On June 29, 2020 VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) diseases and disorders with high unmet need, reported financial results for its fiscal year ended March 31, 2020 (Press release, VistaGen Therapeutics, JUN 29, 2020, View Source [SID1234561549]).

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"As these unprecedented times persist, with the chaotic implementation of public safety measures and the civil unrest in the fight for social justice, we continue to live in a world filled with heightened uncertainty and unfamiliarity. The spike in the number of individuals experiencing anxiety and depression is unparalleled and it appears the upward trajectory will continue. While innovative means of providing mental health support have been initiated, many needs are still not being met," stated Shawn Singh, Chief Executive Officer of VistaGen.

Singh continued, "VistaGen is uniquely positioned to develop a robust investigational pipeline of novel treatments for millions of people globally today and for generations to come who are unfortunately suffering due to this heightened mental health pandemic. We have continued to make progress across our CNS pipeline, notably, with PH94B, our first-in-class, rapid-onset neuroactive nasal spray for social anxiety disorder, having recently announced a strategic collaboration with EverInsight for up to $177 million in upfront and potential milestone payments to develop and commercialize PH94B in key Asian markets. This partnership further highlights the value of this asset, which has global market potential as a rapid-onset and safe, acute anxiety therapy, and provides our company with additional working capital to continue the significant progress we have made in preparation for our Phase 3 program in parallel with emphasis on additional strategic collaborations for development and commercialization of our pipeline in key regional markets outside the U.S."

VistaGen’s CNS Pipeline:

VistaGen is developing three differentiated, patent-protected, CNS product candidates for large global markets where current treatments are inadequate to address rising mental health challenges worldwide, as well as need for non-additive, non-sedating relief from pain, unwanted movement disorders and other neurological conditions besetting increasing numbers of individuals worldwide. VistaGen’s CNS product candidates in development are as follows:

PH94B Neuroactive Nasal Spray

PH94B is a first-in-class neuroactive nasal spray with therapeutic potential in a wide range of indications involving anxiety or phobia. Self-administered in microgram doses, PH94B does not require systemic uptake and distribution to produce its rapid-onset anti-anxiety effects and, therefore, has an excellent safety profile.

Strategic Partnership with EverInsight Therapeutics for up to $177 Million in Upfront and Potential Milestone Payments, in Addition to Royalties

VistaGen and EverInsight Therapeutics, a company currently funded by the CBC Group (formerly C-Bridge Capital), one of the largest and most active healthcare-dedicated investment firms in Asia, entered into a strategic partnership for Phase 3 clinical development and commercialization of PH94B, initially for acute treatment of SAD, in multiple key anxiety markets in Asia.
VistaGen is eligible to receive up to $177M, including a $5 million upfront payment and up to $172 million in potential milestone payments, if Phase 3 development efforts are successful, in addition to royalties.
Social Anxiety Disorder (SAD)

FDA granted VistaGen Fast Track designation for development of PH94B for on-demand treatment of SAD, the first such designation granted by the FDA for development of a drug candidate for SAD. The Company is currently in final-stage discussions with the FDA regarding key details of its plan for Phase 3 clinical development of PH94B for SAD in the U.S., with the initial objective of developing PH94B as the first FDA-approved on-demand, rapid-onset acute treatment of SAD.
Michael Liebowitz, M.D., Professor of Clinical Psychiatry at Columbia University, director of the Medical Research Network in New York City, and creator of the Liebowitz Social Anxiety Scale (LSAS), will serve as Principal Investigator of the Company’s Phase 3 clinical studies.
Adjustment Disorder with Anxiety related to the COVID-19 Pandemic

Through the FDA’s new Coronavirus Treatment Acceleration Program (CTAP), VistaGen submitted a protocol and development plan for an exploratory open-label Phase 2A study of PH94B for treatment of adjustment disorder with anxiety (AjDA) related to the COVID-19 pandemic.
Phase 2A study in AjDA to be conducted in New York City, with Dr. Michael Liebowitz, M.D., serving as Principal Investigator.
Based on its rapid-onset pharmacology, microgram-level dosing, lack of systemic exposure, excellent safety profile and the rapidly rising incidence of anxiety disorders, the Company is also assessing potential exploratory Phase 2A studies of PH94B for treatment of postpartum anxiety, post-traumatic stress disorder (PTSD), preoperative anxiety, and panic disorder.

