On February 16, 2021 INOVIO (NASDAQ: INO) reported that fourth quarter and year-end 2020 financial results will be released after the market close on March 1, 2021 (Press release, Inovio, FEB 16, 2021, View Source [SID1234575102]). Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update regarding its DNA Medicines Platform, including the company’s ongoing vaccine developments for COVID-19.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

On February 16, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported preliminary and unaudited revenues for the fourth quarter and full-year 2020 and provided an update on key highlights for 2021 (Press release, CASI Pharmaceuticals, FEB 16, 2021, View Source [SID1234575118]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We have taken a number of important strides as an organization in 2020, with four strategic pillars underpinning our overall corporate strategy: (1) Steady growth through ongoing business development, punctuated by the announcement of our licensing agreement with BioInvent in the fourth quarter, (2) Continued pre-commercialization preparations ahead of anticipated China NDA filing of CNCT19, CD19 CAR-T program, (3) Continued progress with respect to our current clinical pipeline, and (4) Strategic marketing execution and physician education with our commercial product, EVOMELA. Thanks to the tireless efforts of the CASI team, we have been able to successfully drive these initiatives forward and position ourselves for continued execution excellence in 2021."

Dr. He continued, "While the ongoing pandemic continues to present an array of headwinds from a macro perspective, our plans for 2021 are no less ambitious. We will continue to evaluate potential partners and/or assets that are tactically aligned with our own strategic growth objectives. We also expect to provide several key pipeline updates this year and remain on track to initiate our CID-103 study in multiple myeloma patients in the first quarter, while closely collaborating with our partners, Juventas and BioInvent, as they continue to execute internally. Our commercial team is making extensive preparations for the launch of CNCT19, for which Juventas is expecting to file a New Drug Application (NDA) with the National Medical Product Administration (NMPA) in 2021. And finally, we are pleased by the steady growth we have observed with EVOMELA, which has benefitted substantially from our continued marketing efforts and the manufacturing change we made in the second quarter; we look forward to reporting on our continued progress in the months to come."

Preliminary and Unaudited Fourth Quarter and Unaudited Full-Year 2020 Revenues, Cash Position, and 2021 EVOMELA (melphalan for injection) Revenue Guidance

The Company anticipates that it will report EVOMELA revenue of approximately $4.8 million for the fourth quarter ended December 31, 2020, and approximately $15 million for the full-year ended December 31, 2020, exceeding its projected $14 million guidance, and representing a 269% percent increase over 2019 revenue of $4.1 million.
The Company is targeting full-year 2021 revenue guidance of more than 50% growth over 2020 for EVOMELA.
CASI expects to report approximately $57.1 million of cash and cash equivalents as of December 31, 2020.
The Company’s fourth quarter and full-year 2020 revenues are preliminary and are subject to the completion of the Company’s 2020 audit. Complete fourth quarter and full-year 2020 financial results will be reported in March.
Key Highlights for 2021

CASI plans to continue to advance pipeline products through clinical trial stages in China and globally.

As previously announced, CNCT19 received Breakthrough Therapy Designation based on initial data from the ongoing single-arm, open-label, non-randomized, dose-escalation, Phase 1 study designed to determine the safety and efficacy of CNCT19 in B-ALL. The Phase 2 registration study in patients with B-NHL is currently enrolling, and we expect Juventas to initiate the Phase II registration study in B-ALL in Q1 2021. The commercial team is making preparations for the launch of CNCT19, for which Juventas is expecting to file an NDA with the NMPA in 2021.
Recently, the Company’s partner BioInvent presented early clinical data from their Phase 1/2a trial on BI-1206. Objective responses (2CRs, 4 PRs) were demonstrated in 6 out of 9 patients evaluated, providing exciting evidence that BI-1206 has the potential to restore the activity of rituximab in non-Hodgkin’s lymphoma patients who have relapsed after treatment with rituximab. CASI intends to file an IND for BI-1206 with the NMPA in 2021 to start the clinical trials in China.
Prior to EVOMELA’s entry into the Chinese market, an average of 800 stem cell transplants per year were conducted in the multiple myeloma (MM) treatment setting. Following EVOMELA’s launch in August of 2019, CASI worked closely with KOLs to drive market awareness and expedite adoption in the Chinese market. In 2020, more than 2,600 patients were treated with EVOMELA, representing a more than threefold increase over the previous year’s median usage. CASI continues to pursue a similar strategy with respect to marketing efforts and physician visits to further accelerate the adoption of stem cell transplantation as a standard of care in the MM treatment setting and will continue working to address the persistent high unmet need in this patient population.
Based on the current environment and timetable of our clinical sites, CASI is targeting the CID-103 Phase 1 study initiation in the first quarter of 2021.
Additionally, CASI plans to continue its commitment to actively engage in business development opportunities that will bring meaningful therapies to patients that fit within its product portfolio this year.

