Four ASX shares that are not letting that hold them back are listed below. Here's why they are rising:

Noxopharm Ltd (ASX: NOX)

The Noxopharm share price is up 85% to 10.5 cents. This morning, the biotech company revealed that its CRO-67 preclinical drug candidate for the treatment of pancreatic cancer has been granted orphan drug designation status by the US Food and Drug Administration. The FDA grants this status to drugs that are designed to prevent, diagnose, or treat rare diseases or conditions.

Orora Ltd (ASX: ORA)

The Orora share price is up 2.5% to $2.73. This morning, this packaging company released an update on its proposed acquisition of Saverglass SAS. The release reveals that Olympe SAS is supporting the acquisition and has signed an agreement to sell its shares in Saverglass to Orora.

Ramelius Resources Ltd (ASX: RMS)

The Ramelius share price is up 3.5% to $1.45. This appears to have been driven by a broker note out of Ord Minnett this week. Its analysts believe that the gold miner's shares are cheap and expect them to rerate if the gold price strengthens. The broker has a buy rating and a $2.05 price target on its shares.

Silver Lake Resources Ltd (ASX: SLR)

The Silver Lake share price is up 2% to 84.2 cents. This may also have been driven by a broker note out of Ord Minnett. Its analysts have put a buy rating and lofty price target of $2.00. It highlights that M&A activity has been heating up recently and appears to believe it could continue.

The post Why Noxopharm, Orora, Ramelius, and Silver Lake shares are pushing higher appeared first on The Motley Fool Australia.

In morning trade, the biotech company's shares are up 166% to 16.5 cents.

Why is this ASX healthcare stock rocketing?

Investors have been scrambling to buy the company's shares this morning after its CRO-67 preclinical drug candidate for the treatment of pancreatic cancer was given a major boost from the US Food and Drug Administration (FDA).

According to the release, the FDA has granted orphan drug designation (ODD) status to CRO-67.

The FDA grants ODDs for drugs that are designed to prevent, diagnose, or treat rare diseases or conditions. The designation comes with various benefits that include tax credits for qualified clinical trials, exemption from FDA application fees, and potential seven years of market exclusivity after approval.

The company notes that the designation comes shortly after further encouraging CRO-67 data was presented at the American Association of Cancer Research Special Conference on Pancreatic Cancer.

It also highlights that the disease is set to become the second leading cause of cancer-related deaths in the US by 2040, and has a very poor five-year survival rate of about 9% from the time of diagnosis.

And while it is important to note that this is not FDA approval, it's hard to deny that it isn't a big step in the right direction for the ASX healthcare stock.

Management notes that CRO-67's designation as an orphan drug supports the company's development plan for the asset, and its future commercial value, as Noxopharm continues to build the data package that will be required for regulatory progression.

'A significant milestone'

Noxopharm's CEO, Dr Gisela Mautner, was very pleased with the news. Dr Mautner said:

For CRO-67 to achieve an ODD is a significant milestone in the development of the drug. In addition to financial benefits, the ODD will also strengthen our commercial position in a market that has seen very few new treatments over recent decades. Our pancreatic cancer program is a high priority, and we are committed to progressing its development as quickly as possible. Further studies are in the works, as are investigations into dosing and formulation.

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In earlier trade, the Noxopharm shares exploded 21% to 40 cents.

Let's take a look at what the company announced.

Orphan drug designation

The Noxopharm share price is soaring after the biotechnology company received Orphan Drug Designation (ODD) by the FDA for Veyonda.

Veyonda is the company's lead oncology drug candidate for the treatment of soft tissue sarcoma, an aggressive cancer.

The granting of ODD provides Noxopharm with seven years of market exclusivity for the drug and a waiver of new drug application fees. In 2021, the cost for a new drug application was about $2.9 million.

The FDA will also assist with regulatory guidance during the drug development process. Noxopharm said out of 360 ODD's approved last year, only four went to Australian companies.

Noxopharm is currently conducting a CEP-2 trial using Veyonda in the treatment of patients with soft tissue sarcoma in the United States.

Commenting on the news fuelling the Noxopharm share price today, CEO Dr Gisela Mautner said:

It is pleasing that the Noxopharm application for Orphan Drug Designation was approved so quickly.

The 7-year period of market exclusivity is commercially extremely valuable, as it means that the FDA will not approve a subsequent drug for the same use within this timeframe.

With the FDA orphan drug designation now secured for Veyonda, the Noxopharm team is excited to move our preclinical assets along the drug development process, while continuing to deliver on our clinical program plan.

Thirty patients are being enrolled in the clinical trials to investigate the use of the drug. The City of Hope Cancer Center in Los Angeles has started treatment already.

Noxopharm share price snapshot

The Noxopharm share price has dropped 43% in the last year, while it has fallen 4% year to date. For perspective, the S&P/ASX 200 Index (ASX: XJO) has returned more than 9% over the past year.

In the past month, this ASX healthcare share has dropped 1.3% although it has climbed by almost 9% over the past week.

The company has a market capitalisation of about $108 million.

