CureVac, chasing Moderna's mRNA flu vaccine, runs into the same B strain problems

CureVac and GSK have been racing behind Moderna to try to get the first mRNA flu vaccine to market. But, now, the European partners have come up against the exact same problem as their U.S. competitor when it comes to the "historically challenging" B strains of influenza.

Interim results from an ongoing phase 2 study of the companies’ seasonal influenza candidate showed that the shot “boosted antibody titers against all encoded flu strains and across all age groups and tested dose levels, including the lowest tested dose,” CureVac reported in an April 4 release.

But, while CureVac’s GSK94180-partnered shot was able to beat licensed flu vaccines in triggering an immune response against influenza A strains, the candidate was unable to manage the same feat against strains of influenza B.

Moderna’s flu program ran into the same problem, with a previous version of the U.S. biotech’s mRNA-1010 vaccine failing to meet the non-inferiority threshold for two influenza B strains a year ago. Moderna was later able to bring a new formulation into the clinic that overcame this setback.

CureVac will now also work on “targeted optimizations” to improve the vaccine’s protection against the B strains that will be tested in a separate phase 2 study.

“Immunogenicity for B strains was in line with our expectations also in view of other initial mRNA-based clinical flu development programs,” CureVac Chief Development Officer Myriam Mendila, M.D., said in the release. “We are confident that planned optimizations will improve performance against these historically challenging influenza strains.”

The current phase 2 trial is assessing the vaccine in 480 adults aged 18 to 64 years and another 480 healthy older adults aged 65 to 85, with three dose levels across each age group. In the younger group, immune responses were compared to an approved but unnamed “standard dose seasonal vaccine” while in the older group the responses were compared to a “high dose seasonal flu vaccine,” according to CureVac.

The company said the shot had an “acceptable safety and tolerability profile” with most of the adverse events reported in the week after dosing being either mild or moderate.

“The phase 2 interim data show that CureVac’s highly effective and flexible mRNA technology platform puts us on the right track to advance our joint seasonal influenza vaccine program,” Mendila said.

Despite touting the vaccine’s “strong” results against influenza A strains, the ability to fight off all WHO-recommended strains will be key for CureVac. The WHO recommends protection against the two A subtypes, H1N1 and H3N2, as well as the influenza B Victoria and Yamagata lineages, be included in annual flu shots.

Even if CureVac and GSK can rapidly improve their vaccine’s efficacy against those B strains, they will still be trailing Moderna, which bested GSK’s Fluarix in a phase 3 trial that read out in September 2023. Moderna now has an extension of that study ongoing in older adults and intends to file for approval this year.

Moderna’s mRNA flu ambitions received a shot in the arm last week when Blackstone Life Sciences agreed to provide “up to” $750 million to fund the biotech’s vaccines work, in return for an undisclosed amount of “cumulative” commercial milestone payments and “low-single-digit” royalties on any approved products.

https://www.fiercebiotech.com/biotech/curevac-chasing-modernas-mrna-flu-vaccine-runs-same-b-strain-problems

Merck puts KRAS cancer drug competitor to the test

 

• Merck & Co. has begun a large clinical trial testing an experimental cancer drug it’s developing for tumors that harbor mutations in a tough-to-target gene called KRAS,

• The Phase 3 study, which is set to enroll some 600 people with a common form of metastatic lung cancer, will pit the KRAS inhibitor together with Merck’s immunotherapy Keytruda against Keytruda alone. Researchers will assess whether the combination slows tumor progression and helps people live longer.

• Dubbed MK-1084, the experimental KRAS inhibitor is currently in Phase 1 testing. Based on early results, Merck thinks the drug could work well together with Keytruda to treat certain people with KRAS-mutated lung tumors.

First Amgen and then Mirati Therapeutics won U.S. approvals for KRAS cancer medicines, dispelling the gene’s long-held reputation as “undruggable.”

While sales have been slower than analysts expected, and Amgen has run into confirmatory testing difficulties, the drugs are viewed as building blocks for curbing tumors that resist other treatment. Both Amgen and Bristol Myers Squibb, which bought Mirati last fall, are testing their respective drugs alongside other therapies, as well as in earlier settings.

Merck aims to compete as well and its trial could provide evidence for using MK-1084 alongside Keytruda, which is the dominant immunotherapy for lung cancer treatment. Enrollment is limited to patients who both have confirmed KRAS mutations as well as high levels of a protein that’s associated with response to immunotherapy. The study is set to reach primary completion by 2029, although interim results could come sooner.

