On May 12, 2021 IMV Inc. (the "Company" or "IMV") (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported its financial and operational results for the first quarter ended March 31, 2021 (Press release, IMV, MAY 12, 2021, View Source [SID1234579812]).

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"We remain focused on our commitment to provide effective and well-tolerated immunotherapies for patients with difficult-to-treat cancers. Clinical programs with our lead immunotherapy are progressing as expected, and we are pleased that maveropepimut-S will soon be evaluated in subjects with HR+/HER2- breast cancer, another unmet medical need," announced Fred Ors, Chief Executive Officer at IMV. "We are reaching another milestone as our second immunotherapy, DPX-SurMAGE, is entering into a clinical trial in patients with bladder cancer later this year with the support of a C$1.8M grant. Also, we will now benefit from the expertise of two new board members who are recognized strategic thought leaders in immuno-oncology."

Clinical Programs

Maveropepimut-S: Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")

Following the results of the SPiReL study presented at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting in November, the Company announced in April that it has entered into an agreement with Merck (NYSE: MRK) to initiate a Phase 2B clinical trial to evaluate its lead compound, maveropepimut-S in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy in r/r DLBCL. The study is expected to begin in Q2.

Maveropepimut-S: Phase 2 DeCidE1 Study in Advanced, Recurrent Ovarian Cancer

IMV is currently analyzing translational data with the goal of identifying markers of activity to inform future development and to finalize the design of our Phase 2B trial.

Maveropepimut-S: Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

Enrollment continues for subjects with metastatic bladder cancer, liver cancer (hepatocellular carcinoma, HCC), and for the microsatellite instability high (MSI-H) tumors. IMV intends to provide a clinical update on the trial in the second half of this year.

Maveropepimut-S with Standard of Care, with/without Radiotherapy, or Cyclophosphamide in Breast Cancer

This investigator-initiated clinical study will be conducted at the Providence Cancer Institute in Portland, Oregon. It is a three-arm Phase 1b trial designed to assess the combination of maveropepimut-S plus standard-of-care aromatase inhibitor with/without radiotherapy or CPA prior to surgery. Across the three arms of this study, IMV’s lead compound will be evaluated in 18 subjects with resectable, non-metastatic HR+/HER2 high breast cancer.

The Hormone Receptive (HR+) and HER2 negative (HER2-) is the most common form of breast cancer representing more than 70% of all cases. Investigators at Providence have identified ki67 as a prognostic marker of resistance to treatment that is associated with the upregulation of survivin expression. Targeting survivin with maveropepimut-S T cell therapy in this population represents a promising approach that will be tested in the study.

This investigator-initiated clinical study is expected to begin during Q3 2021.

DPX-SurMAGE, a First-in-Human Dual T Cell Therapy for Bladder Cancer

This IMV-sponsored trial will be led by Yves Fradet, M.D., professor of surgery and researcher in cancer immunotherapy at le Centre de recherche du CHU de Québec-Université Laval and his team, in collaboration with IMV’s team.

Both survivin and MAGE-9 have been associated with a poorer prognosis in bladder cancer and represent promising therapeutic targets to improve outcomes. Dr. Fradet’s team identified immunogenic peptides of the MAGE protein family member A9 (MAGE-A9), a protein which is frequently expressed in various human cancers including bladder, lung, and kidney. These peptides will then be combined with selected immunogenic peptides from the survivin protein. Researchers believe that the formulation of MAGE-A9 and survivin peptides with the DPX platform can generate a sustained, dual targeted T cell response that has the potential to destroy tumors with limited off-target events. Dr. Fradet and his team will evaluate DPX-SurMAGE in an initial clinical application in non-muscle invasive and muscle invasive bladder cancer.

IMV and the CHUQ have successfully completed preclinical evaluations which support the clinical development of DPX-SurMAGE in two distinct Phase 1 studies:

DPX-SurMAGE with or without CPA prior to transurethral resection of recurrent low-grade or high-grade non-muscle invasive bladder cancer
DPX-SurMAGE, CPA and anti-PD-1 for the treatment of muscle invasive bladder cancer prior and after cystectomy.
Based on the current timeline, IMV anticipates that the Phase 1 clinical study will be initiated in subjects with non-muscle invasive cancer in the second half of this year.

DPX-COVID-19: A DPX-Based Vaccine Candidate Against SARS-CoV-2

Due to the evolution of the regulatory landscape and at the request of the Canadian regulatory authorities the Company is currently conducting complementary preclinical studies, including evaluating the impact of new variants, and will provide an update once these preclinical studies are completed.