The post This ASX healthcare share is surging 17% on a new FDA ruling appeared first on The Motley Fool Australia.

The Noxopharm share price finished Monday 5% down at 38 cents as investors responded poorly to the release of its earnings results today.

Noxopharm share price as clinical trials progress

Key takeouts from the company's earnings results include:

• Strong cash position of A$22.6m due to continued judicious expenditure in the best interest of the company and its shareholders
• This amount includes $5.9 million R&D tax incentive for FY21 received in January 2022, considered non-dilutive funding for the company
• Increased investment in R&D of $8.3m compared to $3.0 million in 1HFY20 to advance the clinical trial programs
• DARRT Program Phase 2 clinical trial (Veyonda with low-dose radiotherapy received IND approval from the FDA

What else happened this half for Noxopharm?

The company's progress was hallmarked by clinical trial and drug discovery momentum, particularly as R&D expenditure increased by over $5 million to support these programs.

Noxopharm says that its clinical trial sites "include some of the leading cancer centres in the world, notably, the US number one cancer hospital, the MD Anderson Cancer Center…as well as the Beverly Hills Cancer Center and the City of Hope Cancer Center".

During the half, Noxopharm's DARRT Program Phase 2 clinical trial, investigating Veyonda with low-dose radiotherapy, received investigational new drug (IND) approval from the Federal Drug Administration (FDA).

As such, the company says the trial is underway at two leading U.S. cancer centres – the MD Anderson Cancer Center and the Beverly Hills Cancer Centre. The patient cohort has already completed first dosages and completed the safety assessments, so updates should be on the way later this year.

Not only that, but Noxopharm made progress on the IONIC Phase 1 trial it is conducting with Bristol Myers during the half. The trial is investigating Veyonda with the Bristol Myers Squibb checkpoint inhibitor, nivolumab, that sells under the brand name Opdivo.

Patients have already been enrolled and treated at the first clinical site the company says, and more sites are expected to open in H1 2022.

Management commentary

Speaking on the announcement, incoming CEO of Noxopharm, Dr Gisela Mautner said:

As incoming CEO, it is pleasing to report that Noxopharm is in a strong cash position with a number of promising programs underway. Our Clinical Portfolio, investigating the combination of Veyonda® with established cancer treatments, is tracking to plan. It is also important to note the relationships we have secured with national and international partners such as Hudson Institute of Medical Research and the US National Cancer Institute, as well
as several prestigious clinical study sites in the USA.

What's next for Noxopharm?

The company will endeavour to progress in its clinical trial and drug discovery programmes as outlined in its earnings report on Monday.

Noxopharm did not provide any specific earnings or cost guidance for the remainder of FY22.

Noxopharm share price summary

In the last 12 months, the Noxopharm share price has plunged 52% and sits 3% in the red since we started trading in 2022.

Over the previous month, shares have faltered another 9% and are down 9% this past week too.

The post Clinical trials not enough to stop Noxopharm (ASX:NOX) shares' 5% plunge on Monday appeared first on The Motley Fool Australia.

The move coincides with the drug development company's goal to position itself on the global stage.

At the time of writing, the Noxopharm share price is 6.1% higher, at 43.5 cents apiece.

New blood to take the reins

This morning, Noxopharm announced its new year's resolution would be to make 2022 the year of "generational change". It's appointed its current chief medical officer Dr Gisela Mautner as its new CEO.

Dr Mautner will take over from current CEO Dr Graham Kelly from 1 February.

Comment from current CEO

Dr Kelly said Dr Mautner's experience in the industry would equip the company with the ability to position itself for "a valuable partnering opportunity".

Dr Kelly said:

The company is in the process of transiting from an early-stage biotech company into a serious bio-pharma company looking to make its mark on the world stage.

Having worked alongside Gisela for several years now, I have full confidence in her ability to achieve that objective. I believe she will make an outstanding CEO.

Dr Kelly will transition from an executive to a consultant role. In doing so, he will remain involved in the company's future — remaining its largest shareholder, board member, and inventor of much of the company's Intellectual Property.

Noxopharm is an Australian based biopharmaceutical company with the primary focus of treating cancer and septic shock.

The company is developing its lead drug candidate Veyonda, currently in the second phase of its clinical trials.

Noxopharm share price snapshot

In 2021, the Noxopharm share price dropped by around 20%. It saw its sharpest drop in mid-December, just a few days after enrolling the first group of patients for the first clinical trial of Veyonda as an experimental cancer treatment.

The drop marked the share price's 52-week low.

As of today, the company has a market capitalisation of more than $125 billion with around 292 million shares issued.

The post The Noxopharm (ASX:NOX) share price is jumping 6% after announcing a new CEO appeared first on The Motley Fool Australia.

Noxopharm shares hit an intraday high of 39 cents, a 6.85% gain, before settling at 37 cents at the time of writing, up 1.37%.

Noxopharm is a drug development company working on treating cancer and septic shock.

What did Noxopharm announce today?

It seems investors were responding to an update from the company on a cancer treatment trial.

