diagnosis that is increasing in incidence. The disease, which has a progressive course, is also known as "allergic esophagitis" and is thought to be triggered by food allergens. Both children and adults can be affected and the diagnosis is most common in children in their teens and in adults aged 30-50. The condition is more common in men.

On December 3, 2021 Chemomab Therapeutics Ltd. (NASDAQ: CMMB), (Chemomab) a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported that David M. Weiner, MD has been named Interim Chief Medical Officer, effective immediately (Press release, Chemomab, DEC 3, 2021, View Source,-MD-as-Interim-Chief-Medical-Officer [SID1234596432]). This position will be in a part-time capacity. Dr. Weiner is replacing Dr. Arnon Aharon, who has resigned. Dr. Aharon intends to continue at Chemomab for the next 60 days and as a senior medical advisor thereafter to ensure a seamless transition.

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Dr. Weiner, who is based in the U.S., has more than 25 years of experience in the discovery and clinical development of novel therapeutics and has held senior executive roles at private and public biotechnology companies.

"We believe that Dr. Weiner is a terrific addition to the Chemomab team, bringing us decades of successful industry experience in managing clinical programs in a variety of therapeutic areas," said Dale Pfost, PhD, Chief Executive Officer of Chemomab. "His keen intellect and broad expertise should serve us well as we advance our current clinical programs for CM-101, establish a growing clinical and business presence in the U.S. and potentially expand our drug development activities to include additional therapeutic indications and assets."

Dr. Pfost continued, "We want to thank Dr. Aharon for his many contributions to Chemomab. He has done an excellent job of creating the foundation for our current clinical development efforts and in progressing three discrete clinical programs to Phase 2 trials in a timely and effective way. We wish him well in his future endeavors."

Dr. Weiner most recently served as Chief Executive Officer of Amathus Therapeutics. Previously he was Chief Medical Officer at Lumos Pharma and at aTyr Pharma and, prior to that, he was the Chief Medical Officer and interim Chief Executive Officer of Proteostasis Therapeutics. Dr. Weiner held key development roles over a five-year period at EMD/Merck Serono and spent almost a decade serving in discovery research and clinical development roles of increasing responsibility at Acadia Pharmaceuticals.

"I have been impressed by the commitment to R&D excellence and substantial scientific accomplishments achieved to date by the Chemomab team," noted Dr. Weiner. "As a small startup they characterized and elucidated a completely novel target with promising potential in fibrotic and inflammatory diseases and then developed CM-101─a neutralizing antibody ‘pipeline in a product’ that is advancing in clinical trials for two rare diseases with high unmet need. I look forward to continuing to assess the potential of CM-101, while also working with the executive team as we seek to broaden our R&D activities to potentially include additional indications and clinical candidates."

Dr. Weiner received a BA degree cum laude with highest honors in research from Brandeis University and an MD degree from the School of Medicine and Biomedical Sciences, State University of New York at Buffalo. He has been a director at a number of biotechnology companies and is currently on the Board of Directors of AxoSim. Dr. Weiner serves as a consultant and scientific and clinical advisory board member to a diverse group of biotechnology companies and foundations.

On December 3, 2021 Servier and the pharmatech Aqemia reported that they have entered into a collaboration agreement to accelerate the discovery of small molecule therapeutic drug candidates in immuno-oncology (Press release, Servier, DEC 3, 2021, View Source;utm_medium=rss&utm_campaign=immuno-oncologie-servier-et-aqemia-cooperent-pour-la-decouverte-de-medicaments-a-laide-de-lia [SID1234596431]).

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This collaboration will use Aqemia’s technology based on artificial intelligence and quantum physics. Aqemia will take responsibility for the AI-based design to deliver optimized molecules that fulfill several small molecule design goals. Unlike most AI-based technologies that need experimental data to train their algorithms prior to starting the design, Aqemia will tackle the project from the earliest stage of the drug discovery by generating its own data with quantum and statistical physics-based calculations.

Olivier Nosjean, Head of Open Innovation and Scientific Affairs at Servier R&D: "This collaboration with Aqemia is a concrete example of Servier working side by side with a start-up to create value for both parties, working jointly to accelerate therapeutic innovation for patients. This collaboration is the result of the Start-up @ Servier program, where an initial phase of joint work allows us to carry out a key study or pilot application of a technology, before entering into a classic collaboration. This is our first application of this Start-up @ Servier model, and we are very happy to see it take shape with Aqemia, which is such a promising collaboration."

