Target $10
Wednesday, April 3, 2024
Addex, Perceptive Launch Neurosterix with $63 M to Accelerate Neurological Therapeutics
Addex receives CHF5M and 20% share of Neurosterix
Perceptive Advisors leads $63M investment into Neurosterix
Addex contributes portfolio of preclinical neuroscience assets and allosteric modulator small molecule discovery technology platform to Neurosterix
Harmony Bio Starts Phase 3 in Prader-Willi Trials
Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY) has initiated its global Phase 3 registrational trial, the TEMPO study, to evaluate the safety and efficacy of pitolisant as a treatment for excessive daytime sleepiness (EDS) and behavioral symptoms in patients aged six years and older with Prader-Willi syndrome (PWS).
The TEMPO study initiation follows a successful End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA) and their recent decision to grant Orphan Drug Designation (ODD) for pitolisant in PWS. ODD incentivizes the advancement of promising therapies for rare diseases by providing tax credits for clinical development, waivers for user fees, and seven years of market exclusivity following drug approval.
VBI: Encouraging Early Glioblastoma Tumor Response Data From Phase 2b
- Data highlighted in oral presentation at World Vaccine Congress 2024 on April 3, 2024
- Early data from patients eligible for evaluation at week 12 show two observations of stable disease, indicating no tumor progression, in VBI-1901 treatment arm (n=2/5; 40% disease control rate [DCR])
- By comparison, no tumor responses have been observed in the control arm to-date (n=0/6; 0% DCR), with all patients seeing a 2-8x increase in tumor size by week 6
- FDA has granted both Fast Track Designation and Orphan Drug Designation to VBI-1901 in recurrent GBM following encouraging Phase 1/2a study results
- Additional interim data expected mid-year and year-end 2024
Chinese ADC Investment Boom in Question With China-U.S. R&D Relations in Flux
The future of Western cooperation in antibody-drug conjugate R&D in China is up in the air after a tumultuous first quarter that saw a very public separation between a key industry group and a major Chinese biotech company. Meanwhile, U.S. legislation that would bar federal funding from supporting “foreign adversary” biotech firms is advancing in Congress.
Last month, WuXi AppTec left the Biotechnology Industry Organization (BIO) after U.S. intelligence officials raised suspicion that the company had passed a U.S. client’s intellectual property to the Chinese government without consent. Almost concurrently, both houses of Congress took up the BIOSECURE Act, a bill intended to distance U.S. biomedical R&D from Chinese companies that may pose a national security risk.
Despite these high-profile tensions between the U.S. and China, biopharma is increasingly turning to Chinese partnerships for the development of antibody-drug conjugates (ADCs), a market that is projected to be worth nearly $30 billion by 2028. A January report from GlobalData counted 487 oncology-related strategic alliances and partnerships struck in China between 2019 and 2023, and the fraction of these deals that involved ADCs grew significantly over that time, accounting for nearly a quarter of last year’s collaborations.
Dowdy Jackson, former executive director of ADC biology at Chinese-owned Innovent Biologics who recently started a consultancy in the Washington, D.C., area, said drug companies have been drawn to China for ADC development because Chinese partners can move fast and do the work at fraction of the cost of U.S. and other Western entities. “I don’t anticipate it slowing down anytime soon,” Jackson told BioSpace.
How the political movement will affect this trend remains to be seen. Jake Van Naarden, president of Eli Lilly’s Loxo Oncology division, said that the company is not feeling direct pressure to divest from China. “We’re trying to be cautious about it,” Van Naarden told BioSpace. “A lot of things get discussed in politics and don’t end up happening, [so] I think you have got to be careful how much you react before things have happened.”
He did note that nearly all major pharma companies have contract relationships in China and cautioned against “[throwing] the baby out with the bathwater” by shutting down U.S.-China cooperation on ADC and other drug development.
Market Boom and Political Pushback
In a recent report, life sciences research firm Evaluate called ADCs “the hottest real estate in oncology,” highlighted by Pfizer’s $43 billion acquisition of Seagen last year. Much of this activity invovles companies in China. Roche forged a $1 billion licensing deal with Suzhou, China–based MediLink Therapeutics, for example, and BioNTech’s licensing agreements with DualityBio for three oncology ADCs collectively represent the largest oncology-specific ADC deal in China over the last five years, with a total value of $1.67 billion, Nelluri Geetha, an India-based pharma analyst at GlobalData, told BioSpace in an email.
