On July 20, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and its partner in Greater China, Qilu Pharmaceutical, reported that the first patient has been enrolled in China in the clinical trial to assess the efficacy and safety of Vicineum in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, Sesen Bio, JUL 20, 2021, View Source [SID1234584983]). The milestone comes only four months after the Investigational New Drug (IND) application for Vicineum was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which triggered a $3M milestone payment from Qilu Pharmaceutical, the first of $23M in potential milestone payments to Sesen Bio.

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"The enrollment of the first patient in the clinical trial in China is a significant milestone in realizing our mission to save and improve the lives of patients globally," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Qilu Pharmaceutical has strong clinical and regulatory experience, and we are encouraged by the speed in which Qilu Pharmaceutical is moving forward with its clinical and regulatory efforts. We look forward to working closely with Qilu Pharmaceutical in the coming months as we continue to make progress in bringing Vicineum to market in China."

"We continue to believe in the differentiated clinical profile of Vicineum and its potential to address a significant unmet need in the treatment of BCG-unresponsive NMIBC in the Greater China region," said Oliver Kong, M.D., chief medical officer and corporate vice president of Qilu Pharmaceutical. "We look forward to completing enrollment of the trial, and to working with the NMPA to potentially bring Vicineum to market to make a meaningful impact on the lives of patients."

The open-label, single-arm, multi-center bridging trial will evaluate the efficacy and safety of Vicineum in approximately 53 patients with carcinoma in situ (CIS) with or without papillary disease, high-grade Ta papillary disease or T1 papillary disease of any grade. Patients will be required to have failed previous treatment with BCG for inclusion in the trial. The primary endpoints are the complete response rate (for CIS patients) and the recurrence-free rate (for papillary patients) at six months, with the complete response rate and the recurrence-free rate at three months, safety and tolerability as the secondary endpoints. Based on the partnership agreement between Sesen Bio and Qilu Pharmaceutical, the trial is being run at the sole cost of Qilu Pharmaceutical.

Assuming a successful trial, Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in China in 2022, with potential approval expected in 2023. Sesen Bio believes China represents a large potential market for Vicineum, with unadjusted peak year sales estimated at $155M-$418M.

In the US, the Company believes it remains on track for an FDA decision on its Biologics License Application for Vicineum by the target PDUFA date of August 18, 2021.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On July 20, 2021 AmerisourceBergen (NYSE: ABC), Cardinal Health (NYSE: CAH) and McKesson (NYSE: MCK) reported that they have agreed to pay up to $1.179 billion in a settlement with the State of New York and its participating subdivisions, including Nassau and Suffolk Counties, to resolve opioid-related claims (Press release, Cardinal Health, JUL 20, 2021, View Source [SID1234584967]). This settlement was negotiated in connection with the ongoing negotiations toward a broad resolution under the previously disclosed settlement framework intended to resolve claims brought by other states, counties and other political subdivisions. The companies view today’s settlement as an important step toward finalizing a broad settlement with states, counties, and political subdivisions. If the broad settlement is reached, New York and its participating subdivisions will become part of that broader agreement.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

This settlement reflects an agreement of the plaintiffs to dismiss the cases, which are currently being tried, in exchange for the distributors’ agreement that New York and its participating subdivisions will receive a settlement amount consistent with their allocations under the broad settlement framework, as well as certain attorneys’ fees and costs.

While the companies strongly dispute the allegations at issue in the trial, they believe this resolution will allow the companies to focus their attention and resources on the safe and secure delivery of medications and therapies while delivering meaningful relief to affected communities, and will also support efforts to achieve a broad resolution under the previously disclosed framework.

The distributors remain deeply concerned about the impact the opioid epidemic is having on communities across the nation and remain committed to being part of the solution.

On July 20, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company for ADX-2191 (methotrexate for intravitreal injection) for the treatment of primary vitreoretinal lymphoma (PVRL) (Press release, Aldeyra Therapeutics, JUL 20, 2021, View Source [SID1234584985]). There are no approved treatments for PVRL, a rare, aggressive, high-grade cancer that affects approximately 2,800 people in the United States, with approximately 600 new cases diagnosed annually.

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"PVRL is an often fatal cancer that creates unique challenges for diagnosis and treatment," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "The FDA’s orphan drug designation fosters an important clinical development and commercialization pathway for ADX-2191, which represents the first methotrexate preparation specifically formulated for intraocular injection. The designation is another important step forward for our retinal disease program, complementing our ongoing clinical development of ADX-2191 for the prevention of proliferative vitreoretinopathy, the leading cause of failure of retinal reattachment surgery."

The FDA’s orphan drug designation program is designed to provide financial incentives to sponsors for developing drugs and biologics for rare diseases and conditions, in part defined as affecting fewer than 200,000 people in the United States. Sponsors of designated orphan drugs are eligible for tax credits for clinical trial costs, waiver of the user fee for marketing applications and, upon approval, consideration for seven years of marketing exclusivity.

About ADX-2191

ADX-2191 (methotrexate for intravitreal injection) inhibits dihydrofolate reductase, an enzyme involved in cellular replication and activation. Methotrexate is the most commonly used intravitreal medication for the treatment of PVRL. ADX-2191 was previously granted orphan drug status and fast track designation by the FDA for the prevention of proliferative vitreoretinopathy, a rare but serious sight-threatening retinal disease with no approved treatment.

On July 20, 2021 Paragon Therapeutics, a biotechnology company dedicated to discovering and developing best-in-class antibodies for a range of human diseases, reported a joint venture with FairJourney Biologics S.A. (FJB) and IONTAS Limited (IONTAS), leaders in the discovery and optimization of VHH fully human antibodies. Founded in 2021 by Fairmount Funds Management LLC ("Fairmount"), the joint venture will harness IONTAS’ proprietary mammalian display technology and explore diverse panels of novel antibody candidates with the potential to advance wholly owned candidates into the Paragon Therapeutics discovery pipeline.

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"Through Fairmount, we are excited to establish and advance the joint venture with FairJourney Biologics, a true innovator in antibody discovery," said K. Evan Thompson, PhD., Chief Operating Officer, Paragon Therapeutics. "We look forward to partnering our skills with the capabilities of FJB/IONTAS to identify potential next-generation candidates, which serves as an important step forward in fueling our pipeline of best-in-class antibody therapies."

Under the terms of the agreement, FJB and IONTAS will provide Paragon Therapeutics with access to IONTAS’ novel mammalian display technology to generate a range of therapeutic antibody leads while selecting for key attributes with the potential to address clinically proven targets in novel ways. The collaboration will also provide a dedicated full-time FJB/IONTAS team assigned to the project.

"We are excited to collaborate with Paragon Therapeutics in the joint venture to discover novel, best-in-class antibody therapies," said Dr. António Parada, Chief Executive Officer, FairJourney Biologics and IONTAS. "Our cutting-edge mammalian display technology enables the identification of untapped applications to generate a diverse panel of antibodies with the goal of reaching patients in need."

On July 20, 2021 Cerus Corporation (Nasdaq: CERS) reported that its second quarter 2021 financial results will be released on Tuesday, August 3, 2021, after the close of the stock market (Press release, Cerus, JUL 20, 2021, View Source [SID1234584968]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 6554004. The replay will be available approximately three hours after the call through August 17, 2021.