On April 21, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that its PLACCINE platform technology at the World Vaccine Congress taking place in Washington D.C (Press release, Celsion, APR 21, 2022, View Source [SID1234612748]). In an oral presentation during a Session on Cancer and Immunotherapy, Dr. Khursheed Anwer, Celsion’s Chief Science Officer, highlighted the Company’s technology platform in his presentation entitled: "Novel DNA Approaches for Cancer Immunotherapies and Multivalent Infectious Disease Vaccines." PLACCINE is one of three platform technologies Celsion has for a range of therapeutics in oncology and immunotherapy. A copy of Dr. Anwer’s presentation is available on the investor portion of the Celsion website under Scientific Presentations.

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"PLACCINE is demonstrating the potential to be a powerful platform that provides for rapid design capability for targeting two or more different variants of a single virus in one vaccine," said Dr. Khursheed Anwer, Chief Science Officer at Celsion. "There is a clear public health need for vaccines today that address more than one strain of viruses, like COVID-19, which have fast evolving variant capability to offer the widest possible protection. Murine model data has thus far been encouraging and suggests our approach provides not only flexibility, but also the potential for efficacy comparable to benchmark COVID-19 commercial vaccines with durability to protect for more than 6 months."

Dr. Anwer continued, "In the murine model, our multivalent vaccine targeted against two different variants showed to be immunogenic as determined by the levels of IgG, neutralizing antibodies, and T-cell responses. Additionally, our multivalent vaccine was equally effective against two different variants of the COVID-19 virus while the commercial mRNA vaccine appeared to have lost some activity against the newer variant. We are continuing to evaluate our technology and look forward to the results from our ongoing proof-of-concept non-human primate study evaluating our PLACCINE vaccine against the challenge from live SARS-CoV-2 virus in the second quarter, with durability results available in the second half of this year."

PLACCINE is the company’s first-in-class nucleic-acid vaccine platform used to design its next-generation vaccine technology against multiple antigens. PLACCINE was derived from the Company’s TheraPlas platform and was designed to develop vaccines against infectious diseases that are administered by intramuscular (IM) injection. The platform allows for straightforward adoption of the vaccines to additional applications such as cancer vaccines. PLACCINE demonstrates Celsion’s deep scientific know-how and extensive expertise in the design of novel delivery formulations as well as novel DNA constructs.

Michael H. Tardugno, chairman, president and chief executive officer of Celsion, noted "We are pleased to have our PLACCINE platform and technology highlighted at this prestigious conference. A vaccine that targets multiple strains at once, which could also provide longer lasting immunity, is a logical next step in the COVID-19 vaccination strategy. With our proof-of-concept studies underway, we are optimistic our approach will prove to offer meaningful benefits over current vaccines targeting the SARS-CoV-2 virus."

On April 21, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported that Dr. Milton Werner, Ph.D., the Company’s President & Chief Executive Officer will participate in a fireside chat at the B. Riley Securities’ 2022 Virtual Neuro & Ophthalmology Conference on April 28, 2022 at 2:30pm ET (Press release, Inhibikase Therapeutics, APR 21, 2022, View Source [SID1234612757]).

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A live webcast of the presentation will be available for on-demand viewing under "News & Events" in the Investors section of the Company’s website, www.inhibikase.com. An archived replay of the webcast will be available for approximately 30 days. In addition, the Company recently hosted a virtual Key Opinion Leader investor event on April 20, 2022. A replay of the event can be accessed here.

On April 21, 2022 OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, reported the peer-reviewed publication of results from a Phase 1b trial evaluating navicixizumab, an anti-DLL4/VEGF bispecific antibody, combined with paclitaxel, in patients with platinum-resistant ovarian cancer (PROC) (Press release, OncXerna Therapeutics, APR 21, 2022, View Source [SID1234612760]). The paper, entitled, "Phase Ib Study of Navicixizumab Plus Paclitaxel in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer," was published in Journal of Clinical Oncology and can be found here.

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Featured in the paper are efficacy and safety data from the trial as well as correlative biomarker results generated with OncXerna’s novel RNA gene expression-based diagnostic panel, the Xerna TME Panel. The Xerna TME Panel uses a machine learning-based algorithm to assign scores based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). Given navicixizumab’s anti-angiogenic mechanism of action, patients with high Xerna TME Panel angiogenesis scores were classified as biomarker positive (B+), while those with low angiogenesis scores were classified as biomarker negative (B-).

