On April 21, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data from a recent study in which patients tested with DecisionDx-Melanoma in addition to traditional clinicopathologic factors had improved survival compared to patients with only traditional clinicopathologic factors available to determine their treatment and follow-up plan (Press release, Castle Biosciences, APR 21, 2022, View Source [SID1234612872]). The study is part of the Company’s ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma (CM) cases. The data will be shared in a poster presentation at the 18th European Association of Dermato Oncology (EADO) Congress, being held virtually and in Seville, Spain, April 21-23, 2022.

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"Once again, the real-world data analyzed as part of our collaboration with NCI has shown the potential for a strong survival benefit in patients whose melanoma management plans included personalized test results provided by DecisionDx-Melanoma," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We are committed to improving health through innovative tests that guide patient care. This study data demonstrated the ability of our test to help patients and clinicians in informing disease management and treatment plans that have the potential to improve patient survival."

The poster, titled "Incorporating the 31-gene expression profile test stratifies survival outcomes and leads to improved survival compared to clinicopathologic factors alone: A Surveillance, Epidemiology, and End Results (SEER) Program collaboration," discusses the full cohort of data obtained thus far through the collaboration. The poster examines the impact of testing with DecisionDx-Melanoma on a patient’s survival and the ability of DecisionDx-Melanoma to accurately risk-stratify a group of real-world, unselected, prospectively tested patients with CM. The poster can be viewed here.

As part of Castle’s collaboration with NCI, patient data, including melanoma-specific survival (MSS), overall survival (OS) and additional clinicopathologic information provided by the SEER registries, was linked to data for patients with Stage I-III CM who had been tested with DecisionDx-Melanoma.

To assess if patients tested with DecisionDx-Melanoma had higher survival rates than patients who were not tested with DecisionDx-Melanoma, a group of tested patients (n=3,261) was matched to a group of patients who did not receive DecisionDx-Melanoma test results as part of their clinical care (n=10,863); the matching was based on 11 clinicopathologic and socioeconomic variables using a 1:3 ratio. The untested patients and their clinicians had only the traditional clinicopathologic features upon which to develop a melanoma treatment plan. Matching cases were limited to diagnoses in 2016 and forward to account for potential access to adjuvant therapy. In the study, patients tested with DecisionDx-Melanoma had improved survival compared to untested patients, with a 27% (hazard ratio (HR)=0.73, p=0.028) and 21% (HR=0.79, p=0.006) MSS and OS survival benefit, respectively. This suggests that DecisionDx-Melanoma test results can aid in providing more risk-aligned treatment plans for improved patient outcomes.

Additionally, similar to previously published retrospective and prospective studies, DecisionDx-Melanoma was able to accurately and independently risk-stratify patients for MSS and OS. Moreover, the data indicated that a DecisionDx-Melanoma Class 2B result was a significant and independent predictor of MSS (HR= 8.51, p<0.001) and OS (HR= 2.48, p<0.001), and conferred the highest risk of all clinicopathologic factors included in multivariable analyses that included age, ulceration status, Breslow thickness and sentinel lymph node status.

Overall, the study data showed that the precise, personalized test results provided by DecisionDx-Melanoma have the potential to improve patient survival when used as part of a melanoma management plan. In the study, patients tested with DecisionDx-Melanoma, whose clinicians also had the benefit of the patient’s clinicopathologic factors traditionally used to assess metastatic risk, had improved survival compared to patients with only traditional clinicopathologic factors available to determine their treatment and follow-up plan.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration has resulted in Castle’s analysis of 5,226 clinically tested samples thus far (as of April 21, 2022) in a study to evaluate risk of recurrence; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result.

Through Dec. 31, 2021, DecisionDx-Melanoma has been ordered 90,154 times for patients with cutaneous melanoma.

On April 21, 2022 Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, reported a multi-year $350 million investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities (Press release, Catalent, APR 21, 2022, https://www.catalent.com/catalent-news/catalent-to-invest-350-million-in-integrated-biologics-drug-substance-and-drug-product-manufacturing-at-bloomington-indiana-facility/ [SID1234612725]). The project will serve the industry’s robust biologics pipeline across various modalities with new bioreactors, syringe filling lines, and additional lyophilization capacity, supported by quality control laboratories and complex automated packaging.

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The expansion includes the installation of new 2,000-liter single-use bioreactors and expanded downstream processing capabilities for drug substance, with the versatility to meet customers’ needs with batches of up to 4,000-liters using single-use technology, or 5,000-liters using existing stainless-steel bioreactors. Also included are new quality control laboratories and complex packaging space with additional high-speed, automated cartoning and auto-injector device assembly capabilities. It is envisioned that these new capabilities will be fully operational later this calendar year.

The site will also be adding to its drug product fill/finish capacity, with new syringe filling lines under barrier isolator technology and additional lyophilized vial capacity. When completed in 2024, the site’s broad range of fill/finish offerings will provide great flexibility in dose form presentations and batch sizes to serve customers with everything from early- and late-stage development programs to high-volume commercial supply across various modalities.

Altogether, these expansions are expected to add over 1,000 new jobs to Catalent’s Bloomington workforce in the coming years.

"We continue to see strong growth in demand for biologics development and manufacturing with a deep pipeline across multiple indications," commented Mike Riley, President of Biotherapeutics at Catalent. "These investments will enable us to expand our flagship Bloomington facility and extend our leadership as one of the largest and most comprehensive global centers for integrated manufacturing capabilities. The site offers highly flexible and scalable solutions to companies developing new biological drugs, vaccines, RNA therapies, and other innovative treatments for patients around the world."

This expansion follows a series of recent investments in Catalent Biologics’ global network, including the modernization of its fill/finish and packaging facility in Limoges, France, and the acquisition of a new biologics development and manufacturing facility near Oxford, U.K.

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 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported that the company will release full year 2021 financial results on Tuesday April 26, 2022 after the close of market (Press release, Ambrx, APR 21, 2022, View Source [SID1234612873]). Ambrx will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on the same day to discuss the results and provide a corporate update.

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Individuals interested in listening to the conference call may do so by dialing (844) 200-6205 for domestic callers, or (929) 526-1599 for international callers and reference access code: 9264119; or from the webcast link in the investor relations section of the company’s website at: www.ambrx.com.

A webcast replay of the call will be available beginning April 26, 2022 at 4:30 p.m. PT / 7:30 p.m. ET. The webcast will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

On April 21, 2022 Cerus Corporation (Nasdaq: CERS) reported that its first quarter 2022 financial results will be released on Thursday, May 5, 2022, after the close of the stock market (Press release, Cerus, APR 21, 2022, View Source [SID1234612727]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8280547. The replay will be available approximately three hours after the call through May 19, 2022.