The acquisition agreement comes amid record sales of Novo’s weight-loss drug Wegovy (semaglutide), which during the second quarter earned over $1.1 billion, according to the company’s quarterly earnings report released Thursday. This represents a nearly 550% increase from its sales figures during the same period last year.
Novo did not break down how much it will pay up front for the Inversago buy but noted that the deal will reach its full value of nearly $1.08 billion “if certain development and commercial milestones are achieved.” The companies expect to close the buyout before the end of this year, pending regulatory clearance and other customary conditions.
Thursday’s acquisition deal will allow Novo to further boost its clinical development pipeline in obesity and related disorders, particularly using Inversago’s novel CB1 receptor-based therapies, which “could lead to life-changing new treatment options for those living with a serious chronic disease and, in particular, may offer alternative or complementary solutions for people living with obesity,” Martin Holst Lange, Novo executive vice president for development, said in a statement.
Inversago’s lead asset is INV-202, an oral blocker of the CB1 receptor, which is important for the regulation of metabolism and appetite. According to Novo’s announcement of the acquisition, CB1 is commonly found on peripheral tissues—including the kidneys and liver—and blocking this receptor in has been shown in preclinical studies to have therapeutic effects across a wide range cardiometabolic and fibrotic diseases.
Novo plans on assessing the potential of INV-202 and CB1 blockage in obesity and associated complications.
In June 2023, Inversago presented Phase Ib data for INV-202 during the 83rd American Diabetes Association Scientific Sessions. Over 28 days of treatment, the investigational CB1 blocker was safe and well-tolerated in adults with signs of metabolic syndrome.
A post-hoc analysis also showed that treated participants saw clinically significant progressive weight loss with an average decline of 7.7 pounds, while placebo comparators gained an average of 1.2 pounds.
Once the acquisition is completed, INV-202 and Inversago’s pipeline of CB1 blockers will join Novo’s diabetes and obesity care business, which in the second quarter of 2023 brought in more than $1.5 billion and in the first half of the year raked in nearly $15 billion in revenues.
Aside from Wegovy, Novo’s other top-selling assets in this business segment include Type 2 diabetes drugs Ozempic and Rybelsus, which made more than $3.2 billion and nearly $590 million in the second quarter, respectively. Ozempic and Rybelsus share the active ingredient of Wegovy.
The Company is withdrawing its previously announced fiscal year 2023 guidance, originally issued on May 10, 2023, due to the uncertainty resulting from the potential impact of the recently published local coverage determinations from Novitas, First Coast Services and CGS to limit coverage for treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) to include only Apligraf and Dermagraft. The Company is currently unable to predict the impact that the recently published local coverage determinations will have on its financial position and operating results.
Submission of first U.S. New Drug Application for mavorixafor in WHIM syndrome on track for early 2H 2023
Emerging data from ongoing Phase 2 trial in certain chronic neutropenic disorders show mavorixafor durably increased neutrophil counts and enabled reductions in G-CSF dosing
New market research confirms significant initial target population for mavorixafor given high unmet needs within U.S. chronic neutropenia (CN) market
Plans underway for initiation of Phase 3 trial in certain chronic neutropenic disorders in 1H 2024
Conference call to be hosted today at 8:30 a.m. ET
X4 will host a conference call and webcast today at 8:30 am ET to discuss these financial results and business highlights. The conference call can be accessed by dialing 1-877-451-6152 from the United States or 1-201-389-0879 internationally, followed by the conference ID: 13739751. The live webcast and slide presentation can be accessed on the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com. Following the completion of the call, a webcast replay of the conference call will be available on the website.
Cantex's once daily, orally administered, azeliragon inhibits interactions of the receptor for advanced glycation end products (RAGE)
Researchers showed RAGE inhibition to be a potential target for treatment of triple-negative breast cancer suppressing tumor progression and metastasis
Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, today announced the publication in the peer-reviewed journal, npj Breast Cancer, a Nature Portfolio journal published in partnership with Breast Cancer Research Foundation, with results from in vitro and in vivo models for triple-negative breast cancer showing suppression of metastasis and tumor progression by RAGE inhibition. Cantex's azeliragon, currently in phase 2/3 development for the treatment of major cancers, complications of cancer treatment, and the treatment of other life-threatening illnesses, is a RAGE inhibitor that is orally administered and taken once daily.
MacroGenics has joined the pack of biotechs cutting staff, laying off 15% of its workforce after shuttering a phase 2 clinical trial for anti-cancer antibody enoblituzumab when seven patient deaths occurred.
In July, the Rockville, Maryland-based biotech closed the phase 2 trial assessing the B7-H3-directed program after seven of the 62 participants died. The deaths were potentially linked to hemorrhagic events, a known risk for recurrent or metastatic squamous cell carcinoma of the head and neck—enoblituzumab’s target in the trial—but one that typically occurs at a lower rate than seen in the phase 2 study.
