ChromaDex to Present at Oppenheimer 31st Annual Healthcare Conference

On March 9, 2021 ChromaDex Corp. (NASDAQ: CDXC) reported to participate in a virtual presentation at the Oppenheimer 31st Annual Healthcare Conference on Wednesday, March 17, 2021 at 3:50pm ET (12:50pm PT) (Press release, ChromaDex, MAR 9, 2021, View Source [SID1234576294]).

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A webcast of the presentation will be posted under the investor relations section of ChromaDex’s website at www.chromadex.com. A replay of the presentation will be available following the event.

Management will also be participating in virtual one-on-one meetings on March 16th and 17th. To register for the conference, please contact your Oppenheimer sales representative.

Pacira BioSciences Reports Preliminary Net Product Sales of $36.2 Million for February 2021

On March 9, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales of EXPAREL (bupivacaine liposome injectable suspension) and iovera° of $35.6 million and $0.7 million, respectively, for the month of February 2021 (Press release, Pacira Pharmaceuticals, MAR 9, 2021, View Source [SID1234576293]). EXPAREL average daily sales were 103 percent of the prior year for February 2021.

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"We are off to a terrific start for the year, with February EXPAREL sales surpassing a very strong comparative month in 2020 amid recent severe weather-related shutdowns in key markets and ongoing COVID-19 related challenges. EXPAREL growth continues to significantly outpace the recovery in the elective surgery market as utilization increases across a wide range of anesthesia-driven regional blocks and enhanced recovery after surgery protocols shift more complex, painful elective surgeries to the outpatient setting. We also continue to see a strong uptake in regional blocks for non-elective procedures given the market’s critical need for opioid-sparing approaches. Looking ahead, Pacira remains well-positioned to deliver robust top- and bottom-line growth as we further entrench EXPAREL as the leader in non-opioid postsurgical pain management and advance iovera° in key orthopedic settings," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

The company’s 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the first quarter or full year 2021.

Targovax granted US Patent for ONCOS-102 in combination with checkpoint inhibitors

On March 9, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that the US Patent Office has granted US Patent no 10,940,203 (Press release, Targovax, MAR 9, 2021, View Source [SID1234576289]). The patent covers the use of ONCOS-102 in combination with checkpoint inhibitors (CPI).

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Torbjørn Furuseth, Chief Financial Officer of Targovax, said: "We are delighted that this US patent has been granted, further strengthening Targovax’s intellectual property portfolio covering the very important combination of ONCOS-102 and anti-PD1 checkpoint inhibitors. The results from our melanoma trial presented in December 2020, confirmed ONCOS-102’s ability to turn refractory tumors into response. Securing this patent protects our innovative oncolytic immunotherapy platform and strengthens our market position."

In December 2020 Targovax announced that the combination of ONCOS-102 and checkpoint inhibitor pembrolizumab (Keytruda) demonstrated 35% best objective response rate (ORR) in anti-PD1 refractory malignant melanoma patients. Systemic effects were also observed in multiple patients, including two examples where a non-injected lesion completely regressed. In this open label phase 1 trial the combination of ONCOS-102 and the anti-PD1 checkpoint inhibitor pembrolizumab has been tested in patients with advanced, unresectable melanoma who have had disease progression despite treatment with anti-PD1 checkpoint inhibitor. This is a particularly challenging patient population, which is refractory to approved immunotherapies and has few treatment alternatives available.

Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system. On the back of very encouraging data in several indications, in monotherapy and in multiple combination, the planned development steps for ONCOS-102 is a registrational-directed trial in checkpoint inhibitor refractory melanoma.

Novartis provides update on Phase III study evaluating canakinumab (ACZ885) as second or third-line treatment in combination with chemotherapy in non-small cell lung cancer

On March 9, 2021 Novartis reported the Phase III CANOPY-2 study evaluating canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β), in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival (OS)1 (Press release, Novartis, MAR 9, 2021, https://www.novartis.com/news/media-releases/novartis-provides-update-phase-iii-study-evaluating-canakinumab-acz885-second-or-third-line-treatment-combination-chemotherapy-non-small-cell-lung-cancer [SID1234576288]). The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings2,3. Novartis and CANOPY-2 investigators will analyze the study data and are expected to submit its findings for presentation at an upcoming medical meeting.

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"While results from the CANOPY-2 trial are not what we hoped for in patients with advanced or metastatic non-small cell lung cancer who have been treated with other lines of therapy, these data give us valuable insights into IL-1β inhibition," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis. "Ongoing Phase III studies in non-small cell lung cancer continue, evaluating canakinumab in earlier treatment settings. We sincerely thank the patients and clinical investigators involved in the CANOPY-2 study for their partnership."

CANOPY-1, a Phase III study evaluating canakinumab in combination with immunotherapy and chemotherapy, is expected to report final results before the end of the year2. CANOPY-A, another Phase III study, is investigating canakinumab as an adjuvant therapy and has enrolled more than 950 patients to date and is expected to enroll a total of 1,500 patients3.