Changes in Board of Directors and Management

Appointment of Mr. Kyle Kuvalanka to the Board of Directors

IMV recently announced the appointment of Mr. Kyle Kuvalanka to the Board of Directors on April 1, 2021. Bringing over 20 years of experience as a senior leader in the biopharmaceutical industry, Mr. Kuvalanka has a successful track record in forming and negotiating strategic collaborations, leading financings, facilitating strategy development, as well as building and directing business and finance functions. Currently, Mr. Kuvalanka serves as Chief Financial Officer and Chief Operating Officer at Goldfinch Bio, a kidney precision medicines company.

Appointment of Dr. Michael Kalos to the Board of Directors

On May 11, 2021, IMV also announced the appointment of Michael Kalos, Ph.D. to its Board of Directors effective May 11, 2021. Dr. Kalos is an internationally recognized expert in T cell therapy and immunotherapy. He brings over 25 years of experience and expertise in cell therapy and immuno-oncology. In his career, Mr. Kalos served as Vice President of Immuno-oncology and Oncology Cell Therapies at Janssen and as Chief Scientific Officer of immuno-oncology at Eli Lilly.

Wayne Pisano, who has served on IMV’s Board of Directors since October 2011, retired at the end of the quarter. James Hall will be retiring from the Board of Directors after the annual general meeting in June 2021. James served as a board member for more than 11 years. Andy Sheldon, Board Chairman of IMV, commented: "We are very grateful to Wayne and James for more than 10 years of dedicated service to IMV. On behalf of my fellow board members and IMV’s management team, I would like to thank them for their long service and important contribution to the Company."

Departure of Dr. Joanne Schindler

Dr. Joanne Schindler gave her resignation as Chief Medical Officer (CMO) for personal reasons, effective June 11, 2021. Over the next weeks, Dr. Schindler will transition responsibilities while remaining fully empowered in her role as IMV’s Chief Medical Officer. The Company is actively working with a recruitment firm to hire a new CMO who will drive maveropepimut-S towards registration. Fred Ors, CEO, commented: "We thank Joanne for her contribution during her tenure and wish her the best in the future."

Overview of First quarter 2021 Financial Results

All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).

As of March 31, 2021, the Company had cash and cash equivalents of $30.5 million and working capital of $31.6 million, compared with $36.3 million and $35.6 million, respectively as of December 31, 2020. Based on its current operating plan and not considering the $47.7 million remaining under the $50 million At-The-Market facility executed in October 2020, IMV expects its current cash position will be sufficient to fund operations until Q1 2022.

Research and development expenses were $4.7 million for the three months ended March 31, 2021 compared with $5.1 million for the three months ended March 31, 2020. This decrease of $400,000 was mainly due to a decrease in expenses related to the ongoing basket trial and the timing of manufacturing activities for DPX-Survivac and DPX-SurMAGE, partly offset by an increase in personnel costs due to an increase in headcount, and pre-clinical development of DPX-COVID-19, which was offset by the increase in government assistance described below.

General and administrative expenses were $3.2 million for the three months ended March 31, 2021 compared with $2.3 million for the three months ended March 31, 2020. This increase of $900,000 was mainly attributable to an increase in insurance premium following rate increases in mid-2020.

Government assistance totaled $1.2 million for the three months ended March 31, 2021 compared with $415,000 in Q1 2020. This increase is mainly explained by various government grants for the development of DPX-COVID-19, reimbursed for eligible development expenditures incurred to date.

The net loss and comprehensive loss of $7.0 million ($0.10 per share) for the three months ended March 31, 2021 was $200,000 lower than the net loss and comprehensive loss of $7.2 million ($0.14 per share) for the three months ended March 31, 2020.

As of May 11, 2021, the number of issued and outstanding common shares was 67,795,933 and a total of 5,072,928 stock options, warrants and deferred share units were outstanding.

The Corporation’s audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2020 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar as well as the Company’s website at View Source

Selected Upcoming Milestones

Maveropepimut-S

Q2 2021: Beginning of Phase 2B DLBCL trial
Q2 2021: Translational and biomarker clinical update for ovarian cancer
Q3 2021: Initiation of investigator-led study in breast cancer
H2 2021: Meeting with FDA and final design for next clinical study in ovarian cancer
H2 2021: Clinical update basket trial
H1 2022: Clinical update Phase 2B DLBCL trial
DPX-SurMAGE

H2 2021: Initiation of a Phase 1 clinical study in bladder cancer
Conference Call and Webcast Information

Management will host a conference call and webcast today May 12, 2021 at 8:00 a.m. ET. Investment professionals are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 9284231

Other interested parties can access the live audio webcast at this link: View Source

On May 12, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for a Phase III clinical trial designed to evaluate the safety and efficacy of selinexor (XPOVIO) in the treatment of advanced or recurrent endometrial cancer (the SIENDO trial) (Press release, Antengene, MAY 12, 2021, View Source [SID1234579828]).

