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Boehringer, CureVac Terminate Lung Cancer Project on Poor Performance

On August 17, 2021 CureVac reported that it has revealed in its latest financial report that its lung cancer program with German biotechnology company Boehringer Ingelheim has been terminated (Press release, CureVac, AUG 17, 2021, View Source [SID1234586796]).

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The move ends a €500m exclusive treatment exploration and development partnership which both parties signed seven years ago (2014). The collaboration focused on the viability of using CureVac’s CV9202 therapeutic mRNA vaccine with afatinib in patients who have been diagnosed with advanced or metastatic epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC). It was also being tested in combination with chemo-radiation therapy in patients who have unresectable stage III NSCLC.

However, in a brief statement hidden among its financials, CureVac said that it had terminated the agreement in June, with the process expected to be finalized by November 2021.

The company said that despite the decision to discontinue their partnership on the project, the two firms will still continue to find ways to collaborate on other ways to use CureVac’s RNA technology for other potential treatment purposes. While it did not explicitly state a reason, CureVac added that they were working with a "legacy program" that used an older protamine formulation, which was being developed seven years ago. It also stated that it is continuing its Phase I of II clinical trial for the potential of BI1361849 for NSCLC.

CureVac did not provide any further details about the termination or any other plans moving forward. However, what is noticeable is that it comes just two months after it reported weak efficacy results of only 47% for an mRNA vaccine against COVID-19. Other rival medications had an efficacy of more than 90%. Industry observers had been setting their sights on the vaccine as it was thought to last longer and cost less.

"While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging," said CureVac’s Chief Executive Officer, Dr. Franz-Werner Haas, in a statement. "In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge."

The CureVac-Boehringer trial involved 40,000 participants, with 75% based in Latin America and 25% in Europe. The 47% who showed efficacy represented around 46 cases from the vaccinated group and 88 cases in the placebo group. As part of that deal, CureVac received €35 million and was set to achieve milestone payments of as much as €430 million plus royalties from future sales.

Boehringer has yet to issue an official statement about this revelation.

FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors

On August 17, 2021 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported that the U.S. Food and Drug Administration (FDA) approved a second indication for GSK’s JEMPERLI (dostarlimab-gxly) for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options (Press release, AnaptysBio, AUG 17, 2021, View Source [SID1234586736]).

JEMPERLI was generated by AnaptysBio using its proprietary somatic hypermutation (SHM) antibody platform and subsequently developed by TESARO, Inc., now a part of GSK, under a collaboration agreement. Eight AnaptysBio-generated therapeutic antibodies have advanced into clinical development to date. JEMPERLI is the first AnaptysBio-generated antibody to obtain FDA approval, and this is the second indication for JEMPERLI to be approved by the FDA in 2021. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"We are pleased that JEMPERLI has been FDA-approved for a second indication and will be available to a broader cohort of solid tumor patients," said Hamza Suria, president and chief executive officer of AnaptysBio. "AnaptysBio’s capital-efficient business model is focused upon advancing our wholly-owned first-in-class antibodies to multiple clinical catalysts over the upcoming 18 months and is supported by milestone and royalty revenues under our GSK collaboration."

AnaptysBio has earned a $20 million milestone payment as a result of this second FDA approval for JEMPERLI in dMMR recurrent or advanced solid tumors. Earlier in 2021, AnaptysBio received a milestone payment of $10 million from GSK for acceptance of the BLA filing with the FDA for this second indication. AnaptysBio also received $20 million and $10 million milestone payments in April 2021 for FDA and European Medicines Agency (EMA) approvals of JEMPERLI for adult patients with a certain type of endometrial cancer, after having received a total of $15 million from GSK during 2020 for the FDA’s and EMA’s acceptances of these BLA and Marketing Authorisation Application (MAA) filings for JEMPERLI. We anticipate an additional $15 million and $165 million in milestone payments upon achievement of certain JEMPERLI regulatory and commercial milestones, respectively. Royalties due to AnaptysBio for JEMPERLI range from 8% to 25% of global net sales, where AnaptysBio will receive 8% of annual global net sales below $1 billion, and 12-25% of net sales above $1 billion. GSK has recently disclosed peak year annual sales estimates of £1-2 billion for JEMPERLI.1

JEMPERLI is also being developed by GSK for the treatment of other tumor types and treatment settings, including currently ongoing phase III trials in recurrent or primary advanced endometrial cancer in combination with chemotherapy standard of care (RUBY) and the phase III FIRST study of platinum-based therapy with JEMPERLI and niraparib versus standard of care platinum-based therapy as first-line treatment of stage III or IV non-mucinous epithelial ovarian cancer. In addition, JEMPERLI is being evaluated as monotherapy and in combination therapy across multiple tumor types and other cancers, including platinum-resistant ovarian cancer, non-small cell lung cancer, multiple myeloma and melanoma.

In the US, prevalence of dMMR across solid tumors has been estimated at 14%. Mismatch repair-deficient status is a biomarker that has been shown to predict response to immune checkpoint blockade with PD-1 therapy. Tumors with this biomarker are most commonly found in endometrial, colorectal and other gastrointestinal cancers, but may also be found in other solid tumors.

