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Full-year 2020 results

On February 11, 2021 AstraZeneca reported strong results in the year, in line with guidance that was reconfirmed during the year (Press release, AstraZeneca, FEB 11, 2021, View Source [SID1234574970]). With over half of Total Revenue coming from the fast-growing new medicines1, the Company leveraged its revenue growth to make further progress in profitability, while the strategy of sustainable growth through innovation brought numerous further benefits for patients. AstraZeneca’s patient-centric strategy, focus on innovation and capital-allocation priorities remain unchanged, with sustainable long-term growth in revenue, profit and cash generation set to continue.

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Pascal Soriot, Chief Executive Officer, commented: "The performance last year marked a significant step forward for AstraZeneca. Despite the significant impact from the pandemic, we delivered double-digit revenue growth to leverage improved profitability and cash generation. The consistent achievements in the pipeline, the accelerating performance of our business and the progress of the COVID-19 vaccine demonstrated what we can achieve, while the proposed acquisition of Alexion is intended to accelerate our scientific and commercial evolution even further.

Additional investment in new medicines continued to fuel our rapidly growing oncology and biopharmaceuticals therapy areas. Tagrisso’s future was enhanced with its first regulatory approval in early, potentially-curable lung cancer and further national reimbursement in China in advanced disease. Farxiga again expanded its potential beyond diabetes, while tezepelumab promised real hope for patients suffering from severe asthma. Thanks to the focus on an industry-leading pipeline and consistent execution, I am confident that we will continue to deliver more progress for patients and sustained, compelling results."

Corporate Presenation

On February 11, 2021 AstraZeneca Presented the Corporate Presentaion (Presentation, AstraZeneca, FEB 11, 2021, View Source [SID1234574969])

Thermo Fisher Scientific Invests $25 Million to Support Black Communities and Businesses in the U.S.

On February 11, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported it has committed to investing up to $25 million in minority-serving financial institutions (Press release, Thermo Fisher Scientific, FEB 11, 2021, View Source [SID1234574968]).

"Unequal access to capital is hurting Black-owned businesses, Black entrepreneurs and Black communities in the United States," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Minority-serving financial institutions provide a bridge to empowering historically disenfranchised communities. For Thermo Fisher, supporting these institutions is part of our commitment to addressing inequalities through our business and hiring practices."

The company has committed $20 million to the Black Economic Development Fund (BEDF), which was launched by the Local Initiatives Support Corporation (LISC) to increase financing to Black-led financial institutions, anchor institutions, and businesses. LISC is one of the nation’s oldest and largest Community Development Financial Institutions (CDFIs) and has invested more than $22 billion to expand economic opportunity in nearly every state.

"We know from experience that when investments address racial disparities in health, wealth and opportunity, they also help fuel lasting economic growth," said George Ashton, president of LISC Fund Management, LLC, which oversees the BEDF. "Forward-looking companies like Thermo Fisher are making impact investments that break down barriers and bridge capital gaps for Black businesses, which ultimately helps our economy work better for everyone."

In addition, Thermo Fisher will deposit $5 million in Hope Credit Union’s Transformational Deposits program. Hope Credit Union seeks to provide financing to low-wealth families, people of color and financially underserved communities to finance small businesses, housing, healthcare and other vital needs. HOPE uses Transformational Deposits to import the capital needed to increase economic opportunities for individuals and families across five Deep South states (Mississippi, Alabama, Arkansas, Tennessee, and Louisiana).

"Investments in Black owned financial institutions are a proven way to advance economic mobility," said Bill Bynum, chief executive officer, Hope Credit Union. "Black owned financial institutions are more likely to lend to businesses, support employment and locate in Black communities. Thermo Fisher’s Transformational Deposit is an important step towards closing the racial wealth gap."

In addition to these investments, in August 2020 Thermo Fisher launched "The Just Project" with a donation of $25 million in diagnostic instruments, test kits and related supplies to support the safe reopening of historically black colleges and universities (HBCUs) in the U.S. The company also announced that it is committed to hiring at least 500 students from HBCUs over the next three years.