On February 16, 2021 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported the first patient has been dosed in a Phase 2 study of NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with Bristol Myers Squibb’s Opdivo (nivolumab), a PD-1 blocking antibody, versus nivolumab monotherapy (Press release, NeoImmuneTech, FEB 16, 2021, View Source [SID1234575137]). The purpose of this study is to evaluate preliminary anti-tumor activity of NT-I7 and nivolumab, compared with nivolumab alone, in patients with previously treated advanced or metastatic gastric, gastro-esophageal junction (GEJ), or esophageal adenocarcinoma, and to establish safety and tolerability of the combination in these patients.

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"We are thrilled to have dosed the first patient in this trial and to be evaluating a potential new treatment option for these cancers, especially given the current limited treatment options these patients have," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. "NT-I7’s ability to amplify T cells and excellent safety profile in cancer patients makes it an ideal candidate for a combination therapy with checkpoint inhibitors like nivolumab. It is our hope that this study will pave the way for a potential new treatment in a patient population where it is greatly needed."

The results of this Phase 2, randomized, proof-of-principle study will be used to further clinical development of this combination in selected clinical settings and tumor types.

More information on this trial can be found at www.clinicaltrials.gov, identifier: NCT04594811

Opdivo is a registered trademark of Bristol Myers Squibb.

About NT-I7
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On February 16, 2021 Viracta Therapeutics, Inc. (Viracta or the Company), a precision oncology company targeting virus-associated malignancies, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No. 16/924,082 (Press release, Viracta Therapeutics, FEB 16, 2021, View Source [SID1234575154]). The allowed application, titled "Methods of Treating Virally Associated Cancers with Histone Deacetylase Inhibitors," describes the use of Viracta’s all-oral combination product candidate of nanatinostat, the Company’s proprietary investigational drug, and valganciclovir. The allowed claims cover the anticipated dose regimen to be advanced in the planned global registration trial for the treatment of Epstein-Barr virus (EBV)-associated lymphoma and other lymphoproliferative disorders. Upon its grant, the resulting patent will provide protection into at least 2040.

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"Broadening our patent estate and extending our intellectual property protection is a strategic focus for Viracta, as we advance the development of our all-oral therapy in our global registration trial," said Ivor Royston, MD, President and Chief Executive Officer of Viracta. "We are pleased to have received this Notice of Allowance and look forward to further strengthening our patent portfolio as we expand our development in EBV-positive lymphoma and EBV-positive solid tumors."

A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application. A patent from the recently allowed application is expected to be issued in the coming months. Based on its current development and commercialization plans, Viracta expects this patent to be Orange Book eligible.

Viracta’s Planned Merger with Sunesis Pharmaceuticals

On November 30, 2020, Viracta and Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) announced the parties entered into a definitive merger agreement (the Merger Agreement) pursuant to which Viracta will combine with Sunesis in an all-stock transaction (the Merger). The merged company will focus on the advancement and expansion of Viracta’s clinical stage, precision oncology pipeline targeting virus-associated malignancies, including Viracta’s lead program for the treatment of EBV-positive relapsed/refractory lymphomas. Upon completion of the Merger, the combined company will operate under the name Viracta Therapeutics, Inc. and intends to be listed on the Nasdaq Global Market under the ticker symbol "VIRX".

Under the terms of the Merger Agreement, pending stockholder approval of the transaction, Viracta will merge with a wholly owned subsidiary of Sunesis, and stockholders of Viracta will receive shares of newly issued Sunesis common stock. Viracta stockholders are expected to own approximately 86% and Sunesis stockholders will own approximately 14% of the combined company on a fully diluted basis using the treasury stock method. The percentage of the combined company that Sunesis stockholders will own as of the close of the Merger may be subject to adjustment based on Sunesis’ net cash.

The Merger Agreement has been unanimously approved by the Board of Directors of each company. The transaction is expected to close in the first quarter of 2021, subject to approvals by stockholders of each company and other customary closing conditions.

A more complete description of the terms of and conditions of the merger can be found in Sunesis’ Form 8-K filed on November 30, 2020 with the Securities and Exchange Commission (SEC) and in the Merger Agreement, which is filed as an exhibit to that Form 8-K.

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing latent viral genes which are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in EBV-positive lymphomas in an ongoing Phase 2 clinical trial [NCT03397706].

Viracta has received Fast Track designation from the FDA for the nanatinostat and valganciclovir combination in relapsed/refractory EBV positive lymphomas, as well as orphan drug designations for the treatment of post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and T-cell lymphomas.

On February 16, 2021 Centessa Pharmaceuticals ("Centessa") reported as a novel asset-centric pharmaceutical company designed and built to advance a portfolio of highly validated program (Press release, Centessa Pharmaceuticals, FEB 16, 2021, View Source [SID1234575227])s. Centessa’s asset-centric R&D model applied at scale has assembled best-in-class or first-in-class assets, each of which is led by specialized teams committed to accelerate development and reshape the traditional drug development process. The company was founded by Medicxi and raised $250 million in an oversubscribed Series A financing led by General Atlantic and co-led by Vida Ventures and Janus Henderson Investors. Additional blue-chip investors participated in the financing, including Boxer Capital, Cormorant Asset Management, T. Rowe Price Associates, Inc., Venrock Healthcare Capital Partners, Wellington Management Company, BVF Partners L.P., EcoR1 Capital, Franklin Templeton, Logos Capital, Samsara BioCapital, LifeSci Venture Partners and an undisclosed U.S.-based, healthcare-focused fund.

