Moderna and Merck will launch Phase 3 to study melanoma vaccine. Picture Getty
Health & Biotech
After years of failures, the long awaited cancer vaccine is finally gaining steam and getting closer to reality.
New data from biotech giant Moderna suggest that scientists are finally able to design a vaccine that could teach immune cells to identify and fight cancerous cells.
Moderna showed that a combination of its own vaccine and Merck’s immunotherapy Keytruda led to a statistically significant improvement in survival in a small group of melanoma patients.
This combination was shown to have reduced the risk of certain skin cancers from returning or patient deaths by 44 per cent compared with Keytruda alone.
“These results are highly encouraging for the field of cancer treatment,” said Moderna CEO, Stephane Bancel.
“mRNA has been transformative for COVID-19, and now, for the first time ever, we have demonstrated the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma.
“We are very excited, we are moving very quickly with Merck onto phase 3 for this study,” Bancel added.
This was the first time ever that an mRNA-based cancer vaccine has proven itself in a randomised study, and with an unambiguously positive outcome.
Mind you the study done was small and only enrolled just 157 people who were at their late-stage skin cancer.
Still, even if the results were slightly less dramatic in a bigger study, experts believe the vaccine would still be a game changer.
Bancel says the results offered proof that the combination drug could be applicable for other difficult-to-treat cancers.
“We believe we can go quickly because through the Phase 1/2 study, we have shown there is a safety profile for the combined drugs,” he said.
“Cancer has a lot of pieces that we still don’t understand.
“But we’re still going to try and treat those different tumour types in the clinic because that’s the only way to prove that the mechanism of our product is sound.”
The full readout of the results can be seen here.
| CODE | COMPANY | PRICE | MARKET CAP | 1 WEEK RETURN % | 1 MONTH RETURN % | 1 YEAR RETURN % |
|---|---|---|---|---|---|---|
| AVE | Avecho Biotech Ltd | 0.01 | $23,892,301 | -13.33 | 62.50 | -13.33 |
| HXL | Hexima | 0.02 | $3,674,872 | 15.79 | 37.50 | -94.70 |
| KZA | Kazia Therapeutics | 0.11 | $15,850,671 | 40.00 | 20.69 | -91.63 |
| NEU | Neuren Pharmaceut. | 8.93 | $1,094,641,724 | 7.98 | 20.19 | 136.87 |
| BXN | Bioxyne Ltd | 0.03 | $16,641,135 | -3.85 | 19.05 | -13.79 |
| RSH | Respiri Limited | 0.05 | $36,971,872 | 0.00 | 17.95 | -28.13 |
| PIQ | Proteomics Int Lab | 1.00 | $115,010,769 | 2.04 | 16.28 | -17.70 |
| NYR | Nyrada Inc. | 0.15 | $22,621,262 | 0.00 | 16.00 | -39.58 |
| M7T | Mach7 Tech Limited | 0.68 | $160,223,385 | 18.42 | 15.38 | -17.68 |
| S66 | Star Combo | 0.15 | $20,262,447 | 0.00 | 15.38 | -41.18 |
| VTI | Vision Tech Inc | 0.40 | $12,531,641 | -4.76 | 14.29 | -54.29 |
