On December 21, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) and Alloy Therapeutics ("Alloy"), a biotechnology company dedicated to empowering scientists in the relentless pursuit of making better medicines for all, reported that the companies have entered into a technology partnership to expand Evotec’s antibody discovery platform (Press release, Evotec, DEC 21, 2020, View Source;announcements/press-releases/p/evotec-partners-with-alloy-therapeutics-to-expand-its-antibody-discovery-platform-6010 [SID1234573189]).

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!

Under the terms of the agreement, Evotec receives access to Alloy’s ATX-Gx mouse platform to enable best-in-class in vivo discovery of fully human monoclonal antibodies for use in both its proprietary as well as partnered R&D projects across more than 15 disease areas. ATX-Gx comprises a suite of highly immunocompetent transgenic mice strains that together offer (i) fully human heavy chain repertoire, (ii) human kappa and human lambda chain repertoire, (iii) haplotype diversity, and (iv) limited immunodominance. The integration of ATX-Gx with Evotec’s existing platform capabilities in the area of antibody discovery, especially J.HALSM, Just – Evotec Biologics’ humanoid antibody library for in vitro antibody discovery, is expected to deliver numerous starting points for innovative discovery projects across indications.

With the acquisition of Just – Evotec Biologics in 2019, Evotec made a major push into biologics, and has successfully built a fully-integrated platform to drive monoclonal antibody ("mAb") programmes from concept through commercialisation. ATX-Gx adds to Evotec’s comprehensive suite of large molecule discovery tools, disease biology, state-of-the-art cell line development, machine learning design tools, manufacturing, pre-clinical IND-enabling studies, as well as FIH clinical support, and commercialisation.

Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: "Successful, fully-integrated drug discovery and development requires specific expertise as well as cutting-edge technologies and capabilities. We are delighted to be able to offer the ATX-Gx platform as an important addition to our existing world-class biologics discovery offerings."

Errik Anderson, Chief Executive Officer, Founder and Chairman of Alloy Therapeutics said: "Alloy’s mission is to make medicines through collaboration by democratizing access to foundational drug discovery platforms and services. Integrating ATX-Gx with Evotec’s broad biologics discovery capabilities will expedite the translation of therapeutic antibody programs from concept to commercialization for Evotec scientist customers."

On December 20, 2020 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) reported that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) submitted by its partner Karyopharm Therapeutics Inc. (Nasdaq: KPTI) for oral XPOVIO (selinexor, ATG-010), a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (Press release, Antengene, DEC 20, 2020, View Source [SID1234573118]). This indication was approved three months ahead of its March Prescription Drug User Fee Act (PDUFA) date based on the result of a confirmatory Phase 3 BOSTON study.

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!

XPOVIO was previously approved under the FDA’s Accelerated Approval Program for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

XPOVIO, a first-in-class and only-in-class oral SINE compound, and now the first and only drug approved by FDA for use in both multiple myeloma and diffuse large B-cell lymphoma, discovered and developed by Karyopharm, is currently being developed by Antengene, who has the exclusive development and commercial rights in certain Asia-Pacific markets, including China. In December 2020, National Comprehensive Cancer Network (NCCN) added three different XPOVIO combination regimens to its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for previously treated multiple myeloma.

Antengene has conducted two Phase 2 registrational clinical trials of XPOVIO in China for relapsed or refractory multiple myeloma (MARCH) and for relapsed or refractory diffuse large B-cell lymphoma (SEARCH). A Phase 3 randomized, controlled, open-label and multicenter BENCH trial has also received the IND approval from the National Medical Products Administration (NMPA) in China. Antengene is working on making XPOVIO commercially available in Asia Pacific regions and has submitted the New Drug Applications (NDAs) for XPOVIO to the Health Sciences Authority (HSA) of Singapore and the Australian Therapeutic Goods Administration (TGA) for three indications, including the treatment of patients with multiple myeloma who have received at least one prior therapy.

