The oncology sector – like most of the healthcare sector – has been struggling post-COVID boom, faltering in the face of a tight financial market reluctant to shell out capital in the traditionally riskier biotech sector.
State of the market
Beginning the quarter at 42,647 points on March 31, the ASX200 Healthcare sector lost ground with a 3.1% dip, falling to 41,290 despite a late-quarter rally that took the sector up to 44,953 (+5.4%) on June 5.
The global oncology market is currently valued at US$205 billion, projected to reach US$556 billion by 2030 at a compounding annual growth rate (CAGR) of 7.80%.
Indication-targeted therapies have been growing in popularity in recent years, overtaking broad-spectrum chemotherapy research in an effort to produce treatments with fewer side effects.
Cell- and immuno-based therapies have taken centre stage, with the intention of enhancing or enabling the patient’s body to fight cancer directly itself, alongside chemotherapy combination drugs intended to reduce the negative side effects while enhancing cancer-killing efficacy.
How did small caps fare this quarter?
Patrys
Patrys Ltd (ASX:PAB) successfully resolved a manufacturing hiccup this quarter, engaging with an independent auditor to determine the exact cause of delays to production of its cancer treatment PAT-DX1.
In-depth investigations by the company’s Contract Development and Manufacturing Organisation (CDMO) and an independent auditor found no systemic causes, suggesting the glitch was likely a one-time event.
The audit's finalisation will pave the way for a new PAT-DX1 replacement production run in the coming months.
In other positive news, the US Patent and Trademark Office (US PTO) granted two patents to Patrys in April, providing substantial protection for its deoxymab antibody technology until 2039.
PAB also completed animal dosing for PAT-DX1’s final Good Laboratory Practice (GLP) toxicology studies, clearing the way for an upcoming human clinical trial – the results demonstrated no safety or tolerability concerns.
Finally, CEO Dr James Campbell recently courted interest from pharmaceutical and biotech companies at the BIO International Convention in Boston, presenting potential opportunities for collaboration in the use of Patrys’ deoxymab technology.
Despite a quarterly cash outflow of A$2.662 million due to one-off R&D costs, Patrys holds A$4.045 million in cash and deposits. A further A$2.7 million is expected from the Federal Government's R&D Tax Incentive Scheme in the first half of FY2024.
Imugene
Imugene Ltd (ASX:IMU, OTC:IUGNF) made strong regulatory progress over the last few months, not least of which was securing approval to begin a Phase 1 clinical study of its oncolytic virotherapy candidate, onCARlytics (on-CAR-19, CF33-CD19, HOV4), under the US Food and Drug Administration’s (FDA) Investigational New Drug (IND) clearance.
Simultaneously, Imugene's Phase 1 MAST trial, assessing the safety of the cancer-killing virus VAXINIA (CF33-hNIS), is advancing on schedule, having reached advanced dosing stages across various study arms.
Meanwhile, the first patient was dosed in June for the combination cohort of the IMPRINTER study. This trial evaluates the safety and effectiveness of Imugene’s PD1-Vaxx in combination with Roche's atezolizumab (Tecentriq®) in treating patients with non-small cell lung cancer.
On the non-clinical side of things, IMU partnered with Eureka Therapeutics to present data at the American Society of Gene and Cell Therapy’s Annual Meeting, demonstrating enhanced anti-tumour activity against hepatocellular carcinoma, and new HER-Vaxx data was presented at the World Congress of Gastrointestinal Cancer in Barcelona.
Finally, IMU secured patents to safeguard PD1-Vaxx and appointed renowned US biotech executive Kim Drapkin as a non-executive director – the company ended the June quarter with A$153.2 million in cash or equivalents.
An R&D tax refund of A$12.6 million for the 2022 financial year will support the continued clinical development of its immuno-oncology pipeline.
Prescient Therapeutics
Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) advanced its cancer-targeted cell therapies during the June quarter, specifically PTX-100 alongside cell therapy platforms CellPryme and OmniCAR.
The company added industry veteran Dr Ellen Feigal to the board as a non-executive director and produced encouraging results in its Phase 1b trial of PTX-100, led by principal investigator Professor H. Miles Prince AM – promising enough that PTX has opted to enrol more patients in the ongoing Phase 1b trial.
The company also made progress with its OmniCAR platform, a next-generation CAR-T therapy, and its CellPryme platform, a cell therapy manufacturing enhancement.
The use of CellPryme has produced CAR-T cells with double the effectiveness, lasting longer with higher potency.
Despite sector headwinds, Prescient showcased pre-clinical data from OmniCAR and CellPryme at the International Society of Cell & Gene Therapy (ISCT) annual meeting in Paris.
The company also remains engaged in active business development activities, seeking to raise awareness of its programs among pharmaceutical and biotech companies, researchers and collaborators.
At the end of June 2023, the firm reported holding cash reserves of $21.8 million, an increase from the $19.9 million held at the end of March 2023. The funds included $16 million in term deposits with maturities ranging from 6 to 12 months.
Arovella Therapeutics
Arovella Therapeutics Ltd (ASX:ALA)’s focus remained on the invariant Natural Killer T (iNKT) cell therapy platform for cancer treatment, which is quickly approaching an application for human trials.
During the quarter, ALA presented its first poster at the AACR Annual Meeting with new data demonstrating that ALA-101 has the potential to be a novel ‘off-the-shelf’ cell therapy to treat CD19-expressing leukemias and lymphomas.
