China Rewards Breakthrough Therapy Designation to Innovent & IASO’s CAR-T Cell Therapy

On February 24, 2021 EVERSANA reported The National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted Breakthrough Therapy Designation (BTD) to Innovent and IASO Biotherapeutics’ investigational CAR-T cell therapy IBI326/CT103A for the treatment of relapsed/refractory (R/R) multiple myeloma (MM) (Press release, EVERSANA, FEB 24, 2021, View Source [SID1234575533]).

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IBI326/CT103A is a fully-human anti-B cell maturation antigen (BCMA) targeted CAR-T cell therapy that utilizes lentivirus as a gene vector to transfect autologous T cells, explained Innovent.

In China, BTD is reserved for new medicines that target serious conditions for which clinical evidence suggests the drug in question may demonstrate significant improvement over available therapies.

The CDE elected BTD for IBI326/CT103A based on results from an ongoing Phase 1/2 study of the CAR-T therapy being conducted in R/R MM patients in China—IBI326/CT103A is currently amid a Phase 2 pivotal trial.

Previously, clinical results demonstrating the "impressive" safety, efficacy, and durability of response of IBI326/CT103A as observed in RRMM trials were presented at the 61st Annual Meeting of the American Society for Hematology (ASH) (Free ASH Whitepaper) in 2019.

Dr. Hui Zhou, Vice President of Medical Science and Strategy Oncology at Innovent, commented, "The breakthrough therapy designation from NMPA indicated that IBI326[/CT103A] possesses great potential in treating relapsed or refractory multiple myeloma."

Jinhua Zhang, IASO BIO Founder and CEO, added, "We anticipate expedited development and review in China, allowing more patients with relapsed or refractory multiple myeloma to benefit from this therapy at the earliest possible time."

Syndax Announces Participation at Two Upcoming Investor Conferences

On February 24, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that members of its management team will participate in two upcoming virtual investor conferences (Press release, Syndax, FEB 24, 2021, View Source [SID1234575549]):

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A panel at the Cowen 41st Annual Health Care Conference at 11:40 a.m. ET on Wednesday, March 3, 2021.

A fireside chat at the Barclays Global Healthcare Conference at 3:35 p.m. ET on Tuesday, March 9, 2021.
A live webcast of the Barclays presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

Viracta Therapeutics Announces Closing of Merger with Sunesis Pharmaceuticals and $65M Private Placement

On February 24, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported the closing of its merger with Sunesis Pharmaceuticals, Inc. (previously trading on Nasdaq under "SNSS") (Press release, Viracta Therapeutics, FEB 24, 2021, View Source [SID1234575566]). The combined, publicly traded company will focus on the advancement and expansion of Viracta’s clinical stage pipeline, including Viracta’s lead program for the treatment of Epstein-Barr virus (EBV)-positive lymphoma. Shares of the combined company, which is operating under the name Viracta Therapeutics, Inc., will commence trading on the Nasdaq Global Select Market under the ticker symbol "VIRX" on February 25, 2021.

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Immediately prior to the closing of the merger, Viracta also closed the previously announced $65 million private placement of its common stock. The private placement was comprised of a premier investor syndicate of biotechnology-focused and institutional accredited investors led by BVF Partners L.P. with participation from aMoon, Ridgeback Capital Management, Surveyor Capital (a Citadel company), Logos Capital, Samsara Biocapital, Sectoral Asset Management, Janus Henderson Investors, LifeSci Venture Partners and Serrado Capital LLC, as well as other institutional investors.

Effective as of the merger close, Viracta has over $120 million in cash and cash equivalents with an expected runway into 2024.

"The closing of this merger is transformative for Viracta, and I am extremely proud of the accomplishments of our team to get us to this moment. We believe we are strongly positioned to execute on our operating plans as a well-capitalized publicly traded company with a focused corporate strategy," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "This year we are poised to advance our novel all-oral combination therapy into a global registrational trial in EBV-positive lymphoma, and further expand into EBV-positive solid tumors, and we look forward to driving value to patients and shareholders in the years ahead. We greatly appreciate the support of our new and existing shareholders as we work to achieve these goals, which represent critical steps on the path towards addressing the unmet needs of patients suffering from these virus-associated malignancies."