| ANP | Antisense Therapeut. | 0.10 | $64,897,266 | 12.79 | 12.79 | -50.26 |
| PAB | Patrys Limited | 0.03 | $55,538,993 | 3.85 | 12.50 | -27.03 |
| IRX | Inhalerx Limited | 0.06 | $11,236,017 | 0.00 | 11.11 | -33.33 |
| CDX | Cardiex Limited | 0.35 | $46,794,292 | 2.94 | 11.11 | -49.28 |
| CBL | Control Bionics | 0.17 | $14,929,040 | 0.00 | 10.00 | -61.18 |
| MDR | Medadvisor Limited | 0.26 | $141,400,588 | 8.33 | 8.33 | -34.18 |
| ADO | Anteotech Ltd | 0.06 | $113,341,435 | 1.79 | 7.55 | -81.31 |
| IMC | Immuron Limited | 0.09 | $19,590,658 | 3.61 | 7.50 | -14.00 |
| TRP | Tissue Repair | 0.24 | $10,993,383 | 0.00 | 6.82 | -56.88 |
| EZZ | EZZ Life Science | 0.40 | $5,040,200 | 12.86 | 6.76 | -22.55 |
| LBT | LBT Innovations | 0.06 | $18,515,526 | -3.45 | 5.66 | -51.30 |
| CGS | Cogstate Ltd | 1.94 | $333,910,496 | 3.47 | 5.15 | -19.83 |
| HCT | Holista CollTech Ltd | 0.03 | $8,085,202 | 20.83 | 3.57 | -38.30 |
| MEM | Memphasys Ltd | 0.01 | $13,913,046 | -3.33 | 3.57 | -83.66 |
| BIT | Biotron Limited | 0.03 | $26,156,049 | 3.57 | 3.57 | -69.13 |
| GSS | Genetic Signatures | 0.92 | $129,065,396 | 2.22 | 3.37 | -48.60 |
| PNV | Polynovo Limited | 2.04 | $1,403,527,758 | 5.15 | 2.51 | 33.77 |
| UBI | Universal Biosensors | 0.24 | $49,783,442 | 6.82 | 2.17 | -76.26 |
| RHT | Resonance Health | 0.06 | $27,651,119 | 0.00 | 1.69 | -57.14 |
| BDX | Bcaldiagnostics | 0.06 | $8,165,683 | 0.00 | 1.69 | -52.00 |
| IIQ | Inoviq Ltd | 0.64 | $58,891,969 | 1.59 | 1.59 | -46.44 |
| CHM | Chimeric Therapeutic | 0.09 | $27,036,915 | 8.97 | 1.19 | -66.08 |
| SDI | SDI Limited | 0.89 | $105,790,322 | -1.11 | 1.14 | -12.32 |
| ALT | Analytica Limited | 0.00 | $4,613,801 | 0.00 | 0.00 | -50.00 |
| AMT | Allegra Orthopaedics | 0.11 | $10,968,216 | 0.00 | 0.00 | -30.00 |
| EYE | Nova EYE Medical Ltd | 0.28 | $40,847,366 | -3.45 | 0.00 | -13.85 |
| RNO | Rhinomed Ltd | 0.12 | $32,857,765 | 4.55 | 0.00 | -62.65 |
| TSN | The Sust Nutri Grp | 0.14 | $16,884,894 | 0.00 | 0.00 | -30.00 |
| PBP | Probiotec Limited | 2.23 | $181,351,195 | -0.45 | 0.00 | 1.36 |
| SCU | Stemcell United Ltd | 0.01 | $14,995,837 | 0.00 | 0.00 | 0.00 |
| HGV | Hygrovest Limited | 0.07 | $16,096,779 | 0.00 | 0.00 | 18.64 |
| ICS | ICSGlobal Limited | 0.58 | $6,054,605 | 0.00 | 0.00 | 0.00 |
| AC8 | Auscann Grp Hlgs Ltd | 0.04 | $17,621,884 | 0.00 | 0.00 | -50.62 |
| OVN | Oventus Medical Ltd | 0.02 | $4,834,531 | 0.00 | 0.00 | -77.01 |
| CPH | Creso Pharma Ltd | 0.02 | $36,719,243 | 5.00 | 0.00 | -74.39 |
| 1ST | 1St Group Ltd | 0.01 | $11,593,564 | 0.00 | 0.00 | -34.00 |
| CU6 | Clarity Pharma | 0.98 | $178,263,973 | 0.00 | 0.00 | 32.43 |
| GTG | Genetic Technologies | 0.00 | $27,701,895 | 0.00 | 0.00 | -40.00 |
| EPN | Epsilon Healthcare | 0.03 | $7,508,850 | 13.64 | 0.00 | -64.79 |
| DVL | Dorsavi Ltd | 0.01 | $5,682,075 | 0.00 | 0.00 | -39.06 |
| ARX | Aroa Biosurgery | 1.09 | $377,178,129 | -0.46 | -0.91 | 6.86 |
| CAJ | Capitol Health | 0.32 | $335,009,599 | -1.56 | -1.56 | -19.23 |
