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Thursday, August 8, 2024

CG Oncology Q2

 Final positive safety and efficacy findings from CORE-001 study of Cretostimogene Grenadenorepvec in combination with Pembrolizumab in BCG-Unresponsive NMIBC simultaneously published online by Nature Medicine and featured at ASCO 2024 –

– Announced 54% complete response (CR) rate in the intention-to-treat population at 24-month landmark and meets primary endpoint in the CORE-001 study –

– Demonstrated 75.2% CR rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer in Cretostimogene Monotherapy BOND-003 study –

– Initiated and dosed first patient in Expanded Access Program for Cretostimogene Grenadenorepvec; Enrollment ongoing –

Anticipated Next Milestones

Merck Halts Phase III Trial of Keytruda, Anti-TIGIT Combo in Small Cell Lung Cancer

 

The pharma said Thursday it is stopping a late-stage study of its blockbuster Keytruda, anti-TIGIT antibody vibostolimab and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer, following a recommendation from an independent data monitoring committee.

Merck announced Thursday that it is ending a late-stage trial of its blockbuster Keytruda, anti-TIGIT antibody vibostolimab and chemotherapy in the first line treatment of extensive-stage small cell lung cancer, after a recommendation from an independent data monitoring committee.

The Phase III KeyVibe-008 trial compared the anti-TIGIT, Keytruda and chemo combination against Roche’s Tecentriq. However, extensive-stage small cell lung cancer (ES-SCLC) patients who were taking the combo encountered a higher rate of adverse events, including immune-related adverse events. In addition, data showed that the primary endpoint of overall survival (OS) met the pre-specified futility criteria.

Merck said a comprehensive analysis is ongoing and that the company is notifying study investigators of the trial halt. Patients should stop ongoing treatment with the combination and be offered the option of being treated with Tencentriq, according to the announcement. Merck said it will share the study results with the scientific community.

“Small cell lung cancer remains a difficult disease to treat, as evident by the seven percent five-year survival rate and limited advancements in treatment options,” Marjorie Green, senior vice president and head of oncology global clinical development for Merck Research Laboratories, said in a statement. “Innovative research plays a critical role in improving our understanding to help patients achieve better outcomes, and while we hoped the results would be different, we remain committed to investigating novel approaches to treat this debilitating disease.”

This is not the only setback that Merck has run into for its anti-TIGIT combinations. Last year, Merck axed a Phase II study investigating the combo of Keytruda and vibostolimab which failed to reach statistical significance in progression-free survival in treating metastatic non-small cell lung cancer (NSCLC) patients with progressive disease after treatment with immunotherapy and chemotherapy.

In May 2024, Merck also pulled the plug on a Phase III trial of a Keytruda and vibostolimab combo in skin cancer after a high rate of dropouts due to immune-mediated adverse events, which would have made reaching statistical significance unlikely.

However, Merck is still working on its combination of vibostolimab and Keytruda, investigating the combination in three separate clinical trials to treat NSCLC. The company said the interim external data from the committee safety reviews have not resulted in any modifications and are undergoing “comprehensive safety monitoring.”

Other pharmas have also encountered challenges with anti-TIGIT antibodies. Last month, Roche stopped a Phase III study of its antibody tiragolumab after revealing that it would not improve survival in patients with NSCLC. Last week, Massachusetts-based biotech Agenus announced that Bristol Myers Squibb returned the rights to a bispecific antibody that binds to TIGIT after forging a potential billion-dollar deal in 2021.

https://www.biospace.com/drug-development/merck-halts-phase-iii-trial-of-keytruda-anti-tigit-combo-in-small-cell-lung-cancer

Lilly Beats Q2 Expectations as Tirzepatide Supply Stabilizes, Ups Full-Year Revenue Guidance by $3B

 

Lilly comfortably cleared analyst estimates in the second quarter after improving supply of its blockbuster tirzepatide brands Mounjaro and Zepbound, which together generated more than $4 billion in sales.

Eli Lilly released its second-quarter 2024 earnings report on Thursday, touting total revenues that easily exceeded analyst forecasts and raising its full-year guidance, reflecting recent improvements to the supply of its blockbuster tirzepatide brands Mounjaro and Zepbound.

In Q2, Lilly generated $11.3 billion in revenue, a 36% year-on-year increase from the same period in 2023. The pharma came out far ahead of the analyst projection, which pegged the pharma’s revenue to be $9.97 billion, according to SeekingAlpha. On a per-share basis, Lilly reported earnings of $3.92, surging 86% from the same period last year.

Fueled by its strong market performance, Lilly on Thursday raised its full-year 2024 revenue guidance to a range of between $45.4 billion to $46.6 billion, an increase of $3 billion.

Company shares jumped more than 12% in Thursday’s premarket trading.

