On July 26, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that it has completed its commercial build phase in preparation for the anticipated launch of Vicineum, if approved, in the US, and has advanced to the implementation phase that will focus on executing the Company’s commercial strategy for Vicineum. The Biologics License Application (BLA) for Vicineum, the Company’s lead program, is currently under Priority Review with the Food and Drug Administration (FDA) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in the US, with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021.

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"We are thrilled to have this experienced commercial team on board at Sesen Bio to build capabilities as we approach the potential commercial launch of Vicineum in the US market," said Patricia Drake, chief commercial officer of Sesen Bio. "They have made incredible progress across the core functions of sales, marketing and market access. We also believe our network of Urology and Uro-oncology KOL speakers will play an integral role in allowing us to educate their peers about Vicineum, which we believe will be a new tool in their practices to serve a large unmet medical need in NMIBC."

The Company has completed the hiring of ~25 talented internal employees to support the Company cross-functionally, as well as the hiring of 34 of 35 sales representatives as part of the contract sales organization, which will be deployed across four customer-centric regions and will target approximately 2,000 high-prescribers of BCG to drive awareness, trial and adoption of Vicineum for the treatment of BCG-unresponsive NMIBC. If approved, promotional efforts will begin immediately, and the Company expects Vicineum product to be commercially available to physicians and patients in the fourth quarter of 2021.

In addition to building its sales force, as part of Sesen Bio’s national speaker programs, the Company has identified and commenced training of 14 KOL speakers to engage physicians and educate them on Vicineum for the treatment of BCG-unresponsive NMIBC.

Upon product availability, the Company will utilize a two-pronged market access strategy to ensure maximum coverage for Vicineum. The Company anticipates strong product reimbursement achieved through the deployment of a focused team of National Account Executives (NAEs) who will call on key commercial and Medicare payers. The Company will also provide support to eligible patients with a reimbursement services and support center, which will help with benefit investigation, prior authorizations, a co-pay assistance program, and any other support resources they may require along their journey.

The Company believes it remains on track for an FDA decision on its BLA for Vicineum by the target PDUFA date 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 to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design 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 26, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the Company will be presenting initial data from the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene’s Ltd.’s anti-PD-1 antibody, with or without chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held virtually on September 16-21, 2021 (Press release, Leap Therapeutics, JUL 26, 2021, View Source [SID1234585192]). The Company plans to host a conference call on Thursday, September 16, 2021 to further discuss the data.

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"We are pleased to have the opportunity to share initial data from the DisTinGuish study at ESMO (Free ESMO Whitepaper) in September," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We are encouraged by the potential DKN-01 has to improve response rates as part of first-line therapy for gastric and gastroesophageal junction cancer patients, particularly those patients whose tumors express high levels of DKK1, and look forward to providing additional details at this year’s congress."

Leap Presentation Details:

Title: DKN-01 in combination with tislelizumab and chemotherapy as a first-line therapy in unselected patients with advanced gastroesophageal adenocarcinoma (GEA): DisTinGuish Trial
Abstract Number: 2218
Session type: E-Poster Presentation
Presenter: Samuel J. Klempner, Harvard Medical School
Date and time: Thursday, September 16, 2021; 2:30 a.m. ET

About the DisTinGuish Study

The DisTinGuish study (NCT04363801) is a Phase 2a, non-randomized, open-label, multicenter study of DKN-01 in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in adult patients with inoperable, locally advanced gastric or gastroesophageal junction cancer G/GEJ) adenocarcinoma. The study, which is being conducted in two parts in the United States and the Republic of Korea, completed enrollment of 25 patients with first-line G/GEJ cancer in April 2021 and will enroll up to 48 patients with second-line G/GEJ cancer whose tumors express high levels of DKK1. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

On July 26, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that BRUKINSA (zanubrutinib) has been approved by Health Canada for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (Press release, BeiGene, JUL 26, 2021, View Source [SID1234585191]). This is the second approval for BRUKINSA in Canada, following its initial approval in March 2021 for adult patients with Waldenström’s macroglobulinemia (WM).

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"BRUKINSA was specifically designed by BeiGene scientists to provide deep and durable responses for patients with hematologic malignancies, while also reducing the frequency of certain off-target side effects seen with first-generation BTK inhibitors. Today’s approval in Canada for patients with MCL follows its approval for patients with WM earlier in the year, where Canada was the first country to grant approval for BRUKINSA in patients with WM," said Jane Huang, M.D., Chief Medical Officer, Hematology, BeiGene. "We are excited to continue working with patients and physicians in Canada, as well as in other markets, as part of our broad clinical development program for BRUKINSA investigating eight indications in over 25 clinical trials, with more than 3,100 patients participating."

