On April 13, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, and Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, reported completion of enrollment in the follicular lymphoma primary efficacy population of the global Phase 2 TIDAL study (Press release, Kyowa Hakko Kirin, APR 13, 2021, View Source [SID1234577977]). Topline data from the study is on track to be reported in the fourth quarter. If successful, the complete Phase 2 TIDAL study data are intended to be submitted to FDA to support accelerated approval applications under 21 CFR Part 314.500, Subpart H.

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!

Following discussions with FDA, MEI finalized the sample size to evaluate zandelisib in patients with follicular and marginal zone lymphomas in the global Phase 2 TIDAL study. The primary efficacy population sample size for follicular lymphoma is 91 patients and the primary efficacy population sample size for marginal zone lymphoma is 64 patients. To provide a robust safety database, MEI will maintain the total study enrollment of approximately 120 follicular lymphoma patients and 64 marginal zone lymphoma patients.

"The completion of enrollment in the follicular lymphoma efficacy population arm of the TIDAL study is an important milestone for the zandelisib program, and we are grateful to the patients and healthcare providers that are participating in the TIDAL study as we diligently work to advance the program towards potential U.S. marketing authorization," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "In collaboration with our partner, Kyowa Kirin, we are committed to exploring zandelisib’s full potential, both as a monotherapy and in combination with other agents, for patients with B-cell malignancies."

"I am truly pleased with this news that the enrollment for the patients with the follicular lymphoma has been successfully completed," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of Global R&D Division of Kyowa Kirin. "One of our big missions is to steadily advance this drug, which we believe has the potential to provide new value to patient suffering from the follicular lymphoma. We are looking forward to working closely with MEI Pharma to ensure that we fulfill that mission and our responsibilities."

About Zandelisib
Zandelisib (formerly called ME-401), a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies. In March 2020 the U.S. FDA granted zandelisib Fast Track designation for treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies.

In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S. and will pay MEI escalating tiered royalties on ex-U.S. sales.

Ongoing zandelisib studies include a Phase 2 pivotal study in Japan in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) conducted by Kyowa Kirin.

About the TIDAL Phase 2 Study
The TIDAL study (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma) is a global Phase 2 study evaluating zandelisib as a monotherapy across two study arms: the first study arm for the treatment of adults with relapsed and refractory follicular lymphoma and the second study arm for marginal zone lymphomas, in both cases after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. The primary endpoints of the study are the objective response rate and the tolerability of zandelisib.

Subject to the results and discussions with FDA, data from each study arm are intended to be submitted to FDA to support separate accelerated approval marketing applications under 21 CFR Part 314.500, Subpart H.

The study is evaluating zandelisib administered once daily at 60 mg for two 28-day cycles and then on an intermittent schedule (IS) of once daily dosing for the first seven days of each subsequent 28-day cycle. Approximately 120 follicular lymphoma and 60 marginal zone lymphoma patients will be enrolled and treated with the IS regimen. The primary efficacy endpoint will be the rate of objective responses to therapy and other endpoints will include duration of response and tolerability of zandelisib.

More information about this trial is available at ClinicalTrials.gov.

About Follicular and Marginal Lymphomas
Follicular lymphoma (FL) is the most common indolent lymphoma, comprising about 20-30% of all non-Hodgkin lymphomas. The disease also forms on B cells, is chronic in most cases and tends to progress slowly. Most people diagnosed with FL are over 65 years of age. Sometimes follicular lymphomas can change into diffuse large B-cell lymphoma, a fast-growing (aggressive) type of NHL.

Marginal zone lymphoma (MZL) is a group of indolent, or slow growing, lymphomas. The disease forms on B-cells, a type of white blood cell called a lymphocyte. MZL accounts for approximately eight percent of all non-Hodgkin lymphoma cases; over 77,000 cases of non-Hodgkin lymphoma are diagnosed in the U.S. each year. The average age at diagnosis is 60 years, and it is slightly more common in women than in men.

On April 13, 2021 Incyte (Nasdaq:INCY) reported that it has scheduled its first quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, May 4, 2021 (Press release, Incyte, APR 13, 2021, View Source [SID1234577976]).

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 schedule for the press release and conference call/webcast is as follows:

Q1 2021 Press Release: May 4, 2021 at 7:00 a.m. ET
Q1 2021 Conference Call: May 4, 2021 at 8:00 a.m. ET
Domestic Dial-In Number: 877-407-3042
International Dial-In Number: 201-389-0864
Conference ID Number: 13718346
If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13718346.

The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

On April 13, 2021 Geron Corporation (Nasdaq: GERN) reported that the first patient has been dosed in IMpactMF, the Phase 3 clinical trial evaluating imetelstat, a first-in-class telomerase inhibitor, in refractory myelofibrosis (MF) (Press release, Geron, APR 13, 2021, View Source [SID1234577975]).

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!

"As the only study in refractory MF with overall survival as the primary endpoint, dosing of the first patient in IMpactMF is an important step in developing imetelstat as a potential treatment for these patients," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "With a median overall survival of only approximately 14 – 16 months for patients who fail or no longer respond to JAK inhibitor treatment, there is a significant unmet medical need for therapies that will improve survival."

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

The final analysis for OS is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died (referred to as an event). An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. Under current planning assumptions, the Company expects the interim analysis for IMpactMF to occur in 2024 and the final analysis in 2025. Because these analyses are event-driven, the results may be available at different times than currently expected.