The company also presented at the 5th Annual Allogeneic Cell Therapy Summit in Boston, received positive data on increasing persistence of iNKT cells with its cytokine technology under licence from the University of North Carolina, and completed a $6.3 million placement and share purchase plan.
Looking forward, Arovella intends to achieve several critical milestones, including:
- Reporting initial animal data on ALA-101 in combination with Imugene’s onCARlytics (H2 CY23);
- Optimising and scaling up its CAR-iNKT manufacturing process suitable for phase I clinical trials, including completing cGMP manufacture of its lentiviral vector (H2 CY23);
- Completing Investigational New Drug (IND)-enabling non-clinical safety and efficacy studies (H1 CY24);
- Manufacturing clinical batches for phase I clinical trials (H1 CY24);
- Securing an Investigational New Drug (IND) application with the FDA and/or regulatory filing with TGA to conduct a phase I clinical trial in Non-Hodgkin’s lymphoma (H2 CY24); and
- Commence a phase I clinical trial in Non-Hodgkin’s lymphoma (H2 CY24)
Noxopharm Ltd (ASX:NOX, OTC:NOXOF) progressed its preclinical portfolio, announcing a promising inflammatory skin disease treatment from the Sofra™ technology platform.
NOX strategic partner Hudson Institute of Medical Research’s Associate Professor Michael Gantier subsequently presented related research to the prestigious European Molecular Biology Organization.
Demonstrating its global relevance, Noxopharm was invited to join Austrade’s Advance Australia delegation to the US ahead of the BIO 2023 conference in Boston.
The delegation of senior leaders from a small select group of companies met with key US investors and innovation partners in a formal and structured program comprising site visits, information and pitch sessions, and networking opportunities.
Finally, the company published preliminary data from the IONIC investigator-initiated pilot Phase 1 trial of oncology drug candidate Veyonda® in the form of an abstract at the American Society of Clinical Oncology (ASCO) annual meeting.
Pharmaxis
Pharmaxis Ltd (ASX:PXS, OTC:PMXSF) spent the quarter advancing clinical trials for two of its principal assets – PXS-5505 for myelofibrosis and PXS-6302 for skin scarring.
The company's work is centred on the anti-fibrotic effects of inhibiting lysyl oxidase (LOX) enzymes, which PXS has been developing for 10 years.
During the June quarter, the anti-fibrotic effect of inhibiting lysyl oxidase (LOX) showed unprecedented efficacy, with 60% of PXS’ myelofibrosis patients completing six months’ treatment on PXS-5505 showing a reduction in bone marrow fibrosis of at least one grade, and patients with established scars treated for three months with topical treatment PXS-6302 showing a 30% reduction in collagen content.
“On top of the comprehensive pre-clinical data from our compounds published in Nature Communications and other respected journals we can justifiably claim that we have achieved clinical proof of anti-fibrotic effect,” CEO Gray Phillips said.
Pharmaxis also made progress with other indications, publishing preclinical data in the peer-reviewed Nature Communications journal for PXS-5505 targeted at the myelodysplastic syndrome blood cancers group.
On the commercial side of things, PXS generated $7.4 million in sales of its Mannitol respiratory products; Bronchitol®, an inhaled dry powder for the treatment of cystic fibrosis, and Aridol®, an innovative lung function test designed to help doctors diagnose and manage asthma.
With $14.8 million in the bank as of the end of the quarter, Pharmaxis is well-placed to continue pursuing its clinical ambitions.
Race Oncology
Race Oncology Ltd (ASX:RAC) used last year’s business review as a springboard in the quarter, refining corporate direction and refocusing the development strategy of bisantrene RC220, an IV-administered formulation targeting various cancer indications.
RAC enrolled 20 of 22 patients for its Relapsed/Refractory acute myeloid leukemia trial RI-002 – observations have been “compelling” with several patients being effectively bridged to allogenic stem cell transplant with curative intent.
The company released a detailed commercial assessment of bisantrene’s market potential as a cardio-protective agent or dual cardio-protective and anti-cancer agent in breast, endometrial and ovarian cancers and in settings where anthracyclines are typically used.
RAC also assigned internationally experienced biopharmaceutical executive and former physician Dr Michelle Rashford as chief medical officer (CMO), taking over from interim CMO, Dr Ajay Duggal.
Race held cash and equivalents of $21.52 million at the end of June, offering plenty of capital for further clinical initiatives.
Radiopharm Theranostics
Radiopharm Theranostics Ltd (ASX:RAD) took several important steps toward clinical trials, achieving orphan drug designation from the US FDA for Ga68-Trivehexin (RAD 301), a radiopharmaceutical technology for imaging patients with pancreatic ductal adenocarcinoma (PDAC).
The company also completed a pre-investigational drug (IND) meeting with the FDA for F18-pivalate (RAD 101), a proprietary imaging agent made of F18 radioisotope and pivalate, a small molecule that targets fatty acid synthetase and could aid in detecting cerebral metastasis in patients with brain metastases.
Finally, RAD’s Pivalate (RAD-101) brain glioma imaging study data was published in the peer-reviewed journal European Journal of Nuclear Medicine and Molecular Imaging, suggesting potential for additional indications in Glioblastoma.
On the supply side of things, RAD secured a supply agreement for the provision of isotope Terbium-161 (Tb-161), a core component of RAD 602, a radiotherapeutic agent designed by Radiopharm to target protein tyrosine phosphatase mu (PTPμ), a protein primarily found in cancer cells.
The company had $11.7 million in cash at the end of June, with 87% of operating expenditure accounted for by direct Research and Development expenditure and staff costs.