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Advaxis to Present at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting

On April 28, 2021 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that will present data from Part B of the Phase 1 study of ADXS-503 in combination with pembrolizumab at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually, on June 4-8, 2021 (Press release, Advaxis, APR 28, 2021, View Source [SID1234578641]).

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Presentation Details:

Title: A phase 1 study of an off-the-shelf, multi-neoantigen vector (ADXS-503) in subjects with metastatic non-small cell lung cancer (NSCLC) progressing on pembrolizumab as last therapy.
Session Type: Poster Session
Abstract Number: 2616
Date and Time: June 4, 2021, 9:00 AM (EDT)

BRUKINSA® (Zanubrutinib) Demonstrates Superior Objective Response Rate
by Investigator Assessment and Reduced Rates of Atrial Fibrillation or Flutter at
Interim Analysis in Head-to-Head Trial Against Ibrutinib in Chronic Lymphocytic Leukemia

On April 28, 2021 BeiGene (NASDAQ: BGNE; HKEX: 06160) reported positive results from a planned interim analysis of the Phase 3 ALPINE trial comparing BRUKINSA (zanubrutinib) against ibrutinib in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, BeiGene, APR 28, 2021, View Source [SID1234578640]).

BRUKINSA met the primary endpoint of the trial, demonstrating non-inferiority in objective response rate (ORR) by both investigator and independent review committee (IRC) assessments (p < 0.0001). The trial also demonstrated superior ORR with a statistically significant improvement in ORR for BRUKINSA vs. ibrutinib (p = 0.0006) by investigator assessment, as well as a numerically higher ORR but not statistically significant improvement by IRC (p = 0.0121 compared to the two-sided stringent statistical boundary of p < 0.0099 set for the interim analysis). The interim analysis from this fully-enrolled, ongoing trial is based on 415 of 652 patients followed for a minimum of 12 months.

Data pertaining to progression-free survival (PFS) in the 652 patients, a secondary endpoint of the trial, were immature at the data cutoff for the interim analysis. However, the descriptive summaries of PFS showed an early trend favoring BRUKINSA.

The trial also met a pre-specified secondary endpoint related to safety. Compared to ibrutinib, BRUKINSA demonstrated a statistically significant lower risk of atrial fibrillation or flutter, which is characterized by an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications. Overall, the safety profile of BRUKINSA was consistent with the previously seen profile in its clinical development program.

ALPINE is BeiGene’s second Phase 3 head-to-head trial comparing BRUKINSA to ibrutinib.

Jane Huang, M.D., Chief Medical Officer, Hematology of BeiGene said, "The interim results from this head-to-head trial demonstrated that, as a selective inhibitor designed to deliver sustained and continuous inhibition of BTK, BRUKINSA provides CLL patients with improvements in response and reduced rates of atrial fibrillation or flutter compared to ibrutinib. Data from this interim analysis, in addition to BRUKINSA’s comprehensive clinical program, provide important new information to support its benefit-risk profile."

BeiGene plans to consult with global regulatory authorities on next steps and present these data at an upcoming major medical conference. ORR per IRC will be further assessed at the planned final analysis, and patients will be followed for analyses on key secondary endpoints including PFS.

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults, with a global incidence of approximately 114,000 new cases in 2017.1,2 CLL affects white blood cells or lymphocytes in the bone marrow.1 Proliferation of cancer cells (leukemia) in the marrow result in reduced ability to fight infection and spread into the blood, which affects other parts of the body including the lymph nodes, liver and spleen.1,3 The BTK pathway is a known route that signals malignant B cells and contributes to the onset of CLL.4 Small lymphocytic lymphoma (SLL) is a non-Hodgkin’s lymphoma affecting the B-lymphocytes of the immune system, which shares many similarities to CLL but with cancer cells found mostly in lymph nodes.5

About ALPINE

ALPINE is a randomized, global Phase 3 trial (NCT03734016) comparing BRUKINSA against ibrutinib in previously treated patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

In the trial, a total of 652 patients were randomized into two arms with the first receiving BRUKINSA (160 mg orally twice daily) and the second receiving ibrutinib (420 mg orally once daily) until disease progression or unacceptable toxicity. The primary analysis of objective response rate (ORR), defined by pre-specified non-inferiority of BRUKINSA versus ibrutinib, was assessed by investigator and independent review committee (IRC) using the modified 2008 iwCLL guidelines with modification for treatment-related lymphocytosis for patients with CLL and per Lugano Classification for non-Hodgkin’s lymphoma for patients with SLL. There was hierarchical testing of non-inferiority followed by superiority in ORR as assessed by investigator and IRC. Key secondary endpoints include progression-free survival (PFS), duration of response, overall survival, and incidence of adverse events. The study is ongoing, with pre-specified endpoints of ORR and PFS to be evaluated at the planned final analysis expected in 2022.

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.
BRUKINSA is approved in the following indications and regions:

•For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;

•For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;

•For the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;

•For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021); and

•For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021).

To-date, more than 30 marketing authorization applications in multiple indications have been submitted outside of the United States and China, covering the EU and more than 20 other countries.

*This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

**This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

PRA Health Sciences, Inc. Reports First Quarter 2021 Results

On April 28, 2021 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended March 31, 2021 (Press release, PRA Health Sciences, APR 28, 2021, View Source [SID1234578639]).

"I am delighted to report double-digit revenue and earnings growth for the first quarter of 2021" said Colin Shannon, PRA’s President and Chief Executive Officer. "The year has started on a strong note and we continue to be well-positioned for the remainder of 2021. We are working diligently preparing to close our merger with ICON, which is anticipated to close in July of this year."