"This is the third approved indication for XPOVIO, highlighting its potential of clinical application and broad market prospects. XPOVIO offers patients with rrMM and their physicians the first oral SINE compound and makes more treatment options available to cancer patients with critical unmet medical needs." Dr. Jay Mei, M.D., Ph.D., Founder, Chairman and CEO of Antengene said, "We plan to launch XPOVIO as soon as possible for the treatment of patients with rrMM and rrDLBCL in APAC following regulatory approvals, by leveraging our established commercial infrastructure and seasoned international team."

About the Phase 3 BOSTON Study

The approval of XPOVIO in combination with once-weekly bortezomib plus low-dose dexamethasone (SVd) is supported by the results of the multi-center, Phase 3, randomized study, which evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The study was designed to compare the efficacy, safety and certain health-related quality of life parameters of once-weekly XPOVIO (selinexor) in combination with once-weekly bortezomib plus low-dose dexamethasone (SVd) versus twice-weekly bortezomib plus dexamethasone (Vd). The primary endpoint of the study was progression-free survival (PFS) and key secondary endpoints included overall response rate (ORR), rate of peripheral neuropathy, and others. Additionally, the BOSTON study allowed for patients on the Vd control arm to crossover to the SVd arm following objective (quantitative) progression of disease verified by an Independent Review Committee (IRC). The BOSTON study was conducted at over 150 clinical sites internationally.

Although the study had one of the highest proportions of patients with high-risk cytogenetics (~50%) as compared with other bortezomib-based studies in previously treated myeloma, the median PFS in the SVd arm was 13.9 months compared to 9.5 months in the Vd arm, representing a 4.4 month increase in median PFS (hazard ratio [HR] of 0.70; p=0.0075). The SVd group also demonstrated a significantly greater ORR compared to the Vd group (76.4% vs. 62.3%, p=0.0012). Importantly, SVd therapy compared to Vd therapy showed consistent PFS benefit and higher ORR across several important subgroups.

In addition, the following results favored SVd therapy as compared to Vd therapy:

SVd therapy demonstrated a significantly higher rate of deep responses, defined as ≥ Very Good Partial Response compared to Vd therapy (44.6% vs. 32.4%) as well as a longer median duration of response (20.3 months vs. 12.9 months). Additionally, 17% of patients on the SVd arm achieved a Complete Response or a Stringent Complete Response as compared to 10% of patients receiving Vd therapy. All responses were confirmed by an IRC.
Peripheral neuropathy (PN) rates were significantly lower on SVd compared to Vd (32% vs. 47%). In addition, PN rates ≥ Grade 2 were also significantly lower in the SVd arm compared to Vd (21% vs. 34%).
The most common adverse reactions were cytopenias, along with gastrointestinal and constitutional symptoms and were consistent with those previously reported from other selinexor studies. Most adverse reactions were manageable with dose modifications and/or standard supportive care. The most common non-hematologic adverse reactions were nausea (50%), fatigue (42%), decreased appetite (35%), and diarrhea (32%) and were mostly Grade 1 and 2 events. The most common Grade 3 and 4 adverse reactions were thrombocytopenia (43%), lymphopenia (38%), anemia (17%), and fatigue (13%).

About XPOVIO (selinexor, ATG-010)

XPOVIO (selinexor, ATG-010), a first-in-class and only-in-class oral selective inhibitor of nuclear export compound discovered and developed by Karyopharm, is currently being developed by Antengene, who has the exclusive development and commercial rights in certain Asia-Pacific markets, including China. In July 2019, the US Food and Drug Administration (FDA) approved Selinexor (XPOVIO) in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor (XPOVIO) as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with a request for conditional approval of selinexor (XPOVIO) in this same rrMM indication. On December 18, 2020, the supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA. Selinexor (XPOVIO) is so far the first and only oral SINE compound approved by the FDA. Selinexor (XPOVIO) is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase 3 randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral selinexor (XPOVIO) versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO study of selinexor (XPOVIO) in patients with endometrial cancer passed planned interim futility analysis and that Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned without any modifications. Top-line SIENDO study results are expected in the second half of 2021.

