On April 8, 2021 Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, reported it has entered into a global licensing agreement with Pfizer Inc. (NYSE:PFE) granting Celcuity exclusive rights to Pfizer’s gedatolisib, a Phase 1b pan-PI3K/mTOR inhibitor (Press release, Celcuity, APR 8, 2021, View Source [SID1234577752]). Gedatolisib is in clinical development for the treatment of patients with ER+/HER2-negative advanced or metastatic breast cancer.

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Under the terms of the licensing agreement, Pfizer provided Celcuity with a worldwide license to develop and commercialize gedatolisib. Celcuity paid an upfront license fee of $5 million of cash and $5 million of Celcuity’s common stock as upfront payment. Pfizer is eligible to receive up to $330 million of development and sales-based milestone payments and tiered royalties on potential sales. Additional financial terms of the agreement were not disclosed.

"We are excited about the opportunity to utilize our CELsignia platform to support the development of a potential first-in-class targeted therapy like gedatolisib," said Brian Sullivan, CEO and co-founder of Celcuity. "In light of the important role the PI3K/mTOR pathway plays in driving tumor growth when patients become resistant to endocrine therapies, we believe gedatolisib is a highly promising drug candidate to improve outcomes for patients with breast cancer. Supporting development of a potential first-in-class therapy for breast cancer, such as gedatolisib, with our CELsignia platform is a natural extension of our strategy to develop CELsignia CDx for other breast cancer therapies. We believe developing targeted therapies that benefit from the CELsignia platform while also offering companion diagnostics that enable new drug indications, creates a synergistic advantage for each program."

Approximately 70%-80% of breast cancers in the United States express the estrogen receptor and are thus likely dependent on estrogen signaling to promote tumor growth. Patients with estrogen receptor-positive (ER+)/HER2- metastatic tumors typically receive endocrine therapies, such as tamoxifen, letrozole, or fulvestrant. Most women with ER+/HER2- metastatic breast cancer ultimately develop resistance to these endocrine therapies. One new strategy to treat metastatic ER+/HER2- breast cancer involves blocking pathways enabling partial and complete endocrine resistance by combining gedatolisib and a cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitor with existing endocrine therapy.

To evaluate the efficacy and safety of this new treatment strategy, gedatolisib is currently being evaluated in combination with palbociclib, an oral CDK 4/6 inhibitor, and either letrozole or fulvestrant in the expansion portion of a Phase 1b clinical trial in patients with ER+/HER2-negative advanced or metastatic breast cancer. A total of 103 patients were enrolled in one of four different arms according to their prior treatment history for metastatic breast cancer. A preliminary analysis of the objective response rates as of the January 11, 2021 data cut-off demonstrated that gedatolisib combined with palbociclib and an endocrine therapy achieved superior objective response rates relative to historical control data. Gedatolisib was also generally well tolerated, with the majority of treatment related adverse events (TRAE) being Grade 1 or 2. The most common Grade 3 or 4 TRAEs were neutrophil count decrease and stomatitis.

Added Art DeCillis, M.D., Celcuity’s Chief Medical Officer, "In light of the data reported as of the January 11, 2021 data cut-off, we intend to initiate, subject to feedback from the FDA, a Phase 2/3 clinical trial evaluating gedatolisib in combination with palbociclib and an endocrine therapy in patients with ER+/HER2- advanced or metastatic breast cancer in the first half of 2022."

Webcast Presentation and Conference Call Information

The Celcuity management team will host a webcast/conference call today, April 8, 2021, at 5:00 p.m. ET to discuss the gedatolisib license agreement. To participate in the call, dial 1-877-407-8035. A live webcast presentation can also be accessed using this weblink at: View Source or via Celcuity’s website at View Source A replay of the webcast will be available on the Celcuity website for a limited time following the event.

On April 8, 2021 Median Technologies (Paris:ALMDT) (Euronext Growth – ALMDT), whose Board of Directors met on April 6th, 2021 to approve the consolidated financial statements for the financial year 2020, reported its detailed audited full year financial results for 2020 as well as indicators on its business activity for the first quarter of 2021 (Press release, MEDIAN Technologies, APR 8, 2021, View Source [SID1234577751]).

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2020 results in line with expectations, reflecting the investments needed to accelerate growth and develop the iBiopsy platform

The company, which published indicators on January 14th, 2021 on its 2020 business activity, confirms all the elements previously communicated. As of December 31st, 2020:

– Annual revenue of €13.5m, up 51% on 2019 revenue (€9m), with constant quarterly growth,
– Cash and cash equivalents of €16.3m compared to €19.4m as of June 30th, 2020,
– Order backlog1 of €51.7m, an increase of 35% compared to backlog as of December 31st, 2019 (€38.3m).

During the financial year 2020, the average number of employees in the Group was 125, with an acceleration of recruitment in the second half of the year. On December 31st, 2020, the company had 141 employees.

Given the increase in the company’s headcount to support the growth of the iCRO business (+51% in 2020) and of the iBiopsy technology development, staff costs are up by 37%.

