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]).

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"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.

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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).

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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.

On April 13, 2021 Cancer Advances, Inc., a clinical stage biopharmaceutical company developing therapeutics for gastrointestinal cancers, reported that its abstract entitled, "Vaccination with Polyclonal Antibody Stimulator (PAS) prevents pancreatic carcinogenesis in the KRAS mouse model" has been selected for presentation in a minisymposium at the AACR (Free AACR Whitepaper) Annual Meeting 2021 (Press release, Cancer Advances, APR 13, 2021, View Source [SID1234577972]).

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Jill Smith, MD of the Georgetown Lombardi Comprehensive Cancer Center, will present the results of this study during the week of April 10-15, 2021. The pre-recorded presentation will be available for viewing during the meeting. A live Q&A session will be held April 12, 1:30 pm EDT. In addition, attendees have the opportunity to contact Dr. Smith via a networking portal to discuss the research further.

Details of the abstract and minisymposium are below:

Abstract Title: Vaccination with Polyclonal Antibody Stimulator (PAS) prevents pancreatic carcinogenesis in the KRAS mouse model

Abstract Number: 109

Q&A Session: April 12, 1:30 pm EDT

Abstract/Session Link: View Source!/9325/presentation/1168

On April 13, 2021 BridgeBio Pharma, Inc. (NASDAQ: BBIO), and the University of California, San Diego (UC San Diego) reported a partnership to translate research in genetically driven conditions into potential therapeutic applications for patients, with a focus on oncology and neurology (Press release, BridgeBio, APR 13, 2021, View Source [SID1234577970]).

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"UC San Diego is a leading research institution with a top pharmacology department and a strong profile in neurology and oncology. By leveraging their expertise through our collaboration partnership, we hope to advance discoveries into potential treatments as quickly and safely as possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

Under this partnership, BridgeBio and UC San Diego will collaborate on identifying research programs with strong potential for therapeutic applications that address areas of unmet need. BridgeBio will potentially sponsor research programs and support the development of identified programs toward potential clinical investigation through its licensing and affiliate development model.

"Our world-renown scientists have deep knowledge into genetically driven conditions. Coupling our cross-disciplinary, flexible approach to advancing research with BridgeBio’s developmental expertise and collaborative model presents tremendous opportunity to realize the potential of our work," said UC San Diego Associate Vice Chancellor for Innovation and Commercialization Paul Roben. "I look forward to seeing our collaboration advance around our shared mission to develop life-changing therapies and give patients new hope."

BridgeBio partners with top academic and research institutions, including UC San Diego, to support early, promising research in genetically driven diseases and cancers with clear genetic drivers. Today BridgeBio also announced formal partnerships with Brown University, GlycoNet, The Lundquist Institute, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center and University of California, Davis – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to date. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

With trust, respect and science at the forefront of all collaborations, BridgeBio continuously seeks long-term partnerships with similar institutions that are rooted in trust, engagement, science and respect in order to drive forward its mission of developing life-changing medicines for patients with genetically driven conditions, including in oncology and neurology, as quickly and safely as possible.