On December 3, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:13) reported that, following the 2021 negotiations with the China National Healthcare Security Administration ("NHSA"), on January 1, 2022 the updated National Reimbursement Drug List ("NRDL") will continue to include ELUNATE (fruquintinib) and will now include SULANDA (surufatinib) (Press release, Hutchison China MediTech, DEC 3, 2021, View Source [SID1234596427]).

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Christian Hogg, Chief Executive Officer of HUTCHMED, said, "We welcome the addition of SULANDA into the NRDL, along with the renewal of ELUNATE. The NRDL has made it possible for novel therapies to gain wide reach across the country for diseases with large patient populations."

ELUNATE was first included in the NRDL on January 1, 2020, for the treatment of metastatic colorectal cancer ("CRC"). CRC was the third most diagnosed form of cancer by incidence in China in 2020, with an estimated 450,000 to 550,000 new cases each year[1].

SULANDA was approved in China for the treatment of advanced non-pancreatic neuroendocrine tumors ("NETs") in December 2020 and for advanced pancreatic NETs in June 2021. In China, there were an estimated 71,300 newly diagnosed NET patients in 2020, with potentially up to 300,000 patients living with the disease.[2]

HUTCHMED’s third oncology drug, ORPATHYS (savolitinib), is the first and only approved MET inhibitor in China for the treatment of patients with non-small cell lung cancer ("NSCLC") with MET exon 14 skipping alterations. It was also included in the 2021 negotiations with the NHSA, however HUTCHMED and AstraZeneca, its partner on ORPATHYS, declined inclusion in the NRDL for 2022. This position will be reassessed next year ahead of the next NRDL update. In China, there are an estimated 13,000 newly diagnosed NSCLC patients with MET exon 14 skipping alterations each year.1

About the NRDL
In recent years, the government in China has placed great importance on improving the public affordability of drug use. The NHSA regularly convenes a broad network of experts in medicine, pharmacology and pharmaco­economics to identify innovative drugs to be considered for inclusion in the NRDL. This has led to expansion of reimbursement of Category B drugs, which increasingly include novel oncology drugs. Reimburse­ment of Category B drugs requires varying degrees of copayment from patients, depending on their province of residence or type of NHSA insurance scheme enrollment. Agreements for all included drugs are generally renewed every two years.

In this latest update of the NRDL, the NHSA is adding or renewing over 30 Category B oncology drugs, including ELUNATE and SULANDA. Effective January 1, 2022, included NRDL drugs are expected to be made available in all state-run hospital pharmacies in China and reimbursement will commence for patients included in NHSA insurance schemes.

About fruquintinib (ELUNATE in China)
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFRs") -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

Fruquintinib is marketed in China under the brand name ELUNATE for the treatment of metastatic CRC. It is currently under clinical development for the treatment of gastric cancer and metastatic breast cancer, and in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd.) and sintilimab (TYVYT in China, IBI308, developed by Innovent Biologics, Inc.). The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation for the development of fruquintinib for treating metastatic CRC in June 2020. A Phase III registration study of fruquintinib in metastatic CRC, FRESCO-2, is currently underway in the U.S., Europe, Japan and Australia.

HUTCHMED retains all rights to fruquintinib outside of China. In China, HUTCHMED is partnered with Eli Lilly and Company. Since October 2021, HUTCHMED has been responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.

About surufatinib (SULANDA in China)
Surufatinib is a novel, oral inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

Surufatinib is marketed in China under the brand name SULANDA for the treatment of patients with advanced NETs. It is currently under clinical development in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab and toripalimab (TUOYI, developed by Shanghai Junshi Biosciences Co., Ltd.). A U.S. FDA New Drug Application (NDA) submission was accepted in June 2021, followed by a Marketing Authorisation Application (MAA) submission to the European Medicines Agency (EMA) validated in July 2021. In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic NETs in April 2020, and Orphan Drug Designation for pancreatic NETs in November 2019.

HUTCHMED currently retains all rights to surufatinib worldwide.

About savolitinib (ORPATHYS in China)
Savolitinib is an oral, potent, and highly selective MET inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.

Savolitinib is marketed in China under the brand name ORPATHYS for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.

In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.