The 27% increase in external costs for the year compared to 2019 external costs is related to:

the optimisation and deployment of a new, more efficient IT infrastructure between Europe, the US and China for the iCRO business and for future cloud-based operations of the iBiopsy platform,
increased costs related to outsourcing of independent image readings for the iCRO business and
the iBiopsy related investments.
Considering these elements, the operating result amounts to -€8.8m.

In the context of the debt issue linked to the EIB (European Investment Bank) loan, the Group granted warrants to the EIB. Under IFRS 9, these warrants are derivatives on own shares and must be valued at fair value through profit or loss. This debt impacts the net result in the consolidated IFRS income statements but has and will have no impact on the Group’s cash flow.

Acceleration of growth in Q1, 2021 and post-closing events

As of March 31st, 2021, the company’s quarterly revenue stands at €5.2m, an increase of 86% compared to the revenue in the first quarter of 2020 (€2.8m). The Group is accelerating its quarterly growth momentum with a 27% increase over Q4 2020 revenues, marking a tenth consecutive quarter of growth.

As of March 31st, 2021, the order backlog amounted to €52.6m, up from the backlog as of December 31st, 2020, despite an excellent quarter of invoicing and the cancellation of a project in China for an amount of €1.6m.

Cash and cash equivalents amounted to €39.8m as of March 31st, 2021. It should be noted that the cash position was strengthened by the capital increase by private placement targeting qualified investors finalised on March 25, 2021 for an amount of €28.1m, corresponding to €26.6m net of fees and commissions. The purpose of this fundraising is to allow the Company to finance its activities and fulfil its obligations under its contractual commitments with the EIB. The net proceeds of the capital increase are mainly intended to contribute to the financing of development operations of the iBiopsy business, in particular clinical validations on the three indications: lung cancer, primary liver cancer and NASH, as well as aspects related to regulatory and marketing strategies. The funds may also be used for any project that would accelerate the company’s growth.

In the first quarter of 2021, the Group also announced the signing of a major research collaboration with the University of California San Diego. The purpose of this collaboration is to conduct a new validation study for the iBiopsy clinical development plan in Non-Alcoholic Steatohepatitis (NASH), which will be conducted on an independent cohort of over 300 patients. The first results of this study are expected in the first quarter of 2022.

In addition, the company announced the initiation of a new clinical development plan for the early diagnosis of lung cancer, with first results on a cohort of 1,800 patients to be published in the second half of 2021.

"2020 was an excellent year in terms of our iCRO business performance, stock performance and progress in our iBiopsy clinical development and partnership plans. The recent funding round gives us the means to pursue our ambitions to simultaneously advance our indications for early diagnosis of liver cancer, NASH and, as recently announced, lung cancer as well," said Fredrik Brag, CEO and founder of Median Technologies. "2021 is shaping up to be a very exciting year, with revenue from our iCRO business already up by 86% in the first quarter compared to Q1 revenue last year. Our order backlog has increased despite the very significant increase in invoicing. This year will also see the continued publication of technology and clinical validation results for iBiopsy, as well as the continued implementation of our policy on setting up partnerships as a basis for future development".

Median informs its shareholders and the financial community that its annual financial report on the accounts for the year ended December 31, 2020 was made public and filed with the AMF.

On April 8, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue-targeted therapeutics for the treatment of cancer, chronic viral infections and other serious diseases, reported that it will present preclinical data on its second product candidate, SBT6290, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Conference, taking place virtually April 10-15 (Press release, Silverback Therapeutics, APR 8, 2021, View Source [SID1234577749]). The data highlight the ability of SBT6290, a systemically administered Nectin4-directed TLR8 ImmunoTAC product candidate, to selectively activate myeloid cells in the tumor microenvironment, a promising approach to overcome resistance mechanisms associated with most current immunotherapies.

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"SBT6290 showcases the versatility of our ImmunoTAC platform and along with our lead program SBT6050, exemplifies our goal to target difficult-to-treat solid tumors subset by subset. We are building on learnings from SBT6050, leveraging the same TLR8 linker-payload, which is highly transferrable across different targeting antibodies," said Valerie Odegard, Ph.D., president & chief scientific officer of Silverback Therapeutics. "These preclinical data show that SBT6290 activates human myeloid cells in a Nectin4-dependent manner and that a SBT6290 mouse surrogate confers single agent anti-tumor activity in preclinical studies. We will continue to evaluate SBT6290 in GLP toxicology studies and anticipate submitting an IND for this program in the fourth quarter of 2021."

SBT6290 comprises a selective TLR8 agonist conjugated to a Nectin4-specific monoclonal antibody. Nectin4 is a cell surface adhesion molecule that is overexpressed in multiple solid tumor types including urothelial, triple negative breast, squamous cell head and neck, and non-small cell lung cancers, with limited expression in normal tissues.

