Acurastem, Takeda strike $580M licensing deal for ALS, neurodegenerative drugs
Acurastem Inc. said on Sept. 25 that it struck an out-licensing deal potentially worth $580 million with Takeda Pharmaceutical Co. Ltd. to develop drugs for amyotrophic lateral sclerosis (ALS) and other PIKfyve gene-targeting therapeutics. Under the terms, Tokyo-headquartered Takeda obtains exclusive worldwide rights to Acurastem’s PIKfyve-targeting therapeutics, including Acurastem’s lead AS-202 asset, an antisense oligonucleotide therapy to treat ALS.

Acurastem, Takeda strike $580M licensing deal for ALS, neurodegenerative drugs
Acurastem Inc. said on Sept. 25 that it struck an out-licensing deal potentially worth $580 million with Takeda Pharmaceutical Co. Ltd. to develop drugs for amyotrophic lateral sclerosis (ALS) and other PIKfyve gene-targeting therapeutics. Under the terms, Tokyo-headquartered Takeda obtains exclusive worldwide rights to Acurastem’s PIKfyve-targeting therapeutics, including Acurastem’s lead AS-202 asset, an antisense oligonucleotide therapy to treat ALS.
Japan’s MHLW approves slew of new drugs, including Eisai/Biogen’s Leqembi for Alzheimer’s
Thanks to a raft of new approvals by Japan’s Ministry of Health, Labor and Welfare (MHLW), patients in Japan will soon have access to Biogen Inc./Eisai Co. Ltd.’s Leqembi (lecanemab), an amyloid-beta binder, for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease.
Peptidream, Genentech ink $1B deal for peptide-radioisotope drug conjugates
Peptidream Inc. and Genentech Inc., a Roche Holding company, signed a deal worth up to $1 billion to discover and develop macrocyclic peptide-radioisotope (peptide-RI) drug conjugates. Peptidream, of Kawasaki, Japan, will use its peptide discovery platform system technology to discover, optimize and develop macrocyclic peptide candidates for use as peptide-RI drug conjugates against targets of interest to Genentech. Genentech will pay Peptidream an up-front payment of $40 million and up to $1 billion in potential development, regulatory, and commercial-based milestones. In addition, Peptidream is eligible to receive tiered royalties on net sales (ex-Japan) of any products arising from the collaboration.
Chinabio 2023: Cansino, Gracell, Immuneonco’s C-suites offer IPO insights in China, US
Raising capital has always been a challenge for small to medium biotech firms worldwide, but the economic whiplash and the wider downturn across international markets post-pandemic have pushed Chinese biotechs to make-it-or-break-it scenarios for crossing the IPO threshold, speakers at the Chinabio Partnering Forum 2023 said in Shanghai.
Chinabio 2023: As tide turns to China, what will keep biotechs afloat in rocky capital, political seas?
“Why do the top 10 pharmaceutical companies remain in the top 10?” asked Li Chen, founder and CEO of Hua Medicine, to audience members at the Chinabio Partnering Forum in Shanghai on Sept. 20. “[It comes down to] their ability to innovate themselves, but also the capability to acquire technology from partnerships, [to] manufacture and sell in countries like the U.S."
Chinabio 2023: Big pharma scouts for innovation post-pandemic
Despite China’s near-frozen startup scene and increasingly cautious foreign investors following the COVID-19 pandemic, multinational pharmaceutical firms continued to scout for innovative up-and-coming Chinese biotechs in Shanghai at Chinabio Partnering Forum 2023 over its two-day run.
News in brief
BioWorld Asia briefs for September 26,
Wuhan YZY raises $15 million in Hong Kong IPO to advance BsAbs
Wuhan YZY Biopharma Co. Ltd. made its debut on the Hong Kong Stock Exchange, raising HK$121 million (US$15.48 million) in its IPO on Sept. 22, with shares (HKEX:02496) opening at the lower end of its range at HK$16 per share and ending the day at HK$16.60, a rise of 3.75%.
Inventiva licenses NASH candidate for Japan, South Korea development
Inventiva SA is getting $10 million up front and the possibility of $231 in clinical, regulatory and commercial milestones by exclusively licensing its nonalcoholic steatohepatitis (NASH) candidate, lanifibranor, to Hepalys Pharma Inc. to sell in Japan and South Korea, two massive markets for the indication.
Everest licenses Asian rights to Kezar’s autoimmune drug zetomipzomib
Everest Medicines Ltd. is in-licensing Kezar Life Sciences Inc.’s phase II autoimmune disease candidate, zetomipzomib in a deal worth $132 million for greater China, South Korea and southeast Asia rights. Kezar’s lead molecule zetomipzomib (KZR-616) is a first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases.
Abbvie drops full CD47 collaboration, as I-Mab pushes ahead with phase III
I-Mab Biopharma Co. Ltd. has regained full rights to its CD47 antibody program from Abbvie Inc., including lemzoparlimab, the most advanced candidate. The move, disclosed in a Sept. 22 U.S. SEC filing, eliminates the potential $1.295 billion in milestones associated with the amended collaboration deal signed in 2022.