Viracta’s lead program evaluates the all-oral combination of nanatinostat, its proprietary investigational drug, and valganciclovir in a Phase 2 clinical trial for the treatment of EBV-positive relapsed/refractory (R/R) lymphoma. There are currently no approved therapies for EBV-associated cancers, which are responsible for over 140,000 deaths each year. Viracta’s precision oncology combination therapy targets EBV-positive cancer cells with an inducible synthetic lethality approach. Viracta plans to initiate a registration trial for the treatment of EBV-positive lymphoma in the first half of 2021, and a Phase 1b/2 trial in EBV-positive solid tumors in 2021.

On February 24, 2021, and in connection with the closing of the merger, Sunesis effected a 1-for-3.5 reverse stock split. All issued and outstanding shares of common stock of Sunesis were subject to the reverse stock split. Upon completion of the merger, taking into consideration the reverse stock split and the exchange ratio, Viracta has approximately 37.0 million shares of common stock outstanding, with pre-merger Viracta shareholders collectively owning approximately 86.05% of the combined company and pre-merger Sunesis shareholders collectively owning approximately 13.95% of the combined company.

SVB Leerink LLC and Evercore Group LLC served as placement agents in Viracta’s private placement. Wilson Sonsini Goodrich & Rosati served as legal counsel to Viracta. MTS Health Partners, L.P. served as the financial advisor to Sunesis, and Cooley LLP served as legal counsel to Sunesis.

Management and Organization

Viracta’s management team will continue leading the combined company following this transaction, including Ivor Royston, M.D., President and Chief Executive Officer and Director. In addition to Dr. Royston, the Board of Directors will include pre-merger Viracta Board members Roger Pomerantz, M.D., F.A.C.P, Chairman of the Board, Gur Roshwalb, M.D., MBA, Michael Huang, MBA and Sam Murphy, Ph.D.

Upon the closing of the merger, former member of the Sunesis Board of Directors Nicole Onetto, M.D. will continue on the combined company’s Board of Directors. Dr. Onetto has extensive experience in oncology drug development and previously served as Deputy Director and Chief Scientific Officer at the Ontario Institute for Cancer Research, Chief Medical Officer at ZymoGenetics and OSI Pharmaceuticals, and in senior management positions at Bristol Meyers Squibb, Nexstar Pharmaceuticals (acquired by Gilead Sciences), and Immunex.

Also concurrent with the closing of the merger, Thomas Darcy has been appointed to the Viracta Board of Directors. Mr. Darcy brings financial expertise and extensive experience in the management of public life science companies to Viracta’s Board. Mr. Darcy was previously a co-founder and director of Tocagen Inc. from 2007-2020 and Executive Vice President (EVP) and Chief Financial Officer (CFO) of Tocagen from 2007-2017. Prior to Tocagen, Mr. Darcy served as EVP and CFO of Science Applications International Corporation, a Fortune 500 science and technology company, as well as in leadership roles as an audit partner of PricewaterhouseCoopers, LLP.

Surface Oncology to Participate in Upcoming March Investor Conferences

On February 24, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation therapies targeting the tumor microenvironment, reported that Rob Ross, M.D., incoming chief executive officer, will participate in the following virtual investor conferences (Press release, Surface Oncology, FEB 24, 2021, View Source [SID1234575510]):

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Cowen 41st Annual Healthcare Conference, Monday, March 1, 2021, at 10:20 a.m. ET as part of the Novel IO panel.

H.C. Wainwright Global Life Sciences Conference, March 9-10, 2021, presentation recording will be available to investors during the course of the conference.
The presentations will focus on Surface’s lead programs, SRF617 (targeting CD39) and SRF388 (targeting IL-27), as well as Surface’s emerging pre-clinical program, SRF114 (targeting CCR8).

Lilly to Participate in Cowen Health Care Conference

On February 24, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Cowen and Company 41st Annual Health Care Conference on Thursday, March 4, 2021. Daniel Skovronsky, M.D., Ph.D., Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories, will participate in a fireside chat at 9:10 a.m., Eastern Time (Press release, Eli Lilly, FEB 24, 2021, View Source [SID1234575534]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.