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Endometrial cancer is a common gynecologic malignancy which frequently occurs in women of reproductive age. With a high incidence rate that has continued to rise in recent years, endometrial cancer has become the most prevalent malignancy of the female reproductive tract. Pregnancy, obesity, diabetes and reproductive system diseases are the main risk factors for endometrial cancer[1]. There is a lack of treatment options and curative care for patients with advanced or recurrent endometrial cancer, so effective novel treatments are increasingly important.

Selinexor (XPOVIO) is an US Food and Drug Administration (FDA) approved oral selective inhibitor of nuclear export that has been included in five regimens recommended by the National Comprehensive Cancer Network (NCCN) Guidelines and multiple regimens recommended by the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines, for the treatment of multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL). Selinexor inhibits XPO1, the only clinically proven nuclear export protein target. Based on its unique mechanism of action, selinexor can be combined with various other drugs in order to potentially enhance efficacy. The SIENDO trial is a global trial being conducted at over 80 centers across North America, Europe and Asia.

"This IND approval for selinexor in China marks a major milestone in achieving our mission to transform patients’ lives," said Dr. Jay Mei, founder, Chairman and CEO of Antengene. "The successful initiation of the SIENDO trial is a further step in helping us to explore additional solid tumor indications for the drug candidate. We believe that selinexor has the potential to play an important role in improving treatment options for patients with endometrial cancer. We look forward to working with sites and our partners to execute this trial. If data are positive, we will soon make this innovative therapy available to patients in China and around the world."

[1] Reference: Qingliang ZENG, China Maternal and Child Health,2021,36(08),1723-1725 DOI:10.19829/j.zgfybj.issn.1001-4411.2021.08.006

About Selinexor (XPOVIO)

Selinexor, a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, selinexor also received FDA approval as a combination treatment for multiple myeloma after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with rrMM or rrDLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with rrMM.

Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor 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 III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

Antengene is currently conducting five late-stage clinical trials of selinexor for the treatment of MM, DLBCL, non-small cell lung cancer, and peripheral T and NK/T-cell lymphoma. Furthermore, Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia Pacific markets including China, Australia, South Korea, and Singapore, and was granted the Priority Review status by China’s NMPA and an Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS).

On May 12, 2021 ERS Genomics Limited, which was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property co-owned by Dr. Emmanuelle Charpentier, and GenScript Biotech Corporation (GenScript), the world’s leading research reagent provider, reported a non-exclusive license agreement granting GenScript access to ERS Genomics’ CRISPR/Cas9 patent portfolio (Press release, GenScript, MAY 12, 2021, https://www.genscript.com/ers-cenomics-and-genscript-biotech-corporation-sign-crispr-cas9-license-agreement.html [SID1234580068]).

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GenScript is a global biotechnology company providing life sciences research and application products and services, with a presence in the USA, Asia-Pacific, and Europe. GenScript applies its proprietary oligonucleotide and gene synthesis technology to various fields from basic life sciences research to translational biomedical development, industrial synthetic products, and cell therapeutic solutions. The ERS Genomics license will help further strengthen the GenScript CRISPR portfolio, from providing synthetic sgRNAs, gRNA plasmids, gRNA libraries, to cell line engineering services.

ERS Genomics holds an exclusive worldwide license from co-founder and recent Nobel prize winner Dr. Emmanuelle Charpentier to the foundational intellectual property covering CRISPR/Cas9 for use as a research platform.

On May 12, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported that results of LOTIS-2, a multicenter, open-label, single-arm Phase 2 clinical trial evaluating the safety and efficacy of single-agent ZYNLONTA in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following two or more systemic treatments, have been published online in The Lancet Oncology (Press release, ADC Therapeutics, MAY 12, 2021, View Source [SID1234579762]).

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"Patients with relapsed or refractory DLBCL who have been heavily pretreated and have difficult-to-treat disease represent an urgent area of medical need that newly approved ZYNLONTA is now able to address," said Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University and lead author of The Lancet Oncology paper. "The LOTIS-2 study established that ZYNLONTA demonstrated substantial single-agent activity and produced durable responses with an acceptable safety profile in this patient population."

