On May 2, 2023 Arvinas, Inc. (Nasdaq: ARVN) and Quantum Leap Healthcare Collaborative reported that Arvinas’ vepdegestrant (ARV-471), a novel PROTAC estrogen receptor (ER) protein degrader being co-developed with Pfizer Inc. will be evaluated in the ongoing I-SPY TRIAL endocrine program sponsored by Quantum Leap (Press release, Arvinas, MAY 2, 2023, View Source [SID1234630825]). This study targets patients with newly diagnosed ER positive invasive cancer. Vepdegestrant is in Phase 3 clinical development for the treatment of patients with locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

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The I-SPY-2 Endocrine Optimization Platform (EOP) study (NCT01042379) will include a vepdegestrant monotherapy arm and a vepdegestrant in combination with letrozole arm. This study is focused on patients with clinically high-risk (stage 2/3) ER+/HER2- breast cancer, but molecularly low risk (MammaPrint low risk signature), a subset of patients with substantial risk for late recurrence.

Quantum Leap opened the EOP program in 2021 to specifically assess treatment options for this subset of patients, and work to find an early endpoint to measure the success of therapy. EOP is a sub-study within the main I-SPY-2 clinical trial utilizing neoadjuvant endocrine therapy in patients whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit.

"I-SPY TRIALs focus on high-impact experimental treatments that may benefit patients, providers, and researchers, and Arvinas is thrilled to be part of this innovative I-SPY-2 clinical trial," said John Houston, Ph.D., president and chief executive officer at Arvinas. "There is an unmet medical need for novel agents in life-threatening diseases and this research is vital to advancing patient outcomes. In all of our investigational research, our commitment is to patient safety and care, and we are excited by vepdegestrant’s potential to become a new standard of care for patients with ER+/HER2- breast cancer."

"The heart of the I-SPY TRIALs is to change how new breast cancer treatments are developed, to find treatments that are more personalized, effective, and less toxic, faster. We are excited to be partnering with Arvinas and investigating the potential positive benefits of vepdegestrant. Women need better and more tolerable options for extended endocrine therapy. We hope this will be one of them." said Dr. Laura Esserman, co-principal investigator of the I-SPY TRIAL and founder of Quantum Leap.

Arvinas will provide vepdegestrant and financial support to Quantum Leap for this investigational study. Quantum Leap is the sponsor of the I-SPY program, which includes 41 open sites. All I-SPY sites have the EOP program open.

About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally-bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Use of vepdegestrant in the ongoing and planned clinical trials will continue to monitor and evaluate patient safety and anti-tumor activity.

In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.

On May 2, 2023 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal second quarter ended March 31, 2023 (Press release, Arrowhead Research Corporation, MAY 2, 2023, View Source [SID1234630824]). The company is hosting a conference call today, May 2, 2023, at 4:30 p.m. ET to discuss the results.

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Webcast and Conference Call and Details

Investors may access a live audio webcast on the Company’s website at View Source A replay of the webcast will be available approximately two hours after the conclusion of the call.
For analysts that wish to participate in the conference call, please register at https://register.vevent.com/register/BIf9cd65655e5444119df91cd4891157f8. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call.

Selected Recent Events

•Reported interim results from an ongoing Phase 1/2 clinical study of ARO-RAGE, an investigational RNAi therapeutic for treatment for inflammatory pulmonary diseases, such as asthma. These data represent the first clinical demonstration of the potential utility of Arrowhead’s proprietary Targeted RNAi Molecule (TRiMTM) platform optimized for delivery to the lungs. Key results from Part 1 of the study in normal healthy volunteers included the following:
oMean maximum reduction in soluble RAGE (sRAGE) as measured in serum after two doses of 92 mg on Day 1 and Day 29 was 80% with a maximum reduction of 90%
Duration of pharmacologic effect persisted for at least 6 weeks
oMean reduction in sRAGE as measured in bronchoalveolar lavage fluid (BALF) at Day 31 after a single dose of 92 mg was 75% with a maximum reduction of 92%

o Mean maximum reduction of 56% with a maximum reduction of 68% in serum sRAGE was also observed after a single dose of 92 mg
o Safety and tolerability