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Analysis and data insight

Biopharmas receive $1.43B in BARDA grants in 2023
Grant
Biopharma grants are up nearly 150% compared to the same time period last year, largely due to a number of $100 million-plus grants from the Biomedical Advanced Research and Development Authority (BARDA). Meanwhile, nonprofit deal value has declined year-over-year, with the number of transactions...
Clinical trial data down from 2021 but up 18% from 2019
Clinical
The first seven months of 2023 saw clinical trial data up 1.43% compared to the same time period last year. From January through July this year, BioWorld reported on 2,064 drugs in phase I-III, compared to 2,035 in the same time period in 2022. The number of trial updates is down 14.07% from the...
First seven months of 2023 sees $105.4B in biopharma deals and $37.6B in M&As
Deals and M&A
The June dip in biopharma deal value was short-lived, with July seeing 106 deals worth $17.57 billion, up 72.03% from $10.22 billion in July 2022.
Merck leads in 1H23 clinical trial updates; percentage of COVID-19 therapies continues decline
Clinical
Clinical data in the first half of 2023 is up 1.51% compared to the same time period last year. So far in 2023 BioWorld reported on 1,810 drugs in phase I-III, compared to 1,783 in the first half of 2022. The number of trial updates is down 13.6% from the 2,095 in 2021, but more than 2020’s 1,799...

Financings

Following Hong Kong IPO, Immuneonco looks to be rising star
Cancer
After raising HKD$320 million (US$40.8 million) in its IPO on the Hong Kong Stock Exchange last week, Immuneonco Biopharmaceuticals Co. Ltd.’s stock has continued to rise, and analysts are expecting the Hong Kong market to pick up after a slack start to the year.

Australia

Starpharma’s dendrimer platform delivers impressive results in bowel, ovarian cancer
Clinical
Starpharma Holdings Ltd.'s nanoscale drug delivery technology shows enhanced safety and durable responses in phase II trials compared to standard of care therapies in patients with advanced colorectal and ovarian cancer.

Imagion explores global partnerships to expand molecular MRI footprint for early cancer detection
Cancer
Imagion Biosystems Ltd. signed a flurry of deals recently to expand its pioneering molecular magnetic resonance imaging platform Magsense beyond Australia and into additional indications to detect cancer earlier.
Incannex to begin pivotal trials in US for synthetic cannabinoid for sleep apnea
Clinical
Incannex Healthcare Ltd. is gearing up to begin a pivotal phase II/III trial in the U.S. for its lead asset, IHL-42X (dronabinol/acetazolamide), a synthetic cannabinoid combination drug for sleep apnea.