BMO Capital Markets analyst Evan Seigerman in a note to investors called Lilly’s Q2 performance “impressive,” noting that the revenue beat “reflects improving supply dynamics for the company’s incretin portfolio.”

By comparison, rival Novo Nordisk’s semaglutide brands Ozempic and Wegovy fell short of analyst expectations in Q2, mainly held back by supply headwinds. Novo reported Wednesday that Wegovy’s sales in the quarter surged 53% to $1.7 billion but fell far below analyst forecasts of nearly $2 billion. Ozempic, which jumped 30% to $4.23 billion, also missed analyst estimates.

On Friday, all doses of Lilly’s Mounjaro and Zepbound were taken off the FDA’s Drug Shortage database. This supply update follows months of aggressive investment in its manufacturing capacity, including a $2.5 billion new production facility in Germany in November 2023 and a $5.3 billion injection for its Indiana footprint in May 2024.

Lilly’s Q2 performance is also indicative of the “higher realized prices for Mounjaro in the U.S. driven by dynamics with the company’s access and savings cards,” Seigerman wrote.

Mounjaro, which was approved in the U.S. for type 2 diabetes in May 2022, made nearly $3.1 billion in the quarter, beating the analyst consensus forecast of $2.4 billion, according to Seigerman. Meanwhile, the chronic weight management therapy Zepbound, which the FDA greenlit in November 2023, brought in $1.24 billion, also handily beating consensus expectations of $927 million.

Lilly is looking to drive the growth of its tirzepatide products even higher. According to the pharma, it plans to roll out 2.5-mg and 5-mg single-dose vials of the obesity brand Zepbound “in the coming weeks.”

In addition, Lilly is looking forward to several clinical and regulatory milestones for tirzepatide in the coming months, according to its earnings presentation. The company is gearing up for FDA submissions for tirzepatide in heart failure with preserved ejection fraction, as well as an agency decision on using the blockbuster drug for obstructive sleep apnea.

Lilly is also conducting a Phase III head-to-head study of tirzepatide versus Novo’s semaglutide, dubbed SURMOUNT-5, results from which are expected in November 2024. Lilly has reason to be optimistic. In July 2024, a study published in JAMA Internal Medicine showed that patients on Mounjaro lost 2.4% more weight than Ozempic counterparts at three months, with the advantage widening through six and 12 months of follow-up.

https://www.biospace.com/business/lilly-beats-q2-expectations-as-tirzepatide-supply-stabilizes-raises-full-year-revenue-guidance-by-3b

Amneal Wins FDA Approval for Extended-Release Oral Parkinson’s Drug

 

Crexont was previously rejected by the regulator in June 2023, citing insufficient safety data. However, Amneal Pharmaceuticals’ resubmission included findings from a healthy volunteer study.

Amneal Pharmaceuticals announced Wednesday that the FDA has approved its novel oral formulation of carbidopa/levodopa, now to be marketed under the brand name Crexont, for the treatment of Parkinson’s disease.

Chirag Patel and Chintu Patel, co-CEOs of Amneal, in a statement called Crexont’s approval “a seminal moment in the treatment paradigm for Parkinson’s disease.” The company expects to make the drug available in the U.S. in September 2024 and plans to introduce Crexont internationally soon, they said.

The combination of carbidopa and levodopa (CD/LD) is a well-known treatment for Parkinson’s disease (PD), first becoming commercially available in 1975. Levodopa, a precursor of the neurotransmitter dopamine, is metabolized into the neurochemical once ingested which improves movement and cognition in patients. Meanwhile, carbidopa prevents the conversion of levodopa outside the nervous system, minimizing side effects such as nausea.

However, existing oral immediate-release (IR) CD/LD products are short-acting, resulting in greater fluctuations in their effects. Patients experience greater motor variations and less time without troublesome dyskinesia, particularly as their disease progresses.

“Some PD patients on IR CD/LD take up to 10 daily doses and still experience motor fluctuations,” according to Amneal. “Crexont’s innovative formulation provides a longer duration of ‘Good On’ time with less frequent dosing compared to IR CD/LD.”

Crexont is formulated with both IR granules and extended-release pellets, allowing patients to experience longer stretches of time without suffering from troublesome dyskinesia, with an average dosing frequency of three times per day. Crexont’s formulation allows for the rapid onset of its effects and longer-lasting efficacy, according to Amneal.

The company first filed a New Drug Application for Crexont in November 2022, backing its FDA bid with data from the RISE-PD trial. The study showed that even when dosed less frequently than IR CD/LD, Crexont elicited significantly longer Good On time which RISE-PD defined as the total time without dyskinesia. However, in June 2023, the FDA rejected Crexont citing insufficient safety data, as reported by Reuters at the time.

In February 2024, Amneal resubmitted its application for Crexont and provided additional data from a healthy volunteer study of the drug.