PTC Therapeutics to Host Conference Call to Discuss Fourth Quarter and Year-End 2020 Financial Results

On February 11, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the Company will host a webcast conference call to report its fourth quarter and year-end 2020 financial results and provide an update on the company’s business and outlook on Thursday, February 25, 2021 at 4:30 p.m. (ET) after the closing of the market (Press release, PTC Therapeutics, FEB 11, 2021, https://www.prnewswire.com/news-releases/ptc-therapeutics-to-host-conference-call-to-discuss-fourth-quarter-and-year-end-2020-financial-results-301225991.html [SID1234574967]).

The call can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 2174406. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.

ESSA Pharma Presents Favorable Initial Phase 1 Clinical Pharmacology Data of EPI-7386 for Advanced Forms of Prostate Cancer at the 2021 ASCO Genitourinary Cancers Symposium

On February 11, 2021 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported it will present preclinical and clinical pharmacology data from ESSA’s Phase 1 clinical trial of EPI-7386 for the treatment of patients with metastatic castration-resistant prostate cancer ("mCRPC") at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary ("ASCO GU") Cancers Symposium (Press release, ESSA, FEB 11, 2021, View Source [SID1234574965]). EPI-7386, ESSA’s lead product candidate, is an investigational, highly-selective, oral, small molecule inhibitor of the androgen receptor’s N-terminal domain. ASCO (Free ASCO Whitepaper) GU is being held virtually from Thursday, February 11 to Saturday, February 13, 2021.

The oral poster presentation titled, "Preclinical and clinical pharmacology of EPI-7386, an androgen receptor N-terminal domain inhibitor for castration-resistant prostate cancer," will be presented and available for viewing starting February 11 at 8:00am ET.

Data highlights compare preclinical projections of EPI-7386’s clinical pharmacokinetic parameters to the pharmacokinetic, safety and preliminary clinical data from the initial 200 mg cohort of patients enrolled in ESSA’s multi-center, open-label, ascending multiple-dose Phase 1 study of EPI-7386 to treat patients with mCRPC who have become resistant to standard of care treatments. Patients participating in this trial have progressed on two or more approved systemic therapies for mCRPC, including at least one second generation antiandrogen therapy not necessarily in the metastatic disease setting. In this initial cohort of patients receiving the 200 mg once-daily dose, EPI-7386 was well-tolerated with no SAEs observed. The results from this cohort support ESSA’s preclinical projections regarding the pharmacologic properties of EPI-7386 in patients. EPI-7386 was well-absorbed, demonstrated high exposure levels and was confirmed to have a long half life of at least 24 hours. The predicted exposures of EPI-7386 in patients were similar to our modeled projections and were still below optimal target exposures of EPI-7386 associated with anti-tumor activity in animal models. Despite the suboptimal 200 mg dose, one out of three patients who completed 12 weeks of therapy experienced a prostate specific antigen ("PSA") decline of more than 50 percent after three cycles of EPI-7386 therapy (12 weeks) with ongoing continued PSA declines continuing through six cycles of therapy, despite previously having failed enzalutamide and abiraterone acetate. ESSA recently completed the 28-Day safety evaluation period for the 400mg dose cohort and is currently dosing patients in the 600 mg cohort.

"The results from the initial clinical data are encouraging and suggest a favorable pharmacokinetic profile of EPI-7386 in patients," said Dr. David R. Parkinson, President and Chief Executive Officer of ESSA Pharma Inc. "Additionally, the data demonstrate proof of concept by suggesting that EPI-7386, through its novel mechanism of action of targeting the N-terminal domain, may bypass the resistant mechanisms mCRPC patients may experience on current antiandrogen therapies. While early in our clinical study, we are encouraged to have seen early signs of biological activity and declining PSA levels in a multi-refractory patient at the initial 200 mg dose. An accurate assessment of the full safety and tolerability profile as well as the potential clinical benefits to therapy with EPI-7386 will require longer observation of more patients treated at higher doses. We look forward to continuing to conduct our Phase 1 dose escalation study and anticipate providing more clinical data on the progress of the study in the second half of 2021."

The poster is available on the ASCO (Free ASCO Whitepaper) GU Virtual Symposium and on the "Events & Presentations" section of the Company’s website at www.essapharma.com.

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with metastatic castration-resistant prostate cancer ("mCRPC") whose tumors have progressed on current standard-of-care therapies. The Phase I clinical trial of EPI-7386 began in calendar Q3 of 2020 following FDA allowance of the IND and Health Canada acceptance. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to EPI-7386 worldwide.