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Eagle Pharmaceuticals Receives FDA Approval for Additional Indication for PEMFEXY® in Combination with Pembrolizumab and Platinum Chemotherapy

On December 19, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that the U.S. Food and Drug Administration ("FDA") has approved an additional indication for PEMFEXY (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer ("NSCLC") with no EGFR or ALK genomic tumor aberrations (Press release, Eagle Pharmaceuticals, DEC 19, 2022, View Source [SID1234625397]). Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute ("RTD") novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug ("LD"), ALIMTA.

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"With this fifth indication, PEMFEXY is now approved for all of the same indications as ALIMTA, and we believe it allows for key advantages such as eliminating the need for reconstitution. Since its initial launch in February 2022, PEMFEXY has been an important addition to Eagle’s hospital and acute care product portfolio, and we are pleased to bring this treatment option to patients undergoing chemotherapy. At the same time, we also believe that Eagle is well positioned to capture the commercial opportunity that PEMFEXY represents," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Effective October 1, 2022, the Company amended its agreement to reduce future royalties related to PEMFEXY profits from 25% to a range of 0% to 12.5% based on aggregate profits achieved in exchange for a one-time payment of $15 million.

In February 2020, Eagle received approval from the FDA of its New Drug Application for PEMFEXY, following the settlement agreement of patent litigation with Eli Lilly and Company (NYSE: LLY) in December 2019. The agreement provided for a release of all claims by the parties and allowed for an initial entry of PEMFEXY into the market (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.

Carrick Therapeutics and The Menarini Group Announce Clinical Trial Collaboration to Evaluate Samuraciclib and Elacestrant Combination

On December 19, 2022 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, reported a clinical trial collaboration and supply agreement (Press release, Carrick Therapeutics, DEC 19, 2022, https://www.carricktherapeutics.com/carrick-therapeutics-menarini-group-announce-clinical-trial-collaboration-evaluate-samuraciclib-elacestrant-combination/ [SID1234625396]).

This agreement covers the execution of a Phase 2 clinical trial to evaluate the novel combination of Carrick’s samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, and Menarini‘s oral selective estrogen receptor degrader (SERD), elacestrant, in patients with CDK4/6i resistant HR+, HER2- metastatic breast cancer. Menarini and Carrick will jointly sponsor the clinical trial.

"We are excited to initiate this collaboration with Menarini to explore the potential of samuraciclib in combination with elacestrant for the treatment of advanced breast cancer," said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. "Our pre-clinical work and prior clinical studies have validated the biology for SERD combinations with CDK7, pointing to potential synergies when combining samuraciclib with Menarini’s oral SERD, elacestrant. This collaboration represents a shared commitment to maximizing the potential of novel combination therapies to improve outcomes for people living with breast cancer."

"This new clinical collaboration with Carrick Therapeutics is yet another step we are making to develop elacestrant in an extensive way to address unmet needs of patients resistant to CDK4/6 therapies in HR+, HER2- metastatic breast cancer," said Elcin Barker Ergun, Chief Executive Officer of Menarini. "Menarini will continue to pursue research collaborations that have the potential to improve patients’ lives in breast cancer."

Carrick anticipates initiating the Phase 2 clinical trial in 2023. This new study will expand Carrick’s portfolio of ongoing clinical trials with samuraciclib. The company presented encouraging results from a clinical study combining samuraciclib with fulvestrant at the 2021 San Antonio Breast Cancer Symposium.

Cardinal Health Names Aaron Alt Chief Financial Officer

On December 19, 2022 Cardinal Health (NYSE: CAH) and its board of directors reported that Aaron Alt will become the company’s new chief financial officer (CFO) (Press release, Cardinal Health, DEC 19, 2022, View Source [SID1234625395]). Alt will succeed interim CFO, Trish English and will report to CEO, Jason Hollar, as a member of the company’s Executive Committee effective Feb. 10.

In his capacity as CFO, Alt will lead financial activities across the enterprise, including Financial Strategy, Capital Deployment, Treasury, Tax, Investor Relations, Accounting, and Reporting. Additionally, he will lead the Corporate Development team.

"We’re pleased to welcome Aaron as the new CFO of Cardinal Health," said Jason Hollar, CEO of Cardinal Health. "He’s an exceptional talent with a breadth of experience across complex organizations that will position him well for this critical companywide role. I’d also like to thank Trish for her contributions as interim CFO and her commitment to help with this transition."

Alt most recently served as EVP and CFO for Sysco Corporation, the leading global foodservice distribution company. In this role, he drove significant improvements to the balance sheet and underlying profitability of Sysco.

Prior to Sysco, Alt was SVP and CFO for Sally Beauty Holdings, an international specialty retailer and wholesale distributor of professional beauty supplies. He has also held senior executive roles in Finance, Operations and Grocery Transformation at Target Corporation. Prior to joining Target, he held senior-level Finance and Operations positions with Sara Lee Corporation.