In the PD space, Crexont’s approval follows the FDA’s rejection of Supernus Pharmaceuticals’ drug-device combo SPN-830, citing quality and master filing issues. SPN-830 is an amorphine infusion device that can continuously treat motor fluctuations in PD. In April 2024, AbbVie and NeuroDerm unveiled promising data for their respective continuous levodopa subcutaneous infusions, building toward regulatory submissions later this year.

https://www.biospace.com/fda/amneal-wins-fda-approval-for-extended-release-oral-parkinsons-drug

Outset Medical cut to Sector Perform from Outperform by RBC

 Target to $3 from $6

https://finviz.com/quote.ashx?t=OM&p=d

Harrow Q2 Results

 Second Quarter 2024 and Recent Selected Highlights:

  • Record revenues of $48.9 million
  • GAAP net loss of $(6.5) million
  • Adjusted EBITDA of $8.8 million
  • Cash and cash equivalents of $71.0 million as of June 30, 2024
  • IHEEZO® customer unit demand volume increased by 98% from the first quarter of 2024
  • IHEEZO supply agreements total 24 agreements to date in 2024, including a recent win with the largest and highest volume U.S. retina practice group
  • VEVYE® total prescriptions increased by 212% from the first quarter of 2024
  • Anterior Segment revenues up over 40% from the first quarter of 2024
  • Record quarterly revenues from Harrow’s ImprimisRx subsidiary

Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, announced results for the second quarter and six months ended June 30, 2024. The Company also posted its second quarter Letter to Stockholders and corporate presentation to the “Investors” section of its website, harrow.com. The Company encourages all Harrow stockholders to review these documents, which provide additional details concerning the historical quarterly period and future expectations for the business.

“The second quarter of 2024 marked a financial and operational turning point for Harrow, with revenues surging 46% compared to the same quarter last year and 42% over the previous quarter,” said Mark L. Baum, Chief Executive Officer of Harrow. “This remarkable growth, which was years in the making, was driven by exceptional performance across all Harrow business segments, most notably IHEEZO and VEVYE. Our team also continues to advance the relaunch of TRIESENCE® during 2024, with initial analytical test results for the second process performance qualification (PPQ) batch demonstrating in-specification results and the third PPQ batch scheduled to be manufactured in a matter of days. This outstanding quarterly report is a testament to the dedication of the entire Harrow Family, which is being continuously strengthened by the addition of experienced and motivated high-impact individuals. We are excited about where we are today, confident that we are poised for, and expect to achieve, further revenue and profitability expansion in the coming quarters and years.”

Conference Call and Webcast

The Company’s management team will host a conference call and live webcast tomorrow morning, Thursday, August 8, 2024, at 8:00 a.m. Eastern time to discuss the second quarter 2024 results and provide a business update. Participants can access the live conference call via webcast on the “Investors” page of Harrow’s website. To participate via telephone, please register in advance using this link. Upon registration, all telephone participants will receive a confirmation email with detailed instructions, including a unique dial-in number and PIN, for accessing the call. A replay of the conference call webcast will be archived on the Company’s website for one year.

https://www.businesswire.com/news/home/20240807453796/en/

Conduit Pharmaceuticals in License Agreement with AstraZeneca for Multiple Assets

 

  • Conduit Pharmaceuticals enters into exclusive license agreement with AstraZeneca for HK-4 Glucokinase activators AZD1656 and AZD5658 targeting autoimmune indications and myeloperoxidase inhibitor AZD5904 targeting idiopathic male infertility
  • Assets have shown favorable preclinical and Phase I data. Conduit to initiate Phase II clinical trials

Under the terms of the License Agreement, AstraZeneca will grant Conduit an exclusive license to both AZD1656 and AZD5658 for all human indications, as well as an exclusive license to AZD5904 for use in Idiopathic Male Infertility.

As part of the License Agreement, AstraZeneca will be issued shares of common stock in Conduit, and Conduit will also pay AstraZeneca a share of sublicense revenues, including upfront payments, milestones, and royalties received from future partners.

AstraZeneca will share pre-clinical and clinical data on the assets and supply Conduit with certain quantities of AZD1656, AZD5904, and AZD5658 from its inventory. The License Agreement also includes provisions for the transfer of know-how related to AZD1656, AZD5658 and AZD5904 from AstraZeneca to Conduit. AstraZeneca has been granted a right of first negotiation to develop, manufacture, and commercialize the licensed compounds if Conduit seeks to assign, license, or grant such rights to a third party.

https://www.globenewswire.com/news-release/2024/08/08/2926715/0/en/Conduit-Pharmaceuticals-Enters-into-Exclusive-License-Agreement-with-AstraZeneca-for-Multiple-Assets-to-Advance-Potential-First-in-Class-Treatments.html