Health Check: Cancer drug developers drive further positive Car-T results

• Imugene and Chimeric have unveiled further promising results for their Car-T immune-oncology assets
• Rhythm Biosciences shares soar 18% on kit validation results
• While investors are picky, equity dollars continue to flow

There’s a long drive ahead, but Imugene (ASX:IMU) and Chimeric Therapeutics (ASX:CHM) are heading in the right direction with their Car-T therapies that trick up the body’s T-cells to be better cancer fighters.

Imugene shares this morning leaped 10%, after the company reported two additional ‘partial responses’ in its phase 1b trial.

The study aims to combat relapsed diffuse large B-cell lymphoma (DLBCL), an aggressive blood cancer.

Imugene’s Car-T therapy, azer-cel, could result in the first ‘off the shelf’ Car-T treatment derived from donor cells (rather than the patient).

The trial tally now stands at six ‘complete responses’ and five partial responses.

A complete response is disappearance of signs of cancer – tentatively known as a cure.

A partial response is a cancer reduction of at least 50%.

In all, the trial has achieved an overall response rate of 79%.

On July 14 Imugene said nine out of 12 patients had responded, prompting a circa $37 million capital raising.

The first patients dosed (last year) remain cancer free at 15 months. They had not responded to several therapy attempts.

The trial is underway at ten US sites and six local sites, including Sydney’s Royal Prince Alfred Hospital.

Cells are “hard at work”

Chimeric reports “encouraging early results” after moving to a stronger dose in its phase I/II  study.

The trial tests the company’s Car-T candidate CHM CDH17.

Chimeric reports one patient with stable disease and “anti-tumour activity”, with the lesion shrinking by 12%.

The boffins define stable disease as no change in tumour size, or up to 30% shrinkage.

One patient from the first dose cohort remains with stable disease eight months after dosing, with an 18% shrinkage.

“This is great progress,” says Chimeric CEO Dr Rebecca McQualter.

“We can see the cells are hard at work [and we look forward] to more data”.

The trial has enrolled patients with advanced colorectal cancer, gastric cancer and intestinal neuroendocrine tumours.

CHM CDH17 targets CDH17, a cancer  biomarker “associated with poor prognosis and metastases in the most common gastrointestinal tumours”.

Chimeric expects to enrol 15 patients in the phase I part of the study, with an expanded cohort for phase II.

Rhythm’s test validation is in the groove

Rhythm Biosciences (ASX:RHY) shares today surged a sector-leading ing 18%, on further validation results of the company’s Colostat bowel cancer assay.

Having received its first kits from the manufacturer for final internal testing, the company tested them on new blood samples from patients with no bowel cancer at any of the stages (one to four).

“This study was critical as the initial intended use of Colostat is for symptomatic patients who could well have early and late-stage disease,” the company says.

While Rhythm will complete further studies, the data on 300 patient samples shows that Colostat is equally effective at detecting bowel cancer across all stages.

Rhythm will apply to the local National Association of Testing Authorities to have Colostat approved under the common-used laboratory-developed route.

Lung imager breathes easier with deep-pocketed backer

Friday’s keen investor response to lung imager 4D Medical’s 4D Medical’s (ASX:4DX) funding arrangement with ProMedicus (ASX:PME) no doubt has to do with the mere ‘vibe’ of the latter taking an interest in the market minnow.

In its first tie up with a listed peer, the $30 billion market cap Pro Medicus has extended a $10 million “hybrid debt and equity loan” to 4D Medical.

The duo don’t compete with each other.

4D Medical will use the funds to develop its product pipeline and advance a US Food and Drug Administration (FDA) marketing application.

This is for the company’s ventilation perfusion product, for use in computed tomography.

The loan attracts 12.5% interest and is repayable in cash and “shares valued at the same amount as the cash repayment”.

The deal is non-dilutive if the share price remains where is it, with “upside alignment” for both parties if they perform strongly over the next two years.

4D also reported customer receipts of $1.61 million for the June quarter, up 19%, taking full-year receipts to $12 months to $5.38 million (up 87%).

The company undertook 74,000 scans for the quarter, up 105% year on year.

4D had outflows of $9.47 million, down 16% compared with the March quarter.

The company ended June with cash of $9.9 million, with a $6 million R&D tax refund due “in coming weeks”.

4D Medical shares surged 30% on Friday and edged up a further 10% today.

Spare us a dime?

Other life companies are bringing in the dollars via traditional equity means.

The developer of a non-radiation-based imaging for breast and other cancers, Imagion Biosystems (ASX:IBX) has raised $3.5 million in a two-tranche institutional placement.

The price was 1.5 cents per share, a 10% discount.

The funds will support Imagion’s proposed phase II US trial for Her-2 breast cancers.

Nyrada (ASX:NYR) has raised $8.25 million via a placement.

The company is developing Xolatryp, which blocks a certain ion channel to protect key cells in vital organs when under stress.

This could be after a blood clot or reperfusion (the sudden flow of blood returning to an organ or tissue).

Nyrada is preparing for a phase IIa acute myocardial infarction trial and has nearly finished a phase I cardioprotection study.

Kiwi diagnostics house Pacific Edge (ASX:PEB) has raised NZ$20.7 million in a placement and share purchase plan, having targeted NZ$20 million.

US authorities recently cancelled reimbursement of the Pacific Edge’s bladder cancer test Cxbladder, but the company is challenging the decision.

Finally, foetal monitoring house HeraMED (ASX:HMD) has raised $1.98 million 1.2 cents a share, a 4.8% discount.

Reporting latecomers: please wait to be seated

Companies needed to lodge their quarterly reports within a month. But the ASX ‘ushers’ will still see them to their seats if they’re not too late.

The bourse on Friday suspended Syntara (ASX:SNT) for non-lodgment – but not for long.

The myelofibrosis drug developer was allowed to resume trading, having lodged before the opening of Friday’s trading.

The quarterlies were due on Thursday.

Syntara reported receipts of $78,000, cash outflow of $3.7 million and a $15 million cash balance.

By the end of September, investors should expect final results from the company’s phase II program that evaluated its drug candidate amsulostat, in 16 patients.

An interim readout showed eight of 11 evaluable patients (73%) achieved a reduction of 50% or more in their myelofibrosis symptoms.

Syntara awaits an FDA review of its application to start a follow-on phase II/III trial.

Meanwhile, Syntara will seek shareholder approval to grant 4.769 million of incentive shares to CEO Gary Phillips, at nil consderation.