The company has recruited its first group of patients for its Direct and Abscopal Response to Radiotherapy (DAART-2) phase two clinical trial.

DARRT is a cancer treatment that combines Novopharm's Veyonda drug candidate and a low dose of external beam radiotherapy.

The patients receiving the treatment are suffering from a range of cancers including prostate, breast, and lung.

The patients are enrolled at the Beverly Hills Cancer Centre in Los Angeles and the MD Anderson Cancer Centre in Houston.

Noxopharm said the momentum of patient and site recruitment is on the rise, with a first Australian trial site also now open for enrolment.

The company aims to recruit 100 patients across Australia, the United States, and Europe for this trial.

Management comment

Commenting on the announcement that may have impacted the Noxopharm share price, company Chief Medical Officer Dr Gisela Mautner said:

This phase two study builds on our phase one trial where we saw promising signals that it may be possible to achieve cancer reduction through the abscopal response.

A combination of Veyonda and low-dose radiation therapy would be a very important new treatment option for cancer patients worldwide…

Noxopharm share price snap shot

It's been a tough year for shareholders in the drug development company. The Noxopharm share price has fallen more than 23% in the past 12 months, plunging 24% this year to date.

In contrast, the benchmark S&P/ASX 200 Index (ASX: XJO) has returned nearly 11% in the past year.

Shares in the company reached a 52-week high of 95 cents, while the low was 36.5 cents.

The post Here's why the Noxopharm (ASX: NOX) share price leapt 7% today appeared first on The Motley Fool Australia.

Shares in the drug development company are on the move after it released a key announcement regarding its lead drug candidate Veyonda.

Here's what we know out of Noxopharm's corner today.

What was announced?

The company advised it had received "notices of allowance" from both the Australian and European patent offices covering use of the active ingredient in Veydona, idronoxil.

Veydona is the company's lead drug candidate currently in Phase 2 safety and efficacy clinical trials. The company has the end goal of turning the drug into a label that's indicated in all types of cancer treatment.

Specifically, the patent governs the use of Veydona to "allow dosages of chemotherapy to be lowered to safer levels without compromising their anti-cancer effectiveness".

This involves a particular method where Veydona is supplied with a low dose of chemotherapy drugs in the treatment of various cancers.

Noxopharm is confident the combination therapy can "deliver an even stronger anti-cancer response at the same time as offering the same benefit".

The end result will be that Veydona may be offered as a combination therapy to patients unable to undergo full-strength chemotherapy.

The need, Noxopharm says, originates from the wide-ranging side effects of the current care standard through the use of chemotherapy compounds known as "platinum drugs".

This category ranks among the gold standard of commonly used chemotherapy drugs.

In the population taking these platinum drugs, Noxpharm explained that adverse side effects cause a reduction in therapy in around 30% of cases. They also result in 10% of patients having to stop therapy altogether.

The company says idronoxil, through the Veydona label, purportedly enhances chemotherapy "up to a magnitude of 1,000 times…without increasing the sensitivity to healthy cells to the damaging effects of the drugs".

This concept was proved back in April in the company's CEP-1 study which investigated Veydona's effects when administered this way.

A new study, CEP-2, followed further building on the results obtained from the original clinical trial. Results will be available in due course.

The patent granted today builds on other patent positions it has filed for in both radiotherapy and immunotherapy earlier in the year.

What did management say?

Speaking on the announcement, Noxopharm's CEO Graham Kelly said:

A high proportion of cancer patients are deprived of the benefits of chemotherapies because of toxic side-effects. The development of side-effects leads to drug dosages being lowered or stopped altogether. Other patients either are too ill or too elderly or just unwilling to even start chemotherapy. That is the gap that we see Veyonda filling by allowing the patient to still gain the benefit of the chemotherapy but at dosages that are much better tolerated. With an estimated US$150 billion spent globally each year on chemotherapy, that gap represents a very major medical need and commercial opportunity.

Regarding other patent filings and the company's growth vision, Kelly added:

Allowance of these claims is a major milestone in the Company's aim to see Veyonda become a standard of care companion drug in oncology for chemotherapy, radiotherapy and immunotherapy. With the radiotherapy (ASX Announcement 27 September 2021) and immunotherapy patent positions looking strong, the allowances announced today represent an important step towards achieving that eventual aim, something that we are confident will be attractive to major pharma companies with strong chemotherapy drug portfolios.

Noxopharm share price snapshot

The Noxopharm share price has had a difficult year to date, having posted a return of 12% since January 1.

As such, it has only climbed around 9% in the last 12 months and is in the red by around 2% in the last month.

These results have lagged the S&P/ASX 200 Index (ASX: XJO)'s return of around 21% in the past year.

The post Why is the Noxopharm (ASX:NOX) share price up 4% on Monday? appeared first on The Motley Fool Australia.

The clinical-stage drug development company's shares were up as much as 13% to 63 cents at one stage today.

The Noxopharm share price has since pulled back and is now trading just 3.5% higher at 57.5 cents.

Why is the Noxopharm share price rocketing higher?

The Noxopharm share price was given a big boost this morning from the release of a positive announcement.