Aaron holds an M.B.A. from the J.L. Kellogg School of Management at Northwestern University, a J.D. from Harvard Law School and a B.A. in History and Political Science from Northwestern University.

Arcus Biosciences, Inc. (the “Company”) announced positive results from the fourth interim analysis of ARC-7, its randomized, 150-patient Phase 2 trial in first-line metastatic PD-L1≥50% non-small cell lung cancer

On December 19, 2022, Arcus Biosciences, Inc. (the "Company") reported positive results from the fourth interim analysis of ARC-7, its randomized, 150-patient Phase 2 trial in first-line metastatic PD-L1≥50% non-small cell lung cancer in which the Company is studying domvanalimab in combination with zimberelimab both with and without etrumadenant vs. zimberelimab monotherapy (Press release, Arcus Biosciences, DEC 19, 2022, View Source [SID1234625393]). This interim analysis was conducted at the clinical data cutoff date of August 31, 2022.

At the time of data cutoff, efficacy was evaluated in patients who had at least 13 weeks of follow-up and were therefore potentially eligible for at least two imaging scans (n=133), and safety was evaluated in all enrolled patients (n=149). With a median follow-up time for efficacy duration of approximately 12 months, both the doublet and triplet combinations demonstrated clinically meaningful improvements in median progression-free survival (PFS) and six-month landmark PFS rates compared to zimberelimab monotherapy, with a 45% reduction in risk of disease progression or death for the doublet and 35% for the triplet.

Each of the domvanalimab-containing study arms also demonstrated clinically meaningful improvements in objective response rate (ORR) compared to zimberelimab monotherapy. Confirmed ORR was 27%, 41% and 40% for the zimberelimab monotherapy arm and the domvanalimab-doublet and -triplet arms, respectively. While the triplet arm did not show an improvement over the doublet arm, it reinforces the results observed in the doublet arm, and the study will continue to monitor PFS, as well as overall survival, for the triplet arm as these data mature.

The efficacy results including ORR and PFS are summarized in the table below:

Endpoint

zimberelimab (Z) monotherapy

(n=44)

domvanalimab + zimberelimab (DZ)

(n=44)

etrumadenant + domvanalimab +

zimberelimab (EDZ) (n=45)

Progression-free Survival (PFS)

Median in Months (95% CI)

5.4 (1.8, 9.6)

12.0 (5.5, NE)

10.9 (4.8, NE)

Hazard Ratio* (95% CI)

0.55 (0.31, 1.0)

0.65 (0.37, 1.1)

Six-month PFS rate (95% CI)

43% (27, 59)

65% (49, 80)

63% (48, 78)

Objective Response Rate (ORR)

ORR+ (95% CI)

27% (15.0, 42.8)

41% (26.3, 56.8)

40% (25.7, 55.7)

*Hazard ratio is for comparing domvanalimab-containing study arms to zimberelimab monotherapy.

+Based on confirmed response per RECIST 1.1

NE=not evaluable

No unexpected safety signals were observed across the three study arms at the time of data cutoff. The domvanalimab-containing study arms appeared to be generally well tolerated and showed an overall safety profile consistent with the known safety profiles of each individual molecule to date. Grade ≥3 treatment-emergent adverse events occurred in 58% of participants in the zimberelimab monotherapy study arm, 47% of the doublet arm, and 52% of the triplet arm. Incidence of infusion-related reactions was low across all treatment arms: 4%, 4% and 10% for zimberelimab monotherapy and the domvanalimab-doublet and -triplet arms, respectively. Immune-related adverse events, including the incidences and grades of rash and pruritus, were generally low and manageable with topical corticosteroids.

Anixa Biosciences to Present at Biotech Showcase 2023

On December 19, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that it will present at the Biotech Showcase 2023 conference being held in-person on January 9-11, 2023, at the Hilton San Francisco Union Square in San Francisco, California, and virtually on January 18-19, 2023 (Press release, Anixa Biosciences, DEC 19, 2022, View Source [SID1234625392]).

The presentation will provide an overview of Anixa’s business and highlight recent corporate achievements, including updates on its clinical programs.

Details of the presentation are as follows:

Event: Biotech Showcase 2023
Date: Monday, January 9, 2023
Time: 3:30 PM PST
Location: Yosemite-A, Hilton San Francisco Union Square

Anixa management will be available for one-on-one meetings throughout the conference.

Biotech Showcase is one of the industry’s largest annual healthcare investor and partnering conferences, bringing together biopharmaceutical and life sciences company executives, investors, sector analysts, bankers, and industry stakeholders. More than 350 presentations from mid-, small- and micro-cap public and private companies are expected to present at the event. Qualified investors and buy- and sell-side analysts are invited to request a complimentary registration to attend Biotech Showcase. For more information on attending click here.