London South East | The UK's favourite investor portal.

Roche has got in on the B7-H3 action, agreeing to $570 million in near-term payments to existing partner MediLink Therapeutics for an antibody-drug conjugate targeting the immune checkpoint protein.

The ADC, dubbed YL201, has been developed with MediLink's Tumor Microenvironment-Activatable LINker-payload (TMALIN) platform. The biotech has already taken the therapy into a pair of phase 2 studies in China for small-cell lung cancer (SCLC) and nasopharyngeal carcinoma.

Early data from these trials have “demonstrated promising objective response rates and survival benefits” in second-line SCLC patients, MediLink said in the Jan. 8 post-market release.

In return for the rights to YL201 outside China, MediLink will receive upfront and potential near-term milestone payments that could reach a combined $570 million. The Thursday evening release also refers to “additional development, regulatory and commercial milestone payments” tied to the program, but doesn’t provide a figure.

Should YL201 make it to market, MediLink will also be entitled to tiered royalties on net sales of YL201 outside of China.

Roche first began collaborating with MediLink back in January 2024 via a $1 billion biobucks deal centered on YL211, a mesenchymal epidermal transforming factor (c-MET) ADC under development for solid tumors.

“Our deepening collaboration with MediLink on YL201 reflects Roche's commitment to leveraging cutting-edge innovation from around the globe to address unmet patient needs, particularly within oncology and lung cancer as one of our strategic priorities,” Boris Zaïtra, head of corporate business development at Roche, said in the release.

Related

Patient deaths prompt partial hold for Daiichi-Merck's global phase 3 ADC program

“We are excited to combine MediLink's and Roche's expertise in ADCs with our well-established global development and commercial presence to bring this promising potential therapy option to patients,” Zaïtra added.

Jiaqiang Cai, Ph.D., co-founder, co-CEO and chief scientific officer at MediLink, said YL201 had “demonstrated promising clinical data.”

“This agreement provides YL201, a key asset from our innovative TMALIN platform, with the necessary worldwide reach and resources to potentially become a new treatment option, addressing critical unmet needs for patients with various solid tumors,” Cai added.

B7-H3, an immune checkpoint protein highly expressed on many cancer cells, is already the target of GSK and Hansoh Pharma’s ADC risvutatug rezetecan, which began a global phase 3 study in SCLC in the summer. Meanwhile, Daiichi Sankyo announced last month it had paused enrollment in a phase 3 trial of its Merck & Co.-partnered B7-H3 ADC ifinatamab deruxtecan after an unexpected number of deaths from interstitial lung disease.

$200m and its pre-clinical??? How are we still valued at £35m??? It's a joke, that's soon to change

Soley Therapeutics has secured $200 million in series C funds, which the artificial-intelligence-enabled biotech plans to use to take its lead acute myeloid leukemia (AML) asset into the clinic. The South San Francisco-based company’s pipeline is a product of its cell stress sensing platform, which uses AI and “computer vision” to analyze thousands of responses in human cells that are then used to help design new therapeutic molecules, according to the biotech. The potential of Soley’s tech has already been enough to attract investors like the Doug Leone Family Fund, Breyer Capital and GordonMD Global Investments. They all returned for the series C alongside new backers Surveyor Capital, which acted as the primary investor, as well as HRTG Partners and RWN Management. “We built Soley to measure how living human cells, in health and disease, respond to drug exposure and determine their fate,” Soley CEO and co-founder Yerem Yeghiazarians, M.D., explained in the Jan. 7 release. “We then translate this cellular information into a robust portfolio of novel drug candidates across a broad range of disease areas and indications,” Yeghiazarians continued. “We are thrilled by the strong investor support from life sciences and technology-focused funds as we advance our lead programs into the clinic and expand our platform to continue building a first-in-class pipeline.” Related Sanofi-backed AdvanCell secures $112M series C to fund targeted alpha radiopharma trial The fresh funds have been earmarked for work to take two of Soley’s oncology drugs into the clinic. They are led by a lead asset for AML, with an IND filing penciled in for 2026, while a second asset for solid tumors is due to enter IND-enabling studies. A portion of the cash will also be used to take forward non-oncology stress-reducing drug candidates for neurodegenerative disorders and metabolic diseases, as well as to continue to scale up the platform.

Article today from North West Star - Aussie newspaper

East Timor's president is confident that what he describes as a new era of goodwill between his country, Canberra and Australia's Woodside Energy will finally unlock the development of a major gas project after decades of delays.

Woodside and East Timor agreed last week to study a five million-tonne project at the Greater Sunrise fields, an area containing an estimated 5.1 trillion cubic feet of gas that Australia has been discussing, initially with Indonesia, since the 1980s.

Jose Ramos-Horta said trust between the nations had improved following past tensions, marking a shift from Dili's previous criticism of Canberra and Woodside over delays to the project."I think there is a level of trust ... that did not exist before," he said in an interview during a visit to Perth, pointing to a pick-up in the pace of work on the project and what he saw as goodwill from Canberra in Prime Minister Anthony Albanese's supportive comments from 2024.

Last week's agreement forecast the project would produce gas by 2032-35, the first time a timeline has been announced by both parties.

Ramos-Horta said he expected that schedule to hold.

Woodside declined to comment beyond previous statements.

Previously, the two sides had disagreed over whether to pipe gas to Darwin, which has been Woodside's preference, or build a liquefied natural gas plant on East Timor's south coast.

Woodside dropped its insistence on a Darwin solution under CEO Meg O'Neill, but has not yet backed an East Timor development.

Development was first stalled by a bitter maritime boundary dispute that was resolved in 2018.East Timor has insisted on a greenfield plant and used its sovereign wealth fund to buy out ConocoPhillips and Shell from the project in 2018 and 2019.