PH10 Neuroactive Nasal Spray

Major Depressive Disorder (MDD)

PH10 is an odorless, fast-acting synthetic neurosteroid delivered intranasally that has therapeutic potential in a wide range of neuropsychiatric indications involving depression. Self-administered in microgram doses, PH10 does not require systemic uptake and distribution to produce its antidepressant effects. The Company is initially developing PH10 as a potential fast-acting, non-sedating, non-addictive stand-alone treatment of MDD.

Positive results of exploratory double-blind, randomized, placebo-controlled Phase 2A clinical study of PH10 for treatment of MDD were newly published in peer-reviewed British Journal of Pharmaceutical and Medical Research.
Following successfully completed Phase 2A development for MDD, the Company is preparing for planned Phase 2B clinical development of PH10 in the U.S. for MDD.
Maurizio Fava, M.D., Director of the Clinical Research Program and Executive Vice Chair of the Department of Psychiatry at Massachusetts General Hospital, and Slater Family Professor of Psychiatry at Harvard Medical School, will be the Principal Investigator of the planned Phase 2B study.
U.S. Patent and Trademark Office (USPTO) granted U.S. Patent No. 10,322,138 related to methods of treating MDD with PH10. Newly granted patent will not expire until at least 2034. Counterpart foreign patents have already been issued in China, Europe, Japan and several other countries.
Considering its rapid-onset pharmacology, microgram-level dosing, lack of systemic exposure, excellent safety profile and the rapidly rising incidence of depression-related disorders, the Company is also assessing potential exploratory Phase 2A studies of PH10 for treatment of postpartum depression, treatment-resistant depression and suicidal ideation.

AV-101

AV-101 is a novel, oral prodrug that targets the NMDAR (N-methyl-D-aspartate receptor). Abnormal NMDAR function is associated with numerous CNS diseases and disorders. AV-101’s active metabolite, 7-chloro-kynurenic acid (7-Cl-KYNA), is a potent and selective full antagonist of the glycine coagonist site of the NMDAR. Unlike ketamine and other NMDAR antagonists, 7-Cl-KYNA is not an ion channel blocker. VistaGen is currently assessing AV-101’s potential in combination with probenecid, a safe and well-known oral drug used to treat gout and to increase the therapeutic benefit of numerous antibacterial, anticancer and antiviral drugs, to treat MDD, neuropathic pain, dyskinesia associated with levodopa therapy for Parkinson’s disease, epilepsy and suicidal ideation.