Merck got access to MK-1084 through a 2020 alliance with Taiho Pharmaceutical Co. and Astex Pharmaceuticals.

Amgen and Bristol Myers are also studying their respective KRAS drugs in combination with immunotherapies, including Keytruda.

Sales of Amgen’s KRAS therapy, Lumakras, totaled $280 million in 2023, while Mirati reported $36 million in sales of its drug, Krazati, through the first nine months of 2023.

Bristol Myers, which closed its deal to buy Mirati in January, recently reported positive results from a confirmatory study of Krazati in lung cancer.

https://finance.yahoo.com/m/0ddd1c3d-cf70-3d4e-ac97-7cf23072dc7e/merck-puts-kras-cancer-drug.html

Acumen Pharma Collaborates with Lonza to Advance Sabirnetug for Alzheimer’s

 

• Lonza to manufacture Acumen’s monoclonal antibody, sabirnetug (ACU193), for clinical development and commercialization, if approved
• Sabirnetug is the first monoclonal antibody candidate to enter the clinic developed to selectively target toxic soluble amyloid beta oligomers, which evidence indicates are a primary underlying cause of Alzheimer’s disease (AD)
• Acumen is on track to initiate a Phase 2 clinical trial evaluating sabirnetug in the first half of 2024

https://www.biospace.com/article/releases/acumen-pharmaceuticals-collaborates-with-lonza-to-advance-sabirnetug-for-the-treatment-of-alzheimer-s-disease/

STAAR Surgical Expects Q1 Sales To Beat Consensus

 Thursday, STAAR Surgical Company (NASDAQ:STAA) reported preliminary net sales for the first quarter of 2024 of more than $77 million versus the consensus of $72.13 million, with U.S. ICL sales expected to be $5 million for the quarter.

This represents the company’s highest quarterly ICL sales in the U.S. since the company obtained U.S. FDA approval for the EVO ICL in March 2022.

“STAAR is off to a solid start in 2024 as illustrated by our preliminary first quarter results, including a record quarter in the U.S.,” said Tom Frinzi, President and CEO.

“U.S. ICL sales were up approximately 20% sequentially to $5 million in the first quarter, which reflects early signs of our increased market focus. EMEA ICL sales were up approximately 11% year over year and ICL sales in our APAC region were up approximately 9%, including approximately 10% growth in China.

We are pleased by the first quarter performance across all major geographies and will provide further detail on our results and outlook during our upcoming earnings call, but at this time we believe our fiscal 2024 net sales can be at the higher end of our previously announced outlook range of $335 million to $340 million.”

Cash, cash equivalents, and investments available for sale were approximately $248 million, and accounts receivable were approximately $70 million as of March 29, 2024.

Needham writes that if the seasonal pattern of 2024 follows that of 2022 and 2023, it’s anticipated that 2024 revenues will likely approach $355 million.

Despite this, achieving STAAR Surgical’s revenue target for 2026 seems challenging, especially considering the necessary acceleration.

During a recent expert call, a doctor mentioned no expectation for an increase in their ICL mix.

While Needham analysts see the 2024 guidance as cautious, and anticipate a gradual domestic growth. Needham maintains the Hold rating.

https://finance.yahoo.com/news/eye-lens-maker-staar-surgical-195413292.html

AngioDynamics Unveils Upbeat 2024 Financial Outlook

 Thursday, the FDA granted 510(k) clearance to AngioDynamics Inc’s (NASDAQ:ANGO) AlphaVac F1885 System for pulmonary embolism (PE).

The expanded FDA indication allows for the utilization of the AlphaVac F1885 System for PE, which broadens the applicability of the AlphaVac F1885 System in the non-surgical removal of thrombi or emboli from the venous vasculature.

The indication expands treatment options for patients with PE, reducing thrombus burden and improving right ventricular function.

In December 2023, AngioDynamics completed patient enrollment in its Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study that enrolled 122 patients.

The APEX-AV Study showed a mean decrease in the RV/LV ratio from baseline to 48 hours post-procedure of 0.45 (significantly greater than the pre-defined performance goal of 0.12 and an MAEs rate of 4.1% (significantly lower than the pre-defined performance goal of 25%.

