On February 3, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, reported the initiation of its Phase 3 ENVISION study of UGN-102 (mitomycin) for intravesical solution, in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) (Press release, UroGen Pharma, FEB 3, 2022, View Source [SID1234607670]).

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ENVISION is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low-grade, intermediate-risk NMIBC. The study design is similar to the Phase 2b OPTIMA II study in that patients will have the same clinical characteristics, treatment regimen, assessment, and qualitative follow up but with different endpoints. ENVISION is expected to enroll approximately 220 patients across 90 sites. Based on discussions with the U.S. Food and Drug Administration (FDA), and enrollment expected by end of 2022, assuming positive findings, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024.

"The start of the ENVISION trial marks the final phase of validating primary chemoablation for the treatment of recurrent intermediate risk NMIBC," said Sandip Prasad, Urologist, Atlantic Health System, Morristown Medical Center, NJ, and lead study investigator for the ENVISION trial. "This study is designed to support the clinical potential of UGN-102 as a new treatment for patients that are under-served by the current standard of care, including those patients at risk for recurrence and those that are unwilling or unable to endure surgery or anesthesia."

For the new Phase 3 trial, study participants will receive 6 once-weekly intravesical instillations of UGN-102. The planned primary endpoint is the complete response rate at three months after the first instillation, and the key secondary endpoint will be durability over time in patients who achieve complete response at the three-month assessment.

"We have achieved consistent results with similar study designs in the past and believe that it increases our probability for technical and regulatory success for UGN-102 in patients with low-grade, intermediate-risk NMIBC," added Mark Schoenberg, Chief Medical Officer, UroGen. "We look forward to reporting data from ATLAS and acquiring new scientific evidence from ENVISION as we continue to explore the potential benefits of chemoablation in other types of bladder cancer, including high-grade disease and other specialty cancers."

About LG IR NMIBC

Out of the 80,000 estimated cases of bladder cancer per year in the U.S., approximately 35,000 are low-grade NMIBC patients comprised of both low-risk (approximately 15,000) and intermediate risk (approximately 20,000). These patients face a future of recurrence and additional surgeries.

Recurrence in low-grade intermediate-risk NMIBC is pervasive and often underestimated. In patients who recur, approximately 68 percent will experience two or more recurrence episodes throughout the course of their disease, a high and frequent rate in contrast to other non-metastatic cancers.

Currently, the only effective primary treatment available is a surgical procedure known as transurethral resection of bladder tumor, or TURBT. Every time TURBT is performed it imposes more burden and serious risks on patients. Approximately 25 percent of patients are not appropriate for TURBT, whether due to physical factors such as age and comorbidities or an unwillingness to undergo surgery.

On February 3, 2022 Simbec-Orion reported that Lupuzor is an in-development treatment for Lupus, a chronic inflammatory disease thought to affect around 5 million people worldwide (Press release, Simbec-Orion, FEB 3, 2022, View Source [SID1234607666]). Having recently undergone FDA approval, Lupuzor is commencing into phase 3 clinical trials.

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Simbec-Orion are proud to have been selected by ImmuPharma as a partner to conduct the international phase 3 trial of Lupuzor involving pharmacokinetic study. Phase 3 research has been granted ethic committee approval, and volunteer selection and screening is set to be conducted in December 2021.

The Lupuzor phase 3 pharmacokinetic trial aims to deliver data by the end of 2022’s first quarter, with dosing of volunteers getting underway in January 2022. This builds upon the first pivotal phase 3 Lupuzor trial completed in 2018, which assessed the drug through open label extension study.

Progress from phase 1 and 2 Lupuzor trials has been promising. ImmuPharma have taken the opportunity to improve the drug’s product characterisation and analytical method validations. As a result, research has made developments with a new proprietary synthesis of P140, resulting in greater IP protection and lower production costs.

Find out more about our clinical development services.

Lupuzor: Key Findings So Far
ImmuPharma have made significant advancements in developing a new treatment for Lupus. This drug, Lupuzor has shown potential as a treatment for Lupus during clinical research and has undergone significant testing across clinical trial phases.

Throughout clinical research stages, Lupuzor has shown strong efficacy in treating Lupus and has also demonstrated a strong safety profile. This provides promising results in the development of a new Lupus treatment, as the current standard treatment presents several side effects.

Phase 3 LupuzorTrials
As part of phase 3 Lupuzor research, Simbec-Orion partnered with ImmuPharma to complete the initial phase 3 trial. As a CRO with expertise in Lupus research, our team ran the first Lupuzor phase 3 trial, which enrolled 62 patients to complete an open label extension study.

This initial Lupuzor phase 3 trial confirmed a successful safety profile for the drug, reporting no serious side effects or reactions. These insights enabled our trial management team to commence with an optimal phase 3 trial design together with ImmuPharma.

The next stage of phase 3 Lupuzor research will involve a pharmacokinetic study, helping further evaluate the drug’s safety profile and efficacy.

Why Lupus Research is Important
Affecting an estimated 5 million people worldwide, Lupus is a chronic inflammatory, autoimmune disease that can be life threatening. Lupus can impact various parts of the body, including skin, kidneys, the brain, heart and lungs.

Diagnosis can be challenging, since Lupus can appear in several different forms and although awareness is steadily increasing, it does not have the greatest level of recognition.

As well as challenges in diagnosis, the current standard treatment for Lupus can often present adverse side effects. As well, the standard treatment has limited efficacy. As a result, there is an unmet need for an effective Lupus treatment with stronger efficacy and fewer side effects.

Partner With Simbec-Orion
Experts in clinical trial management, we’re here to support you with your clinical development. Get in touch with our expert team to find out more.