VistaGen reported new positive preclinical data of AV-101 administered with probenecid, demonstrating substantially increased brain concentration effects of AV-101 (7-fold) and its active metabolite, 7-Cl-KYNA (35-fold).
AV-101 with probenecid could result in far more profound therapeutic benefits for patients with MDD than in prior clinical studies that did not involve probenecid
VistaGen and Nuformix entered strategic agreement to develop novel crystalline forms of AV-101 that may have superior delivery, an enhanced therapeutic profile and additional intellectual property protection.
The Company reported positive results of preclinical study of AV-101 in widely-used MPTP non-human primate model for reproducing unwanted movement complications of Parkinson’s disease (PD). Antidyskinetic activity of AV-101 measured compared favorably with observations with amantadine in parkinsonian monkeys. Better than amantadine, with its known side effects (in humans with PD and in parkinsonian monkeys), no adverse effects with AV-101 were observed. This study supports AV-101’s potential to treat dyskinesia associated with levodopa therapy for PD, while maintaining the antiparkinsonian benefits of levodopa therapy and without causing hallucinations or other serious side effects that may be associated with amantadine therapy.
USPTO issued Notice of Allowance for U.S. Patent Application 16/003,816 related to therapeutic use of AV-101 for treatment of dyskinesia induced by the administration of levodopa. Patent, once issued, will be in effect until at least 2034.
FDA authorized Investigational New Drug (IND) application for AV-101 as a potential new treatment of dyskinesia in individuals with PD receiving levodopa therapy.
The Company announced positive results of preclinical study examining AV-101’s analgesic and behavioral profile compared to pregabalin in accepted "gold standard" preclinical model for chronic neuropathic pain caused by nerve damage. AV-101, which does not bind to opioid receptors, demonstrated robust analgesic effects, similar to pregabalin, but with fewer side effects as measured in the rotarod assay, providing complementary support to an earlier preclinical study involving gabapentin, of AV-101’s potential to treat debilitating neuropathic pain, without causing the burdensome side effects and safety concerns associated with the medications currently used by millions to treat neuropathic pain, such as risk of abuse, drowsiness, dizziness and sedation.
Successful results from AV-101 first-step, Phase 1B clinical study with healthy U.S. military Veterans conducted by Baylor University measured NMDAR target engagement of AV-101, supporting potential, with probenecid, for next step AV-101 exploratory Phase 2A study for treatment of suicidal ideation in Veterans.
Successful Baylor Study and the recent preclinical studies involving AV-101 and adjunctive probenecid suggest AV-101’s potential in NMDAR-focused CNS indications for which Company has positive AV-101 preclinical data without probenecid (depression, epilepsy, levodopa-induced dyskinesia and neuropathic pain). Company conducing additional preclinical studies of AV-101 with probenecid to determine most appropriate next-steps to support exploratory Phase 2A clinical studies.
Financial Results for the Fiscal Year Ended March 31, 2020:

Research and development (R&D) expense: R&D expense decreased to $13.4 million for fiscal 2020, compared with $17.1 million in fiscal 2019. In fiscal 2019, our acquisition of the PH94B and PH10 licenses through the issuance of our common stock, resulted in an aggregate of $4.25 million of noncash expense and primarily accounts for the decrease. Other noncash expenses included in research and development expense (excluding the PH94B and PH10 license acquisitions in fiscal 2019), primarily stock compensation and lab equipment depreciation, accounted for approximately $1.4 million in both fiscal 2020 and fiscal 2019.

General and administrative (G&A) expense: G&A expense totaled $7.4 million in fiscal 2020 compared to $7.5 million in fiscal 2019. Increased noncash stock compensation and warrant modification expenses were generally offset by decreases in cash-based salaries and benefits and investor and public relations expenses. Noncash general and administrative expense accounted for approximately $3,543,000 and $2,622,000 in fiscal 2020 and fiscal 2019, respectively.

Net loss: Net loss attributable to common stockholders for the fiscal year ended March 31, 2020 decreased to approximately $22.0 million compared to $25.7 million for the fiscal year ended March 31, 2019, the decrease resulting primarily from the $4.25 million noncash expense associated with the stock-based acquisition of the licenses to develop and commercialize PH94B and PH10 in fiscal 2019.

Cash: At March 31, 2020, VistaGen had cash and cash equivalents of $1.4 million. Subsequent to March 31, 2020, the Company received proceeds of approximately $3.0 million, including proceeds of approximately $2.8 million from equity sales and approximately $200,000 from a potentially forgivable loan under the Paycheck Protection Act. In addition, in June 2020, the Company entered into a strategic licensing and collaboration agreement with EverInsight for the development and commercialization of PH94B for anxiety disorders in multiple key Asian markets. Under the agreement, VistaGen is eligible to receive up to $177 million in upfront and potential milestone payments, in addition to royalties, including a $5 million upfront payment.

Shares outstanding: As of June 29, 2020, there were 55,773,682 shares of the Company’s common stock outstanding.

On June 29, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that The Lancet Oncology published data from the NAVIGATOR clinical trial showing an unprecedented overall survival (OS) rate and a well-tolerated safety profile for AYVAKIT (avapritinib) in patients with advanced PDGFRA D842V mutant gastrointestinal stromal tumor (GIST) (Press release, Blueprint Medicines, JUN 29, 2020, View Source [SID1234561548]). The paper, titled "Avapritinib in advanced PDGFRA D842V-mutant gastrointestinal stromal tumour (NAVIGATOR): a multicentre, open-label, phase 1 trial," was published online in The Lancet Oncology on June 29, 2020.