The study also showed a 35.5% mean reduction in clot burden from baseline to 48 hours post-procedure.

Concurrently, AngioDynamics reported third-quarter 2024 sales of $75.18 million, slightly below the consensus of $75.73 million.

On a pro forma basis, excluding the Dialysis and BioSentry businesses, sales increased 8% to $66.0 million, an increase of 8.0% compared to the prior-year quarter.

Pro forma Med Tech net sales of $25.7 million increased 12.6% Y/Y, and med device net sales reached $40.3 million, up 5.5%.

The company reported an adjusted EPS loss of $(0.16), missing the consensus of $(0.13).

Guidance: Angiodynamic expects the fiscal year 2024 sales of $270 million-$275 million, reflecting the PICC and midline businesses divestiture and discontinuance of radiofrequency ablation and syntrax businesses, which accounted for ~$50 million of prior guidance of $320 million -$325 million vs. the consensus of $312.14 million.

https://finance.yahoo.com/news/medical-devices-focused-angiodynamics-unveils-185306837.html

AstraZeneca, BMS, Pfizer Among Big Pharma to Present at Inaugural AACR Event

 While American Association for Cancer Research (AACR) membership has historically been dominated by academics, the organization is making an effort to engage with the biopharma industry. Thursday and Friday, ahead of the opening of the AACR annual meeting in San Diego, the group is holding its inaugural “industry partnering” event to bring together drug and biotech companies, venture capitalists and investment bankers with academic oncology regulars.

This is the first time the program has not been purely academic and scientific, according to AACR Foundation trustee Christiana Bardon, co-managing partner of biotech investment firm MPM BioImpact. A dozen Big Pharma companies, including Boehringer Ingelheim, Takeda, Novartis and Genentech, will have dedicated “industry spotlight” sessions where their top oncology R&D officials will detail their future therapeutic interests.

“What we wanted to do was encourage more dialogue between all the different parties, including traditional pharma, biotech, investors, as well as academics, Bardon, co-chair of the event, told BioSpace. “Our goal at the AACR is to translate the great scientific discoveries of our scientists into drugs that go into clinical trials and ultimately get to patients.”

Details of what the companies will present remain to be seen, but pipelines may be shifting in the context of the Inflation Reduction Act (IRA) and its “pill penalty” that grants longer protections from Medicare price negotiations for biologics than for small molecules. Notably, Pfizer announced a month ago that it was shifting much of its oncology R&D to biologics.

A Gathering of Biopharma Bigwigs

AACR invited major pharma firms working in oncology to present their early-stage pipelines. Bardon expects to hear plenty about novel targets and modalities, including preclinical R&D now underway.

“We want to see your [their] vision for cancer over the next five to 10 years,” she explained. Five years ago, presentations like those may have mentioned antibody-drug conjugates (ADCs) or radiotherapeutics, two categories that have become popular in oncology development today.

In addition, the event will host several panel discussions. One is about how to grow from a privately held biotech to a public firm. Clay Siegall, president and CEO of Immunome, is on that panel half a year after leading privately held radiotherapy startup Morphimmune through a merger with Immunome and then taking the helm of the larger company.

In an email to BioSpace, Siegall said that he is “most excited about sharing Immunome’s plans and extensive pipeline with investors.”

The Exton, Pa.–based company has been busy in the capital markets of late, completing a $230 million public offering in February and just last week closing its purchase of a Phase III small molecule gamma secretase inhibitor from Ayala Pharmaceuticals.

Still, the biopharma investment market is not back to its COVID-19 peak in early 2021, Bardon said. Higher interest rates have chilled the flow of capital, and many of the more general investors who rushed into biopharma and biotech in 2020 have since left. However, the “healthy M&A environment” is a positive sign, she added.

Event creator and co-chair, former AACR President Michael Caligiuri, likened this forum to a J.P. Morgan Healthcare Conference of sorts but specific to oncology. Currently, he told BioSpace, “there’s nothing focused on cancer where you can start to build your network.” Caligiuiri is a leukemia and hematologic researcher at City of Hope National Medical Center who recently ended a five-year term as president of the Duarte, Calif.–based cancer center.

He said that while AACR excels in science and in pharma, the organization struggles with the connection between the two—“how we get the science to pharma and how we get pharma to know of the science.” Plenty of discoveries wind up in what Caligiuri called a “valley of death” between academia and ultimate commercialization.

