On December 1, 2021 IFM Therapeutics (IFM), a privately-held biopharmaceutical company focused on developing therapies that modulate novel targets in the innate immune system, reported that IFM Due, an IFM subsidiary company, has extended its collaboration and exclusive option agreement with Novartis to develop immunotherapies that inhibit the cGAS-STING pathway to treat a range of serious inflammatory and autoimmune diseases (Press release, IFM Therapeutics, DEC 1, 2021, View Source [SID1234596368]).

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Under the terms of the agreement that began in September 2019, Novartis will continue to make fixed payments sufficient to fully finance IFM Due’s research and development costs for the cGAS-STING program in exchange for the option to acquire the IFM Due subsidiary. Upon option exercise, IFM Due’s shareholders will be entitled to consideration in aggregate value of up to $840 million, including an upfront payment upon option closing and other contingent consideration.

"At IFM, we believe innate immune biology offers a multitude of genetically-validated, clinically-relevant targets and pathways across several therapeutic areas," said H. Martin Seidel, Ph.D., CEO of IFM Therapeutics. "The continuation of our collaboration with Novartis underscores the value and relevance of this approach. By advancing novel therapies that selectively target the cGAS-STING pathway, we have the potential to deliver powerful therapeutic options for patients with serious chronic illnesses that, to-date, have not been adequately served by existing treatments."

The cGAS-STING (cyclic GMP-AMP Synthase, Stimulator of Interferon Genes) pathway functions within the innate immune system to sense cytosolic DNA, which is a signal of cellular danger, and then triggers a STING-dependent inflammatory response. Mutations that activate this pathway can cause a variety of serious autoinflammatory and autoimmune diseases in humans that are characterized by excessive interferon/cytokine signaling, including rare diseases such as Aicardi-Goutières syndrome (AGS), STING-associated vasculopathy with onset in infancy (SAVI) and a subset of systemic lupus erythematosus (SLE). Aberrant cGAS-STING activation, such as in the setting of mitochondrial dysfunction, also underlies more common diseases such as nonalcoholic steatohepatitis (NASH), chronic obstructive pulmonary disease (COPD), age-related macular degeneration (AMD) and Parkinson’s disease.

About IFM Due

IFM Due (pronounced du-eh), a subsidiary of IFM Therapeutics, is a biopharmaceutical company developing a suite of small-molecule antagonists and inhibitors targeting aberrant inflammatory responses of the innate immune system triggered by the cGAS-STING pathway, which is believed to underlie a variety of serious diseases. The Company is developing small-molecule, orally available drug candidates to address a breadth of potential therapeutic indications, including rare, autoimmune, fibrotic, and neurodegenerative diseases.

On December 1, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with Kyprolis (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy (Press release, Halozyme, DEC 1, 2021, View Source [SID1234596366]). This approval follows Janssen’s regulatory submission to the FDA in February 2021.

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"We are pleased that Janssen received U.S. FDA approval for the ninth indication for DARZALEX FASPRO in multiple myeloma, this time in combination with Kyprolis (carfilzomib) and dexamethasone," said Helen Torley, president and chief executive officer at Halozyme. "With its three-to-five-minute subcutaneous administration, DARZALEX FASPRO is now a treatment option for a broader range of patients suffering from multiple myeloma."

The FDA approval for DARZALEX FASPRO is based on data from Janssen’s PLEIADES Study, which met its primary endpoint of overall response rate. For more information about the PLEIADES study and its findings, please view Janssen’s press release issued today.

DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

On December 1, 2021 Compass, Inc. (NYSE: COMP), a leading technology-enabled residential real estate brokerage, reported that it will participate in the following investor conferences (Press release, Compass Therapeutics, DEC 1, 2021, View Source [SID1234596365]). Robert Reffkin, Founder, Chairman, and Chief Executive Officer, and Kristen Ankerbrandt, Chief Financial Officer, will both present at:

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UBS Global Technology, Media and Telecommunications Conference on Tuesday, December 7, 2021 at 5:00 p.m. ET.
Barclays Global Technology, Media and Telecommunications Conference on Wednesday, December 8, 2021 at 12:40 p.m. ET.
Both live and replay versions of the presentations will be available under the Events & Presentations section of the Compass Investor Relations website, View Source

On December 1, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the company will present at the RBC Capital Markets Healthcare Private Company Conference, taking place virtually on December 15-16, 2021 (Press release, Sapience Therapeutics, DEC 1, 2021, View Source [SID1234596364]).

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Dr. Barry Kappel, CEO and President, will participate in a fireside chat on December 16, 2021 at 2:30 PM ET. In addition, company management will participate in one-on-one meetings with life science investors during the event.

On December 1, 2021 TOT BIOPHARM International Company Limited (TOT BIOPHARM, 1875.HK) reported its self-developed Pusintin (TAB008, bevacizumab injection) has been officially granted approval by the National Medical Products Administration ("NMPA") for marketing in mainland China (i.e., excluding Hong Kong, Macau and Taiwan regions) for the treatment of patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer and patients with metastatic colorectal cancer (Press release, Tot Biopharm, DEC 1, 2021, View Source [SID1234596363]). Pusintin is the first antibody drug of TOT BIOPHARM approved for marketing.

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Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF) which can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing angiogenesis and inducing degeneration of existing blood vessels, and inhibit tumor growth. As a broad-spectrum anti-tumor drug, bevacizumab injection has become a globally recommended standard therapy in the treatment guidelines for a variety of malignant tumors, which had abundant real-world evidence of its efficacy and safety since its entry into the market in 2004. Bevacizumab injection has currently been included in the National Medical Insurance Directory. According to the Frost & Sullivan Report, bevacizumab’s market share in China will increase to RMB 6.4 billion in 2023 and RMB 9.9 billion in 2030.

Pusintin is a biosimilar to bevacizumab injection sold under the trade name of Avastin in China. TOT BIOPHARM strictly followed the NMPA’s "Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars" and has taken rigorous and comprehensive head-to-head comparisons between Pusintin and the reference bevacizumab. The results from pharmaceutical studies, non-clinical studies, and clinical studies proved that Pusintin has similar PK characteristics with the originator drug and presents clinically equivalent with highly similarity in safety and immunogenicity.

Bevacizumab has been approved for 8 indications globally, and 6 indications in China, including mCRC, NSCLC, glioblastoma multiforme (GBM), and for the treatment of hepatocellular carcinoma (HCC), ovarian cancer, and cervical cancer. According to the "Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars", Pusintin will be eligible for application by way of extrapolation for use in all indications of Avastin approved in China.

TOT BIOPHARM has established large-scale commercial production base in Suzhou Industrial Park that meets international standards, covering an area of 50,000 square meters with a capacity of monoclonal antibodies reaches 20,000L until the first half of 2022. Pusintin adopts the self-developed Perfusion-batch mixed culture technology (PB-Hybrid Technology) for commercial production. This technology has been verified in the production of Phase III clinical drugs, which can simplify the process and shorten the production cycle, reduce production costs, and greatly improve the cost advantage of Pusintin.

Dr. Liu Jun, CEO of TOT BIOPHARM, said, "We are very pleased for the Pusintin ‘s marketing approval of NMPA, which can provide high-quality and affordable treatment options for more cancer patients. This is really a key milestone for TOT BIOPHARM. Meanwhile, it has once again verified the superiority of our one-stop innovative drug R&D and production platform. By virtue of our highly competitive commercial production platform and technology platform, we will constantly accelerate the implementation of innovative achievements and improve the availability of medicines, and let the achievements of national medicine benefit more patients."