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Friday, February 7, 2025

Acelyrin, Alumis Merge to Tackle Immune-Mediated Diseases

 

Alumis held its initial public offering in June last year, while Acelyrin debuted on the Nasdaq in mid-2023.

California biotechs Acelyrin and Alumis are merging to combine cash and assets—eyeing the development of “transformative” treatments for immune-mediated conditions.

The all-stock deal, announced Thursday, will see Alumis absorb Acelyrin. The combined entity will carry Alumis’ name and will be led by its current executive leadership. Acelyrin, meanwhile, will surrender approximately $448 million in cash, cash equivalents and marketable securities, as well as its drug pipeline.

Both Alumis and Acelyrin are new to the Nasdaq. Alumis made its bid in June 2024, eventually making a modest $250 million, slightly lower than its initial target. Acelyrin, meanwhile, was ahead by more than a year, with an initial public offering (IPO) in April 2023 that bagged the biotech $540 million—one of the largest that year.

Combined with Alumis’ $289 million, the post-merger company will have enough money to tide it over until 2027, which should help it reach “multiple planned key data readouts,” according to Thursday’s news release. Acelyrin and Alumis expect to close the deal in the second quarter of this year. Acelyrin stockholders will own 45% of the combined entity while the remaining 55% will be held by Alumis’ stockholders.

In a statement, Alumis CEO Martin Babler said that the merger will give the company “financial flexibility and runway” to work on its late-stage clinical pipeline of immune therapies. “As we move forward together, we will maintain financial discipline and a flexible capital allocation strategy,” he added.

In an email to employees, however, Babler reassured his staff, writing that “there will be no changes to Alumis’ existing development programs” and that the company does not “anticipate any change to your existing roles and responsibilities,” according to an SEC disclosure.

In December 2024, Acelyrin announced that the asset that helped it bag its IPO—the IL-17A inhibitor izokibep—failed a Phase IIb/III trial in uveitis, forcing the biotech to discontinue its development. Also contributing to this decision was another Phase IIb/III failure of izokibep in hidradenitis suppurativa, announced in September 2023.

Alumis’ original, pre-merger pipeline includes ESK-001, an oral drug candidate that inhibits tyrosine kinase 2 and which is currently in the Phase III ONWARD program for moderate-to-severe plaque psoriasis. Late-stage data for the asset in this indication are expected in the first half of 2026.

ESK-001, which the companies on Thursday called a “potentially best-in-class molecule,” is also being proposed for systemic lupus erythematosus.

Alumis is also developing another tyrosine kinase 2 blocker, A-005, for neuroinflammatory and neurodegenerative conditions such as multiple sclerosis and Parkinson’s disease. The asset is currently in early studies, with a Phase II trial expected in the second half of this year.

From Acelyrin, the post-merger Alumis pipeiline will also feature lonigutamab, a subcutaneous anti-IGF-1R antibody for thyroid eye disease, currently in Phase II studies.

https://www.biospace.com/business/nasdaq-neophytes-acelyrin-alumis-merge-to-tackle-immune-mediated-diseases

Tonix Pharmaceuticals reports positive topline trial outcomes of TNX-1500

 Tonix Pharmaceuticals has reported positive topline outcomes from its Phase I single ascending dose study of its crystallisable fragment (Fc)-modified humanised anti-CD40 ligand (CD40L) monoclonal antibody, TNX-1500, in healthy subjects.

The trial aimed to evaluate the tolerability, safety, pharmacodynamics, and pharmacokinetics of the intravenous form of the antibody, to support dosing for a subsequent Phase II trial in recipients of kidney transplants.

During the trial, TNX-1500 was administered intravenously to subjects at doses of 3mg/kg, 10mg/kg, and 30mg/kg for one hour.

Subjects were monitored for one day post-infusion and attended periodic clinic visits for up to 120 days.

To assess the therapy’s immune modulation potency, a Keyhole Limpet Hemocyanin (KLH) challenge was administered on day 2 and day 29.

Across three cohorts, 26 subjects were enrolled, and 24 completed the trial. The therapy demonstrated a ‘favourable’ tolerability and safety profile.

The pharmacokinetics analysis revealed that the half-life of the therapy varied with dosage, averaging 19.6 days at 3mg/kg, 37.8 days at 10mg/kg, and 33.7 days at 30mg/kg.

At higher doses, TNX-1500 blocked both primary and secondary anti-KLH antibody responses while the lowest dose blocked the primary response and reduced the secondary response.

Following these results, Tonix plans to engage with the US Food and Drug Administration (FDA) in an end-of-Phase I meeting to discuss the findings and seek alignment on the design of the Phase II study for kidney transplant recipients.


https://finance.yahoo.com/news/tonix-pharmaceuticals-reports-positive-topline-164304779.html

Novo Nordisk’s haemophilia A drug stops bleeds in 74% of children

 Novo Nordisk’s haemophilia A therapy Mim8 stopped bleeding completely in 74.3% of children in a Phase III trial.

