Bone Medical ties up BN006 research collaboration

THE ROADHOUSE PHARMACY: Bone Medical Ltd (ASX: BNE) has entered into a research agreement with William Harvey Research Limited (WHRL), to further study the company’s anti-inflammatory molecule for rheumatoid arthritis (RA), BN006, and support its progress towards clinical studies in man.

WHRL is part of the William Harvey Research Institute in London and a world leading independent centre for pharmacological research.

Bone Medical chief scientific officer Dr Roger New explained that in previous experiments BN006 has demonstrated efficacy in an RA disease model that was similar to the current market-leading product but with reduced inhibition of an important immune system marker.

“This could represent the profile of a breakthrough new medicine for RA with potentially less risk of the immunosuppressive side effects that limit current treatments–and given orally rather than by injection,” New said in the company’s announcement to the Australian Securities Exchange.

New comments were supported by world-renowned expert in physio-pharmacology and inflammation professor Rod Flower, who is overseeing the collaboration.

Flower noted that despite treatment advances for inflammatory and auto-immune diseases like RA, a need existed for more selective new products that have less suppressive effects on the normal functioning of the immune system.

“Understanding the mechanism of action of BN006 may point the way to an entirely new class of therapeutic agent for this category of disease,” professor Flower said.

The collaboration is being funded by funds raised under Bone Medical’s recently completed recapitalisation.

The company said the results will potentially position BN006 for Phase 1 human trials in the near future.

Bone Medical noted the top three products for auto-immune diseases like RA turned over US$25billion in 2012.

Website: www.bone-ltd.com

Imugene allowed Israel patent for cancer vaccine

THE PHARMACY: Australian biopharmaceutical company Imugene Limited (ASX: IMU) has been issued an Intention to Grant notice from the Israeli Patent Office for the company’s proprietary cancer vaccine HER-Vaxx (Patent no. IL 194162, 2027expiry).

In its announcement to the ASX Imugene explained HER-Vaxx to be a proprietary therapeutic cancer vaccine that stimulates a polyclonal antibody response to HER-2/neu, the same biomarker targeted by the $US6.9 billion per annum drug Herceptin®.

Imugene said HER-Vaxx has successfully completed a Phase 1 study in breast cancer and the next stage of development will be a Phase 2 study in gastric cancer.

Gastric or stomach cancer is the second most common cause of cancer-related death in the world and the fourth most commonly diagnosed cancer, with over 1 million new cases diagnosed each year.

Website: www.imugene.com

Patrys advances PAT-LM1 to clinical development

THE PHARMACY: Clinical stage biotechnology company Patrys Limited (ASX: PAB) has released an update on the development program for the company’s anti-cancer product, PAT-LM1.

Patrys said PAT-LM1 is the second IgM antibody in the company’s pipeline to enter clinical development.

The company explained PAT-LM1 is a natural human antibody that has shown much promise in preclinical development as a potential treatment for multiple types of cancer, including colon, lung, breast, ovary, pancreatic and various haematological cancers.

Recent laboratory experiments focused on the evaluation of the efficacy of PAT-LM1 in blood cancers including different types of leukaemias and lymphomas.

PAT-LM1 showed strong and specific binding to more than 90 per cent of tested lymphoma cell lines and patients samples.

Patrys said PAT-LM1 was able to induce cell death in mantle cell lymphoma and histiocytic lymphoma cells as well as bonding specifically and strongly to some very rare lymphoma types such as marginal zone B-cell and Burkitt lymphoma, indicating it may have broad therapeutic application covering the whole range of different lymphomas.

Despite there being numerous drugs on the market for lymphoma, Patrys said there is an unmet medical need especially in patients with relapsed and refractory disease.

The prognosis for these patients is poor and therefore the development of novel agents, such as PAT-LM1, is urgently needed.

The cell line development of PAT-LM1 for production has been successfully completed and early data indicate that the resultant yield from a GMP manufacturing run is likely to be much higher than yields achieved to date.