| PAR | Paradigm Bio. | 1.43 | $396,938,344 | -1.72 | -1.72 | -23.85 |
| ZNO | Zoono Group Ltd | 0.10 | $16,358,672 | 2.08 | -2.00 | -73.87 |
| PYC | PYC Therapeutics | 0.07 | $222,664,827 | 16.67 | -2.10 | -48.15 |
| TRU | Truscreen | 0.04 | $14,151,784 | -2.50 | -2.50 | -48.00 |
| PSQ | Pacific Smiles Grp | 1.53 | $244,160,365 | -3.77 | -2.55 | -47.78 |
| ILA | Island Pharma | 0.19 | $8,000,571 | -2.63 | -2.63 | -27.45 |
| TLX | Telix Pharmaceutical | 7.20 | $2,217,562,818 | 1.12 | -2.70 | -7.10 |
| MX1 | Micro-X Limited | 0.14 | $74,515,258 | 3.70 | -3.45 | -45.10 |
| RCE | Recce Pharmaceutical | 0.66 | $115,751,552 | 0.77 | -3.68 | -36.41 |
| MVP | Medical Developments | 1.54 | $128,594,711 | 0.65 | -3.75 | -68.70 |
| AHC | Austco Healthcare | 0.12 | $34,778,081 | 4.35 | -4.00 | -17.24 |
| MXC | Mgc Pharmaceuticals | 0.01 | $34,390,168 | 0.00 | -4.00 | -67.57 |
| LDX | Lumos Diagnostics | 0.05 | $10,080,981 | 2.13 | -4.00 | -94.85 |
| OSL | Oncosil Medical | 0.05 | $45,735,144 | -2.13 | -4.17 | 3.47 |
| OPT | Opthea Limited | 0.91 | $422,561,206 | -0.55 | -4.23 | -30.12 |
| RAD | Radiopharm | 0.11 | $25,138,818 | 0.00 | -4.35 | -71.19 |
| RAD | Radiopharm | 0.11 | $25,138,818 | 0.00 | -4.35 | -71.19 |
| AGH | Althea Group | 0.06 | $22,766,875 | 3.28 | -4.55 | -72.00 |
| OIL | Optiscan Imaging | 0.10 | $62,610,560 | 0.00 | -4.76 | -44.44 |
| SOM | SomnoMed Limited | 1.29 | $106,759,516 | 0.00 | -5.49 | -45.11 |
| ACR | Acrux Limited | 0.07 | $19,474,721 | -5.56 | -5.56 | -32.00 |
| ZLD | Zelira Therapeutics | 1.00 | $9,577,116 | -1.96 | -5.66 | -82.68 |
| CTE | Cryosite Limited | 0.71 | $35,142,885 | 0.71 | -6.00 | 51.61 |
| ALC | Alcidion Group Ltd | 0.15 | $187,040,185 | 3.45 | -6.25 | -45.45 |
| PXS | Pharmaxis Ltd | 0.06 | $42,420,688 | 1.72 | -6.35 | -50.83 |
| MVF | Monash IVF Group Ltd | 0.93 | $362,360,401 | -3.63 | -6.53 | -11.85 |
| GLH | Global Health Ltd | 0.21 | $12,180,710 | 0.00 | -6.67 | -40.00 |
| 1AD | Adalta Limited | 0.04 | $13,824,129 | -6.67 | -6.67 | -47.50 |
| AT1 | Atomo Diagnostics | 0.06 | $31,399,005 | 0.00 | -6.78 | -81.67 |
| RGS | Regeneus Ltd | 0.04 | $12,257,477 | -16.67 | -6.98 | -50.00 |
| PAA | Pharmaust Limited | 0.07 | $20,599,305 | 4.84 | -7.14 | -35.00 |
| NXS | Next Science Limited | 0.65 | $139,613,587 | 4.84 | -7.14 | -47.79 |
| IBX | Imagion Biosys Ltd | 0.03 | $26,911,645 | 0.00 | -7.41 | -67.11 |
| ALA | Arovella Therapeutic | 0.02 | $16,164,831 | -4.00 | -7.69 | -38.46 |
| JTL | Jayex Technology Ltd | 0.01 | $2,741,514 | 0.00 | -8.33 | -42.11 |
| ATH | Alterity Therap Ltd | 0.01 | $24,164,184 | 11.11 | -9.09 | -52.38 |
| VLS | Vita Life Sciences.. | 1.36 | $71,749,434 | -4.58 | -9.67 | -28.68 |
| IVX | Invion Ltd | 0.01 | $57,780,829 | 0.00 | -10.00 | -57.14 |
| PGC | Paragon Care Limited | 0.31 | $200,643,008 | -7.58 | -10.29 | -15.28 |
| RHY | Rhythm Biosciences | 1.03 | $223,682,617 | 0.00 | -10.43 | -33.55 |
| PCK | Painchek Ltd | 0.03 | $42,781,378 | -2.94 | -10.81 | -37.54 |