Investigators assessed six of the deaths to be secondary to disease progression and/or unrelated to the study treatment. One of the deaths was deemed to be possibly related to the treatment. Participants took enoblituzumab in combination with one of MacroGeneic's other therapies, either the anti-PD-1 monoclonal antibody retifanlimab or the PD-1×LAG-3 bispecific tebotelimab. Deaths occurred in both arms of the clinical trial.
Now, less than a month after stopping the trial, the biotech is closing two satellite facilities and laying off employees to cut costs and save resources, according to an August 8 release. Based on the biotech’s team size of 419, as reported on LinkedIn, the 15% workforce cut represents about 63 employees. The layoffs will occur either immediately or over time as the biotech shutters a Brisbane, California-based research site and a non-commercial manufacturing site in Rockville.
MacroGenics doesn’t believe the shuttered trial bears weight on its other B7-H3-directed programs or its ability to potentially develop enoblituzumab in other indications. The biotech said enoblituzumab’s effect on prostate cancer should be further evaluated, citing data from an ongoing phase 2 trial being conducted by Johns Hopkins University in patients with localized prostate cancer.
The trial isn’t the first setback MacroGenics’ protein B7-H3s have faced. A B7-H3xCD3 bispecific was discontinued in 2020 in a separate company restructure.
The company is now turning its focus to MGC018, an antibody-drug conjugate that targets B7-H3 for patients with metastatic castration-resistant prostate cancer, with plans to launch a phase 2/3 study dubbed Tamarack by the end of 2022.
“With these actions, we believe our updated cash runway should enable the delivery of interim data from the phase 2 portion of the Tamarack study of MGC018 by the end of 2024,” said MacroGenics CEO Scott Koenig, M.D., Ph.D.
Patient recruitment continues in a phase 1/2 dose escalation study of MGC018 in combo with the company's investigational, bispecific molecule lorigerlimab for various advanced solid tumors, the CEO said.
The company’s restructuring was announced after market close Monday. The biotech’s stock rose about 11% Tuesday to $5.07, compared to a previous close of $4.55.
This summer has proved challenging for biotech, with several companies culling pipeline programs—and staff—amid the prolonged bear market. MacroGenics' layoffs were disclosed the same day that Atara Biotherapeutics revealed a similar cull.
Biofrontera AG Inc. (NASDAQ:BFRI) (the "Company"),a biopharmaceutical company specializing in the commercialization of dermatological products, announces that patient enrollment is now complete in the Phase 3 clinical study evaluating Ameluz®-PDT in combination with the BF-RhodoLED®lamp for the treatment of basal cell carcinoma (BCC). This study is being conducted by Biofrontera Bioscience GmbH.
"Completing patient enrollment in this Phase 3 clinical study is an important milestone in our strategy to expand the Ameluz® label beyond actinic keratosis (AK). As awareness about skin cancer increases, so does demand for non-surgical BCC treatments without ionizing radiation. According to the Skin Cancer Foundation, of the 5.4 million annual cases of non-melanoma skin cancer in the U.S., approximately 3.6 million, or 67%, are BCC. There is a significant unmet medical need for more effective, less invasive and cost-efficient therapies that treat BCC as well as underlying premalignancies. We look forward to sharing results from this Phase 3 study in mid-2024," said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc.
"In addition to treating individual lesions, Ameluz® is indicated by its prescribing information* for the lesion-directed and field-directed treatment of skin areas with multiple AKs. Superficial BCC is another, more severe form of neoplastic damage that such a field may carry, and inclusion into the label broadens the use of Ameluz® in field-directed treatment, starting a new chapter of PDT for non-melanoma skin cancer", he continued.
This randomized, double-blind, placebo-controlled study aimed at enrolling 186 patients at 19 U.S. sites. With 183 patients now treated, and four more patients screened and awaiting histological results and treatment, the clinical sites have been informed that the enrollment is complete. Each patient had one or more clinically and histologically confirmed superficial BCC. Patients receive one cycle of two PDTs (either Ameluz®-PDT or placebo-PDT) 1-2 weeks apart, which may be repeated after three months if required. The last assessment of the patient will take place three months after the final PDT cycle. The primary endpoint is the composite complete clinical and histological clearance of a main BCC lesion, which was selected at the beginning of the study. In addition, data on drug safety as well as secondary efficacy parameters of all BCCs will be evaluated. After completion of the trial, patients will be followed for an additional five years.
The wildfires that ravaged Canada this summer have some experts calling for a more aggressive approach to the blazes than the country’s historically reactive, case-by-case approach.
As of Tuesday, 1,160 fires are burning across the country. This year, nearly 30 million acres have burned across Canada, an area bigger than several individual U.S. states. The area burned — the fourth-most of any season on record — is too large to rely on colder weather and precipitation to do the bulk of the work in extinguishing the blazes.