"For many patients treated with previously approved BTK inhibitors for MCL, adequate responses are not achievable, or they can be forced to discontinue treatment early due to side effects. Today, we have a new option for our adult patients in Canada who have received one prior systemic or targeted therapy and are living with MCL, an aggressive blood cancer that is often diagnosed at a more advanced stage," said John Kuruvilla, M.D., FRCPC, Associate Professor of Medicine at the University of Toronto and Clinical Investigator at the Princess Margaret Cancer Centre in Toronto.

"The approval of BRUKINSA as a second line therapy is positive news for patients undergoing treatment for mantle cell lymphoma," said Antonella Rizza, Chief Executive Officer at Lymphoma Canada. "Expanded treatment options have the potential to transform the patient experience and provide hope to people living with a mantle cell diagnosis."

The Health Canada approval for BRUKINSA in MCL is based on efficacy results from two single-arm clinical trials. Across both trials, as assessed by independent review committee (IRC) per 2014 Lugano Classification BRUKINSA achieved an overall response rate (ORR) of 84%, defined as the combined rate of complete responses (CRs) and partial responses (PRs).

In the multicenter Phase 2 trial of zanubrutinib in patients with relapsed or refractory (R/R) MCL BGB-3111-206 (NCT03206970), with a median follow-up time of 18.5 months, the ORR was 84% (95% CI: 74, 91), including 69% CRs (FDG-PET scan required) and 15% PRs; the median duration of response (DoR) was 19.5 months (95% CI: 16.6, NE). In the global Phase 1/2 trial BGB-3111-AU-003 (NCT02343120), with a media follow-up time of 18.8 months, the ORR was 84% (95% CI: 67, 95), including 25% CRs (FDG-PET scan not required) and 59% PRs; the median DoR was 18.5 months (95% CI: 12.6, NE).

Of the 118 patients with MCL who received at least one prior therapy and received BRUKINSA treatment, 13.6% of patients discontinued treatment due to adverse events in the trials, with the most frequent being pneumonia (3.4%). Adverse events leading to dose reduction occurred in 3.4% of patients, including hepatitis B, neutropenia, allergic dermatitis, and peripheral sensory neuropathy (in one patient each).

The overall safety profile of BRUKINSA is based on pooled data from 779 patients with B-cell malignancies treated with BRUKINSA in clinical trials. The most common adverse reactions (≥10%) with BRUKINSA were neutropenia, thrombocytopenia, upper respiratory tract infection, anemia, rash, musculoskeletal pain, diarrhea, cough, contusion, pneumonia (grouped terms), urinary tract infection, hemorrhage (grouped terms), and hematuria. Overall, 18% of patients experienced serious adverse reactions. The most frequent (≥2%) serious adverse reactions were pneumonia (10.0%) and hemorrhage (2.1%).

The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.

BRUKINSA is available in Canada for the treatment of MCL and Waldenström’s macroglobulinemia through the myBeiGene patient support program, established to support patients, caregivers, and health care providers.

About Mantle Cell Lymphoma (MCL)
Mantle cell lymphoma is a B-cell non-Hodgkin lymphoma (NHL). It develops in the outer edge of a lymph node called the mantle zone. Mantle cell lymphoma occurs more often in men than in women. It is usually diagnosed in people in their early 60s.i Approximately one out of 200,000 individuals per year are diagnosed with MCL.ii MCL usually has a poor prognosis, with a median survival of three to four years, and is often diagnosed at a later stage of disease.iii

About BRUKINSA (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

About myBeiGene Patient Support Program
The myBeiGene patient support program is designed to support patients, caregivers, and healthcare providers with access to BRUKINSA. It goes beyond financial assistance support to provide patients and caregivers with education about their disease and treatment with BRUKINSA, as well provide practical and emotional support by connecting them to third-party resources that can address their individual needs. Oncology Nurse Advocates are available Monday through Friday from 8 a.m. to 5 p.m. Eastern Time at 1-833-234-4366.

BeiGene Oncology
BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

On July 26, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported that Interim CEO and Chief Operating Officer, Brian Leuthner, and Senior Vice President, Chief Clinical Development Officer, Sandra Aung, Ph.D., will participate in a fireside chat at the BTIG Virtual Biotechnology Conference being held Monday, August, 9th – Tuesday, August 10th, 2021 (Press release, OncoSec Medical, JUL 26, 2021, View Source [SID1234585190]).

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BTIG Virtual Biotechnology Conference
Date: Monday, August 9th
Time: 2:00pm ET

For those not attending, a replay of the presentation will be available until the end of the conference on the BTIG conference website. Must be a BTIG client to attend and access the replay.

On July 26, 2021 INOVIO (NASDAQ: INO) reported that second quarter 2021 financial results will be released after the market close on August 9, 2021 (Press release, Inovio, JUL 26, 2021, View Source [SID1234585189]). Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update regarding its DNA Medicines Platform, including the company’s ongoing vaccine developments for COVID-19.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.