| OCC | Orthocell Limited | 0.41 | $80,853,259 | 3.80 | -10.87 | -19.61 |
| IDT | IDT Australia Ltd | 0.08 | $19,281,744 | 0.00 | -11.11 | -68.63 |
| BOT | Botanix Pharma Ltd | 0.05 | $61,749,016 | -8.62 | -11.67 | -5.36 |
| MDC | Medlab Clinical Ltd | 6.73 | $15,367,968 | 2.75 | -12.03 | -70.09 |
| NOX | Noxopharm Limited | 0.15 | $42,374,503 | -3.33 | -12.12 | -62.82 |
| 4DX | 4Dmedical Limited | 0.40 | $116,324,276 | 5.33 | -12.22 | -70.74 |
| DOC | Doctor Care Anywhere | 0.05 | $17,965,470 | -7.55 | -12.50 | -92.28 |
| CAN | Cann Group Ltd | 0.21 | $81,203,822 | 0.00 | -12.77 | -30.51 |
| PTX | Prescient Ltd | 0.14 | $97,294,256 | 10.20 | -12.90 | -41.30 |
| CMP | Compumedics Limited | 0.20 | $35,432,590 | 0.00 | -13.04 | -45.95 |
| CYC | Cyclopharm Limited | 1.19 | $110,268,784 | 0.85 | -13.45 | -27.44 |
| VHT | Volpara Health Tech | 0.55 | $137,402,080 | 1.87 | -13.49 | -47.60 |
| ATX | Amplia Therapeutics | 0.08 | $15,908,454 | -8.89 | -13.68 | -50.30 |
| AN1 | Anagenics Limited | 0.03 | $5,531,660 | 0.00 | -13.79 | -58.33 |
| ACW | Actinogen Medical | 0.10 | $175,206,459 | 1.02 | -13.91 | -38.13 |
| IPD | Impedimed Limited | 0.08 | $133,761,499 | 6.76 | -14.13 | -54.86 |
| CYP | Cynata Therapeutics | 0.30 | $42,982,978 | -4.76 | -14.29 | -44.95 |
| BPH | BPH Energy Ltd | 0.02 | $15,796,781 | 0.00 | -14.29 | -50.43 |
| DXB | Dimerix Ltd | 0.15 | $46,526,682 | -6.45 | -14.71 | -40.82 |
| RAC | Race Oncology Ltd | 1.99 | $318,355,831 | -1.49 | -14.96 | -44.72 |
| VBS | Vectus Biosystems | 0.82 | $43,349,458 | 5.16 | -15.10 | -42.20 |
| ONE | Oneview Healthcare | 0.11 | $58,620,617 | -4.35 | -15.38 | -58.49 |
| TD1 | Tali Digital Limited | 0.00 | $4,205,268 | 0.00 | -16.67 | -86.22 |
| NTI | Neurotech Intl | 0.07 | $58,526,658 | 0.00 | -16.67 | 16.67 |
| AHK | Ark Mines Limited | 0.22 | $7,614,223 | 15.79 | -16.98 | -6.38 |
| OSX | Osteopore Limited | 0.15 | $17,590,236 | -3.33 | -19.44 | -35.56 |
| ADR | Adherium Ltd | 0.00 | $19,917,753 | 0.00 | -20.00 | -63.64 |
| NSB | Neuroscientific | 0.12 | $17,216,597 | -14.29 | -20.00 | -64.18 |
| SHG | Singular Health | 0.12 | $8,100,236 | 4.55 | -20.69 | -58.93 |
| IHL | Incannex Healthcare | 0.18 | $277,726,812 | 2.86 | -21.74 | -71.20 |
| IMM | Immutep Ltd | 0.28 | $241,806,297 | -1.75 | -22.22 | -42.86 |
| IMU | Imugene Limited | 0.14 | $931,148,777 | -1.72 | -22.97 | -64.38 |
| ICR | Intelicare Holdings | 0.02 | $2,730,522 | -4.76 | -23.08 | -75.52 |
| NC6 | Nanollose Limited | 0.05 | $7,742,091 | -11.86 | -30.67 | -48.00 |
| EXL | Elixinol Wellness | 0.02 | $6,325,311 | 0.00 | -33.33 | -72.22 |
| LCT | Living Cell Tech. | 0.01 | $15,424,365 | -15.38 | -35.29 | 83.33 |
| BNO | Bionomics Limited | 0.04 | $51,405,740 | -2.78 | -45.31 | -68.18 |
| BWX | BWX Limited | 0.17 | $32,997,938 | 6.25 | -73.02 | -96.06 |
Avecho surged after announcing ethics approval of its pivotal Phase III clinical trial testing its oral CBD softgel capsule for insomnia.