China

Hutchmed’s sovleplenib meets primary, secondary endpoints in China phase III ITP trial
Clinical
Hutchmed (China) Ltd.’s sovleplenib (HMPL-523) met the primary endpoint of durable response rate and all secondary endpoints in the pivotal phase III trial in adults with primary immune thrombocytopenia (ITP) in China.
Innovent scores first approval for PCSK9 inhibitor in China
Regulatory
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China.
Oricell clears IND hurdle for homegrown CAR T in China
Regulatory
Oricell Therapeutics Co. Ltd. has become the latest Chinese biotech to advance an independently developed CAR T therapy, announcing Aug. 10 that China’s regulatory body gave IND approval for Oricar-017. Oricar-017 is the Shanghai-based biotech’s GPRC5D-directed CAR T therapy developed to treat...
China’s Biocity expands to US with pipeline of bispecific antibodies and ADCs
Newco news
Biocity Biopharmaceutics Co. Ltd. is advancing its pipeline of differentiated, modality-independent therapeutics for oncology that include small molecules, monoclonal and bispecific antibodies, as well as antibody-drug conjugates (ADCs). The Wuxi, China-headquartered company is focused on...
Kelun’s Trop2 ADC meets primary endpoints in phase III triple-negative breast cancer trial
Clinical
Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic...

Regulatory

Rx quality problems continue to aggravate supply issues
U.S.
In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and...

Newco news

Dotbio emerges with $5.6M pre-series A to advance multifunctional antibodies
Cancer
Emerging from stealth mode, new immuno-oncology company Dotbio Pte. Ltd. closed an oversubscribed $5.6 million pre-series A round to accelerate development of its multifunctional and intracellular antibody therapies.

Viage to advance gut-drug for cognitive impairment to phase II
Neurology/Psychiatric
Viage Therapeutics Inc. – formerly Digestome Therapeutics Inc. – on July 26 unveiled positive data from its phase I study on DGX-001 for mild cognitive impairment in Alzheimer’s disease (AD) and Parkinson’s (PD). The randomized, double-blind, placebo-controlled study demonstrated changes in brain...
Argenica raises AU$4M to advance neuroprotective agent in ischemic stroke
Asia-Pacific
After raising AU$4 million (US$2.6 million), Argenica Therapeutics Pty. Ltd. is gearing up to begin phase II trials in ischemic stroke for ARG-007, a glutamate receptor modulator that is believed to reduce brain tissue death after stroke.

Science

Pan-cancer studies take pan-oramic view on proteogenomics
Omics
The vast variety of tumors makes each cancer a world. For researchers, understanding the commonalities and divergences in their molecular underpinnings could help find successful treatments. Scientists from the Clinical Proteomic Tumor Analysis...
In Zoonomia project, evolutionary lens hones search for functional genomic variants
Genetic/Congenital
A base-by-base comparison of the genome sequences of 240 species of mammals has pinpointed sites in the human genome where mutations are likely to cause disease. The sites are all perfectly conserved across the mammalian family tree over 100...
Biocom 2023: There’s science going on 250 miles above your head
Analysis and data insight
Performing experiments and potentially manufacturing products in space offers some unique advantages in a near-zero gravity environment. Space changes buoyancy, hydrostatic pressure and convective heat flow. Researchers are studying how those...
Nanomaterial allows location-specific fat targeting
Clinical
The positively charged nanoparticle polyamidoamine generation 3 (P-G3) can be specifically targeted to either visceral or subcutaneous fat, and affects both types of fat in different ways, researchers from Columbia University reported in two...
Amyloid plaques recast as cause of neural network dysfunction
Neurology/Psychiatric
Researchers have identified a link between amyloid plaques and dysfunctional neuronal conduction in animal models of Alzheimer’s disease (AD). Their study, which was published in the Dec. 1, 2022, issue of Nature, suggests new ways to think about...
Innate immunity can drive radiation-induced abscopal effect
Clinical
A combination of radiation therapy and CD47 blockade induced an abscopal effect in animal studies even in animals that lacked T cells, researchers reported in the Nov. 21, 2022, online issue of Nature Cancer.

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