3 days ago
Health Check: Stuck in biotech's ‘death zone', Opthea and Patrys check in on the sat phone
Opthea and Patrys report they are still alive after failing to reach the summit, but the line's a bit crackly
Renerve in Berkeley tie up for soft tissue repair
Imugene furthers trial of 'off Broadway' asset
With the Everest climbing season at its peak, the news from the 'death zone' is that the stricken Opthea is still alive.
Can the company execute an organised descent?
In a corporate update today, the eye disease drug developer said it was unable to clarify things until it had finished negotiating with its funders.
So perhaps more of a non-update from camp four, although radio comms that high up can be patchy.
But the company did announce that four of its eight board members would hang up their crampons.
The departees are Dr Julia Haller, Dr Susan Orr, Quinton Oswald and Anshul Thakral.
That leaves chairman Jeremy Levin, Kathy Connell, Lawrence Gozlan and Sujal Shah to battle on with depleted oxygen tanks.
On March 24 the company reported the first of its two phase III eye disease trials failed to hit its primary endpoints.
The second one fared no better and both have been abandoned in the blizzard.
The studies focused on the hard-to-treat wet aged-related macular degeneration.
Investors are asking how much of Opthea's residual cash of US$113 million ($176 million) will remain, if any.
Under a development funding agreement (DFA), the company could be in hock to a cabal of investors for up to US$680 million.
Opthea says it remains in 'active negotiations with its DFA investors … to explore possible options to deliver the best outcome for the company and its shareholders."
Opthea shares were suspended on March 17 at 60 cents, for an illusory $738 million market cap.
In reality, the shares potentially are worth nothing.
The company promises a briefing when the DFA discussions are finalised.
Stay tuned
Meanwhile, Patrys' corporate update tomorrow should show whether the company has abandoned all attempts to reach the summit.
Remember Patrys?
The company was to launch a first-in-human phase I trial for its antibody cancer candidate, PAT-DX1.
In October last year, the company said safety testing showed unacceptable margins of tolerance, so the program was canned.
Patrys is forging ahead with a less favoured program, Pat-DX3 (not sure what happened with PAT-DX2).
The company also intended to partner the DX-1 program.
Patrys shares trade at a fraction of a cent, so are at base camp. Perhaps they can scale great heights again with the help of a decent Sherpa, er, partner.
Renerve enrolls at Berkeley
Nerve regeneration outfit Renerve has joined with the San Francisco based Berkeley Biologics to develop and commercialise two tissue-based products.
Renerve recently started selling its FDA-cleared flagship product, the Nervalign Nerve Cuff, in the US.
The company also has a nerve graft product.
One initial product from the collaboration addresses the need for human dermal tissue (deeper layers of the skin often sourced from donors).
The other provides amniotic tissue products, which are known for their regenerative and healing properties.
'These products have application in the medical procedures that Renerve seeks to address with its current and future Nervealign products,' Renerve says.
'Accordingly, their sale will be a natural extension of Renerve's current sales activities, using the same sales network and targeting the same surgeon and hospital customers.'
The parties target the first product for a September quarter launch, with the second due on market before the year is out.
Renerve will elaborate in an investor webinar scheduled for 11 am tomorrow.
Imugene opens cancer site for 'off Broadway' program
Immune-oncology drug developer Imugene has opened its first Australian trial site for a clinical study that hones in on a rare-ish subset of colorectal (bowel) cancer.
That target is called mismatch repair-deficient/microsatellite instability high colorectal cancer, which accounts for 15% of all bowel tumours.
The drug candidate is called PD1-Vaxx, which is all about inducing the body to produce polyclonal antibodies that block the PD-1 signalling pathway.
This hopefully restores the immune system's ability to detect and destroy cancer cells.
The trial is part of B-cell immunotherapy platform 'deprioritised' by Imugene, in favour of more show-stopping stuff such as Car-T therapies.
But sometimes the off-Broadway stuff can prove the box office hit.
The investigator-led phase II study is being carried out by Cancer Research UK Southampton Clinical Trials, the Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trial Group.
The study's primary objective is the degree to which tumours reduce with PD1-Vaxx, pre surgery.
Makes sense …
Meanwhile, Imugene will seek shareholder consent to consolidate its stupendous 7.4 billion on issue, to around 200 million.
Meanwhile, Inoviq (ASX:IIQ) shares this morning vaulted more than 30% after the company updated a US oncology powwow about its "breakthrough" ovarian cancer test results.
As we noted already, Inoviq shares had moved already, but on 'old news' – fake news? – rather than today's 'new news'.
The results were aired at the American Society of Clinical Oncology's get together in Chicago.