About canakinumab (ACZ885)
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human interleukin-1beta (IL-1β)6,7 and neutralizes IL-1β activity by blocking its interaction with its receptors8. By neutralizing IL-1β, preliminary evidence suggests that canakinumab inhibits pro-tumor inflammation (PTI) to 1) enhance anti-tumor immune response; 2) reduce tumor cell proliferation, survival and invasiveness; and 3) impair angiogenesis8. Pro-tumor inflammation enables tumor development by driving cancer-causing processes and by suppressing anti-tumor immune responses9,10. Canakinumab is a first-in-class interleukin-1beta (IL-1β) inhibitor of PTI in non-small cell lung cancer10.

About the CANOPY program
Novartis launched the CANOPY study program after observing significantly lower than expected rates of lung cancer mortality among patients in the Phase III cardiovascular CANTOS trial. The CANTOS trial evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack (CRP≥2 mg/L)8,9. Patients in the CANTOS trial were also at high risk for inflammatory cancers, like lung cancer, due to advanced age, smoking history and other clinical risk factors8,9. Based on these findings, Novartis launched three, large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to investigate canakinumab as a potential treatment option in non-small cell lung cancer (NSCLC).

CANOPY-1 (NCT03631199) is a Phase III trial evaluating canakinumab as a first-line treatment for locally advanced or metastatic NSCLC in combination with pembrolizumab and platinum-based doublet chemotherapy2
CANOPY-2 (NCT03626545) is a Phase III trial investigating the role of canakinumab in combination with the chemotherapy agent docetaxel in second- or third-line therapy versus docetaxel alone in NSCLC. Part 1 of the CANOPY-2 trial – a safety run-in study to determine the appropriate dosage, was previously presented at ASCO (Free ASCO Whitepaper) 2019. Part 2 of the trial, reported today, evaluated overall survival (OS)4
CANOPY-A (NCT03447769) is a Phase III trial studying canakinumab in the adjuvant setting, following surgical resection and cisplatin-based chemotherapy. The adjuvant study is designed to determine if treatment with canakinumab can prevent cancer relapse3
CANOPY-N (NCT03968419) is a non-registrational Phase II neoadjuvant trial evaluating canakinumab in combination with pembrolizumab among patients with resectable NSCLC prior to their planned surgery5

Novartis and Lung Cancer
Lung cancer is the most common cancer worldwide, accounting for more than 2 million new cases diagnosed each year11. There are two main types of lung cancer – small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)12. NSCLC accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 1.7 million new cases each year11,13. Currently, the five-year survival rate for lung cancer is less than 20%14, decreasing further when the disease is diagnosed at later stages15. The majority of people with NSCLC are diagnosed with advanced or Stage III or IV disease16, and treatment options are limited for people with lung cancer who experience cancer growth or progression while on standard of care treatments17-19. More people die of lung cancer every year than any other cancer type11. Novartis is committed to developing best-in-class treatments for lung cancer patients around the world. With a focus on both targeted, personalized medicine and the role of newer, immuno-oncology therapies, the lung cancer drug development program at Novartis is among the most robust in the industry. With research activities informed by long-term relationships with leading lung cancer thought leaders and patient advocates, Novartis is focused on reimagining the treatment of lung cancer.

Compelling Preclinical Breast Cancer Results

On March 9, 2021 Race Oncology Limited (ASX: RAC) reported the final results of our collaborative preclinical research program with the eminent cancer researcher, Associate Professor Nikki Verrills of The University of Newcastle and Hunter Medical Research Institute (Press release, Race Oncology, MAR 9, 2021, View Source [SID1234576285]).

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The aim of this research program was to identify combinations of existing breast cancer drugs which when paired with Bisantrene show equivalent or better efficacy to existing treatment options, but with reduced side effects. Activity of Bisantrene alone against a range of breast cancer genetic subtypes, including those resistant to standard of care drug treatments, was also explored.

The interim results demonstrated that Bisantrene was an effective chemotherapeutic agent across a wide range of genetically distinct breast cancer subtypes (ASX announcement: 24 Nov 2020). Bisantrene was able to kill some cancer subtypes that were resistant to the currently used anthracyclines doxorubicin and epirubicin. Importantly, Bisantrene showed near identical additive benefit when used in combination with cyclophosphamide to that seen with either doxorubicin or epirubicin.

Final results showed Bisantrene to be an effective chemotherapeutic agent across a diverse panel of genetically defined breast cancer subtypes and to also kill breast cancer cells resistant to a wide range of breast cancer treatment drugs.

Race’s CSO Dr Daniel Tillett commented "The final results from Nikki’s team highlights Bisantrene’s potential use in breast cancers resistant to current treatments. Not only does Bisantrene offer a potentially safer alternative to existing chemotherapeutic drugs, it may also help patients who have exhausted other treatment options."

Race’s CEO Mr Phillip Lynch added, "This new research underscores our confidence in moving Bisantrene into Phase II breast cancer trials and continues to build on the body of evidence we have supporting Bisantrene’s broader applications. Our aim here is to bring a valuable new treatment forward for the management of breast cancer."