GSK continues to develop additional antibodies partnered with AnaptysBio, including cobolimab, an AnaptysBio-generated anti-TIM-3 antagonist antibody, and GSK4074386, an anti-LAG-3 antagonist antibody. Under the terms of the collaboration, AnaptysBio is due to receive development and regulatory milestone payments for each of the first two indications for each of these antibodies. AnaptysBio can potentially receive a total of $1.1 billion in aggregate milestone payments under this collaboration. In addition, AnaptysBio will receive royalties ranging from 4% to 8% on global net sales of cobolimab and GSK4074386 and 1% of GSK’s global net sales of ZejulaTM.

Ascendis Pharma A/S Announces Second Quarter 2021 Financial Results and Business Update Conference Call on August 25

On August 17, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported that the company will hold a conference call and live webcast on Wednesday, August 25, 2021 at 4:30 p.m. Eastern Time (ET) to review its second quarter 2021 financial results and provide a business update (Press release, Ascendis Pharma, AUG 17, 2021, View Source [SID1234586726]).

Conference Call Details

A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

PureTech Founded Entity Akili Enters Strategic Licensing Agreement with TALi, Extending Akili Portfolio and Industry Leadership in Prescription Digital Therapeutics for Cognitive Impairments

On August 17, 2021 Akili Interactive ("Akili"), a leading prescription digital therapeutics company and maker of EndeavorRx, the first and only prescription video game treatment, and Australian Securities Exchange listed digital health company TALi (ASX:TD1), ("TALi"), reported they have completed an agreement for Akili to license TALi’s technology designed to address early childhood attention impairments (Press release, PureTech Health, AUG 17, 2021, View Source [SID1234586707]).

TALi’s patented technology utilizes new mechanisms specifically engineered to assess, target, and improve attention in early childhood (ages 3-8) and is delivered through an engaging video game experience. Combining over 25 years of research in developmental psychology and cognitive neuroscience, TALi’s training program has demonstrated improved attention in both neurodiverse and neurotypical children, specifically showing improvements in numeracy skills, gains in selective attention skills, and behavioral improvements in a classroom setting. Study data have been published in multiple peer-reviewed papers. The technology is currently available in Australia, India, Singapore and Hong Kong, marketed as TALi DETECT (screening) and TALi TRAIN (attention training).

The terms of the deal, estimated at $37.5M in future contingent milestone payments plus royalties on potential revenues, are structured to leverage each organization’s expertise. Building on their collective clinical development experience and Akili’s success in bringing EndeavorRx through the U.S. regulatory process and to market, the companies will work together to execute clinical trials of the TALi technology in pediatric ADHD and pursue U.S. Food and Drug Administration (FDA) regulatory clearance. Under the terms of the agreement, Akili will lead U.S. commercialization and roll-out.

Through this agreement, Akili is expanding its leadership in prescription digital therapeutics (PDTs) for cognitive impairments and charting a path for a new patient demographic to benefit from innovative technologies proven to improve attention. TALi’s technology builds on Akili’s product portfolio and complements its flagship product EndeavorRx, which is FDA-cleared to improve attention function in children ages 8-12 with ADHD (full indication below).

"Akili is continuously seeking opportunities to expand our suite of targeted treatments for cognitive impairments, including through strategic collaborations with companies that share our commitment to delivering high-quality patient experiences built on scientific rigor," stated Eddie Martucci, PhD, Akili’s co-founder and CEO. "Focused on early childhood intervention targeting attention, TALi’s impressive technology is an ideal addition to Akili’s portfolio. We are committed to changing the way people think about medicine, and strategic agreements like this will allow us to expand our vision to treat cognitive impairments in entirely new ways and usher in the next generation of digital therapeutics."

"Akili is leading the digital therapeutics industry with its ability to dramatically scale into mainstream medicine while maximizing value to patients and to the business, making it an ideal partner for expanding the reach and impact of our technology," said Glenn Smith, Managing Director of TALi. "We’re looking forward to working with the Akili team to provide solutions that deliver digital-first support to the millions of children living with attention issues."

Understanding Prescription Digital Therapeutics

Prescription Digital Therapeutics (PDTs) are clinically validated software-based interventions that prevent, manage, or treat a medical disease or disorder. PDTs are approved by regulators and available by prescription for use alone or alongside other medications or medical devices. Akili is creating PDTs informed by decades of neuroscience and cognitive research and delivered through high-quality video game experiences to treat cognitive impairments across multiple diseases and disorders.

MEI Pharma and Kyowa Kirin Announce First Patient Dosed in the Phase 3 COASTAL Study Evaluating Zandelisib Plus Rituximab in Relapsed or Refractory Indolent Non Hodgkin’s B-cell Lymphoma

On August 17, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, reported the dosing of the first patient in a Phase 3 study of zandelisib known as COASTAL (Press release, MEI Pharma, AUG 17, 2021, View Source [SID1234586704]). COASTAL is evaluating zandelisib, a selective phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor, in combination with rituximab in patients with relapsed or refractory (r/r) follicular lymphoma (FL) or marginal zone lymphoma (MZL) who have received at least one prior line of therapy.

