Health Check: Syntara shares recover after promising blood cancer trial update

•  Syntara shares leap on myelofibrosis trial results showing “ongoing safety and efficacy”
• Another week, another big-ticket deal for Starpharma
• Orthocell signs a Canadian distributor

Syntara (ASX:SNT) shares have received a much need pep-up, surging up to 16% on the back of updated data from its key myelofibrosis trial.

The company reports “sustained” safety and efficacy with its phase IIa effort, going out to 52 weeks.

The trial test drives the company’s lead candidate amsulostat, in combo with the standard-of-care ruxolitinib.

The top-line data showed an improvement of 50% or more in the ‘total symptom’ score, TSS, evident as early as 12 weeks.

Eight out of 11 patients (73%) achieved TSS improvement at week 24 or beyond.

Two patients reaching the 52 weeks achieved a 100% resolution of symptoms from baseline.

They showed no signs of cancer.

Of the enrolled patients, 11 reached 24 weeks, eight of them reached 38 weeks and seven patients completed the full 52 weeks.

While that seems a high drop-out rate, the patients had been treated with ruxolitinib for an average of three years. They had symptoms “indicative of high disease burden” and weren’t in a good way.

“We couldn’t have expected more from the drug,” says Syntara chief Gary Phillips.

“We recruited a group of patients who had already been extensively treated with the current best standard of care and yet still had enlarged spleens and significant symptoms.”

The company notes the patient withdrawal rate was “consistent with that seen in other myelofibrosis studies of patients with similar disease severity.”

What now?

Myelofibrosis is a rare and poorly treated blood disease and patients can expect to live for only five years on average.

On August 11 Syntara shares lost half their value after the US Food & Drug Administration (FDA) advised the company to do a placebo-controlled phase II trial.

The agency wants “additional safety and efficacy data”.

In effect, the company can’t leapfrog to a planned phase II/III trial, as planned.

The company now is likely to carry out a 90-patient phase 2b study, probably with 60 on active treatment and 30 on placebo.

Phillips estimates the cost “in order of US$25 million”. The phase II/III study likely would cost around $80 million, so perhaps the FDA decree was not all bad news.

The company expects to start the trial in the second half of 2026.

Starpharma enters another big-ticket deal

Meanwhile, fellow cancer drug developer Starpharma (ASX:SPL) has inked its second alliance in less than two weeks, this time with Radiopharm Theranostics (ASX:RAD).

The duo has teamed to develop a cancer drug conjugate, based on Starpharma’s dendrimer drug platform and Radiopharm’s radiation-based molecule.

Subject to “successful development and marketing”, Starpharma will grant Radiopharm an exclusive option to license the asset.

The deal involves Radiopharm paying Starpharma a $2 million upfront payment and a $500,000 exclusivity option fee.

If the product kicks off, Starpharma also gets up to $89 million of success-based milestone payments.

On September 22 Starpharma entered an exclusive global licensing deal with Genentech, worth $8.3 million up front and up to $855 million.

Starpharma will develop its dendrimer drug conjugates that incorporate Genentech medicines for “certain oncology targets”.

Starpharma shares almost doubled on that news. Today the stock gained a further 13%, while Radiopharm shares eased 3%.

Orthocell finds a Canadian buddy

Orthocell (ASX:OCC) has laid ground in the Canadian market by appointing a distributor for its flagship product, the Remplir nerve repair wrap.

The company has secured exclusive distributorships for Alberta and British Columbia. It expects to make further appointments to cover additional provinces.

The company cites the Canadian opportunity at US$75 million.

Orthocell will launch its Canadian push at the upcoming annual meeting of the American Society for Surgery of the Hand in Vancouver.

“The Canadian distributor has a wealth of expertise in nerve, spine and orthopaedic implant distribution, with established networks and a strong reputation in the local healthcare sector to drive product adoption,” Orthocell says.

The company targets first sales for the December quarter.

Nothing to see here, says Oncosil

In response to a query from the bourse, targeted radiation cancer treatment house OncoSil Medical (ASX:OSL) says it released results from a phase I/II study as early as it could.

The company placed its shares on trading halt pre-open on September 17 and announced the results first thing on September 18 (last Thursday).

The Amsterdam University Medical Centre (UMC) carried out the open-label, single-arm study, dubbed Pancosil.

The preliminary results were aired on September 16, at the Cardiovascular and Interventional Radiological Society of Europe annual shindig in Barcelona, Spain.

Oncosil said it became aware of the prezzo when presented in the wee hours of September 17, Sydney time.

“The trial data is collected and owned by Amsterdam UMC, the initiator of the trial. It remained confidential and not available to OSL until the time of the presentation.”

The study found Oncosil’s eponymous device to be “safe and feasible to deliver” in the intended percutaneous manner.

The company imposed the trading halt “to allow the
company to undertake the necessary analysis and interpretation of the  results.”

The company undertook this process “promptly and without delay”.

Not for the first time, the ASX query highlights the disclosure dilemma for companies that don’t directly control the release of trial information.

By convention, trial data is often ‘announced’ by way of a peer reviewed publication, or a presentation to one’s learned peers.

After the company’s announcement, the shares surged 26 cents, or 16%.

Given the shares were on trading halt at the time of the prezzo, no harm done in the slight delay.

Just sayin’.

Uscom throws in the towel

Some biotechs simply fade away, but the struggling respiratory device play Uscom (ASX:UCM) has formally thrown in the towel by selling its business and assets in a $2.59 million deal.

The buyer is the Singapore based venture capitalist AXO Medtech.

The $3 million market cap Uscom has suffered negative cash flow for some years and has struggled to raise cash on the ASX.

AXO assumes $2.59 million of debt owed to Uscom chair Professor Rob Phillips and Uscom shareholder Jetan Pty Ltd.

The proceeds amount to just under one cent per share, compared with Uscom’s last trade price of 1.2 cents.

Unusually, Uscom focused on the Chinese market for its non-invasive cardiovascular and pulmonary medical  devices.