On March 7, 2021 China Oncology Focus Limited (COF), an affiliate of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharm, HKEX: 950) reported that its anti-PD-L1 antibody, Socazolimab, licensed from Sorrento to COF for the greater China territory, has been cleared to begin a multicenter, randomized, double blinded, parallel-group clinical trial of Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as ZKAB001) combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer (Press release, Sorrento Therapeutics, MAR 7, 2021, View Source [SID1234576176]). The clearance is based on the results from an earlier Phase Ib trial in which Socazolimab combined with carboplatin and etoposide showed a promising efficacy and safety profile in patients with extensive-stage small-cell lung cancer. The Principal Investigator for the clinical trial will be Professor Shun Lu from the Shanghai Chest Hospital and the site is expected to initiate patient recruitment in the second quarter of 2021.

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Socazolimab is an in-licensed product from Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") for the People’s Republic of China, Hong Kong, Macau and Taiwan. Three Phase I clinical trials of Socazolimab monotherapy have been completed: (1) recurrent or metastatic cervical cancer; (2) advanced urothelial carcinoma; and (3) high-grade osteosarcoma after adjuvant chemotherapy for maintenance purposes. For recurrent or metastatic cervical cancer, a pivotal study has been completed and breakthrough therapy designation was granted by the NMPA in February 2021. Lee’s Pharm expects to file the New Drug Application for Socazolimab in recurrent or metastatic cervical cancer in the second quarter of 2021. Apart from monotherapies, several studies of Socazolimab combining with chemotherapy are being conducted in advanced urothelial carcinoma (Phase Ib), extensive-stage small-cell lung cancer (Phase III), and neoadjuvant treatment in esophageal carcinoma (Phase Ib+II).

Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, stated, "We at Sorrento are pleased with the collaboration with our colleagues at Lee’s Pharm and with the further advances of our first therapeutic antibody partnership in Socazolimab."

About Socazolimab

Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB library platform. COF received exclusive rights to develop and commercialize the antibody for Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Socazolimab has the following potential advantages over its competitors:

Fully human antibody potentially allows it to have minimal immunogenicity; demonstrated by its negative antigen-derived antibody (ADA) generation in humans in studies to date.
Potentially lower dose required to achieve efficacy compared to other anti-PD-L1 antibodies.
Dual mechanism of action observed with both immune-checkpoint inhibition and antibody-dependent cellular cytotoxicity (ADCC) effect.
The antibody has been tested or is being tested in various cancer indications including recurrent or metastatic cervical cancer, maintenance therapy for high-grade osteosarcoma after adjuvant chemotherapy, locally advanced and metastatic urothelial carcinoma, extensive small cell lung cancer in combination with carboplatin and etoposide, and advanced urothelial carcinoma in combination with albumin-bound paclitaxel and esophageal carcinoma.

On March 5, 2021 Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), reported that The Lancet has published data from the pirtobrutinib (previously referred to as LOXO-305) global Phase 1/2 BRUIN clinical trial in relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin’s lymphomas (Press release, Eli Lilly, MAR 5, 2021, View Source [SID1234576138]). Pirtobrutinib is an investigational, highly selective, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor.

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The data in the publication include key findings previously presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The publication includes safety and efficacy data for 323 relapsed or refractory patients (including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström’s macroglobulinemia and 66 with other B-cell lymphomas) that were enrolled to the BRUIN Phase 1/2 trial as of September 27, 2020.

"Patients with B-cell malignancies who have been previously treated with the most commonly used regimens represent an area of growing and urgent unmet need", said Anthony Mato, M.D., director of the CLL Program at Memorial Sloan Kettering Cancer Center and lead author of The Lancet paper. "These data establish that the third generation BTK inhibitor pirtobrutinib possesses a compelling efficacy and safety profile with the potential to address this exact unmet need."

"While covalent BTK inhibitors and venetoclax have transformed the treatment of CLL, we now see many patients needing new therapeutic alternatives," said Brian Koffman, MDCM (retired), chief medical officer of the CLL Society. "In the coming years, we envision that this need will grow, and we are pleased to see data that pirtobrutinib may be a new option for these patients."

"We are extremely pleased to see the pirtobrutinib data from the ongoing Phase 1/2 BRUIN study published in The Lancet and shared with the broader clinical community", said David Hyman, M.D., chief medical officer of Loxo Oncology at Lilly. "The data to date from this study have continued to strengthen our conviction that pirtobrutinib has the potential to meaningfully improve the inadequate treatment options available to CLL and MCL patients who have been previously treated with the main treatment classes of today’s standard of care. We are focused on quickly advancing the pirtobrutinib development program, including through a series of Phase 3 studies that will be initiated over the course of 2021."

In addition to the Phase 1/2 BRUIN clinical trial, Loxo Oncology at Lilly plans to initiate four global, randomized Phase 3 studies for pirtobrutinib in 2021, three in CLL and one in MCL.

