Health Check: It's ‘nothing personal' as major US biotech fund calls time on Syntara
Alcidion shares soar 15% on earnings upgrade
Optiscan enters 'win-win' supplier collab
Syntara (ASX:SNT) CEO Gary Phillips says the exit of a long-term US backer should not be seen as a judgment on the company's late-stage myelofibrosis drug program.
In a block trade the San Francisco BVF Partners has disposed of its $5 million, 6%, Syntara stake.
The shares were taken up by some of Syntara's existing institutional holders.
BVF's exit last week sent Syntara shares down by 25%, despite the company's previous Friday's positive update on its phase II myelofibrosis trial update.
Phillips says the trial news created a 'liquidity event' which BVF availed of.
But it was not a case of BVF (as in Biotech Value Fund) spurning Syntara's drug program.
Rather, the fund grew to the extent where it can't justify a minimum investment below US$30-50 million.
'They always liked our science,' Phillips says. 'They have visited our labs and were always encouraged, but they just got bigger and bigger.'
With US$9 billion of assets, BVF has called time on all its ASX investments.
In May BVF divested its $3 million in Actinogen Medical (ASX:ACW), also via a block trade.
The fund had also invested in Opthea (ASX:OPT), but got off before the eye drug developer's' trials went pear shaped.
BVF also invested in immune-oncology drug developer Viralytics, famously taken over by Merck for an eyebrow-raising $500 million in 2018.
Syntara's blood cancer program looks the goods
Syntara's 'liquidly event' stemmed from further data from its phase II myelofibrosis trial, evaluating its drug candidate SNT-5505 in combo with the standard-of-care drug ruxolitinib.
The patients had been treated with ruxolitinib, so had symptoms such as enlarged spleen size and blood counts 'indicative of high disease burden'.
The results showed eight of 11 evaluable patients (73%) achieved a reduction of more than 50% at 24 weeks, as measured by a standard gauge called TSS50.
Four out of nine patients (44%) had a spleen volume reduction of 25% at week 24 or beyond.
The ongoing trial enrolled 16 patients with intermediate or high-risk myelofibrosis, for 52 weeks of treatment.
However, five dropped out by the 24-week mark. This is a 'withdrawal rate consistent with that seen in other myelofibrosis studies of patients with similar disease severity."
Eight patients reaching 38 weeks showed and average 56% reduction in symptoms, while five reaching 52 weeks exhibited a 63% decline.
Syntara intends to chat with the FDA in the September quarter about the design of a pivotal phase 2c/3 study.
Too much of a good thing for Immutep?
With four trial updates on separate programs in less than two months, immunology drug play Immutep (ASX:IMM) must also feel underappreciated.
Immutep stock has fallen around 10% in this period and trades at close to five-year lows, despite the upbeat clinical vibes.
Too much activity from the multi-tentacled Immutep confusing investors, perhaps?
Today, Immutep said a phase I autoimmune study showed 'significant T-cell suppression', thus highlighting potential efficacy of its candidate IMP-761.
Initial data from placebo-controlled, double-blinded effort also showed good safety at the highest dosing level to date.
By stimulating the LAG-3 (lymphocyte-activation gene-3) agonist antibody, IMP-761 promises to treat conditions including rheumatoid arthritis, Type 1 diabetes and multiple sclerosis.
Since May 5 Immutep also has updated investors on its head and neck cancer, lung cancer and soft tissue sarcoma trials.
Miya My! Alcidion has upgraded earnings
Hospital patient management software supplier Alcidion (ASX:ALC) has upped its full-year earnings outlook, with strong take-up of its flagship Miya prompting clients to adopt its broader wares.
'Over the past few months this has resulted in several customers of varying size seeking extensions or module upgrades," CEO Kate Quirke says.
"This has contributed to our improved financial position."
Having guided to earnings before interest, tax depreciation and amortisation of $3 million, the company now expects the number to exceed $4.5 million (for the year to June 30 2025).
The company earlier guided to revenue of at least $40 million.
Alcidion provides to more than 400 hospitals and 87 healthcare organisations in the UK, here and New Zealand.
In the UK, the most capacious market, the beloved National Health Service (NHS) is being merged with Department of Health and Social Care.
This poses both threat to – and opportunities for – Alcidion, given it sells to NHS organisations.
In April, Quirke said the push for more NHS productivity with fewer staff was likely to mean greater demand for Alcidion's digital platforms.
'I see the opportunity increasing,' she said.
'But we are waiting to see what the ten-year plan indicates in terms of where the priority areas are.'
PYC gets FDA OK
PYC Therapeutics (ASX:PYC) has provided evidence that the FDA continues to function, with the agency approving the company's proposed trial design at a preliminary (Type B) meeting.
The company currently is undergoing a phase 1-2 trial of its drug candidate VP-001, to treat the blinding eye disease retinitis pigmentosa type 11 (RP11).
With positive data to date, PYC wants to progress to a phase2/3 study pitched at FDA approval.
The FDA says PYC can use similar endpoints and says trial design features (such as use of a sham arm and inclusion exclusion criteria) are OK as well.
The company will use this guidance to finalise its proposed registrational study design.
Tryptamine study aims to put binge eating disorder to BED
Meanwhile, Tryptamine Therapeutics (ASX:TYP) has won ethics approval for the world's first trial, to test intravenously infused psilocin for binge eating disorder (BED).
BED is the most common eating disorder in the US and second most common here.
BED results in multiple other conditions including depression, anxiety, PTSD (post-traumatic stress disorder) and compulsive behaviours.
A collaboration with Swinburne University, the local trial will enrol 12 patients and administer them with with Tryptamine's drug candite TRP-8803.
They will be given two doses 14 days apart and also undergo psychotherapy.
The trial has started recruiting, with first dosing expected in the September quarter.
Investors can expect top-line results before the year is out.
The good OIL on a 'win-win' collab
Optiscan (ASX:OIL) has entered a five-year collaboration agreement with the US based Long Grove Pharmaceuticals, which provides a contrast agent for Optiscan's fluorescence-based endomicroscopic imaging systems.
The idea of the collab is to use Long Grove's fluorescein drug, AK-FLUOR, with Optiscan's imaging technology in clinical studies.
This potentially will identify new applications for the drug and expedite regulatory submissions.
On the Optiscan side of things, the data should support the company' efforts to win FDA approval for its Invue device.
Invue enables surgeons to gain real-time pathology insights and make on-the-spot decisions.
Optiscan CEO Dr Camile Farah dubs the agreement a 'clear-cut win-win for both companies' development strategies'.
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