National oil company Timor Gap holds more than 56 per cent of the field located about 140km south of East Timor and more than 400 km from Darwin.

MST Marquee analyst Saul Kavonic has estimated that building a plant in Timor could cost $US5 billion more than in Darwin, but potential Chinese involvement could push Canberra to back Timor's plan for geopolitical reasons.

Ramos-Horta, who has said East Timor would prefer to work with Australia and partners Woodside and Japan's Osaka Gas over Chinese firms that have expressed interest in the project, stressed Canberra's strategic role.

"Australia is indispensable to Timor Leste's interests, to its security, to its economic wellbeing," he said.

He reiterated that East Timor is willing to spend more from its sovereign fund to develop the onshore concept in hope that it kick-starts new onshore industries.

"We are so confident of the Timor option, that we don't have any contingency plan," he said.

Now if only we knew a company poised to commence Paediatric trials?!..🤞

A bill sponsored by Rep. Michael McCaul, R-Texas, has passed the House of Representatives which would restore the FDA's rare pediatric review voucher program, which expired in December of last year.

The U.S. House of Representatives has given a unanimous thumbs up to the Give Kids A Chance Act, which would revive the FDA’s rare pediatric review voucher program following its expiration in December of last year.

Rep. Michael McCaul, R-Texas, introduced the legislation in February alongside support from five other Republican Congressmen and five Democrats. The bill now advances to a Senate vote.

“By strengthening incentives for pediatric drug development, restoring essential programs such as the FDA Rare Pediatric Disease Priority Review Voucher, and ensuring that life-saving therapies reach the children who need them most, we are making meaningful progress,” Rep. Gus Bilirakis, R-Fla., said in a release.

The initiative, which was established in 2012, offered drugmakers a financial incentive in the form of a priority review voucher (PRV) to develop rare disease treatments for children.

PRVs are valued commodities in the biopharma industry because they can slash the FDA’s review time of drug applications from the standard 10 months to six months. In many cases, companies that were awarded PRVs for developing approved rare disease drugs sold them to other drugmakers anxious to bring a lucrative product to the market.

As it previously appeared that the pediatric review voucher program was not going to gain Congressional reauthorization and the availability of PRVs grew scarce, their prices increased from a standard $100 million. In August of last year, Ipsen received $158 million from an unnamed buyer for a PRV it gained from the FDA upon approval of the rare disease drug Sohonos in August of 2023.

Six months ago, an unnamed buyer paid Bavarian Nordic $160 million for a PRV awarded by the FDA under its tropical disease incentive program for the February approval of the chikungunya vaccine Vimkunya. In May, Abeona Therapeutics sold a PRV for $155 million that it had gained just two weeks earlier upon the approval of its gene therapy Zevaskyn.

After the rare pediatric review program expired, there were calls from the industry to reestablish it, while critics raised concerns that the ability to sell PRVs at high prices distorted the program's original purpose.

In an article published in February, lawyers at Hyman, Phelps & McNamara suggested the end of the rare pediatric PRV program could lead to increased value of the tropical disease PRVs, potentially to a level on par with a record $350 million that AbbVie paid United Therapeutics in 2015.

Meanwhile, in June of this year, the FDA introduced a new PRV program designed to shorten drug review time to as little as one or two months.

Estonia’s digital health DNA: Trust, data, and biotech in focus

From e-health records to a biotech hub in Tartu, Estonia is harnessing data, digital infrastructure, and investment to drive life sciences growth.

With just 1.3 million residents, Estonia’s digital footprint far exceeds its size.

When Barack Obama visited Tallinn in 2014, he wryly noted that he “should have called the Estonians” when setting up his administration’s healthcare website – a remark that reflected the country’s quietly formidable reputation in digital governance. From online voting and national ID cards to near-universal e-health records, Estonia has built systems that continue to draw international attention.

In healthcare, one of the most sensitive digital sectors, Estonia has treated scarcity as a driver of innovation rather than a limitation. Security and citizen control are central: decentralised systems mean no single entity holds all data, and patients legally own their health records.

Today, roughly 99% of patient data is digitised, with more than 200 million documents stored in the Estonian Central Health Information System, including prescriptions, test results, and clinical notes – many patients contributing multiple records over time.

At the heart of this network is X-Road, a secure, decentralised data-exchange platform enabling providers, insurers, and patients to access comprehensive medical histories online.

Estonia’s long-term vision of interoperable, citizen-centred services extends beyond its borders: cross-border e-prescriptions now function across the European Union, a testament to both technical foresight and the country’s awareness of the regional and geopolitical challenges that have shaped its digital approach.

At the heart of Estonia’s biotech ambitions lies the Estonian Biobank, established in 2001 and managed by the University of Tartu. With over 210,000 participants – roughly 20% of the population – it is a vital resource for both medical research and personalised medicine. Through the My Genome portal, participants receive insights into health risks and ancestry. Lily Milani, head of the Biobank, notes: “Only 1% of people oppose it – we don’t know any other initiative with that level of public support.”

The Biobank also underpins commercial innovation. Finnish company Nightingale Health has analysed 200,000 samples, generating 250 biomarker profiles, 39 of which are clinically validated, providing critical support for early disease prevention strategies.

While Tallinn is Estonia’s digital hub, Tartu is the epicentre of biotech innovation. At the University of Tartu, the TeamPerMed project integrates genomics, IT, clinical medicine, and socio-economic data to develop EU-wide guidelines and AI-driven decision-support tools.'

Not a bad place to be!

Latest Share Chat

Member Info for glasshalfdrunk

Followers

Following

Posts (Last 30 Days)

Posts (All Time)

Last Post

Member Since

Share Chat Post Distribution (Last 30 Days)

Activity Log (Last 30 Days)