Overall, no patterns of adverse changes in any clinical safety parameters
No reported serious or severe adverse events
No dropouts related to drug or related to adverse events

oThese results include 4 of 5 escalating dose levels. Data are not yet available for single or multiple dose cohorts at 184 mg, the highest dose being tested
•Announced a planned R&D Day on June 1, 2023, which will include presentations on cardiometabolic, pulmonary, and newly announced central nervous system (CNS) pipeline programs
oThe company expanded its TRiMTM platform to include an optimized intrathecal administration for CNS delivery with good distribution throughout the brain and in all relevant brain cell types. The first development candidate to utilize this new delivery platform, ARO-SOD1, is on track for a clinical trial application filing in the third quarter of 2023 to begin clinical studies
oIn preclinical studies, ARO-SOD1 achieved 95% spinal cord tissue mRNA knockdown after a single intrathecal dose in human SOD1 transgenic rats and maintained greater than 80% spinal cord tissue mRNA knockdown three months after a single intrathecal dose in non-human primates
•Earned a $40 million milestone payment from Takeda (TSE:4502/NYSE:TAK) after the first patient was dosed in the Phase 3 REDWOOD clinical study of fazirsiran (TAK-999/ARO-AAT) for the treatment of alpha-1 antitrypsin deficiency associated liver disease (AATD-LD)
•Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ARO-APOC3 for reducing triglycerides in adult patients with familial chylomicronemia syndrome
•Earned a $30 million milestone payment from GSK (LSE/NYSE: GSK) following the start of GSK’s Phase 2b trial of GSK4532990, formerly called ARO-HSD, an investigational RNAi therapeutic for the treatment of patients with non-alcoholic steatohepatitis (NASH)

•Initiated dosing in a Phase 1/2a single ascending dose and multiple ascending dose clinical study of ARO-MMP7, Arrowhead’s third pulmonary targeted investigational RNAi therapeutic being developed as a potential treatment for idiopathic pulmonary fibrosis
•Reported interim results from an ongoing Phase 1/2 clinical study of ARO-C3, an investigational RNAi therapeutic for treatment of various complement mediated diseases, demonstrating mean reductions of 88% in C3 and 91% in AH50, a marker of alternative complement pathway hemolytic activity
•Regained rights to ARO-PNPLA3, formerly called JNJ-75220795, which was part of a 2018 research collaboration and option agreement between Arrowhead and Janssen Pharmaceuticals, Inc. ARO-PNPLA3 is an investigational RNAi therapeutic developed using Arrowhead’s proprietary TRiMTM platform and designed to reduce liver expression of patatin-like phospholipase domain containing 3 (PNPLA3) as a potential treatment for patients with NASH
•Announced topline results with Takeda from the Phase 2 SEQUOIA clinical study of investigational fazirsiran for the treatment of AATD-LD and provided an outline of a Phase 3 study that was co-developed by Takeda and Arrowhead and will be conducted by Takeda. Key results from SEQUOIA included the following:

oFibrosis regression observed in 50% of patients receiving fazirsiran

oMedian reductions of 94% of Z-AAT accumulation in the liver and mean reduction of 68% in histologic globule burden

oTreatment emergent adverse events were generally well balanced between fazirsiran and placebo groups
oResults consistent with AROAAT-2002 open-label study previously published in The New England Journal of Medicine

On May 2, 2023 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that management will participate in a corporate presentation at the BofA Securities 2023 Healthcare Conference in Las Vegas on Wednesday, May 10, 2023, at 2:20 p.m. PT (Press release, Alector, MAY 2, 2023, View Source [SID1234630823]).

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A live webcast of the presentation will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.

On May 2, 2023 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported it will announce financial results for the first quarter 2023 on Monday, May 8, 2023, before the opening of the U.S. financial markets (Press release, Aclaris Therapeutics, MAY 2, 2023, View Source [SID1234630822]).

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Management will conduct a conference call at 8:00 AM ET on the same day to discuss Aclaris’ financial results and to provide a corporate update, including a summary of final results from the Phase 2a trial of zunsemetinib (ATI-450) in subjects with moderate to severe hidradenitis suppurativa. The conference call will be webcast live over the internet and can be accessed by logging into the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. The webcast will be archived for at least 30 days on the Aclaris website.

On May 2, 2023 AbbVie (NYSE: ABBV) reported that it will participate in the Bank of America Securities Healthcare Conference on Tuesday, May 9, 2023 (Press release, AbbVie, MAY 2, 2023, View Source [SID1234630821]). Robert A. Michael, vice chairman and president, Scott Reents, executive vice president, chief financial officer, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, senior vice president, development and regulatory affairs and chief medical officer, will present at 10:00 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.