LOTIS-2 enrolled 145 patients, including those with high-risk characteristics for poor prognosis, such as double-/triple-hit, transformed, and primary refractory DLBCL. Key results include:

Overall response rate (ORR) was 48.3% (70/145 patients), including a 24.1% (35/145 patients) complete response rate and 24.1% (35/145 patients) partial response (PR) rate
Median time to first response, analyzed post-hoc, was 41 days
Median duration of response was 10.3 months (as of the data cut)
Durable responses in high-risk patient groups included 46.2% (6/13 patients) ORR in those who had progression after prior CAR-T therapy, 33.3% (5/15 patients) ORR in double or triple hit and 44.8% (13/29 patients) ORR in transformed DLBCL
ZYNLONTA demonstrated an acceptable safety profile. The most common Grade ≥3 treatment-emergent adverse events were neutropenia (25.5%), thrombocytopenia (17.9%), and increased gamma-glutamyltransferase (16.6%)
"We are proud to have the results of our LOTIS-2 trial published in a prestigious peer-reviewed journal," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer at ADC Therapeutics. "On the heels of the FDA approval, this further reinforces the value of ZYNLONTA as the first CD19-targeted ADC single-agent treatment for relapsed or refractory DLBCL and the potential for it to become the standard-of-care for 3L+ DLBCL patients in need of new treatment options."

The study can be found on The Lancet Oncology’s website at: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00139-X/fulltext.

About ADC Therapeutics

ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in late-stage clinical trials in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a late-stage clinical trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, the Company has multiple PBD-based ADCs in ongoing clinical and preclinical development.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit View Source and follow the Company on Twitter and LinkedIn.

ZYNLONTA is a trademark of ADC Therapeutics SA.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The FDA approval was based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with r/r DLBCL following two or more prior lines of systemic therapy. Results from the trial demonstrated an overall response rate (ORR) of 48.3% (70/145 patients), which included a complete response (CR) rate of 24.1% (35/145 patients) and a partial response (PR) rate of 24.1% (35/145 patients). Patients had a median time to response of 1.3 months and the median duration of response (mDoR) for the 70 responders was 10.3 months (inclusive of patients who were censored). In a pooled safety population the most common adverse reactions (≥20%) were thrombocytopenia, gamma-glutamyltransferase increased, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea and musculoskeletal pain. In LOTIS-2, the most common (≥10%) grade ≥3 treatment-emergent adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), gamma-glutamyltransferase increased (17.2%) and anemia (10.3%).

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

Important Safety Information

WARNINGS AND PRECAUTIONS

Effusion and Edema

Serious effusion and edema occurred in patients treated with ZYNLONTA. Grade 3 edema occurred in 3% (primarily peripheral edema or ascites) and Grade 3 pleural effusion occurred in 3% and Grade 3 or 4 pericardial effusion occurred in 1%.

Monitor patients for new or worsening edema or effusions. Withhold ZYNLONTA for Grade 2 or greater edema or effusion until the toxicity resolves. Consider diagnostic imaging in patients who develop symptoms of pleural effusion or pericardial effusion, such as new or worsened dyspnea, chest pain, and/or ascites such as swelling in the abdomen and bloating. Institute appropriate medical management for edema or effusions.

Myelosuppression

Treatment with ZYNLONTA can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Grade 3 or 4 neutropenia occurred in 32%, thrombocytopenia in 20%, and anemia in 12% of patients. Grade 4 neutropenia occurred in 21% and thrombocytopenia in 7% of patients. Febrile neutropenia occurred in 3%.

Monitor complete blood counts throughout treatment. Cytopenias may require interruption, dose reduction, or discontinuation of ZYNLONTA. Consider prophylactic granulocyte colony-stimulating factor administration as applicable.

Infections

Fatal and serious infections, including opportunistic infections, occurred in patients treated with ZYNLONTA. Grade 3 or higher infections occurred in 10% of patients, with fatal infections occurring in 2%. The most frequent Grade ≥3 infections included sepsis and pneumonia.

Monitor for any new or worsening signs or symptoms consistent with infection. For Grade 3 or 4 infection, withhold ZYNLONTA until infection has resolved.

Cutaneous Reactions

Serious cutaneous reactions occurred in patients treated with ZYNLONTA. Grade 3 cutaneous reactions occurred in 4% and included photosensitivity reaction, rash (including exfoliative and maculo-papular), and erythema.

Monitor patients for new or worsening cutaneous reactions, including photosensitivity reactions. Withhold ZYNLONTA for severe (Grade 3) cutaneous reactions until resolution. Advise patients to minimize or avoid exposure to direct natural or artificial sunlight including exposure through glass windows. Instruct patients to protect skin from exposure to sunlight by wearing sun-protective clothing and/or the use of sunscreen products. If a skin reaction or rash develops, dermatologic consultation should be considered.