"This prestigious publication highlights the encouraging, durable clinical activity of navicixizumab in a heavily pretreated platinum resistant ovarian cancer patient population where the treatment options are very limited," said Kathleen Moore, M.D., Professor at The Stephenson Cancer Center, The University of Oklahoma. "In addition to seeing activity regardless of prior treatments, this study showed the potential of the Xerna TME panel to address the unmet need for a predictive biomarker for response to anti-angiogenic treatment."

Key data and conclusions from the paper include:

Navicixizumab plus paclitaxel showed promising and durable clinical activity in a heavily pretreated patient population regardless of prior treatment (median of four prior therapies)
Overall response rate (ORR) across all evaluable patients: 43% (19/44)
ORR in patients previously treated with bevacizumab (Avastin): 33% (10/30)
ORR in patients previously treated with a PARP inhibitor: 45% (9/20)
11 of 19 patients with partial or complete response had progressive disease as best response to immediate prior therapy
Median duration of response: 6 months
B+ classification showed enrichment of patients with tumor response
ORR in B+ vs. B- patients: 62% (8/13) vs. 25% (5/20)
Best response of progressive disease in B+ vs. B- patients: 0% (0/13) vs. 30% (6/20)
Median progression-free survival in B+ vs. B- patients: 9.2 months vs. 3.9 months
The safety profile of navicixizumab plus paclitaxel was consistent with known toxicities with no new safety signals or unexpected safety findings. The monitoring and management plan for hypertension and pulmonary hypertension was effective in reducing risk of severe toxicity and showed recovery upon treatment discontinuation. No grade 3 pulmonary hypertension or grade 4 hypertension reported. Treatment related adverse events led to discontinuation in 9% (4/44) of patients.
Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna Therapeutics, commented, "We are thrilled with both the strength of our data and the external validation that comes from its publication in such a high-impact journal. Biomarkers to improve the selection of patients who are more likely to respond to therapy and prevent those less likely to respond from receiving an ineffective late-stage treatment are an important unmet need for cancer patients. This study provides proof of principle for further development of navicixizumab, a drug designed to address resistance to anti-VEGF and chemotherapies, as well as the potential of the Xerna TME panel to provide a predictive biomarker for anti-angiogenic treatment. To confirm this finding, the Xerna TME Panel will be used to stratify patients enrolled in a planned Phase 3 study."

OncXerna’s planned Phase 3 study, REVELARE, is designed as an open-label, randomized study of navicixizumab ± paclitaxel vs. paclitaxel monotherapy in pretreated PROC patients stratified by Xerna TME Panel biomarker status. Additional information on this planned trial can be found using ClinicalTrials.gov identifier NCT05043402.

About the Phase 1b Trial

The Phase 1b trial was an open-label, non-randomized, dose-escalation and expansion study of the safety, tolerability, and efficacy of navicixizumab plus paclitaxel in patients with platinum-resistant ovarian cancer. The trial enrolled patients who previously received Avastin (bevacizumab) and/or more than two prior lines of therapy. Patients were treated with navicixizumab once every two weeks together with weekly paclitaxel. The primary endpoint of the trial was incidence of dose limiting toxicities. Secondary endpoints included response rate assessed by RECIST criteria 1.1 and progression-free survival. For more information, see ClinicalTrials.gov Identifier: NCT03030287.

About Navicixizumab

Navicixizumab is an anti-DLL4/VEGF bispecific antibody product candidate that demonstrated antitumor activity in patients who were previously treated with Avastin (bevacizumab) in a Phase 1b clinical trial. The U.S. Food and Drug Administration granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal, or fallopian tube cancer in patients who have previously received Avastin and/or more than 2 prior lines of therapy. Navicixizumab is an investigational agent that has not been approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced ovarian cancer.

About the Xerna TME Panel

The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). The Xerna TME Panel is an investigational assay that has not been approved and has not been demonstrated to be safe or effective for any use.