Patrys has now commenced the manufacturing process to produce PAT-LM1 for a future clinical trial.

“The results demonstrated in this preclinical work confirm the potential of PAT-LM1 as an effective therapy for a broad range of lymphomas,” Patrys Limited CEO Dr. Marie Roskrow said in the company’s announcement to the Australian Securities Exchange.

“Currently we anticipate that this antibody will be moved into clinical trial at the University of Würzburg where we will be working with the same clinicians who successfully executed the recent PAT-SM6 multiple myeloma trial.

“Professor Einsele and his team are very excited by the prospects for PAT-LM1 in treating patients with relapsed and refractory lymphomas.”

Email: info@patrys.com

Website: www.patrys.com

Source: Company announcement

Bionomics receives BNC105 Phase II trial results

THE PHARMACY: Bionomics Limited (ASX: BNO) has announced the results of
the DISRUPTOR-1 trial of BNC105 in patients with metastatic renal
cancer.

“The DISRUPTOR-1 trial has been the first of its kind in testing the
combination of an mTOR inhibitor with a vascular disrupting agent in
renal cancer, with the prospect of adding a new dimension to the renal
cancer treatment armamentarium,” Bionomics CEO and managing director Dr
Deborah Rathjen said in the company’s announcement to the Australian
Securities Exchange.
 
“Significant progress has been made in validating BNC105 as an anti-cancer agent.

“Through patient subgroup analysis and association of biomarkers to
treatment benefit, the data from this trial shows us the best way
forward to maximising the utility of BNC105 for renal cancer patients,
as well as how to best employ the drug in other cancer types.”

Bionomics conducted this randomised Phase II clinical trial in patients
with metastatic renal cell cancer with 139 patients enrolled at sites
across the US, Singapore and Australia.

The trial design targeted patients who had previously failed up to two
tyrosine kinase inhibitor therapies, randomising them to either of two
treatment arms: one receiving the standard of care renal cancer drug
Afinitor and the other receiving both Afinitor and BNC105.

Patients who were progressing or who were intolerant to Afinitor
monotherapy, were allowed to receive BNC105 single agent treatment.

Patients were treated until disease progression or until adverse effects prohibited further therapy.

Data from a total of 136 patients (69 in the BNC105 + Afinitor arm and
67 in the Afinitor-only arm) treated in this study were able to be
analysed.

The combination of BNC105 and Afinitor was safe and tolerable.

The adverse event profile of the combination arm did not significantly
differ from that of the Afinitor-only arm, and mirrored the known and
expected toxicities of Afinitor.

“DISRUPTOR-1 has produced a ground-breaking discovery of potential
biomarkers that may allow pre-treatment selection of patients most
likely to benefit from BNC105,” Dr Rathjen said.

“We are exploring partnership opportunities for BNC105 and expect to
attract a depth of interest given the compelling data generated from
this trial and the recent ovarian cancer trial data.”

Antisense Therapeutics commences stem Cell mobilisation trial

THE PHARMACY: Antisense Therapeutics (ASX: ANP) has commenced dosing in
its Phase I Stem Cell Mobilisation (SCM) Human Proof of Concept trial of
ATL1102, the company’s second generation antisense drug targeting the
VLA-4 receptor.

Antisense said the trial will assess the safety, tolerability and effect
of ATL1102 on the release of hematopoietic stem cells (CD34+) into the
blood when dosed alone and in combination with an existing therapy
(Granulocyte Colony Stimulating Factor (G-CSF)).

The randomised, open label study of ATL1102 dosed over 5 days (given on
day 1, 3 and 5) in 10 healthy volunteers is being conducted by clinical
research organisation, Nucleus Network at its clinical trial unit at the
Alfred Hospital in Melbourne, Victoria.

With the necessary screening, dosing and follow up of patients,
Antisense anticipates results from the trial will be available to be
reported mid-2014.