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"The data published in The Lancet Oncology show that patients with PDGFRA D842V mutant GIST treated with AYVAKIT had deep and durable clinical responses as well as a high overall survival rate. These results represent a transformative advancement for patients whose tumor type is resistant to other approved therapies," said Michael Heinrich, M.D., Professor of Medicine at Oregon Health & Science University and primary author of the paper. "As a scientist who has dedicated my career to understanding the molecular basis of GIST and as a clinician treating patients, it’s tremendously rewarding to be able to offer – for the first time – a highly effective treatment option to my patients with PDGFRA D842V mutant GIST."

"Based on the compelling clinical data from the NAVIGATOR trial, AYVAKIT was granted a full approval by the FDA earlier this year and has become the new standard of care for patients with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "We are now focused on bringing AYVAKIT to additional patients with this genomically defined form of GIST in other geographies, including Europe."

Highlights from The Lancet Oncology Publication Data

The Lancet Oncology paper reported efficacy and safety results from the NAVIGATOR trial, including all patients enrolled in the dose escalation part of the trial and the subset of patients with PDGFRA D842V mutant GIST enrolled in the expansion part of the trial. The efficacy population comprised 56 patients with PDGFRA D842V mutant GIST. The safety population comprised 82 patients, including 26 patients with non-PDGFRA D842V mutant GIST enrolled in the dose escalation part of the trial. All results were as of a data cutoff date of November 16, 2018.

In patients with PDGFRA D842V mutant GIST, the overall response rate (ORR) was 88 percent (95% CI: 76-95%) with 9 percent of patients achieving a complete response. AYVAKIT demonstrated durable clinical benefit in this patient population with a 12-month duration of response rate of 70 percent (95% CI: 54-87%), a 12-month progression-free survival (PFS) rate of 81 percent (95% CI: 69-93%) and a 24-month OS rate of 81 percent (95% CI: 67-94%).

AYVAKIT was generally well-tolerated with most treatment-related adverse events (AEs) reported as Grade 1 or 2. The most common treatment-related AEs were nausea, fatigue, diarrhea, periorbital edema, anemia, decreased appetite, vomiting and memory impairment. Cognitive effects occurred in 40 percent of patients, with the majority of events reported as Grade 1.

About AYVAKIT (avapritinib)

AYVAKIT (avapritinib) is a kinase inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT is the first precision therapy approved to treat a genomically defined population of patients with GIST and the only highly active treatment for PDGFRA exon 18 mutant GIST. The FDA granted Breakthrough Therapy Designation to avapritinib for the treatment of unresectable or metastatic GIST harboring the PDGFRA D842V mutation. For more information, visit AYVAKIT.com.

Avapritinib is not approved for the treatment of any other indication in the U.S. by the FDA or for any indication in any other jurisdiction by any other health authority.

Blueprint Medicines is developing avapritinib globally for the treatment of advanced, smoldering and indolent systemic mastocytosis (SM). The FDA granted Breakthrough Therapy Designation to avapritinib for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of avapritinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for avapritinib in the rest of the world.

About GIST

GIST is a sarcoma, or tumor of bone or connective tissue, of the GI tract. Tumors arise from cells in the wall of the GI tract and occur most often in the stomach or small intestine. Most patients are diagnosed between the ages of 50 to 80, and diagnosis is typically triggered by GI bleeding, incidental findings during surgery or imaging and, in rare cases, tumor rupture or GI obstruction.