On April 21, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the first quarter ended March 31, 2022 (Press release, Quest Diagnostics, APR 21, 2022, View Source [SID1234612761]).

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"We’re off to a good start in 2022, as we drove strong year-over-year growth in our base business, which excludes COVID-19 testing," said Steve Rusckowski, Chairman, CEO and President. "COVID-19 volumes remained strong early in the quarter and decreased in February and March, in line with the market. We continue to make investments to further accelerate growth in the base business, while our efforts to improve productivity are helping us to offset inflationary pressures. Based on our strong performance in the quarter and our expectations for the remainder of 2022 we have raised our full year guidance."

Three Months Ended March 31,

2022

2021

Change

(dollars in millions, except per share data)

Reported:

Net revenues

$ 2,611

$ 2,720

(4.0)%

Base business revenues (a)

$ 2,012

$ 1,892

6.3%

COVID-19 testing revenues

$ 599

$ 828

(27.6)%

Diagnostic information services revenues

$ 2,541

$ 2,643

(3.9)%

Revenue per requisition

(5.2)%

Requisition volume

1.3%

Organic requisition volume

—%

Operating income (b)

$ 513

$ 660

(22.3)%

Operating income as a percentage of net revenues (b)

19.7%

24.3%

(4.6)%

Net income attributable to Quest Diagnostics (b)

$ 355

$ 469

(24.3)%

Diluted EPS (b)

$ 2.92

$ 3.46

(15.6)%

Cash provided by operations

$ 480

$ 731

(34.2)%

Capital expenditures

$ 63

$ 86

(26.7)%

Adjusted (b):

Operating income

$ 554

$ 708

(21.8)%

Operating income as a percentage of net revenues

21.2%

26.0%

(4.8)%

Net income attributable to Quest Diagnostics

$ 392

$ 508

(23.0)%

Diluted EPS

$ 3.22

$ 3.76

(14.4)%

(a)

Excludes COVID-19 testing.

(b)

For further details impacting the year-over-year comparisons related to operating income, operating
income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Updated Guidance for Full Year 2022
The company raises its Full Year 2022 guidance as follows:

Updated Guidance

Prior Guidance

Low

High

Low

High

Net revenues

$9.2 billion

$9.5 billion

$9.0 billion

$9.5 billion

Net revenues decrease

(14.7)%

(11.9)%

(16.6)%

(11.9)%

Base business revenues (a)

$8.35 billion

$8.50 billion

$8.3 billion

$8.5 billion

Base business revenues increase

4.1%

6.0%

3.5%

6.0%

COVID-19 testing revenues

$0.85 billion

$1.00 billion

$0.7 billion

$1.0 billion

COVID-19 testing revenues decrease

(69.3)%

(63.9)%

(74.7)%

(63.9)%

Reported diluted EPS

$7.88

$8.38

$7.63

$8.33

Adjusted diluted EPS

$9.00

$9.50

$8.65

$9.35

Cash provided by operations

At least $1.6 billion

At least $1.6 billion

Capital expenditures

Approximately $400 million

Approximately $400 million

(a) Excludes COVID-19 testing

Note on Non-GAAP Financial Measures
As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, costs associated with donations, contributions, and other financial support through Quest for Health Equity (our initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities), gains and losses associated with changes in the carrying value of our strategic investments, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information
Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on April 21, 2022 until midnight Eastern Time on May 5, 2022, by phone at 800-583-8095 for domestic callers or 203-369-3815 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On April 21, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers, reported that it will report financial results for the first quarter 2022 on Monday, May 9, 2022, after market close (Press release, Revolution Medicines, APR 21, 2022, View Source [SID1234612762]). At 4:30 p.m. Eastern Time that day (1:30 p.m. Pacific Time), Revolution Medicines’ senior management team will host a conference call and webcast to discuss the financial results for the quarter and provide an update on corporate progress.

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Conference Call and Webcast Information:

Dial-in: (833) 423-0425 (U.S.) or + 1 (918) 922-3069 (international); conference ID 6994747.
Live webcast with slides can be accessed at: View Source." target="_blank" title="View Source." rel="nofollow">View Source
A replay of the webcast will be available on the company’s website shortly after the conference call concludes at View Source and will be archived there for at least 14 days.