"Zandelisib has the potential to provide a best-in-class therapeutic profile that delivers a meaningful and improved clinical benefit to patients with relapsed or refractory follicular or marginal zone lymphomas," said Professor Wojciech Jurczak, M.D., Ph.D., COASTAL principal investigator, Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology in Kraków, Poland. "Because most patients diagnosed with follicular and marginal zone lymphomas will experience disease relapse or some may not respond well to initial treatments, additional chemotherapy-free therapeutic options are invaluable after first line chemoimmunotherapy."

About the Phase 3 COASTAL Study
The global, randomized, two-arm Phase 3 COASTAL study will compare zandelisib plus rituximab to standard of care chemotherapy plus rituximab, in patients with r/r FL or MZL who received ≥ 1 prior line of therapy, which must have included an anti-CD20 antibody in combination with chemotherapy or lenalidomide. COASTAL is expected to enroll 534 patients. Zandelisib will be administered once daily for two 28-day cycles followed by an intermittent schedule of once daily dosing for 7 days of each subsequent 28-day cycle for a total of 24 months, in combination with rituximab (R) in the first 6 months only. The control arm will consist of 6 cycles of the standard chemoimmunotherapy regimens R-CHOP or R-bendamustine. The primary efficacy endpoint is progression-free survival; secondary endpoints include overall response rate, overall survival, patient reported outcomes assessments, and safety and tolerability.

COASTAL is intended to support marketing applications in the U.S. and globally in r/r FL and MZL patients who have received at least one prior line of treatment. COASTAL is also intended to act as the required confirmatory study for the potential U.S. accelerated approval of zandelisib based on the ongoing Phase 2 TIDAL study evaluating patients with r/r FL and MZL patients who have received two or more prior lines of treatment.

"Phase 1b zandelisib data reported at the ASCO (Free ASCO Whitepaper) annual meeting earlier this year, including the 95% overall response rate achieved in combination with rituximab in relapsed or refractory follicular lymphoma patients and a low incidence of Grade 3 adverse events, are encouraging and supports our expanding clinical development efforts as we initiate the Phase 3 COASTAL study," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "In close collaboration with our global partner Kyowa Kirin, we are excited to advance the zandelisib development program into patients with follicular or marginal zone lymphomas that have received at least one prior line of treatment, building on our efforts to realize zandelisib’s potential as a novel treatment for patients with B-cell malignancies."

"The Phase 3 COASTAL study occupies an important position in evaluating the potential efficacy of zandelisib in patients with relapsed or refractory follicular or marginal zone lymphomas," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin. "Together with MEI Pharma, we hope to deliver zandelisib as a new treatment option to patients as soon as possible, and we commit to working with medical professionals and the patient community as an R&D-driven pharmaceutical company pursuing advances in life sciences and technologies."

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. Differentiated by its molecular structure and pharmacologic properties, zandelisib is administered on an optimized dosing schedule consisting of daily therapy for induction/remission followed by intermittent dosing therapy intended to mitigate immune-related adverse events while providing continued therapeutic benefit.

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 Pharma and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI Pharma and Kyowa Kirin are co-developing and co-promoting zandelisib in the U.S., with MEI Pharma booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

Ongoing clinical studies of zandelisib include TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), 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 endpoint of the study is the objective response rate. 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.

COASTAL is the Phase 3 study evaluating zandelisib in combination with rituximab in patients with r/r indolent non-Hodgkin’s lymphoma (iNHL). COASTAL is intended to support FDA approval for additional indications and regulatory marketing applications globally. COASTAL is also intended to act as the required confirmatory study for a potential U.S. accelerated approval of zandelisib in patients with r/r FL or MZL being evaluated in the Phase 2 TIDAL study who have received two or more prior lines of treatment.

Another Phase 2 pivotal study in Japan is evaluating zandelisib 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. This study is intended to support a Japanese filing with PMDA.

About PI3K Delta
Phosphatidylinositol 3-kinase delta ("PI3Kδ") is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancers. Zandelisib displays high selectivity for the PI3Kδ isoform and has distinct pharmaceutical properties from other PI3Kδ inhibitors.

About Follicular and Marginal Zone Lymphomas*
Follicular lymphoma (FL) is the most common indolent lymphoma, comprising about 20% of all non-Hodgkin’s lymphomas (NHL), which is one of the most common cancers in the U.S., accounting for about 4% of all cancers. FL derives from a type of white blood cell called a B-lymphocyte, and tends to progress slowly in most cases. The average age of people with FL is about 60 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 another group of indolent, or slow growing, lymphomas. The disease also forms on B-cells. MZL accounts for approximately 5% to 10% of all non-Hodgkin’s lymphoma cases in the U.S. The average age of people with the most common form of marginal zone lymphoma is 60 years of age.

*American Cancer Society: View Source, and View Source Accessed June 16, 2021