Clover Biopharmaceuticals Raises $230 Million in Oversubscribed Series C Financing

On February 22, 2021 Clover Biopharmaceuticals, a global clinical-stage biotechnology company developing transformative biologics as vaccines and therapeutics for the world’s most debilitating diseases, reported the completion of an oversubscribed $230 million Series C financing (Press release, Clover Biopharmaceuticals, FEB 22, 2021, View Source [SID1234575399]). This financing round brings Clover’s total capital raised in the last 12 months to over $400 million (over RMB 2.5 billion). The Series C round was co-led by GL Ventures and Temasek, with participation from Oceanpine Capital, OrbiMed and existing investor Delos Capital.

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The proceeds will support the continued development and expansion of Clover’s pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag© technology platform. Clover expects to initiate a global Phase 2/3 efficacy trial for SCB-2019 (S-Trimer), its COVID-19 vaccine candidate, in the first half of 2021 and has initiated production planning for potentially hundreds of millions of vaccine doses in 2021. Clover has also initiated development of additional vaccine programs including multivalent SARS-CoV-2 (covering multiple variants), rabies and influenza. SCB-313, a novel TRAIL-Trimer fusion protein targeting intracavitary malignancies (including malignant ascites), is in multiple ongoing Phase I clinical trials in Australia and China, with encouraging efficacy signals and a favorable safety profile demonstrated to-date. Clover also expects to advance multiple new pipeline products to the clinic in 2021 and further expand its in-house R&D and cGMP commercial biomanufacturing capabilities.

Joshua Liang, Chief Executive Officer and Board Director of Clover said, "Our goal has always been to bring our innovative vaccines and biologic therapies to the world by leveraging our proprietary Trimer-Tag© platform technology, state-of-the art cGMP biomanufacturing capabilities, and passionate team of over 500 scientists, experienced industry professionals and advisors. We look forward to using the proceeds from this financing round to accelerate development of our pipeline, expand our in-house R&D and biomanufacturing capabilities and move closer to our mission of improving the quality of life and wellbeing for patients around the world."

Michael Yi, Co-CIO and Partner of Hillhouse Capital, said: "We are pleased to support the continuous development of Clover’s promising pipeline, centered on its novel Trimer-Tag© technology platform. Clover has had a tremendous year of growth with the rapid advancement of the COVID-19 S-Trimer vaccine candidate through clinical development, and we look forward to potentially seeing the Company provide this much-needed vaccine to communities in need across the globe. In addition, Clover’s robust and differentiated pipeline of vaccines and biologic therapeutics hold great promise to make a difference in other infectious diseases and oncology indications."

Personalis to Report Fourth Quarter 2020 Financial Results on February 25, 2021

On February 22, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its fourth quarter 2020 financial results after the market closes on Thursday, February 25, 2021 (Press release, Personalis, FEB 22, 2021, View Source [SID1234575398]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 5065084. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

Eagle Pharmaceuticals to Host Fourth Quarter and Full Year 2020 Financial Results and Pipeline Review on March 2, 2021

On February 22, 2021 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that the Company will release its 2020 fourth quarter and full year financial results on Tuesday, March 2, 2021, before the market opens (Press release, Eagle Pharmaceuticals, FEB 22, 2021, View Source [SID1234575397]).

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Scott Tarriff, Chief Executive Officer, Brian Cahill, Chief Financial Officer, senior members of Eagle’s executive leadership team, and other distinguished external speakers will host a 90- minute conference call as follows:

A replay of the conference call will be available for one week after the call’s completion by dialing 800-934-7612 (US) or 402-220-6980 (International) and entering conference call ID EGRXQ420. The webcast will be archived for 30 days at the aforementioned URL.

Alpine Immune Sciences to Participate in Upcoming Virtual Healthcare Conferences

On February 22, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the company will participate at the Cowen 41st Annual Virtual Health Care Conference, H.C. Wainwright Global Life Sciences Conference, and Oppenheimer 31st Annual Virtual Healthcare Conference (Press release, Alpine Immune Sciences, FEB 22, 2021, View Source [SID1234575396]).

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Cowen 41st Annual Virtual Health Care Conference
Date: Monday, March 1, 2021
Time: 10:20 a.m. ET/7:20 a.m. PT
Event: Novel IO Panel

H.C. Wainwright Global Life Sciences Conference
Date: Tuesday, March 9, 2021
Time: Available on demand beginning 7:00 a.m. ET/4:00 a.m. PT
Event: Company Presentation

Oppenheimer 31st Annual Virtual Healthcare Conference
Date: Wednesday, March 17, 2021
Time: 1:50 p.m. ET/10:50 a.m. PT
Event: Company Presentation

A webcast of the H.C. Wainwright and Oppenheimer presentations will be available online in the investor relations section of the company’s website at View Source A replay of the presentations will be available on the company website for 90 days following the webcast.

Agilent PD-L1 IHC 22C3 pharmDx Receives Expanded FDA Approval in Non-small Cell Lung Cancer (NSCLC)

On February 22, 2021 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved the company’s PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (NSCLC) (Press release, Agilent, FEB 22, 2021, View Source [SID1234575395]). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo (cemiplimab-rwlc). This announcement underscores Agilent’s continuing commitment to the development of IHC-based diagnostics for cancer therapy.

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"With the FDA approval of PD-L1 IHC 22C3 pharmDx as a companion diagnostic for treatment with Libtayo monotherapy in advanced NSCLC, Agilent further strengthens its ability to elevate pathologist confidence in reporting results to oncologists and bolsters our role as a global pioneer in developing companion diagnostics for targeted treatments."

Lung cancer is the leading cause of cancer death in both men and women in the United States, with NSCLC making up 85% of all lung cancer cases.1,2 PD-L1 expression is a biomarker for response to anti-PD-1 therapy in NSCLC; this expanded indication enables pathologists to identify patients with advanced NSCLC who may be eligible for treatment with Libtayo. Currently, PD-L1 IHC 22C3 pharmDx is the only companion diagnostic with FDA approval for this use.

"Anti-PD-1 therapies, including Libtayo, continue to broaden the potential for the treatment of patients across different cancer types," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "With the FDA approval of PD-L1 IHC 22C3 pharmDx as a companion diagnostic for treatment with Libtayo monotherapy in advanced NSCLC, Agilent further strengthens its ability to elevate pathologist confidence in reporting results to oncologists and bolsters our role as a global pioneer in developing companion diagnostics for targeted treatments."

Regeneron and Sanofi developed Libtayo and partnered with Agilent for the use of PD-L1 IHC 22C3 pharmDx to evaluate PD-L1 expression in patients in the pivotal EMPOWER-Lung 1 clinical trial.3

PD-1 immunotherapies such as Libtayo offer new treatment options for patients with advanced NSCLC, for whom the 60-month overall survival rate is 0–10% in patients with stage IVA–IVB disease.2

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.3