About 5 to 6 percent of primary GIST cases are caused by a PDGFRA D842V mutation, the most common PDGFRA exon 18 mutation. Prior to the approval of AYVAKIT, there were no highly effective treatments for PDGFRA D842V mutant GIST. Published data have shown poor outcomes in patients with PDGFRA D842V mutant GIST treated with imatinib and other approved therapies, including a median OS of 15 months, a median PFS of 3 months and an ORR of 0 percent.1

Important Safety Information

Intracranial hemorrhage (e.g., subdural hematoma, intracranial hemorrhage, and cerebral hemorrhage) occurred in 1% of 267 patients (0.7% Grade 3 or 4) with GIST and overall in 3% of 335 patients (1.2% Grade 3 or 4) who received AYVAKIT. Overall, 0.9% of patients receiving AYVAKIT required permanent discontinuation for an intracranial hemorrhage. Withhold AYVAKIT and then resume at a reduced dose upon resolution, or permanently discontinue AYVAKIT based on severity.

In 335 patients receiving AYVAKIT, CNS adverse reactions occurred overall in 58% of patients including cognitive impairment (41%; 3.6% Grade 3 or 4), dizziness (20%; 0.6% Grade 3 or 4), sleep disorders (15%; 0.3% Grade 3 or 4), mood disorders (13%; 1.5% Grade 3 or 4), speech disorders (6%; none Grade 3 or 4), and hallucinations (2.1%; none Grade 3 or 4). Overall, 3.9% of patients required permanent discontinuation of AYVAKIT for a CNS adverse reaction. Depending on severity, withhold AYVAKIT and then resume at the same dose or at a reduced dose upon improvement, or permanently discontinue AYVAKIT.

AYVAKIT can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential and pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use an effective method of contraception during treatment with AYVAKIT and for 6 weeks after the final dose of AYVAKIT. Advise women not to breastfeed during treatment with AYVAKIT and for two weeks after the final dose. Advise females and males of reproductive potential that AYVAKIT may impair fertility.

In 204 patients with unresectable or metastatic GIST, the most common adverse reactions (≥ 20%) were edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, hair color changes, increased lacrimation, abdominal pain, constipation, rash and dizziness.

Avoid coadministration of AYVAKIT with strong and moderate CYP3A inhibitors. If coadministration with a moderate CYP3A inhibitor cannot be avoided, reduce dose of AYVAKIT. Avoid coadministration of AYVAKIT with strong and moderate CYP3A inducers.

Please click here to see the full Prescribing Information for AYVAKIT.

On June 29, 2020 VITRAC Therapeutics, LLC (VITRAC) reported that initiated the global clinical development of VIC-1911, an oncology candidate formally known as TAS-119, which was licensed from Taiho Pharmaceutical Co., Ltd. (Taiho), a Japan-based oncology company (Press release, VITRAC Therapeutics, JUN 29, 2020, View Source [SID1234561547]). Two Phase-1 clinical studies have been conducted in the US and Europe by Taiho. VITRAC obtained an exclusive and global development and commercialization rights for TAS-119, and its IND has been successfully transferred to VITRAC in the US with a new code name, VIC-1911.

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"It is our honor to succeed the development of this drug that has been diligently developed by Taiho, and to be able to develop a potent Aurora A specific inhibitor, VIC-1911. This drug will give more treatment options to cancer patients since Aurora Kinase plays key oncogenic roles related to their mitotic activity, promote cancer cell survival, and proliferation," said Keizo Koya, Ph.D., President of VITRAC Therapeutics.

VITRAC also made an alliance with JS InnoMed Holdings (JSI) by sublicensing the China rights of VIC-1911 to accelerate the global development. "JSI is an amazing biopharmaceutical company filled with creative and distinguished scientists managed by a notable leader, Dr. Jintao Zhang. It is exciting to collaborate on a global scale towards the development of this drug with potential to ameliorate the lives of patients," said Dr. Koya.

On June 29, 2020 Arya Sciences Acquisition Corp. (NASDAQ: ARYA or "Arya"), a special purpose acquisition company sponsored by Perceptive Advisors, and Immatics Biotechnologies GmbH ("Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported that its respective shareholders approved the business combination between Arya and Immatics announced on March 17, 2020 (Press release, Arya Sciences, JUN 29, 2020, View Source [SID1234561546]). None of Arya’s shareholders redeemed their shares in connection with the ARYA shareholder approval. The respective boards of directors of both Arya and Immatics had previously approved the business combination.