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In conjunction with its launch, Centessa has completed the merger of 10 private biotech companies ("Centessa Subsidiaries") that will each continue to develop its assets with oversight from the Centessa management team. Each Centessa Subsidiary team is asset-focused, in that it prosecutes a single program or biological pathway, with leadership provided by subject matter experts who are given a high degree of autonomy to advance each program. With a singular focus on advancing exceptional science, combined with proprietary capabilities, including structure-based drug discovery and design, the subsidiary teams enable Centessa to potentially develop and deliver impactful medicines to patients.

"The vision of Centessa is to build a pharmaceutical company with a unique operational framework that aims to reduce some of the key R&D inefficiencies that classical pharmaceutical companies face because of structural constraints," said Francesco De Rubertis, Ph.D., Co-Founder and Partner at Medicxi and Chairman of the Centessa Pharmaceuticals Board of Directors. "Our operations will be driven by an asset-centric approach, whereby each Centessa Subsidiary is solely focused on the execution of its programs with oversight from the highly experienced Centessa management team. The ambition of applying asset centricity at scale is to be able to deliver life altering medicines to patients with improved efficiency by boosting R&D productivity."

Our Approach
Centessa brings together 10 companies from Medicxi’s portfolio with 15 high conviction programs led by experienced teams. Each Centessa Subsidiary is led by industry leaders and subject matter experts with deep experience directly related to key biological pathways that underpin the programs being advanced. These entrepreneurs who have catalyzed the creation of subsidiary companies will continue to advance novel science within the Centessa enterprise.

The Centessa Subsidiaries are comprised of ApcinteX, Capella BioScience, Janpix, LockBody, Morphogen-IX, Orexia Therapeutics, Palladio Biosciences, PearlRiver Bio, Pega-One and Z Factor. The current Centessa Pharmaceuticals portfolio consists of four clinical stage programs, including two that are in late-stage clinical development, and more than 10 additional programs spanning diseases with high unmet need across oncology, hematology, immunology, inflammation, neuroscience and rare diseases.

"With this first-of-its-kind model, we are bringing together programs with robust genetic and biological validation under one new pharmaceutical company that provides centralized resources to enable and empower asset-focused teams to advance highly impactful programs for patients," said Saurabh Saha, M.D., Ph.D., Centessa’s Chief Executive Officer. "This approach encourages an environment where scientific teams are incentivized to maintain an unwavering focus on advancing medicines to key go/no-go inflection points based on data-driven decisions."

Centessa will have the flexibility to deploy capital by adhering to a "follow-the-data" philosophy and will support each Centessa Subsidiary with centralized capabilities that enable advancement of its respective programs. These include manufacturing, regulatory and operational support to enable and expedite scientific prosecution of programs by subsidiary teams. Each team is uniquely incentivized to expeditiously interrogate key scientific hypotheses.

Moncef Slaoui, Ph.D, Chief Scientific Officer, Advisor of Centessa added, "In creating Centessa, we have strategically assembled our subsidiary portfolio to include programs with strong biological validation, mechanistic diversification, and teams with proprietary capabilities and insights. This high-quality portfolio aims to deliver enhanced diversification, reduced risk and asymmetric upside with a view to withstanding the inherent low probability of success associated with drug development."

Meet the Team
The Centessa Pharmaceuticals management team consists of biotech and pharmaceutical industry leaders who oversee decisions related to capital allocation, development plans and strategic transactions in partnership with the Centessa Subsidiaries.

Saurabh Saha, M.D., Ph.D., former Senior Vice President, R&D, and Global Head of Translational Medicine at Bristol Myers Squibb, has been appointed as the company’s Chief Executive Officer and a member of the Board of Directors. In addition, Moncef Slaoui, Ph.D., former Chief Scientific Advisor of Operation Warp Speed, former Chairman of R&D at GlaxoSmithKline, and Partner at Medicxi, has been appointed as Chief Scientific Officer, Advisor.

The Centessa Board of Directors includes Francesco De Rubertis, Ph.D., Medicxi, who will serve as the company’s Chairman; Aaron Kantoff, Medicxi; Brett Zbar, M.D., General Atlantic; and Arjun Goyal, M.D., M.Phil., Vida Ventures.

"We believe Centessa represents a unique opportunity in our sector," said Brett Zbar, M.D., Managing Director and Global Head of Life Sciences at General Atlantic. "The high-quality science and entrepreneurial drive within each of the Centessa Subsidiaries, combined with this deeply experienced leadership team, has the potential to bring important medicines to patients with speed and efficiency."

"Centessa’s bold vision and unique operating model are supported by compelling clinical programs, strong data and a stellar team," said Arjun Goyal, M.D., M.Phil., Co-Founder and Managing Director at Vida Ventures. "We believe Centessa’s approach can ultimately lead to impactful medicines that will benefit patients globally."