About Pirtobrutinib (LOXO-305)
Pirtobrutinib is an investigational, oral, highly selective, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including chronic lymphocytic leukemia, mantle cell lymphoma, Waldenström macroglobulinemia, and marginal zone lymphoma. Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations. In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition. Pirtobrutinib was designed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate, preserve activity in the presence of the C481 acquired resistance mutations, and avoid off-target kinases that have complicated the development of both covalent and investigational non-covalent BTK inhibitors. Interested patients and physicians can contact the Loxo Oncology at Lilly Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305 or email [email protected].

About the BRUIN Phase 1/2 Trial
This first-in-human, global, multi-center Phase 1/2 trial evaluates pirtobrutinib as a single agent in patients with previously treated chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin’s lymphomas (NHL). The trial includes a Phase 1 dose escalation phase and a Phase 2 dose expansion phase. The Phase 1 dose escalation enrolls patients with CLL/SLL or NHL who have received at least two prior lines of therapy and have progressed or are intolerant to standard of care. The dose escalation phase followed a "3+3" design with pirtobrutinib dosed orally in 28-day cycles. As dose cohorts were cleared, additional patients could enroll in cleared cohorts and intra-patient dose escalation was permitted. The primary objective of the Phase 1 portion of the trial is to determine the maximum tolerated dose and recommended Phase 2 dose. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Overall Response Rate (ORR) and Duration of Response, as determined by appropriate histology-specific response criteria). In the Phase 2, patients are enrolled across various cohorts, depending on disease type and prior therapy. The primary endpoint for Phase 2 is ORR. Secondary endpoints include duration of response (DOR), overall survival (OS), safety, and pharmacokinetics (PK).

About Loxo Oncology at Lilly
Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo Oncology at Lilly brings together the focus and spirit of a biotech with the scale and resources of large pharma, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.

On March 5, 2021 Compass Therapeutics, Inc. (OTCQB: CMPX), a clinical-stage biotechnology company developing proprietary antibody therapeutics intended to engage the immune system to treat both solid tumors and hematological malignancies, reported fourth quarter and full year 2020 financial results and provided a business update (Press release, Compass Therapeutics, MAR 5, 2021, View Source [SID1234576157]).

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"2020 was a transformational year for Compass," said Thomas J. Schuetz, M.D., Ph.D., co-founder and chief executive officer. "We initiated the dose expansion stage (Phase 1b) of our Phase 1 study for our lead product candidate CTX-471 (CD137 agonist) in September after successfully completing the dose escalation stage of the study in July. Importantly, among the six evaluable patients in the dose expansion stage of the study, who have reached their week 9 evaluation, five patients had stable disease. Subsequently, one of those patients who has advanced small cell lung cancer had a partial response (PR) at week 17. In addition, in the dose escalation stage of the study (Phase 1a) we reported a patient with melanoma of mucosal origin who had a 24% decline in his linear tumor burden. These early signs of anti-tumor activity are encouraging, and we look forward to receiving more CTX-471 data as the study progresses. Top-line data from the Phase 1b stage of the study is expected in the second half of the year, and we could initiate a Phase 2/3 study in the second half of 2022.

"On the financing side, we completed a $60M private placement and became a public reporting company in June 2020. We also recently announced that our common stock has been cleared for trading on the OTCQB tier of the OTC market. These events represent significant achievements for the company as we continue to build the infrastructure to support the future growth of Compass."

Development Pipeline Update and Highlights:

CTX-471, a CD137 Agonist monoclonal antibody:

Completed CTX-471 Phase 1a dose escalation study and found CTX-471 to be generally well-tolerated
Initiated CTX-471 Phase 1b dose expansion study and treated 11 patients in the study as of February 28, 2021
Of the six evaluable patients in the dose expansion part of the study, five patients with advanced solid tumors who have reached their week 9 evaluation had stable disease. Additionally, a patient with advanced small cell lung cancer had a PR at week 17 of the study
Data published in the peer-reviewed Journal of Clinical Investigation Insight (JCI Insight) demonstrated the preclinical monotherapy activity and safety of CTX-471 across various syngeneic tumor models
CTX-8371, a PD-1 X PD-L1 Bispecific:

Initiated IND-enabling studies and the GMP manufacturing campaign
Generated preclinical data that demonstrated the differentiation between CTX-8371 and commercially available single PD-1 blockers, single PD-L1 blockers or combinations of PD-1 and PD-L1 blockers
Initiated preparation of IND submission materials with the goal of submission of the IND in early 2022 and potential for early safety and top-line data later in 2022
Financial Highlights:

Completed $60.5M in gross proceeds ($54.2M net of expenses) private placement financing in combination with reverse merger with a public shell that transitioned the company to a public company and enabled listing of the company stock on the OTC market under the symbol "CMPX"
Established public company reporting process including internal controls over financial reporting
Other Business Updates:

Promoted Vered Bisker-Leib, Ph.D., to Chief Operating Officer in January and President and COO in July
Strengthened our board with the addition of Brett Kaplan as an independent board member and chair of the audit committee of the board and audit committee financial expert
Published preclinical data in the journal Science supporting the potential of CTX-2026, a novel antibody to the butyrophilin BTN3A1 in ovarian cancer tumor models
Based on a review of our pipeline, made a strategic decision to deprioritize the development of our NKp30 innate cell engager platform and discontinued efforts to advance CTX-8573 to IND-enabling studies
Entered into a new lease agreement for our lab and office space and relocated our operations to 80 Guest Street, Boston, MA
Financial Results for Fourth Quarter and Full Year Ended December 31, 2020

Net loss for the full year 2020 was $29.5 million or $0.96 per common share, compared to $34.7 million or $5.19 per common share for the full year 2019. Net loss for the fourth quarter of 2020 was $8.4 million or $0.16 per common share, compared to $6.6 million or $0.95 per common share in the fourth quarter of 2019.

Research and development (R&D) Expenses

R&D expenses were $14.9 million for the full year of 2020, as compared to $22.4 million for the same period in 2019, a reduction of $7.5 million or 34%. The lower costs were principally driven by a strategic reduction in head count and the completion of preclinical efforts for CTX-471. R&D expenses were $4.4 million during the fourth quarter of 2020, as compared to $3.3 million for the same period in 2019, an increase of $1.1 million or 33%. The higher costs were primarily related to manufacturing expenses and toxicological studies for CTX-8371.

General and Administrative (G&A) Expenses

G&A expenses were $12.9 million for the full year 2020, as compared to $11.6 million for the same period in 2019, an increase of $1.3 million or 11%. The higher costs were principally driven by an increase in stock-based compensation expenses and costs associated with the transition of the company from private to public. G&A expenses were $3.5 million during the fourth quarter of 2020, as compared to $3.1 million for the same period in 2019, an increase of $0.4 million or 14%. The higher costs were driven by higher stock-based compensation expenses.

Cash Position

As of December 31, 2020, cash and cash equivalents were $47.1 million as compared to $25.3 million as of December 31, 2019, providing the Company with an anticipated cash runway into the second quarter of 2022. During 2020, the Company increased its cash position through proceeds from financing activities of $48.5 million, primarily from $54.2 million of net proceeds from issuance of common stock, partially offset with loan payments of $5.6 million. The Company used $26.8 million of cash to fund operations.

On March 4, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that it has priced an offering of $400.0 million aggregate principal amount of 2.550% Senior Notes due 2031 at an issue price of 99.965% of the principal amount and $400.0 million aggregate principal amount of 3.625% Senior Notes due 2051 at an issue price of 99.999% of the principal amount (Press release, PerkinElmer, MAR 4, 2021, View Source [SID1234576104]).

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The issuance of the notes is expected to close on March 8, 2021, subject to customary closing conditions. The notes will pay interest on a semi-annual basis.

PerkinElmer plans to use approximately $561 million of the net proceeds of the offering to repay amounts borrowed under its senior unsecured revolving credit facility to fund a portion of the purchase price for its acquisition of Oxford Immunotec Global PLC. PerkinElmer expects to use the remaining net proceeds of the offering to repay at maturity a portion of its outstanding €300.0 million aggregate principal amount of 0.600% senior notes due 2021.

The joint book-running managers for the offering are J.P. Morgan Securities LLC, BofA Securities, Inc., and Wells Fargo Securities, LLC.

The offering is being made pursuant to an effective registration statement on Form S-3 (including a prospectus) filed with the U.S. Securities and Exchange Commission ("SEC"). Prospective investors should read the prospectus forming a part of that registration statement and the prospectus supplement related to the offering and the other documents that PerkinElmer has filed with the SEC for more complete information about the company and this offering. These documents are available at no charge by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the prospectus supplement and the accompanying prospectus relating to the offering can be obtained by calling one of the joint book-running managers at the following: J.P. Morgan Securities LLC collect at 1-212-834-4533 or BofA Securities, Inc. toll-free at 1-800-294-1322.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes, nor shall there be any offer, solicitation or sale of the notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On March 5, 2021 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported that the Company’s management team will participate in a fireside chat at the Roth Conference being held from March 15-17, 2021 (Press release, Humanigen, MAR 5, 2021, View Source [SID1234576158]). An Advance Video Webinar will also be available starting on Monday, March 8, 2021, not March 5, 2021 as previously communicated.

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Management will discuss its Phase 3 clinical trial of lenzilumab in patients hospitalized with COVID-19 including the timeline for the topline data release and the submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration, provide an update on the commercial preparation ahead of a potential EUA for lenzilumab and an overview of the Company’s other development programs.

Details for the upcoming webcasts are below:

Roth Conference

Advance Video Webinar viewable starting on Monday, March 8, 2021
Webcast Link: View Source

Live Fireside Chat with Roth Analyst Tony Butler
Date: Tuesday, March 16, 2021
Time: 1:00 PM ET
Time: View Source