That announcement reveals that the company is positioning its Veyonda (idronoxil) product as a COVID-19 treatment. This is based on a well-tolerated and selective anti-inflammatory action.

According to the release, this follows an important discovery about the anti-inflammatory mechanism of action of idronoxil through its partnership with Hudson Institute of Medical Research.

The release reveals that the discovery is the identification of the enzyme, TANK-binding kinase 1 (TBK1), as the molecular target of idronoxil in terms of its anti-inflammatory properties.

However, it is worth noting that the discovery is not yet peer reviewed in a scientific publication. A submission is anticipated in two months.

Management commentary

The Hudson Institute's Associate Professor and Head of the Nucleic Acids and Innate Immunity Laboratory, Michael Gantier, said: "TBK1 is a point of convergence of many inflammatory pathways, and a target under significant investigation by several big pharmaceutical companies. Our latest findings, which are being prepared for publication, demonstrate that idronoxil may have applications in a range of diseases where TBK1 facilitates aberrant inflammation."

"Critically, TBK1 also directly controls production of interferon-beta, a cytokine associated with long-COVID symptoms. This suggests that idronoxil may not only be useful to prevent progression of COVID-19 patients from mild to severe disease, but also may decrease the risk of long-lasting post-infectious symptoms, seen in up to half of COVID-19 patients," he added.

The Noxopharm share price is up 22% since the start of the year.

The post Noxopharm (ASX:NOX) share price jumps 13% on COVID treatment update appeared first on The Motley Fool Australia.

At the time of writing, the Noxopharm share price is 64 cents – 7.56% higher than its previous close.

Let's take a closer look today's release from the drug development company.

Possible European patent

Noxopharm announced it's received a notice of allowance on a key patent for its first pipeline drug candidate Veyonda.

According to Noxopharm, it's a positive sign the European Patient Office will likely grant the patent.

Currently, Veyonda is in phase 2 of clinical trialling. Noxopharm hopes Veyonda will prove to be a useful cancer treatment.

If granted, the patent will relate to the use of idronoxil, the active ingredient in Veyonda. The patent will cover a formulation designed to provide a steady-state blood level of the drug.

It will also see Noxopharm with enforceable rights to idronoxil for another 16 years.

Veyonda is expected to treat any type of cancer and be given to patients undergoing chemotherapy or radiotherapy.

According to Noxopharm, if granted, the European patent will be a good sign the drug is likely to be patented in other important territories, like the United States.

Commentary from management

Noxopharm's CEO Graham Kelly commented on the notice of allowance, saying:

This allowance is very pleasing validation of our strategy of building a strong IP position around Veyonda based on a series of inter-connected patents. The interconnection is between method of administration and clinical use and removes the reliance on the strength of any single patent.

A granted patent also will help underpin our commercial aim of Veyonda becoming a standard of care drug in combination with other major forms of cancer therapy.

Noxopharm share price snapshot

The Noxopharm share price has been performing well lately.

It's currently 30% higher than it was at the start of 2021. It's also gained 265% since this time last year.

The company has a market capitalisation of around $184 million, with approximately 288 million shares outstanding.

The post The Noxopharm (ASX:NOX) share price is soaring 7% appeared first on The Motley Fool Australia.

At the time of writing, Noxopharm shares are swapping hands for 69 cents apiece, down 1.43%

What did Noxopharm announce?

Investors are selling Noxopharm shares after digesting the clinical-stage drug development company's latest release.

According to Noxopharm, it is on track to undertake a multi-national study for its flagship cancer-fighting drug, Veyonda. The drug is used in conjunction with radiotherapy.

Titled DARRT-2 (Direct and Abscopal Response to RadioTherapy), the phase 2 trial aims to treat late-stage prostate, breast and lung cancer patients for whom traditional treatment options such as chemotherapy and radiotherapy have failed.

The trial seeks to generate the phenomenon of the abscopal response in cancer patients. This is when a low dose of radiation not only shrinks a targeted tumour, but triggers an immune response that results in other tumours melting away. Noxopharm hopes the cancer cells could be eradicated within a matter of weeks.

The phase 2 trial is seeking to recruit 100 participants across 15 sites in Australia, the United States, France, and Hungary. International contract research organisation Parexel has been appointed to oversee the study.

Management commentary

Noxopharm CEO and managing director Dr Graham Kelly said:

The abscopal response is a highly attractive cancer treatment goal because it provides the opportunity for a major anti-cancer outcome from a generally safe and minimally invasive treatment. The challenge is that it is a very rare phenomenon that to date has proven difficult to reproduce on a consistent basis.

Recent research has pointed to a reason for this being the need to block a certain type of repair process called autophagy of mitochondrial DNA damaged by the radiation. Other research points to idronoxil, the active ingredient in Veyonda, blocking autophagy. It is the combination of that effect and the drug's known immuno-stimulatory effects, together with the earlier DARRT-1 trial data, that provides the confidence that we might have the ability to achieve consistently higher response rates to make DARRT a practical treatment option.