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Following the Arya shareholder vote, Immatics and Arya commenced final procedures towards the closing of the business combination and expect the closing to be completed in the coming days. It is further expected that the trading of the shares of the combined company, called Immatics N.V., will commence under the symbol "IMTX" on the first trading day thereafter. Immatics will continue to operate under its existing management team led by Chief Executive Officer, Harpreet Singh, Ph.D.

About the Transaction
On March 17, 2020, Immatics entered into a definite business combination agreement with Arya and in connection with the entry into the business combination agreement, a group of leading U.S. healthcare institutional investors committed to invest in Immatics N.V. through an ordinary share private investment in public equity ("PIPE"). Immatics shareholders, Arya shareholders and the PIPE investors will hold shares in Immatics N.V.

Advisors
Goldman Sachs International is acting as lead financial advisor with SVB Leerink, BofA Securities and Kempen serving as financial advisors to Immatics. Jefferies LLC is acting as lead financial and capital markets advisor to Arya as well as sole private placement agent. Chardan Capital Markets LLC is also serving as advisor to Arya. Goodwin Procter LLP and CMS Legal Services EEIG are acting as legal counsel to Immatics. Kirkland & Ellis LLP is serving as legal counsel to Arya.

On June 29, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported positive topline results from the phase 2 single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer (Press release, Seattle Genetics, JUN 29, 2020, View Source [SID1234561545]). Results from the trial showed a 24 percent confirmed objective response rate (ORR) by independent central review [95% Confidence Interval: 15.9%-33.3%] with a median duration of response (DOR) of 8.3 months. The most common treatment-related adverse events (greater than or equal to 20 percent) included alopecia, epistaxis (nose bleeds), nausea, conjunctivitis, fatigue and dry eye. The data will be submitted for presentation at an upcoming medical meeting.

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Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor, which is expressed on cervical cancer and can promote tumor growth, angiogenesis and metastases.1 Standard therapies for previously treated recurrent and/or metastatic cervical cancer generally result in limited objective response rates of typically less than 15 percent with median overall survival ranging from 6.0 to 9.4 months, in an all-comers population.1-8 Tisotumab vedotin is being developed by Seattle Genetics in collaboration with Genmab.

"Available therapies upon progression after first line chemotherapy in recurrent or metastatic cervical cancer are limited, and there is a significant unmet need for new treatment options," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "Tisotumab vedotin has demonstrated clinically meaningful and durable objective responses with a manageable safety profile, and we look forward to discussing with the FDA the potential submission of a Biologics License Application to support an accelerated approval."

Cervical cancer originates in the cells lining the cervix. Over 13,500 women are expected to be diagnosed with cervical cancer in the U.S. in 2020, with approximately 4,200 deaths.9 Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying annually; the vast majority of these women being in the developing world.10 Routine medical examinations and the human papillomavirus (HPV) vaccine have lowered the incidence of cervical cancer in the developed world. Despite these advances, women are still diagnosed with cervical cancer, which often recurs or becomes metastatic.

Additional clinical trials of tisotumab vedotin are currently enrolling patients, including in combination with pembrolizumab, carboplatin or bevacizumab, and with a weekly dosing schedule in patients with locally advanced or metastatic cervical cancer. Tisotumab vedotin is also being evaluated in other tissue factor expressing tumor types, including ovarian and other solid tumors.

About innovaTV 204 Trial

The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab. Additionally, patients were eligible if they had received up to two prior lines of therapy in the metastatic setting. In the study, 101 patients were treated with tisotumab vedotin at multiple centers in the U.S. and Europe. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, progression-free survival, overall survival, safety and tolerability.

The study was conducted in collaboration with European Network of Gynaecological Oncological Trial Groups (ENGOT) and Gynecologic Oncology Group (GOG). For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About Tisotumab Vedotin

Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seattle Genetics’ ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a protein that can promote tumor growth, angiogenesis and metastases.1 Based on its high expression on many solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seattle Genetics, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

Tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer and in combination with other commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three weeks dosing schedule.