Net new business for our Clinical Research segment for the three months ended March 31, 2021 excluding reimbursement revenue was $797.2 million, representing growth of 31.8% and a net book-to-bill ratio of 1.24 for the period. Net new business for our Clinical Research segment for the three months ended March 31, 2021 including reimbursement revenue was $1,154.4 million, representing growth of 20.8% and a net book-to-bill of 1.33 for the period. We continue to see strength across the entire Clinical Research segment and our new business continues to be diversified across a number of different therapeutic areas. The mix of our new business awards continues to be in line with prior years with approximately 50% of our new business coming from large pharma and the remainder coming from mid-sized pharma and biotech. Net new business, excluding reimbursement revenue, contributed to an ending backlog at March 31, 2021 of $5.5 billion, an increase of 16.4% year over year.

For the three months ended March 31, 2021, revenue was $933.8 million, which represents an increase of 19.1%, or $150.1 million, compared to the three months ended March 31, 2020 at actual foreign exchange rates. On a constant currency basis, revenue increased $137.6 million, an increase of 17.6% compared to the first quarter of 2020. By segment, the Clinical Research segment generated revenues of $866.6 million, representing an increase of 19.3%, while the Data Solutions segment generated revenues of $67.1 million, representing an increase of 16.6%. Our customer concentration continues to be well-diversified, with our top five clients representing approximately 35% of revenue, with no client representing more than 10% of our revenue during the quarter.

Direct costs, exclusive of depreciation and amortization, were $472.0 million during the three months ended March 31, 2021 compared to $403.9 million for the three months ended March 31, 2020 at actual foreign exchange rates. On a constant currency basis, direct costs increased $57.5 million compared to the first quarter of 2020. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment as we continue to hire to support our growth and increased data costs in our Data Solutions segment as we renew existing contracts and add new data assets. Direct costs were 50.5% of revenue during the first quarter of 2021 compared to 51.5% of revenue during the first quarter of 2020.

Selling, general and administrative expenses were $122.8 million during the three months ended March 31, 2021 compared to $107.0 million for the three months ended March 31, 2020. Selling, general and administrative costs were 13.1% of revenue during the first quarter of 2021 compared to 13.6% of revenue during the first quarter of 2020.

GAAP net income was $56.9 million for the three months ended March 31, 2021, or $0.86 per share on a diluted basis, compared to GAAP net income of $40.7 million for the three months ended March 31, 2020, or $0.63 per share on a diluted basis.

EBITDA was $114.4 million for the three months ended March 31, 2021, representing an increase of 10.8% compared to the three months ended March 31, 2020. Adjusted EBITDA was $135.8 million for the three months ended March 31, 2021, representing an increase of 21.1% compared to the three months ended March 31, 2020.

Adjusted net income was $89.6 million for the three months ended March 31, 2021, representing an increase of 33.0% compared to the three months ended March 31, 2020. Adjusted net income per diluted share was $1.35 for the three months ended March 31, 2021, representing an increase of 28.6% compared to the three months ended March 31, 2020.
Acquisition by ICON plc

On February 24, 2021, we entered into the a definitive merger agreement with ICON plc (ICON), ICON US Holdings Inc. (US Holdco) and Indigo Merger Sub, Inc. (Merger Sub). Under the terms of the merger agreement, Merger Sub will merge with and into PRA, with PRA surviving as a wholly owned subsidiary of ICON and US HoldCo. Upon successful completion of the merger, our stockholders will receive $80.00 per share in cash and 0.4125 ICON ordinary shares for each share of our common stock.

Conference Call Details

PRA will not hold a first quarter 2021 conference call.

Additional Information

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per share, to the corresponding GAAP measures is included in this press release.

A financial supplement with first quarter 2021 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q1 2021 Earnings Presentation."

Corporate Slide Presentation of Galera Therapeutics, Inc. dated April 28, 2021

On April 28, 2021 Galera Therapeutics, Inc. (the "Company") Presented the Corporate Presentation (Presentation, Galera Therapeutics, APR 28, 2021, View Source [SID1234578638]).

ORIC Pharmaceuticals to Present Initial Data from Ongoing Phase 1b Study of ORIC-101 in Combination with Nab-paclitaxel at the 2021 ASCO Annual Meeting

On April 28, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that two abstracts highlighting preliminary results from the Phase 1b study of ORIC-101 in combination with nab-paclitaxel have been accepted for poster presentations during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4 – 8, 2021 (Press release, ORIC Pharmaceuticals, APR 28, 2021, View Source [SID1234578637]).

"We are pleased to participate in the 2021 ASCO (Free ASCO Whitepaper) program and report initial data from the ongoing Phase 1b study of ORIC-101, our glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors," said Jacob Chacko, M.D., president and chief executive officer. "This represents the first of two data readouts from our two ongoing Phase 1b trials of ORIC-101. We expect to report initial data from the second trial, ORIC-101 in combination with enzalutamide in prostate cancer, in the second half of this year."

Poster Presentations:

Presentation Title: Initial results from a Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors
Date and Time (On-Demand): June 4, 2021 (6:00 am PT)
Abstract Number: 2553

Presentation Title: Biomarker results supporting selection of RP2D from a Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors
Date and Time (On-Demand): June 4, 2021 (6:00 am PT)
Abstract Number: 3110

The posters will be available at www.oricpharma.com/publications following presentation at the meeting.