Noxopharm share price summary

Despite today's dip, Noxopharm shares have surged by more than 250% over the past 12 months. The company's share price reached a 52-week high of 99 cents in February, before treading lower from profit taking.

On valuation grounds, Noxopharm has a market capitalisation of roughly $201 million, with approximately 288 million shares outstanding.

The post Noxopharm (ASX:NOX) share price edges lower after clinical trial update appeared first on The Motley Fool Australia.

In morning trade, the clinical-stage drug development company's shares are up 3% to 72 cents.

This means the Noxopharm share price now up over 50% since the start of the year.

Why is the Noxopharm share price rising?

Investors have been buying Noxopharm shares following the release of an announcement this morning.

According to the release, headline data from the phase 3 VISION trial was released overnight. This trial looked at the effectiveness of Lu-PSMA-617 as a treatment for late-stage prostate cancer. Lu-PSMA-617 is owned by Novartis.

The release explains that Lu-PSMA-617 could become an important new treatment for late-stage prostate cancer on the basis of Phase 3 clinical trial data released overnight.

Why is this good news for Noxopharm?

This is potentially very good news for Noxopharm because its recent LuPIN trial data shows an even stronger survival outcome when Lu-PSMA-617 is combined with its own Veyonda product.

Noxopharm's CEO and Managing Director, Dr Graham Kelly, said: "This result is positive news for Noxopharm for two reasons."

"The first is that it confirms that Veyonda in combination with Lu-PSMA-617 provides a considerable survival advantage over Lu-PSMA-617 alone. The LuPIN mOS outcome of 19.7 months still remains the best survival outcome of any drug approved for use in men with endstage prostate cancer including enzalutamide, abiraterone, docetaxel, cabazitaxel, and now Lu-PSMA-617."

"The second is that having Lu-PSMA-617 likely to come to market as a 3rd line therapy provides a clear development pathway now for Veyonda to come to market itself, with a distinct opportunity to make the Veyonda/Lu-PSMA-617 combination a new standard of care for endstage prostate cancer," he concluded.

This sentiment was echoed by Noxopharm Chief Medical Officer, Dr Gisela Mautner.

Dr Mautner said: "Noxopharm welcomes this news because it has a major interest in seeing Lu-PSMA-617 come to market and become a standard of care for prostate cancer. The Company believes that the LuPIN study has demonstrated that Veyonda has the ability to enhance the efficacy of Lu-PSMA-617, with a greater survival benefit from the combination than Lu-PSMA-617 alone. This well-tolerated combination therapy should increase the attractiveness of radioligand therapy for men with late-stage prostate cancer even more."

The post Why the Noxopharm (ASX:NOX) share price is charging higher again appeared first on The Motley Fool Australia.

Lets take a closer look at what propelled the Noxopharm share price higher.

Independent trial

Noxopharm shares shot up today on the news that a new independent trial supports the use of Veyonda as a new anti-cancer drug.

The LuPIN trial was in conjunction with Novartis AG (NYSE: NVS)'s Lu-PSMA experimental radiopharmaceutical drug. Novartis is a Swiss pharmaceutical giant with a market capitalisation of $218 billion.

Promisingly, the company advised that the combination of Veyonda and Lu-PSMA delivered a median overall survival outcome of 19.7 months, which inferred a 71% increase in survival outcome over an earlier study known as the WARMTH trial.

Also of note is that the study has helped Noxopharm validate that a higher dosage of the drug is well tolerated for a greater anti-cancer effect.

The LuPIN study will not formally conclude until October 2021 when the final data will be announced. As a result of the positive news announced today, the company also announced the possibility of a larger Phase 2 LuPIN study.

Management comments

Dr Graham Kelly, Noxopharm CEO and managing director, welcomed the news:

This result further supports the Company's belief that Veyonda has the potential to become a standard of care drug to be used in combination with the most common forms of anti-cancer treatments.

He added:

Based on early data from our CEP-1 and DARRT-1 clinical studies, we believe that the unique multiple anti-cancer actions of Veyonda have the potential to produce meaningful survival benefits as a combination treatment across multiple treatment combinations. The striking difference in mOS outcomes between the LuPIN and WARMTH trialsserves to further support that belief.

About the Noxopharm share price

Noxopharm is an Australian clinical stage drug development company focused on the treatment of cancer.

The Noxopharm share price is up an impressive 250% over the last year. Far eclipsing the 24.7% return of the All Ordinaries Index (ASX: XAO).

The post Why the Noxopharm share price rocketed 22% today appeared first on The Motley Fool Australia.

In earlier trade, the company's shares reached an intraday high of 58 cents before retreating to their current level.

Here's what Noxopharm announced and why shares in the company are flying.

What's driving the Noxopharm share price?

The Noxopharm share price is shooting the lights out today after the company provided an update regarding its flagship Veyonda drug candidate.

According to the update, Noxopharm's CEP-2 study will commence shortly. The CEP-2 study will be testing the chemo-enhancing effect of the company's Veyonda drug candidate in conjunction with low doses of chemotherapy.