Antengene is conducting two registrational Phase 2 clinical trials of selinexor (XPOVIO) in China for relapsed refractory multiple myeloma (MARCH) and for relapsed refractory diffuse large B-cell lymphoma (SEARCH), and has initiated clinical trials for high prevalence cancer types in the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).

On December 20, 2020 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported positive efficacy and safety results from a Phase 2a clinical study of the company’s lead drug candidate, STP705, for treatment of squamous cell skin cancer (Press release, Sirnaomics, DEC 20, 2020, View Source [SID1234573119]).

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 open label, dose escalation study was designed to evaluate the efficacy and safety of intralesional injection of STP705 in adult patients with cutaneous squamous cell carcinoma in situ (isSCC, Bowen’s disease), confirmed with biopsy samples. The objective was to determine the safe and effective recommended dose of STP705 for the treatment of isSCC, as well as to analyze biomarkers common to isSCC formation pathways including TGF-β1 and COX-2. The trial was comprised of five dose escalation cohorts ranging from 10 μg to 120 μg with five patients in each group, and a total of 25 patients were enrolled in the trial. Participants received injections of STP705 once a week for up to six weeks.

The primary endpoint of this trial was to evaluate patients for complete histological clearance of the tumor cells within the treated isSCC lesion. Based upon the analysis of the five groups, a clear dosage-dependent efficacy curve was observed with 76% of all patients (19/25) achieving the complete histologically clearance. The two optimal dosing ranges achieved 90% histological clearance of tumor cell in the lesion. The study showed promising results of key secondary endpoints. There were no significant investigational product treatment related adverse events, as well as no serious adverse events, reported in the study. Of particular importance is the fact that no significant cutaneous skin reactions were noted in the treatment groups, and the company was able to define a clear therapeutic window.

An exploratory immunohistochemistry analysis was also conducted on the pre- and post-treatment tissues from the clinical trial, to obtain evidence of the mechanism of action of this novel RNA therapeutic candidate. The analysis reported significant inhibition of the target gene, TGF-β1 and COX-2, and expression and down regulation of several key cancer related biomarkers (including Ki67, NF-kB, β-Catenin). Moreover, an increased infiltration of CD8+ and CD4+ T cells was observed in the treated tumor lesion which supports the role of TGF-β1.

"This marks a significant milestone as evidenced by the number of patients treated with STP705 for squamous cell skin cancer achieving the primary endpoint in a dose dependent manner," said Patrick Lu, Ph.D., the founder, President and CEO of Sirnaomics. "The readout not only demonstrates the potential of RNAi therapeutics in oncology, but also illustrates the safety and efficacy of polypeptide nanoparticle formulation of siRNA therapeutics. In addition, the positive gene silencing data validates TGF-β1 and COX-2 as important cancer drug targets and our dual-targeting strategy for novel RNAi cancer therapeutics. This successful clinical study result indicates that Sirnaomics is leading the charge in using RNAi drugs for anticancer therapeutics."

"This is a landmark study for Sirnaomics as we were able to achieve high rates of histological clearance, which is the gold standard for skin cancer. This was combined with an excellent safety profile and a lack of local cutaneous skin reactions, which is very important to both patients and clinicians as they look for alternatives to surgical excision of these lesions," said Michael Molyneaux M.D., Sirnaomics Chief Medical Officer. "The fact that we were able to demonstrate target gene knockdown along with reduction in important downstream biomarkers makes the results more impactful as we advance into later stage trials and prepare for potential commercialization. Sirnaomics would like to acknowledge the great work of The Center for Clinical and Cosmetic Research (CCCR), under the direction of Mark S. Nestor, M.D., Ph.D., and Brian Berman, M.D., Ph.D.