Embryo-Fetal Toxicity

Based on its mechanism of action, ZYNLONTA can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (SG3199) and affects actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ZYNLONTA and for 9 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZYNLONTA and for 6 months after the last dose.

ADVERSE REACTIONS

In a pooled safety population of 215 patients (Phase 1 and LOTIS-2), the most common (>20%) adverse reactions, including laboratory abnormalities, were thrombocytopenia, increased gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain.

In LOTIS-2, serious adverse reactions occurred in 28% of patients receiving ZYNLONTA. The most common serious adverse reactions that occurred in ≥2% receiving ZYNLONTA were febrile neutropenia, pneumonia, edema, pleural effusion, and sepsis. Fatal adverse reactions occurred in 1%, due to infection.

Permanent treatment discontinuation due to an adverse reaction of ZYNLONTA occurred in 19% of patients. Adverse reactions resulting in permanent discontinuation of ZYNLONTA in ≥2% were gamma-glutamyltransferase increased, edema, and effusion.

Dose reductions due to an adverse reaction of ZYNLONTA occurred in 8% of patients. Adverse reactions resulting in dose reduction of ZYNLONTA in ≥4% was gamma-glutamyltransferase increased.

Dosage interruptions due to an adverse reaction occurred in 49% of patients receiving ZYNLONTA. Adverse reactions leading to interruption of ZYNLONTA in ≥5% were gamma-glutamyltransferase increased, neutropenia, thrombocytopenia, and edema.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to ADC Therapeutics at 1-855-690-0340.

On May 12, 2021 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the first quarter ended March 31, 2021 (Press release, Delcath Systems, MAY 12, 2021, View Source [SID1234579779]).

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Recent Business Highlights

During and since the first quarter the company:

Reported positive preliminary results from the FOCUS Clinical Trial (NCT02678572) for Patients with Hepatic Dominant Ocular Melanoma treated with HEPZATO KIT based on an analysis of currently evaluable patients. The preliminary analysis included 87% of treated patients and final results are expected later in the year.
The primary endpoint, overall response rate (ORR), exceeded the prespecified threshold for success by a large enough margin to ensure that final results based on 100% of patients will be positive.
Both prespecified ORR and Progression Free Survival comparative analyses versus the best alternative care arm demonstrated a statistically significant improvement.
The safety profile was consistent with the safety profile of CHEMOSAT treatment described in previous European single-center and multi-center publications with no new safety signals observed in this patient population and no treatment related deaths on study.
Announced that the United Kingdom’s National Institute for Health and Care Excellence, has updated its guidance for the Delcath CHEMOSAT Hepatic Delivery System for Melphalan (CHEMOSAT) in the treatment of patients with metastases in the liver from Ocular Melanoma. Under this designation, private insurance may be more likely to fund treatment with CHEMOSAT, some regional funding may be more accessible, and a process is now available to seek national reimbursement.
Announced an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held virtually June 4-8, 2021.
"The recently released preliminary results from the FOCUS trial strongly indicates that HEPZATO’s benefit risk ratio is a significant improvement versus an earlier generation of Delcath’s proprietary percutaneous hepatic perfusion system," said Gerard Michel, CEO of Delcath. "We look forward to continued progress in the balance of the year, as we prepare both to file an NDA in early 2022 and expand the development of HEPZATO into additional areas of high unmet need."

First Quarter 2021 Financial Results:

Income Statement Highlights.

Product revenue for the three months ended March 31, 2021 was approximately $0.4 million, compared to $0.3 million for the prior year period from our sales of CHEMOSAT procedures in Europe. Selling, general and administrative expenses were approximately $3.3 million compared to $2.3 million in the prior year quarter. Research and development expenses for the quarter were $3.7 million compared to $3.0 million in the prior year quarter. Total operating expenses for the quarter were $7.0 million compared with $5.3 million in the prior year quarter. First quarter expenses included approximately $2.2 million of stock option expense compared to no material stock option expense in the prior year quarter.

We recorded a net loss for the three months ended March 31, 2021, of $6.8 million, compared to a net income of $7.9 million for the same period in 2020

Balance Sheet Highlights.

At March 31, 2021, we had cash, cash equivalents and restricted cash totaling $26.7 million, as compared to cash, cash equivalents and restricted cash totaling $4.7 million at March 31, 2020. During the three months ended March 31, 2021 and March 31, 2020, we used $4.6 million and $5.2 million, respectively, of cash in our operating activities.

Conference Call Information

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