Tackling cancer – what we saw in the March quarter

Biotech companies took the global spotlight during the COVID-19 pandemic as many investors came to grips with the size and scale of the global market for health solutions.

But while COVID-19 might have exited the stage for the time being, treating cancer is an enduring pursuit and an area of continuing unmet medical need.

A raft of developments was underway in the March quarter, as Australian biotech companies chased novel solutions to one of our thorniest problems – how to treat and cure cancer.

Biotech stocks – what the market tells us

The past two years have been a rollercoaster ride for biotechs as the sector experienced a boom and a post-pandemic slump. In 2021, 78 biotech IPOs in the US peaked at $14 billion collectively raised, outstripping the 2020 high point, according to Biopharma Dive. For comparison, these offerings raised only $5.4 billion in the pre-pandemic year, 2019.  

A recent sell-down of the US biotech sector has impacted the local players. The Australian notes that the Nasdaq biotech index has slid around 17%, while the S&P Biotech Select Industry Index has fallen by roughly 40%.

Source: Commsec.

But pre- and post-COVID-19 statistics may not be helpful when thinking about buying biotech stocks, which, given development outlays and timelines, are a long-haul proposition – particularly when it comes to cancer treatment.

Once biotechs are well established, they can perform well under pressure. The time may be ripe for investors to turn their attention to well-funded and developed cancer-focused biotech stocks.

In the spotlight: ASX oncology biotech stocks

Here are some of the Australian biotechs making a difference in the medical landscape by working to bring treatments for cancer to market.

Amplia Therapeutics

Cancer-focused biotech Amplia Therapeutics Ltd (ASX:ATX) has secured all-important Human Research Ethics Committee approval to conduct a Phase 2 pancreatic cancer trial, which is supported by key data from an animal model.

The company is off to see the Food and Drug Administration (FDA) in the US for a pre-IND (investigational new drug) meeting about the development of AMP945.

It has also kicked off extended toxicology studies of the asset to support a Phase 2 trial for the treatment of lung fibrosis.

Amplia’s balance sheet was strengthened in the quarter by the receipt of $0.84 million, being the second and final drawdown of a R&D funding facility – total proceeds received from the facility were $2.1 million.

Race Oncology 

Race Oncology Ltd (ASX:RAC) announced in January that it had received a $708,000 R&D tax refund for the previous financial year, which it said reflected strong investment in Australian based R&D projects to encourage the use of Australian-based resources.

On the clinical front, in March, RAC released some compelling preclinical findings for Zantrene, targeting kidney cancer, both on its own and in combination with existing treatments.

The asset was also shown to be highly effective in a mouse model of extramedullary AML, a form of leukaemia, when combined with decitabine.

These results support advancing Zantrene into human kidney cancer trials, which the company plans to kick off post quarter.

These plans have been accelerated by a supply agreement with Astex Pharmaceuticals (NASDAQ:ASTX) for ASTX727 – oral decitabine and cedazuridine – for use in clinical trials.

Imugene

Imugene Ltd (ASX:IMU, OTC:IUGNF) has had an interesting quarter, with a Phase 1 clinical trial of CHECKvacc for triple-negative breast cancer to proceed to the second dose cohort.

The company’s PD1 Vaxx asset has completed its Phase 1a monotherapy dose-escalation and will proceed to combination dose-escalation after review by Cohort Review Committee (CRC).

IMU also secured the green light from the Western Institutional Review Board (WIRB) to start a Phase 1 clinical trial of VAXINIA in multiple solid tumours in patients.

Meanwhile, patent applications to protect HER Vaxx immunotherapy have successfully moved through the approvals process at the South Korean Intellectual Property Office and the European Patent Office, while the patent for CF33, including VAXINIA and CHECKVacc, has been secured at the Japanese Patent Office.

Chimeric Therapeutics

Chimeric Therapeutics Ltd (ASX:CHM) is targeting the aggressive brain cancer, glioblastoma. Its Phase 1 clinical trial of its CORE NK platform demonstrated optimal safety and strong signs of clinical benefit.

The company also received encouraging initial data on this front for the second dose cohort of its CHM 1101 (CLTX CAR T) Phase 1 dose-escalation study and has now started dosing first participants in the third dose cohort.

The sought-after US patent covering the CLTX CAR technology used in both CHM 1101 and CHM 1301 has been secured.

During the quarter the company forged a collection and distribution partnership with Be The Match BioTherapies, to support Chimeric’s expanded clinical development of CHM 1101 through expedited collection, transport and delivery of cellular starting material and clinical drug products.

Chimeric also signed a Sponsored Research Agreement with the University of Pennsylvania to support the continued research and development of CHM 2101 for preclinical studies in gastrointestinal cancers.

The company has boosted its cash position following a non-renounceable entitlement offer and follow up shortfall placement to raise around $14.4 million before costs.

Noxopharm 

Noxopharm Ltd (ASX:NOX) finished the quarter in a solid financial position of around $18.1 million, in line with planned clinical and pre-clinical work programs.

The cancer biotech has secured Orphan Drug Designation from the US FDA, bringing benefits to the ongoing clinical and commercial development of its lead drug candidate Veyonda, which targets soft tissue sarcoma.

Meanwhile, cohort 1 of the DARRT-2 Phase 2 trial – which trials Veyonda in combination with low-dose radiotherapy – is fully enrolled with the first dose safe and well-tolerated and cohort 2 recruitment continues. The first patient has now been enrolled in the Phase 1 trial for CEP-2 - Veyonda® in combination with chemotherapy drug doxorubicin – at the City of Hope Cancer Centre in Los Angeles.

A series of specific preclinical drug candidates for pancreatic cancer have been identified for further screening and advancement.

New CEO and managing director Dr Gisela Mautner, appointed during the quarter, brings international pharmaceutical industry experience to lead Noxopharm through the next stages of growth.

Arovella Therapeutics 

Arovella Therapeutics Ltd (ASX:ALA), which targets cancer and conditions that affect the central nervous system, kicked off work with Q-Gen, its selected plasmid and lentiviral vector manufacturer for ALA-101 (CAR19-iNKT). During the quarter it also appointed Dr Mini Bharathan as vice president of Development and Translational Medicine.

After the reporting period, Arovella entered into a Services Agreement with its chosen cell therapy manufacturer, Q-Gen, to initiate manufacturing of CAR-iNKT cells.

Also post quarter, Arovella received notification from the US Patent and Trademark Office that its anagrelide patent would proceed to grant.

Arovella’s cash position was boosted following a $4.57 million placement with cornerstone participation from well-known life sciences institutional investor, Merchant Group, and an oversubscribed $2 million share purchase plan.

Kazia Therapeutics 

Brain cancer drug developer Kazia Therapeutics Ltd (ASX:KZA, NASDAQ:KZIA)’s lead candidate paxalisib targets a variant of glioblastoma that accounts for 15% of all brain cancers.

In the March quarter, the company’s preclinical data for paxalisib in rare childhood brain cancer was among five abstracts presented at the American Association of Cancer Research (AACR) Annual meeting.  

Kazia’s Phase 2 study of paxalisib – in combination with metformin and ketogenesis – has commenced participant recruitment.

“Paxalisib has become one of the most interesting drug candidates in this field, and we look forward to working with clinicians and researchers to further explore the drug in this group of patients,” Kazia CEO Dr James Garner said.

On the finance front, the company has launched an ‘at-the-market’ financing facility with Oppenheimer and Co, allowing Kazia to respond rapidly and cost-effectively to investor interest in the US market.