The affected area has included regions more prone to large fires, such as British Columbia and Saskatchewan. Fires in eastern provinces such as Quebec, where blazes are less common, blanketed the eastern U.S. in haze earlier this summer. In those provinces, wildfire agencies that are equipped to fight fewer and smaller fires were largely unprepared for the circumstances.
“[T]he fires are burning hotter and spreading faster than they usually do. The image of a firefighter spraying water on a fire, or a water bomber dropping water right on the fire needs to be dispelled: under the current conditions, humans cannot get within 100s of meters of the fires: so no direct spraying can be done on most fires,” Chris Stockdale, a fire research scientist at the Northern Forestry Centre in Edmonton, Alberta, told The Hill in an email.
“Furthermore, you have to consider the whole perimeter of the fire as dangerous and capable of spreading,” Stockdale added.
The current wildfire situation “takes a level of waterbombing and human power that is literally impossible to address,” he said. “Even if most of an individual fire’s perimeter is fully extinguished, any parts that are not put out have the potential to flare up days or even weeks later under the right weather conditions.”
Historically, Canada’s approach to fires has been largely reactive and mostly concerned with immediate extinguishment of active fires, said Mohammad Reza Alizadeh, a researcher with McGill University’s Department of Bioresource Engineering.
“The limited understanding of fire ecology at that time necessitated the immediate suppression of fires to protect valuable timber resources,” Alizadeh told The Hill in an email.
More recently, however, the country has taken steps including increased specialization of fire agencies, improved communications systems and strategic use of water-bombing from the air, he said. The more fire-prone regions of the country have also shifted their thinking to a more preventive approach and a perspective that acknowledges the value of controlled burns, he said.
“This shifted the focus to early detection and prompt response, exemplified by the adoption of controlled burns to create firebreaks and reduce fuel accumulation. Simultaneously, a more balanced and enlightened perspective has shaped by a growing recognition of fire’s ecological role and its effect on biodiversity,” Alizadeh said. “This paradigm shift changed away from strict fire suppression and toward an inclusive approach to fire management.”
However, the sheer number and size of active fires, as well as their presence in areas less accustomed to dealing with the threat, has strained local resources and illustrated the limits of a case-by-case strategy.
“[W]e have many fires in many parts of the country drawing upon a limited number of resources, both within Canada and internationally,” Canadian Emergency Preparedness Minister Bill Blair said in June. Firefighters have been deployed to assist from the U.S., Australia, South Korea and Mexico.
While American forest management is typically handled at the federal level under the jurisdiction of the U.S. Forest Service, Canadian management operates on more of a provincial and territorial basis.
“Each province is responsible for maintaining its own resources and personnel for firefighting. Historically, most provinces employ full-time enough resources to deal with their average fire seasons,” Stockdale said.
Smoke billows from the Donnie Creek wildfire burning north of Fort St. John, British Columbia, Canada, on July 2. Associated Press/Noah Berger
That province-level approach to management has meant officials must frequently make hard decisions about what to prioritize saving from the path of the fires, said John Gradek, a faculty lecturer and the coordinator of McGill University’s aviation management program.
“The question you have to ask yourself is: What is the vision of the government in protecting that resource? Is there enough money? Are there enough assets in place to protect that resource?” he told The Hill in an interview. “If the resource is not threatening established infrastructure … that resource is not going to be protected from fire to the extent that [government officials] would look at fire suppression.”
Particularly in Quebec and British Columbia, Gradek said, “the amount of fire suppression has been focused on those fires that are threatening human infrastructure. What’s happening is, at this point in our strategy, we’re not looking at all forest fires. We’re being very selective.”
In future wildfire seasons, he said, officials may find it more effective to find ways to take preventive action to minimize fires farther from human infrastructures as well, including the daunting task of potentially clearing underbrush from forest floors.
“The provincial governments who are responsible for minimizing the [fires] have decided the strategy will be focused on protecting infrastructure that’s supporting human settlement,” he said. “They’ve left all the remote fires … to burn themselves out, and that’s generating a lot of smoke and that’s generating discomfort across North America, because of that smoke.”
Other experts, however, argue the nature of the fires, and the land they’re burning, mean firefighters have limited options.
“[T]he area is too large and too remote and the fuels are too dry. In addition, there are many fires occurring simultaneously, which stretches resources (e.g., aircraft) and firefighting labor,” Robert Scheller, a professor of landscape ecology at North Carolina State University, told The Hill in an email. “Firefighting under these circumstances can really only protect property and people. They’ve managed to limit losses to people and property and so I’d argue they’ve been quite successful.
“There are a limited number of proactive approaches that are appropriate at large scales. Prescribed fires and forest thinning are the two most common approaches,” Scheller added. “However, neither of these is appropriate for the boreal forests of Canada. Prescribed burning is only appropriate for forests that are adapted to frequent fires, such as forests in [California]. Boreal forests are not adapted to frequent fires.”
