On July 20, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer, reported that it will host a key opinion leader webinar on Tuesday, July 27, 2021, at 8 am Eastern Time (Press release, Infinity Pharmaceuticals, JUL 20, 2021, View Source [SID1234584965]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The webinar will provide updates on the MARIO-3 TNBC and MARIO-275 UC clinical studies, both of which add eganelisib to approved standard of care regimens. MARIO-3 is a Phase 2 triplet combination study evaluating the addition of eganelisib to the approved standard of care combination of Tecentriq and Abraxane in the front-line setting in TNBC. MARIO-275 is a randomized, controlled Phase 2 combination study evaluating the addition of eganelisib to the approved standard of care Opdivo monotherapy in the second line setting for immune-oncology naïve UC patients who have progressed on a platinum therapy.

The webinar will feature a presentation by Erika P. Hamilton, M.D. of Sarah Cannon Research Institute at Tennessee Oncolgy, of updated data from MARIO-3 in the context of the current standard of care. Dr. Hamilton presented initial MARIO-3 TNBC data at the 2020 San Antonio Breast Cancer Symposium in December 2020 and will be available to answer questions following the formal presentation.

Brian Schwartz, M.D., Consulting Chief Physician of Infinity, will present a status update on eganelisib in UC that builds upon the initial data from MARIO-275 Phase 2 study in second line patients with UC, which he presented at the 2021 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February 2021 and will be available to answer questions following the formal presentation.

To register for the webinar, please click here.

Dr. Hamilton joined Sarah Cannon as investigator, drug development and women’s cancer in 2013. Her responsibilities include overseeing the breast cancer research program as well as caring for patients with breast and gynecologic cancers in the clinic. After receiving an undergraduate degree from Washington and Lee University in Virginia, Dr. Hamilton completed her medical degree and residency from University of North Carolina in Chapel Hill. She received her fellowship training in hematology and oncology from Duke University in Durham, North Carolina, where she was recognized as a Top 5 Finalist for Duke’s Annual House staff Fellow Teaching Award. Dr. Hamilton is board certified in internal medicine and oncology.

Dr. Brian Schwartz has more than a decade of experience as a drug development expert in pharmaceutical and biotechnology industries, spanning several therapeutic areas including oncology, dermatology, neurology and rare diseases. In senior leadership roles at ArQule, Ziopharm, Bayer and Leo Labs, Dr. Schwartz has accumulated a number of successful New Drug Applications (NDA), numerous Investigational New Drug (IND) applications, preclinical and clinical drug development programs. During his time in biotech, Dr. Schwartz acquired knowledge of investors relations, partnering and capital raising. Currently, Dr. Schwartz is an advisor for California Institute of Regenerative Medicine, numerous biotech companies and board member of LifeSci Acquisition Corp. Dr. Schwartz qualified as a medical doctor in South Africa followed by additional fellowship training in Canada.

On July 20, 2021 Pacira BioSciences, Inc. (NASDAQ:PCRX) reported that it will report its second quarter financial results before the open of the U.S. markets on Tuesday, August 3, 2021 (Press release, Pacira Pharmaceuticals, JUL 20, 2021, View Source [SID1234584982]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To participate in the conference call, dial 1-877-845-0779 and provide the passcode 9991311. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 9991311. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

On July 20, 2021 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that it will report financial results for the quarter ended June 30, 2021, and provide a corporate update on Tuesday, August 3, 2021, after the close of the market (Press release, Aptose Biosciences, JUL 20, 2021, View Source [SID1234584966]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference Call & Webcast:

The live conference call can also be accessed through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the year and quarter ended June 30, 2021 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.