Following positive outcomes of its CEP-1 study, the new study will see higher dosages of Veyonda used. The CEP-2 study will involve 40 patients with a range of soft tissue sarcomas using Veyonda/doxorubicin as first-line therapy.

In further news boosting the Noxopharm share price, the company noted that the study will help it achieve its ultimate goal of seeing Veyonda used as a standard booster for all major forms of cancer therapy.

The healthcare company also highlighted its strong cash position, after raising $23 million in capital in December 2020. In addition, the company announced it has appointed a contract research company to oversee the study.

More on Noxopharm

Noxopharm is an Australian clinical-stage drug development company focused on its Veyonda drug candidate. Veyonda (formerly known as NOX-66) is a dual-acting cytotoxic and immune-oncology drug candidate designed to enhance the effectiveness of traditional chemotherapy.

Veyonda acts by using the body's immune cells to attack cancer cells that survive initial treatment. According to Noxopharm, Veyonda appears to work across a broad spectrum of cancers. In addition to cancer, Veyonda has also undergone studies for its effectiveness against long-term septic shock symptoms resulting from infections and viruses such as COVID-19. 

The company sees a major commercial opportunity for Veyonda to be used as a booster for all four major forms of cancer therapy. These include chemotherapy, external radiotherapy, internal radiotherapy and checkpoint inhibitor therapy.

Earlier this year, Veyonda was granted approval from the United States Food and Drug Administration (FDA). The Investigational New Drug (IND) approval allows Noxopharm to trial Veyonda in combination with other therapies. Noxopharm received encouraging outcomes from its CEP-1 pilot study earlier this year.

Noxopharm share price snapshot

Over the past year, Noxopharm shares have soared by 228%. Year to date, the company's shares have gained around 15%. Based on the current share price, Noxopharm has a market capitalisation of around $135 million.

The post Here's why the Noxopharm (ASX:NOX) share price is flying 16% today appeared first on The Motley Fool Australia.

At the time of writing, the clinical-stage drug development company's shares are up 6% to 67 cents.

Why is the Noxopharm share price charging higher?

Investors have been buying Noxopharm's shares after it provided an update on its Veyonda product.

According to the release, the company has lodged an international patent application aimed at protecting the use of Veyonda in blocking the development of septic shock associated with infections such as COVID-19 and influenza viruses.

Veyonda is being developed as an anti-cancer drug that enhances the effectiveness of standard anticancer treatments.

The release notes that one of its anti-cancer actions is the blocking of a signalling pathway called STING that serves as trigger for an immune response and repair of damaged tissue. In some individuals, the STING response is inappropriately excessive, pushing the individual over into septic shock. Veyonda appears to be the first drug that blocks STING in the clinic.

With an estimated one person dying globally every 3 seconds from cancer and one every 3 seconds from septic shock, management notes that the commercial opportunity for Veyonda has just doubled. It feels this underlines the commercial importance of the recent patent lodgement.

What about COVID-19?

The company advised that "long COVID" symptoms, such as long-lasting fatigue, breathing problems, headaches, along with severe organ damage and death, are all outcomes associated with septic shock.

Septic shock currently is managed with supportive treatments including drugs and fluids to restore blood pressure, anti-inflammatories such as dexamethasone, and antibiotics/antivirals. However, Noxopharm notes that the key need, that of providing a reduction in cytokine levels in a safe and comprehensive manner, remains largely unmet.

As a result, it sees a significant opportunity for the Veyonda product in this market.

The post Here's why the Noxopharm (ASX:NOX) share price is surging 6% higher appeared first on The Motley Fool Australia.

It can sometimes be useful to take a look at which shares are bucking a sector-wide trend. This can assist in pinpointing which are valuable opportunities and which could be underperformers.

In saying that, let's take a look at 3 ASX healthcare shares that have been sluggish over the past 30 days.

ASX healthcare shares feeling off

Pro Medicus Ltd (ASX: PME)

Shares in the health imaging software provider have now been following a downward trend for nearly a month. Following the announcement of several new contract signings for its software, the company released its 2021 half-year results.

The company's results were reasonable with growth across all metrics. However, the market might be apprehensive to buy at these prices due to the founders selling down their holdings following the release. Both Dr. Sam Hupert and Mr. Anthony Hall sold 1 million shares each. This represented 4% of their respective shareholdings.

The Pro Medicus share price has fallen 6.3% in the last month. Whereas the company's shares have appreciated by 62% in the past 6 months.

Volpara Health Technologies (ASX: VHT)

The Volpara Health share price has been under pressure since February. The New Zealand-based healthcare software provider of breast imaging services has fallen nearly 15% over the last month.

Despite the company's revenue growth and expansion through acquisition, this ASX healthcare share has continued to sell-off. Most recently, Volpara announced the signing of its highest value contract to date. The deal with CRA Health is worth US$400,000 per year in annual recurring revenue (ARR) terms.

It is possible that the market wasn't overly impressed with the announcement considering CRA Health was acquired by Volpara recently. Hence, the payment from CRA is more so internal money shifting.