"The promise of a non-surgical, non-invasive treatment for this common non-melanoma skin cancer is a major therapeutic advancement for patient care. We have observed a high rate of clinical clearance that was dose dependent with no significant treatment related adverse events and no serious adverse events. The mechanism of action also holds significant promise in the treatment of other skin cancers as well as non-cancerous lesions. We look forward to the continuing work on this promising new therapy," said Dr. Nestor.

Based on the results of the STP705 Phase 2a trial, Sirnaomics intends to initiate a Phase 2b trial of STP705 in patients with isSCC, as well as clinical studies during the first half of 2021 for additional indications: superficial basal cell carcinoma, hypertrophic scar, keloid scarless healing and liver cancers. Detailed study results, including additional secondary endpoints, histology and biomarker details, will be submitted for presentation at upcoming medical meetings and for publication.

Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04293679.

About Non-melanoma Skin Cancer and Squamous Cell Carcinoma In Situ
Skin cancer is the most common type of all cancers diagnosed each year in the United States. It is estimated that nearly half of cancers diagnosed every year will be skin cancers. Over the past decade, the incidence of skin cancers has increased dramatically. According to the JAMA Dermatology paper (Rogers, et. al. JAMA Dermatol. 2015151(10):1081-1086), an estimated 3.3 million people in the US suffer from non-melanoma skin cancer (NMSC) along with 5.43 million people that are currently living with cancer lesions. Data on specific types of NMSC were 2.55 million cases for basal cell carcinoma (47%): 2.57 million cases for squamous cell carcinoma including squamous cell carcinoma in situ (46.7%), plus another 332,000 cases of unspecified type of skin cancers.

A World Health Organization authorized report from "International Agency for Research on Cancer" (2019) has demonstrated that the number of deaths in 2018 globally for both men and women from NMSC is 65,155, where the mortality of Asia NMSC patients represents 41.9% of the global total, significantly more than other individual areas.

Squamous cell carcinoma in situ, also called Bowen disease, is the earliest form of squamous cell skin cancer (SCC). Along with basal cell carcinoma, SCC is one of two major subtypes of NMSC. The key driver for development of SCC is ultraviolet rays from the sun. It is believed that development of SCC is linked closely to genomic perturbations, genetic mutations, and altered expression of key molecules (e.g., overexpression of TGF-β1 and COX-2) that impacts squamous cell lineage commitment and terminal differentiation.

Surgery is the currently the most common treatment option for the treatment of NMSC. The various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection and bleeding. Surgery can also have a significant recurrence rate. As a result, there is a high unmet need for an FDA approved local injection therapy that is safe and effective.

About STP705
Sirnaomics’ leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma and primary sclerosing cholangitis. Preclinical animal models using STP705 have demonstrated a dramatic improvement in T-cell penetration into tumors in the liver with single agent action as well as improvement in the efficacy of an anti-PD-L1 antibody checkpoint inhibitor in an HCC model. This effect may improve other immune checkpoint inhibitor efficacies in addition to those targeting the PD-1/PD-L1 axis.

On December 20, 2020 Autobahn Labs, a virtual incubator partnering with top academic and research institutions to catalyze early-stage drug discovery and development, reported a strategic collaboration with the University of California San Francisco (UCSF) (Press release, Evotec, DEC 20, 2020, View Source;announcements/press-releases/p/autobahn-labs-and-ucsf-announce-strategic-drug-discovery-collaboration-6012 [SID1234573156]). The organizations will partner to identify promising early science with significant therapeutic potential, forming jointly owned ventures to accelerate the translation of scientific ideas to novel therapeutics.

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!

"UCSF combines world-class medicine, cutting-edge research, and a strong track record of innovation in drug discovery," said Thomas Novak, PhD, Chief Scientific Officer of Autobahn Labs. "We’re excited to partner their great science with Autobahn Labs’ resources and capabilities to spark the development of meaningful new therapies for patients."