The abstract is now available on the AACR (Free AACR Whitepaper) Annual Meeting website. Details of the poster presentation are as follows:

Title: SBT6290, a Systemically Administered Nectin4-Directed TLR8 ImmunoTAC Product Candidate, is Designed for Tumor-localized Activation of Myeloid Cells

Abstract Number: 1858

Session Category: Immunology

Session Title: Therapeutic Antibodies, Including Engineered Antibodies

Virtual Poster Session Date and Time: The poster will be made available on the AACR (Free AACR Whitepaper) website and Silverback website on April 10, 2021 at 8:30 a.m. ET

On April 8, 2021 Volastra Therapeutics reported that Co-founder Samuel Bakhoum, M.D., Ph.D., and Scientific Advisory Board Member David Pellman, M.D., will both deliver plenary presentations at the April session of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (Press release, Volastra Therapeutics, APR 8, 2021, View Source [SID1234577748]).

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The plenary session, titled "Mechanisms, Impact, and Exploitation of Cancer Chromosomal Instability," is dedicated to exploring a key driver of tumor progression. Volastra is building on this groundbreaking work into the biology of chromosomal instability, which will be shared throughout the plenary session, to develop new therapies for metastatic cancer.

"Volastra is at the forefront of identifying novel techniques to measure and modulate chromosomal instability for the future treatment of patients with advanced cancers, and we’re delighted to be sharing the most current insights into this important field with the scientific community," said Charles Hugh-Jones, M.D., Chief Executive Officer at Volastra.

The session will feature four presentations. Dr. Pellman, HHMI Investigator, Professor of Cell Biology and Pediatrics at Harvard Medical School and the Dana-Farber Cancer Institute, will lead off the plenary session, focusing on the mechanisms driving the rapid evolution of cancer genomes. Dr. Bakhoum, a radiation oncologist and faculty member at Memorial Sloan Kettering Cancer Center, will follow, presenting on the role of chromosomal instability in tumor evolution.

"We have known about chromosomal instability for decades, but only now do we fully understand its critical role in tumor progression. Its importance to the future of cancer treatment is underscored by AACR (Free AACR Whitepaper)’s decision to devote a leading plenary session to the topic," said Dr. Bakhoum. "I’m honored to be participating in the plenary with leading researchers from around the world, and I’m proud to be translating these insights into groundbreaking drug discovery programs at Volastra."

The plenary session, which will include several discussion periods, will be available as a live stream for registered conference attendees. Presentation details can be found below:

Session PL06: Discovery Science Plenary: Mechanisms, Impact, and Exploitation of Cancer Chromosomal Instability
April 10, 2021
9:30 – 11:30 a.m. ET

On April 8, 2021 Magellan Rx Management, a division of Magellan Health, Inc. (NASDAQ: MGLN), and Trapelo Health, reported that they are collaborating to champion a more comprehensive, integrated approach to value-based care in the new era of precision oncology treatments (Press release, Magellan Health Services, APR 8, 2021, View Source [SID1234577747]).

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The collaboration combines the unique strengths of the two organizations: Magellan Rx’s comprehensive oncology management solution, and the Trapelo precision-medicine platform that enables fast, precise test and treatment decision support, including test order management, results interpretation and streamlined prior authorizations.

To learn more, listen to an in-depth conversation with leaders from both companies on the Precision Medicine Podcast.

The role of actionable molecular tests is growing significantly in the selection of advanced cancer therapies. The provision of high-quality cancer care requires the appropriate identification of patients to be tested while ensuring the correct tests are ordered for those patients. Accurate interpretation of the test results, based on current medical evidence is crucial. Clinical data is being published at such an unprecedented pace that providers and payers need access to a shared, unbiased decision-support technology.

The Trapelo decision-support platform ensures comprehensive, personalized testing for every cancer patient every time while allowing payers autonomy regarding contracted lab selection. Using Trapelo, oncologists will be able to order the appropriate molecular tests and receive results faster through a simplified and automated prior authorization process. Treatment selection is also streamlined by identifying relevant treatments based on molecular test results, evidence-based guidelines and clinical trials. Trapelo’s patent-pending technology incorporates health plan policy and eliminates unnecessary medical redocumentation to speed approvals for both cancer genomic testing and drug therapy selection.

"We recognize that contemporary oncology care requires changes in the approach to oncology management," said Caroline Carney, M.D., Chief Medical Officer of Magellan Health and Magellan Rx Management. "This collaboration allows us to extend the value of the services we can provide to our health plan customers, and strengthens our shared commitment to ensuring that every patient receives the opportunity for the best possible outcome."

This solution will support Magellan Rx Management’s medical pharmacy program which offers comprehensive, patient-focused oncology solutions and cost savings so that payers can deliver true value and improved quality of life. Magellan Rx’s offering includes integrated, flexible interventions that address the many facets of cancer care, such as: guideline-supported prior authorization; drug wastage; personalized dosing; oral oncology management; post-service claim edits; provider network management; specialty formulary solutions; site of service; and holistic patient care management.

"We are delighted to be working with Magellan. This gives us a significant opportunity to advance our vision for a more collaborative approach in oncology that streamlines workflow and eases administrative burden for providers, labs and payers while improving patient access and outcomes," added Clynt Taylor, CEO of Trapelo Health.