Noxopharm Ltd (ASX: NOX)

This ASX healthcare share has certainly seen better days. The Noxopharm share price has dropped by 27% in the past month of trading.

The clinical-stage drug development company has been in a state of decline since it reported half-year results. Being in the early stages of drug development, Noxopharm reported a hefty $6.7 million loss on the bottom line for the half.

Unfortunately for Noxopharm, this result was released around the time when investors began being more cognisant of valuations. As a result, it appears not even news of the company's Veyonda drug moving to its final stage of the clinical trial has been able to turnaround the market's sentiment.

On a positive note, the Noxopharm share price has gained 106% in the last 6 months. 

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At the time of writing, the share price is 2.9% higher, trading at 70 cents a share.

Drug trial advances moving the Noxopharm share price

Today's announcement from Noxopharm specified that its Veyonda drug has been approved to move to its final stage of the NOXCOVID-1 clinical trial.

The thumbs up for proceeding to the second and final stage comes after the company completed Part 1. This process involved 26 patients with moderate COVID-19 disease. As a part of the trial, Noxopharm assessed daily Veyonda doses of 400, 600, 800, 1200, and 1800 mg. It has been deemed that the 1,800 mg dosage was the most optimal. The high dosage exhibits evidence of the safety of using the developed drug.

CEO commentary

Noxopharm's CEO, Dr. Graham Kelly commented on the findings:

The high potency of Veyonda in blocking cytokine release from damaged tissue in the laboratory meant we were obliged to adopt a very cautious and methodical approach when being used for the first time in patients with poor lung function. We can now be confident that Veyonda, despite its potency, is well tolerated at a dosage we believe will be therapeutic.

The progression to Part 2 moves it closer to being an effective and safe treatment for septic shock. The company is excited about its potential, as septic shock is not only experienced by COVID-19 patients but is also one of the most common causes of human deaths in the event of infection and severe trauma.

What's next for Noxopharm?

From here, Part 2 of the trial will involve 10 to 15 patients with moderate to severe lung dysfunction.

The recruited patients will then be treated with the selected 1,800 mg dosage of Veyonda each day over 14 days.

Lastly, the company also noted:

Part 1 patient blood (Cohorts 1-4) currently is being analysed for 60 pro-inflammatory (cytokines, chemokines) factors in what the Company believes will be one of the most comprehensive analyses of its kind in COVID-19 disease.

The Noxopharm share price is now up 327% in the last 12 months. In comparison, the S&P/ASX 200 Index (ASX: XJO) is up 9.8% over the same period of time.

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Noxopharm is an Australian clinical-stage drug development company. Its Veyonda drug is being designed to support cancer patients undertaking chemotherapy or radiotherapy treatment.

Noxopharm share price rockets upon survival benefit results

The company announced today that it would present its latest research findings at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium later this week. 

The research pertains to extending the lives of patients who have late-stage prostate cancer. 

Noxopharm's LuPIN study enrolled a total of 56 patients with metastatic castration-resistant prostate cancer. Patients were treated with a combination of Veyonda with ¹⁷⁷Lu-PSMA-617, an experimental radiopharmaceutical.

The goal of the combined (LuPIN) treatment was to slow or block tumour progression so that patients can live a better quality of life, and their survival is extended in a well-tolerated way.

The median overall survival (mOS) for the 56 participants in the LuPIN study was 19.7 months, an increase on the 17.1 months reported 12 months ago.

This survival benefit exceeds that reported for any current standard of care treatment, including one acquired by Pfizer Inc (NYSE: PFE) in 2016 for US$14 billion.

The LuPIN data reinforces Noxpharma's belief that a combination of Veyonda and ¹⁷⁷lutetium-PSMA-617 represents a "long-awaited forward leap" in cancer treatment.

Words from the CEO

Commenting on the company's latest progress, CEO Dr Graham Kelly said:

Today's clinical data continues to cement the view that Veyonda is on track to become a major new immunotherapy oncology drug of medical and commercial significance.

The DARRT program has already suggested this and the LuPIN program now confirms it. All of which augurs well for our upcoming IONIC program. Collectively, these three programs highlight the diversity of use and potential value of Veyonda.

The Noxopharm share price has gained more than 41% year-to-date and is up more than 250% over the past 12 months.

The post Noxopharm (ASX:NOX) share price closes 21% higher after clinical milestone appeared first on The Motley Fool Australia.

At the time of writing, the Noxopharm share price trading up 7.69% at 63 cents.

Let's take a closer look at the clinical stage drug development company and what we learned from today's announcement.

What's lifting the Noxapharm share price today?

Noxopharm told the market today that it received $21.4 million net from the issue of shares during the December quarter. Another $201,000 was gained from shareholders exercising options. This resulted in cash reserves totalling $22.9 million at the end of the quarter.

The company spent a significantly less amount of money on operating activities for the period. Noxopharm reports that net cash used in operating activities during the December quarter amounted to $2.6 million, compared to $3.3 million in the September quarter.

Research and development (R&D) activity costs also dropped down in the December quarter coming in at $1.4 million, compared to $1.6 million for the September quarter.