IMpactMF is currently enrolling patients. The Company plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia and Asia. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

On April 13, 2021 Genmab A/S (Nasdaq: GMAB) reported Annual General Meeting held on April 13, 2021, the Company’s Board of Directors met to constitute itself (Press release, Genmab, APR 13, 2021, View Source [SID1234577974]). Ms. Deirdre P. Connelly was appointed Chair and Ms. Pernille Erenbjerg was appointed Deputy Chair . It was decided to grant 15,920 restricted stock units to the new member of Management and employees of the Company and the Company’s subsidiaries and 17,075 warrants to the new member of Management and employees of the Company and the Company’s subsidiaries.

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!

Each restricted stock unit is awarded cost-free and provides the owner with a right and obligation to receive one share in Genmab A/S of nominally DKK 1. The vesting of the restricted stock units granted to the members of executive management will be subject to forward looking performance criteria. The fair value of each restricted stock unit is equal to the closing market price on the date of grant of one Genmab A/S share, DKK 2,148.

The restricted stock units will vest on the first banking day of the month following a period of three years from the date of grant. Furthermore, the restricted stock units are subject to vesting conditions set out in the restricted stock unit program adopted by the board of directors in accordance with the Remuneration Policy adopted by the shareholders at the annual general meeting. Information concerning Genmab’s restricted stock unit program can be found on www.genmab.com under Investors > Compensation > Equity Programs > Restricted stock units.

The exercise price for each warrant is DKK 2,148. Each warrant is awarded cost-free and entitles the owner to subscribe one share of nominally DKK 1 subject to payment of the exercise price. By application of the Black-Scholes formula, the fair value of each warrant can be calculated as DKK 667.76.

The warrants vest three years after the grant date, and all warrants expire at the seventh anniversary of the grant date. The new warrants have been granted on the terms and conditions set out in the warrant program adopted by the board of directors on February 23, 2021. Information concerning Genmab’s warrant schemes can be found on www.genmab.com under Investors > Compensation > Equity Programs > Warrants.

On April 13, 2021 Theseus Pharmaceuticals, a biotechnology company shaping the future of targeted oncology by developing best-in-class, pan-variant kinase inhibitors, emerged from stealth reported the close of a $100 million Series B financing led by Foresite Capital (Press release, Theseus Pharmaceuticals, APR 13, 2021, View Source [SID1234577973]). Theseus also announced data from a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, which demonstrated that the Company’s lead product candidate, THE-630, has potent activity against all major classes of activating and resistance mutations observed in patients with KIT-mutant gastrointestinal stromal tumors (GIST).

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!

OrbiMed incubated Theseus to develop therapies designed to outsmart treatment-resistant cancer mutations, funding the Company’s Series A in 2018. In addition to Foresite Capital, the Series B raise was supported by a syndicate of other new investors, including Adage Capital Management, Boxer Capital, Farallon Capital Management, Longitude Capital, Nextech Ventures, Omega Funds, Pontifax Venture Capital, Rock Springs Capital, and T. Rowe Price, as well as OrbiMed. In conjunction with the financing, Michael Rome, Ph.D., Managing Director of Foresite Capital, has joined the Theseus Board of Directors, which also includes Carl Gordon, General Partner at OrbiMed.

"We are thrilled by the validation of this discerning group of investors and welcome Michael to Theseus’ board of directors," said William C. Shakespeare, Ph.D., Co-founder and President of Research and Development at Theseus Pharmaceuticals. "For many driver-oncogene targets, current standard-of-care kinase inhibitors have insufficient activity to cover the broad array of variants that could lead to resistance, so they are limited by constantly mutating cancer. At Theseus, we take a pan-variant approach to targeting oncogenes with kinase inhibitors specifically designed to retain their effectiveness even as cancer mutates. Using sophisticated assays, we can predict how cancers will change, enabling new therapies to stay ahead of future mutations and overcome the demonstrated burden of treatment resistance."

Theseus is developing a pipeline of pan-variant tyrosine kinase inhibitors (TKIs) that can anticipate and inhibit new cancer mutations. The Company’s lead candidate, THE-630, is a next-generation pan-variant KIT inhibitor in development for the treatment of refractory GIST. The Company expects to file an IND before the end of the year. Theseus’ pipeline also includes a selective EGFR inhibitor to overcome C797S-mediated resistance to first- or later-line osimertinib treatment for patients with non-small cell lung cancer, and a third kinase target candidate for an undisclosed indication.

Iain Dukes, D. Phil., Co-founder and Interim CEO of Theseus Pharmaceuticals, and Venture Partner of OrbiMed, commented, "The scientific co-founders of Theseus are a team of distinguished drug discovery and development leaders who have pioneered the development of pan-variant kinase inhibitors. Together at ARIAD Pharmaceuticals, they discovered and developed multiple kinase inhibitors in areas of high clinical need, two of which they brought to market, ponatinib and brigatinib, and a third, mobocertinib, that is now in late-stage clinical development. With this foundation of expertise, combined with the backing of a top-tier syndicate of investors, Theseus is well positioned to develop best-in-class, pan-variant TKIs that provide durable benefit for people living with cancer."

At the AACR (Free AACR Whitepaper) meeting, Theseus presented preclinical data demonstrating that THE-630 has potent activity against all classes of activating and resistance mutations observed in KIT-mutated GIST. These data showed that THE-630 was highly efficacious in tumor models containing mutations that confer resistance to approved TKIs. These data highlight the potential for a pan-variant inhibitor such as THE-630 to deliver meaningful clinical benefit for patients with refractory GIST. The presentation can be found on Theseus’ website.