"The goal of Innovation Ventures is to help UCSF faculty and students transition their innovations from the lab to the marketplace, where they can do the most good," said Barry Selick, PhD, vice chancellor for business development, innovation and partnerships. "Partnering with Autobahn Labs will allow us to bridge our extensive scientific expertise with their experience in drug development to get the best therapies out there quickly for patient benefit."

The collaboration with UCSF is the second partnership announced by Autobahn Labs since the organization’s launch in June 2020, and expands the reach of the innovative partnership between Samsara BioCapital and Evotec. Samsara conceived of the unique investment model to systematically identify and build investible companies based on cutting-edge academic discoveries. The firm found a natural partner in Evotec, a company with an established track record of translating early-stage academic research to drug discovery and development through its "BRIDGE" (Biomedical Research, Innovation & Development Generation Efficiency) program. The Autobahn Labs model provides Principal Investigators with scientific and operational strategy, direct and immediate access to Evotec’s state-of-the-art drug discovery and development technologies and capabilities, and an investor syndicate with deep therapeutic expertise.

"As a virtual incubator for academic life science projects, Autobahn Labs is all about innovation efficiency," said Dr. Werner Lanthaler, CEO of Evotec SE. "With UCSF we welcome another top-tier academic institution to Autobahn Labs. By providing direct access to both our leading drug discovery and development platform as well as substantial funding, we are confident that Autobahn Labs will kick start early-stage innovation out of academia through jointly owned new ventures."

"We are thrilled to have this opportunity to bring UCSF’s renowned faculty together with Evotec’s sophisticated drug discovery infrastructure and expertise as well as an experienced network of drug developers and investors. UCSF has a wealth of compelling early-stage programs that we look forward to developing in close collaboration with their researchers," said Michelle Kim-Danely, PhD, SVP of Operations for Autobahn Labs.

On December 18, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported favorable results for the cost-effectiveness of Vicineum based on an independent analysis issued by ICER in its final report published on December 17, 2020 (Press release, Sesen Bio, DEC 18, 2020, View Source [SID1234573078]).

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!

ICER is the leading Health Technology Assessment body in the United States, and is an independent non-profit, research organization that conducts assessments to examine the clinical and economic value of health care innovations such as prescription medications.

The final report used publicly available clinical data from the Company’s Phase 3 VISTA trial, and focused on adults with BCG-unresponsive, high-risk non-muscle invasive bladder cancer (NMIBC), including those with Carcinoma in situ, as well as those with high-risk Papillary (Ta/T1) disease.

The ICER report states that for many patients with NMIBC that is unresponsive to BCG, there are limited treatment options that are bladder preserving. As a potential treatment option for patients with NMIBC, the report describes Vicineum as demonstrating Complete Response and Recurrence-Free Survival rates that appear to be greater than would be expected, based on historical data, with few serious adverse events and low discontinuation rates.

The majority of the ICER Council (8 yes votes; 3 no votes) judged that the evidence was adequate to demonstrate that the net health benefit of Vicineum is superior to that of best supportive care.

The report estimates that treatment with Vicineum results in an additional per-patient cost of approximately $123,000 in year one — with net savings in the following years, leading to a decline in cumulative health care costs, compared to usual care, of approximately $101,000 by year five.

"We are very pleased with the final ICER report and found the entire process to be transparent, evidence-based and professional," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "The findings in the ICER report give us confidence in the value and cost-effectiveness of Vicineum. It is our goal to bring Vicineum to market to improve patient outcomes while reducing health care costs. The ICER report is very encouraging in that regard, and we look forward to working physicians, patients and payers to make that goal a reality."

The full report, including relevant disclaimers and assumptions, can be accessed at the following link: View Source

The Company is on track to complete and submit its Biologics License Application for Vicineum to the FDA by next week.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk 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 conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. 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. 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.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the sixth most commonly diagnosed cancer in the United States, and approximately 80 percent of patients have non-muscle invasive bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and more than 60 percent of all patients diagnosed with NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.