At the same time, activity picked up on the BIOSECURE Act, bipartisan legislation introduced in Congress to avoid funding “foreign adversary biotech companies of U.S. national security concern,” according to the House Select Committee on the Strategic Competition Between the United States and Chinese Communist Party. Early last month, a Senate committee voted to advance the bill, which would effectively prohibit funding by National Institutes of Health grants and other federal sources from supporting partnerships with companies deemed to be a national security threat. Senate leadership has not set a date to consider the bill. Meanwhile, the House version of the legislation is still pending in the select committee, as Chairman Rep. Mike Gallagher (R-Wis.), a cosponsor of the bill, is resigning from Congress April 19.
On March 5, Gallagher wrote a letter to Attorney General Merrick Garland accusing BIO of advancing “the interest of the Chinese Communist Party” and raising “concerns that it is operating as an unregistered agent of a foreign principal” by lobbying on behalf of WuXi AppTec. Within a week, WuXi AppTec had resigned as a member of BIO, and BIO had publicly announced support for the BIOSECURE Act.
BIO did not respond to BioSpace’s request for comment.
Why Investment May Continue
Jackson said he understands the concern coming from Capitol Hill, but in working with Chinese counterparts, he has not personally seen instances “where they have willfully taken intellectual property and used it to the advantage of some company in China.”
Jackson sees the U.S.-China tension in the context of whether competition is fair. He noted that many Chinese companies—not just in biopharma—are “substantially subsidized” by the Beijing government, giving them an unfair advantage in the global market.
While tensions might be heightened because this is a presidential election year in the U.S., Jackson does not believe the issue will completely blow over after November. “I think there’s going to be ongoing scrutiny and concern,” he said.
Van Naarden did not specifically opine on the BIOSECURE Act, but cautioned against reactionary measures. “On one hand, the sanctity of our data and our intellectual property is paramount. We do everything we can to protect that within reason,” he told BioSpace. “That ‘within reason’ is important because [an abrupt change] will be incredibly disruptive to medicine creation and delivery in the United States.”
Amazon Pulls Plug on Cashierless System in US Grocery Stores
Amazon.com Inc. is removing its cashierless Just Walk Out system from grocery stores, a retreat from an ambitious technology designed to let shoppers skip the line.
Amazon will pull the system as it remodels existing Fresh grocery stores and won’t feature it in new locations that will start opening later this year, an Amazon spokesperson said.
Tony Hoggett, Amazon’s senior vice president of grocery stores, joined the company in 2022 and launched a far-reaching revamp of the grocery business, which has struggled to build market share in an industry dominated by the likes of Walmart Inc. and Kroger Co.
Amazon plans to rely more heavily on its Dash Cart, which lets shoppers scan items as they go. But the company has dialed back the complexity of the technology.
The carts initially used a set of cameras to automatically identify what shoppers had grabbed from the shelf. Newer versions stripped out some cameras, and shoppers are now asked to hold the item in front of a pair of scanners, which can read bar codes among other cues. Shoppers can also use a touchscreen to ring up merchandise, such as produce, that lacks bar codes.
The Information reported the scrapping of Just Walk Out technology earlier.
The system uses ceiling-mounted cameras and shelf sensors, backed by algorithms, to determine what a shopper took from a store. Customers are charged automatically upon exiting.
The company began developing the technology more than a decade ago, part of a push by Jeff Bezos, then chief executive officer, to develop a unique offering to accompany Amazon’s move into physical stores.
The technology debuted in 2018 with the opening of a convenience store in the lobby of Amazon’s Seattle headquarters. The company built dozens of Amazon Go branded convenience stores and later installed the cashierless system in Fresh Stores and a pair of Whole Foods Market locations.
Genmab to Broaden, Strengthen Oncology Portfolio with Acquisition of ProfoundBio
- Genmab to acquire ProfoundBio for USD 1.8 billion in cash
- Acquisition will give Genmab worldwide rights to three candidates in clinical development, including rinatabart sesutecan (Rina-S), plus ProfoundBio’s novel antibody-drug conjugate (ADC) technology platforms
- Rina-S is a novel, next-generation, potential best-in-class Topo1 ADC targeting folate receptor alpha (FRα) in development for the treatment of ovarian cancer and other solid tumors
- Genmab to host conference call today at 1:00 PM CEST / 12:00 PM BST / 7:00 AM EDT
Genmab will hold a conference call to discuss the transaction today, April 3 at 1:00 PM CEST / 12:00 PM BST / 7:00 AM EDT. To join the call please use the following registration link: https://register.vevent.com/register/BI9da0549848d848cdaa4b6cd96079bafd. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN. To listen to a live webcast of the call please use the following link: https://edge.media-server.com/mmc/p/fxctprh2. An archive of the webcast and relevant slides will be available at https://www.Genmab.com/investors/.
Subscribe to:
Posts (Atom)