“There’s no one in the middle connecting all those dots to facilitate the development of the discovery further along, such that it can get to a patient,” Caligiuri explained. “This conference . . . is kind of an information exchange, with the idea of closing the gap between discovery and FDA approval so that patients get drugs quicker for their cancer.”

https://www.biospace.com/article/astrazeneca-bms-pfizer-j-and-j-among-big-pharma-to-present-at-inaugural-aacr-event/

Companies Detail Potential Fallout as Pressure on WuXi AppTec Builds

 WuXi AppTec, a key partner for many U.S.-based biopharma companies, has recently been caught up in controversy pertaining to the proposed BIOSECURE Act. Now, companies including Merck, Iovance Biotherapeutics and Kyverna Therapeutics, have detailed interactions with the SEC about potential impacts on their future programs.

Introduced in January 2024 by Rep. Mike Gallagher (R-WI), the BIOSECURE Act aims to guarantee that taxpayer money isn’t used to help fund “foreign adversary biotech companies” posing threats to U.S. national security. It also prohibits federal contracting with “certain biotechnology providers” tied to foreign adversaries. The biotech companies of concern listed in the proposed legislation are WuXi AppTec, BGI, MGI and Complete Genomics.

If signed into law, the legislation would prevent biopharma companies that contract with “companies of concern” from also having contracts with the U.S. government, according to the law firm Foley Hoag.

On March 14, news emerged that WuXi had separated from the trade organization BIO after U.S. intelligence officials told senators that the company had shared a U.S. client’s intellectual property with the Chinese government without consent.

In an SEC document filed Feb. 28, cell therapy biotech Iovance noted that it has contracted a WuXi subsidiary to manufacture its cell therapy products commercially, but also stated that the “current geopolitical tensions” with China may “impact our ability to expand manufacturing capacity” with the company’s facilities. Jen Saunders, senior director of investor relations and corporate communications at Iovance, told BioSpace in an email that the biotech does not anticipate any “significant impact” from the BIOSECURE Act—or a different version of it—on its ability to manufacture and meet the demand for its recently approved cell therapy Amtagvi.

“Our manufacturing facility, the Iovance Cell Therapy Center, is built to support several thousand patients annually,” Saunders said, adding that the company is comfortable with its internal capabilities to address anticipated near-term demand and is currently working to expand its existing facility to more than double capacity.

In February 2024, Rep. Gallagher and Rep. Raja Krishnamoorthi (D-IL) penned a letter to Commerce Secretary Gina Raimondo, Treasury Secretary Janet Yellen and Defense Secretary Lloyd Austin, asking them to investigate WuXi and have the company placed on control lists. These lists include the DoD’s Chinese Military Companies List (1260H list), the Department of Commerce’s Bureau of Industry and Security Entity List and the Department of Treasury’s Non-SDN Chinese Military-Industrial Complex Companies List.

Iovance noted in the document that if WuXi is added to any of these lists, it could “materially impact” its manufacturing service agreement with the company.

In its own SEC filing last week, Kyverna explained that it has partnered with a WuXi subsidiary to manufacture its CAR T cell candidate KYV-101 while developing its manufacturing methods. As with Iovance, the addition of WuXi to one or more of the aforementioned lists could “materially impact” Kyverna’s use of the subsidiary, according to the filing.

In a statement emailed to BioSpace, a Kyverna spokesperson said it is aware of the “ongoing concerns related to the BIOSECURE Act” and is “closely monitoring the developments.”

And it isn’t just smaller biotechs that could end up caught in the crosshairs of this proposed legislation. Merck detailed in an SEC document filed Feb. 26 that its business in China has been growing over the past few years, and said the country’s importance to its vaccine and pharma business has increased. Merck also has “significant” research and production operations in China and does work with WuXi.

“If geopolitical tensions were to increase and disrupt the Company’s operations in China, such disruption could result in a material adverse effect on the Company’s product development, sales, business, cash flow, results of operations, financial condition and prospects,” according to the document.

BioSpace reached out to Merck for further comment but has not heard back.

Elsewhere, Jacob Van Naarden, president of Eli Lilly’s Loxo Oncology division, told BioSpace in a previous interview that the company is not facing direct pressure to divest from China but is “trying to be cautious” about the situation.

https://www.biospace.com/article/companies-detail-potential-fallout-as-pressure-on-wuxi-apptec-builds/