The study is the largest randomised, placebo controlled study being undertaken in Australia to support registration of cannabidiol as an over-the-counter medicine with the Therapeutic Goods Administration (TGA).
It was purposefully designed to produce relevant clinical evidence, which is applicable to support product registration with key global regulatory bodies including the TGA, the FDA and the EMEA.
Kazia announced a collaboration with QIMR Berghofer Medical Research Institute, one of Australia’s foremost cancer research centres, to explore novel uses of paxalisib in solid tumours.
The research project is led by Professor Sudha Rao, a leading expert in transcriptional biology, particularly as it applies to the function of the immune system in cancer.
Professor Rao’s laboratory works closely with pharmaceutical companies and with clinicians to explore innovative approaches to cancer treatment.
The collaboration is ongoing and will build on initial research that has already led to the filing of a patent, including the use of paxalisib as an immune modulator in the treatment of diseases such as breast cancer.
Neuren has submitted an Investigational New Drug (IND) application for NNZ-2591 in Prader-Willi syndrome.
The new IND application was submitted to the US FDA on 22 December for approval to proceed with a Phase 2 trial in Prader-Willi syndrome.
The company also provided an update on progress in its ongoing Phase 2 clinical trials for each of Phelan- McDermid, Angelman and Pitt Hopkins syndromes.
Clinical trials are currently ongoing in each of the other three syndromes, which are the first trials of NNZ- 2591 in children with each syndrome.
In the Phelan-McDermid syndrome trial and in the Angelman syndrome trial, the first subject in the oldest age group has now completed the treatment period of 13 weeks, with a good safety and tolerability profile.
The four trials will likely complete at different times, with a series of top-line results announcements now anticipated from H2 2023, commencing with Phelan-McDermid syndrome.
Respiri has secured another primary care practice, Hand Family Healthcare, located in Clovis, New Mexico, US.
Under the deal, Respiri’s wheezo RPM (remote patient monitoring) program will be provided to patients with asthma and Chronic Obstructive Pulmonary Disease (COPD) at the clinic.
New Mexico has a large rural population, making RPM an important clinical primary service given the distances patients would need to travel to receive treatment.
Respiri believes the wheezo device’s ease of use, secure integrated systems and Access Telehealth’s clinical staff monitoring provides an ideal solution for such family practices.
The company is expected to generate revenues from device sales and RPM fees from this arrangement.
Bionomics share plunged after announcing that its PREVAIL study did not statistically meet its primary endpoint.
The study however noted consistent trends in strong safety and tolerability profile of BNC210 across the 13 clinical trials conducted to date.
BNC210 has a novel mechanism of action that involves negative allosteric modulation of the α7 nicotinic acetylcholine receptor.
“The findings indicate that BNC210’s novel mechanism of action through allosteric modulation of the α7 nicotinic acetylcholine receptor is promising and we remain committed to the ongoing Phase 2b ATTUNE Study in PTSD with topline data expected mid-2023,” said Errol De Souza, Executive Chairman of Bionomics.
Health & Biotech
Health & Biotech
Health & Biotech
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