The FRONTIER3 trial (NCT05306418) achieved its co-primary endpoints, demonstrating a statistically significant and superior reduction of treated bleeding episodes with both once-weekly and once-monthly Mim8 versus no prophylaxis treatment and prior coagulation factor prophylaxis treatment in 70 children aged one to 11 years. The drug has also been evaluated in adults and adolescents.


Following the positive data, Novo Nordisk expects to make its Mim8 regulatory submission in 2025.


https://finance.yahoo.com/news/novo-nordisk-haemophilia-drug-stops-173745348.html

Lilly Crohn's disease med achieved sustained clinical remission and endoscopic response at two years

 More than 90% of Omvoh-treated patients who were in clinical remission at one year sustained it with two years of continuous treatment

Nearly 90% of patients who achieved endoscopic response at one year sustained it at two years

Omvoh is the first IL-23p19 antagonist to demonstrate multi-year, sustained efficacy and safety for both Crohn's disease and ulcerative colitis

https://www.prnewswire.com/news-releases/most-patients-on-lillys-omvoh-mirikizumab-mrkz-for-crohns-disease-achieved-sustained-clinical-remission-and-endoscopic-response-at-two-years-302370878.html

Cytokinetics started at Buy by Citi

 Target $86

https://finviz.com/quote.ashx?t=CYTK&ty=c&ta=1&p=d

JD Vance tapped to oversee potential TikTok sale as April 5 deadline looms

 Vice President JD Vance will be overseeing the sale of social media platform TikTok from its Chinese parent company, The Post has learned, after President Trump threw the popular app a lifeline on Day One by giving it additional time to find a US buyer.

Vance, who formerly owned his own venture capital firm, and national security adviser Michael Waltz will quarterback TikTok’s qualified divestment from Beijing-based ByteDance, according to sources familiar with the matter.

Waltz and other national security hawks in Congress have long warned about the threat the platform poses to Americans, with both congressional and independent investigations confirming that a trove of 170 million US users’ data is accessible by the Chinese Communist Party.

Vice President JD Vance will be overseeing the sale of the social media platform TikTok from its Chinese parent company, The Post has learned, after President Trump threw it a lifeline on Day One to find a US buyer.AP
Waltz and other national security hawks in Congress have long warned about the threat the platform poses to Americans, with both congressional and independent investigations confirming that a trove of 170 million US users’ data is accessible by the Chinese Communist Party.AFP via Getty Images

Trump teased last month that Microsoft had expressed interest in the purchase — but added that it could erupt into a full-blown “bidding war” among US companies.

Punchbowl News, which first reported on Vance and Waltz teaming up for the sale, also said Frank McCourt, the billionaire business partner of “Shark Tank” host Kevin O’Leary, visited Capitol Hill this week to speak with Republicans about a possible purchase.

Congress had passed, and President Joe Biden had enacted, legislation this past April requiring TikTok to be spun off from ByteDance or be banned in the US.

Biden had signed another law in 2022 that banned the social media app on government devices.REUTERS

One of the Republicans who met with McCourt was Senate Intelligence Committee Chairman Tom Cotton (R-Ark.), who is pushing for a full divestment and “complete break from Communist China in accordance with the law,” a spokesman for his office told Punchbowl.

The qualified divestment had been scheduled to take effect on Jan. 19, with the app briefly going dark the previous day.

On Jan. 20, Trump signed an order extending the sale deadline by 75 days, giving all parties until April 5 to reach a deal.

https://nypost.com/2025/02/07/us-news/vice-president-jd-vance-tapped-to-oversee-potential-tiktok-sale-as-april-5-deadline-looms/

Canada Tells Ministries to Restrict Use of DeepSeek

 Canadian officials are recommending that all ministries ban the use of China's DeepSeek chatbot application on government-issued devices.

In a memo circulated to government departments, the country's chief information officer said it is recommended that use of DeepSeek on government-issued devices be restricted, citing "serious privacy concerns" associated with the collection and retention of personal information.

Departments "should consider blocking the application and website on their departmental network and devices," said the memo.

The memo's contents were earlier reported by the National Post newspaper.

DeepSeek, a disruptive new Chinese AI company, emerged seemingly out of nowhere last month. DeepSeek gave its models away, as open-source code, which helped make it immediately popular among consumers, businesses and developers.

In the U.S., lawmakers in Congress intend to introduce a bill Friday to ban DeepSeek's chatbot application from U.S. government-owned devices.

In 2023, Canada banned the TikTok app from government-issued devices, due to levels of risk and security posed by the China-backed digital platform.

https://www.morningstar.com/news/dow-jones/202502077292/canada-tells-ministries-to-restrict-use-of-deepseek