On February 3, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers, reported that the company will participate in the Guggenheim Healthcare Talks 2022 Oncology Conference (Press release, Revolution Medicines, FEB 3, 2022, View Source [SID1234607665]). Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines, will be the featured participant in a fireside chat at the event.

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Details of the company’s participation are as follows:

Guggenheim Healthcare Talks 2022 Oncology Conference
Conference Date: February 9-11, 2022
Fireside Chat Time/Date: 12:30 p.m. Pacific on Thursday, February 10, 2022
Format: Virtual conference; webcast available
To access the live webcast of the fireside chat, please visit the "Events & Presentations" page of Revolution Medicines’ website at View Source Additionally, a replay of the webcast will be available on the "Events & Presentations" page of the Revolution Medicines website for at least 14 days following the conference.

On February 3, 2022 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a research collaboration and license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to discover novel ADCs for three targets (Press release, Mersana Therapeutics, FEB 3, 2022, View Source [SID1234607662]). The agreement was facilitated by Johnson & Johnson Innovation.

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"We are very excited to enter into this collaboration with Janssen as we work to transform outcomes for patients," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "Our fully homogenous Dolasynthen platform enables both precise control of drug-to-antibody ratio (DAR) as well as the ability to vary the DAR across a broad range. Dolasynthen provides a unique opportunity to optimally design an ADC matched to a given target. We look forward to bringing both the differentiated capabilities of our Dolasynthen platform and our deep expertise in optimizing ADCs to this collaboration."

Ms. Protopapas continued, "In addition, by extending our platforms and expertise to new programs beyond our promising wholly-owned and first-in-class pipeline of ADC candidates, we see this value-driving collaboration as further strengthening our financial position as we seek to deliver important new treatments for patients living with cancer."

Under the terms of the agreement, Janssen will provide proprietary antibodies for three targets. Mersana will apply its expertise and its proprietary Dolasynthen platform to discover novel ADC product candidates. Mersana may leverage Synaffix’s GlycoConnectTM technology as its preferred site-specific ADC bioconjugation technology. Mersana will collaborate with Janssen on target candidates during preclinical development, with Janssen being solely responsible for clinical development and commercialization. Mersana will receive an upfront payment of $40 million. Mersana is eligible to receive reimbursement of certain costs as well as more than $1 billion in potential milestone payments, plus mid-single-digit to low double-digit percentage royalties on worldwide net sales of ADCs against the selected targets.

On February 3, 2022 Dewpoint Therapeutics, Inc., the biomolecular condensates company, reported the completion of a $150 million Series C financing (Press release, Dewpoint Therapeutics, FEB 3, 2022, View Source [SID1234607661]).

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The funding round was led by SoftBank Vision Fund 2, along with other new investors General Catalyst, Mubadala Capital, 3E Bioventures, Mirae Asset Capital, and NS Investment. Also joining the round were existing investors Leaps by Bayer, Polaris Partners, Samsara BioCapital, ARCH Venture Partners, EcoR1 Capital, and Maverick Ventures.

Proceeds from the financing will be used to advance multiple pipeline programs through to IND and further invest in Dewpoint’s fully integrated, multi-component biology platform as well as its artificial intelligence-driven data science platform. Dewpoint will also expand research infrastructure to support the company’s growth with over 20 pipeline programs in discovery and development spanning oncology, neuromuscular, cardiopulmonary, and virology indications.

"We are delighted to have achieved this significant milestone, which allows us to welcome several high-calibre tech and biotech investors to our existing syndicate of innovative life-science investors," said Ameet Nathwani, Dewpoint Chief Executive Officer. "This latest financing will further accelerate our goal of developing breakthrough medicines to address a vast array of diseases resulting from dysregulation of biomolecular condensates. We are extremely grateful for the commitment of our existing investors and multiple pharmaceutical alliance partners in supporting the advancement of this cutting edge field of drug discovery."

Condensates are membraneless organelles that form dynamically throughout the cell via a process called phase separation. Their behavior is governed by the concentrations of, and multivalent interactions between, proteins and nucleic acids. These subcellular compartments organize and concentrate molecules within cells enabling key biochemical processes, and drive various diseases. Through understanding condensate biology, Dewpoint has developed the ability to tackle the root cause of complex diseases and address previously undruggable targets.

Over several years, Dewpoint has invested in a digital discovery platform and state-of-the-art biological or "wet lab" methods of investigating condensate function and targeting. This includes the development of advanced AI and computer vision capabilities, proprietary data and small molecule libraries, a proprietary knowledge graph of condensates and their functional connection to disease pathology, and compounds that modulate their behavior. Such compounds are referred to by the company as c-mods, and target condensates to restore normal condensate properties and cellular function.

"Research into biomolecular condensates has unveiled whole new ways for how we can intervene and prevent life-threatening diseases", said Vikas Parekh, Managing Partner at SoftBank Investment Advisers. "We believe that Dewpoint is a leader in this emerging sector with a highly-experienced management team and partnerships with some of the largest pharmaceutical companies in the world. We are thrilled to partner with the Dewpoint team to help realize condensates’ transformative potential for drug discovery."

"These are exciting times for drug discovery and development, where breakthrough innovation is poised to drive a shift from treating symptoms to reversing the root cause of diseases," said Dr. Juergen Eckhardt, Head of Leaps by Bayer. "Dewpoint’s integration of novel biology with its AI-driven platform is charting a pathway to drive this paradigm shift. I’ve been impressed by the team’s ability to uncover new insights into the complex behavior of biomolecular condensates, and optimistic about the potential impact for patients."