Looking ahead, Noxopharm expects to receive a cash rebate in excess of $4 million coming from the Federal Government's R&D tax incentive rebate scheme.

More about Noxopharm 

Noxapharm's primary focus is on the development of Veyonda to boost the effectiveness of all 3 current methods of cancer treatment: immune-oncology therapy, radiotherapy and chemotherapy.

The company currently has two major clinical programs under way – the DARRT program and the LuPIN program.

According to Noxopharm, the purpose of the programs is "to establish Veyonda as an essential adjunct to radiotherapy in the treatment of prostate cancer".

The Noxopharm share price skyrocketed 14% earlier this month on news that Veyonda is emerging as a major new treatment based on its ability to support all current methods of cancer treatment.

In addition to the DARRT and LuPIN programs, the company is planning to recruit for a third study, IONIC. Furthermore, Noxopharm's NOXCOVID-1 study has also been progressing.

The post Why the Noxopharm (ASX:NOX) share price is bouncing up today appeared first on The Motley Fool Australia.

At the time of writing, the Noxopharm share price is up 14.13% to 52 cents.

Why is the Noxopharm share price increasing?

Cancer drug update

Noxopharm released a shareholder update to the market this morning pertaining to its drugs in development.

In the update, Noxopharm states that its immunotherapy drug, Veyonda, is emerging as a major new treatment. The company goes on to describe the potential value as 'multi-billion dollar', based on its ability to boost the effectiveness of all 3 current methods of cancer treatment: immune-oncology therapy, radiotherapy, and chemotherapy.

The immunotherapy drug is currently undergoing various testing by IONIC, LuPIN, and DARRT-2 to assess its ability in different applications.

Noxopharm has also advised that its NOXCOVID trial is progressing as planned. The aim of this drug is to block the cytokine release syndrome in COVID-19 patients, preventing deaths and long-term disability. The company foresees the trial to likely expand as COVID-related deaths rise across Europe.

Positioning for commercial transactions

Noxopharm later mentioned that it believes its leading position in restoring immune function to tumours will translate shortly into commercial discussions. Due to this, the company is building an in-house business development capability to meet this opportunity.

Future plans

Noxopharm detailed 2 programs it is focusing on for its drug pipeline for 2021. The first being treatments for pancreatic carcinoma and cholangiocarcinoma. The second being treatments for brain cancers, based on the inhibition of metabotropic glutamate receptor activity.

The company is expected to have identified lead drug candidates and be underway with standard pre-clinical testing programs by mid-2021.  

Lastly, Noxopharm has elaborated on the new subsidiary, Pharmorage Pty Ltd. The purpose of the new entity is to build upon an existing drug that was found to be potentially useful in treating cytokine release syndrome and septic shock. Pharmorage has reportedly initiated a number of drug discovery programs which will be reported on progressively throughout the year.

The Noxopharm share price has gained 102% over the last 12 months.

The post Why the Noxopharm (ASX:NOX) share price is jumping 14% higher today appeared first on The Motley Fool Australia.

At one stage today the clinical-stage drug development company's shares were up as much as 8% to 54 cents.

The Noxopharm share price has since pulled back a touch but is still up 2% to 51 cents at the time of writing.

Why did the Noxopharm share price surge higher?

Investors were buying Noxopharm shares today after it announced that it has joined a pilot study (IONIC-1) to explore the ability of Veyonda to boost the effectiveness of Bristol Myers Squibb's nivolumab (Opdivo) for the treatment of cancer.

Veyonda is a second-generation immuno-oncology drug candidate based on selective inhibition in cancer cells of the pro-survival secondary messenger, sphingosine-1-phosphate (S1P).

The company notes that the body uses a gradient of S1P levels (high to low) to move immune cells between blood and tissues. Cancers express high levels of S1P, reversing that gradient and thereby expelling immune cells from tumours.

By inhibiting S1P in tumours, Veyonda is designed to restore a normal gradient, thereby allowing immune cells to repopulate tumours in a so-called COLD to HOT conversion.

What is IONIC-1?

Immune checkpoint inhibitors such as nivolumab have revolutionised the treatment of some cancers with what can be dramatic life-saving benefits. However, management notes that some patients have inherent resistance to immune checkpoint inhibitors.

The IONIC-1 study will investigate whether Veyonda is able to overcome this resistance in patients with cancers such as breast, ovarian, prostate, and sarcoma cancers.

Principal Investigator and eminent oncologist, Professor De Souza, commented: "I'm excited to be working with Noxopharm and Bristol Myers Squibb on this study. Checkpoint inhibitors have made a tremendous difference to some patients with advanced cancer and if we can increase the number of patients that respond through the addition of Veyonda to their treatment regimen, we will make a significant impact, not only to those individuals, but also on the oncology landscape."

The checkpoint inhibitor market, encompassing PD-1, PD-L1 and CTLA-4 inhibitors, is a multi-billion-dollar market which is experiencing rapid year on year growth. It is currently dominated by two major global pharmaceutical companies, one of which is Bristol Myers Squibb.

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