“The stem cell mobilisation opportunity for ATL1102 while commercially
attractive with, by our estimation, a market potential of several
hundred million dollars per annum, also presents as an excellent return
on investment proposition given costs are expected to be relatively low
for developing the drug in this indication,” Antisense Therapeutics CEO
and managing director Mark Diamond said in the company’s announcement to
the Australian Securities Exchange.

“We believe that positive outcomes from this trial will strongly enhance
our drug’s potential for this application and naturally we relish the
opportunity to further develop a drug that can potentially provide
better outcomes for cancer patients.

“We look forward to successfully conducting the study and to reporting
results from this SCM trial which are anticipated mid-year.”

Antisense explained the mobilisation (release) of these stem cells from
the bone marrow into the blood is part of an important medical procedure
used to improve outcomes for patients undergoing chemotherapy to treat
certain cancers.

The stem cells released into the blood are then collected and stored
before high dose chemotherapy and then re-infused to replace those lost
during chemotherapy in order to re-establish the immune system.

The basis for using ATL1102 in the SCM indication is related to the role
of VLA-4 in regulating the release of CD34+ stem cells from the bone
marrow, with another drug that also targets VLA-4 having been shown to
increase CD34+ stem cell release in humans.

The company said in a previous study involving Multiple Sclerosis
patients, ATL1102 demonstrated similar activity to that drug by
increasing CD34+ levels in the blood.

“This human Phase I trial of ATL1102 is designed to evaluate whether
ATL1102 can improve mobilisation of CD34+ stem cells when used in
combination with standard mobilisation therapy to levels that would make
it clinically beneficial for use in the collection of stem cells for
transplantation,” Nucleus Network medical director and principal
investigator for the trial Dr Jason Lickliter said in Antisense’s ASX
announcement.

“There is an acknowledged clinical need for increasing mobilisation
levels beyond those achieved by the current therapeutic approach, and so
I am very pleased to be working with Antisense Therapeutics to assess
the merits of ATL1102 in this important clinical setting.”

Website: www.antisense.com.au

Viralytics announces International Institutional ownership

THE PHARMACY: Viralytics Limited (ASX: VLA) has completed a $27.1
million equity offering that included a number of new institutional
investors who specialize in healthcare.

The offering was finalised after approval by shareholders at the company’s general meeting on 6 March 2014.

The major participants in the placement were United States-based
Cormorant Asset Management, which now holds an 8.9 per cent stake in
Viralytics;

BVF Partners L.P., also located in the United States (6.7 per cent);

Abingworth, headquartered in the United Kingdom (6.1 per cent);

Sabby Capital, headquartered in the United States (5.8 per cent); and

Hunter Hall, located in Australia (4.9 per cent).

The capital raised will fully fund the company through 2016, including its expanding clinical trial program.

Viralytics currently has a Phase 2 study and a Phase 1/2 trial ongoing
with an additional randomised Phase 2 melanoma clinical trial in the
planning stage.

The studies are evaluating the company’s lead product CAVATAK™ in
late-stage cancer patients and will provide important data to guide its
further development.

Website: www.viralytics.com

 

Unilife Secures $60M debt financing

THE ROADHOUSE PHARMACIST: Unilife Corporation (ASX: UNS) has entered
into a $60 million debt financing agreement with an affiliate of
healthcare sector investment firm OrbiMed.

Unilife said $40 million was funded to Unilife at the closing of the
deal. Under the terms of the agreement, provided Unilife is in
compliance, two additional tranches of $10 million each will be provided
to the company in December 2014 and June 2015.

“OrbiMed is one of the premier healthcare investors in the world,”
Unilife chairman and CEO Alan Shortall said in the company’s
announcement to the Australian Securities Exchange.

“With OrbiMed and their independent advisors having conducted extensive
due diligence into all aspects of our business, including our products,
IP and commercial pipeline, we believe this agreement represents a
significant endorsement of Unilife.

“In particular, I believe OrbiMed’s decision to accept a small share of
our future net sales highlights their confidence in our business model
and future growth.

“This $60 million commitment provides us with the necessary capital to
drive business growth as we bring several large contracts with existing
customers through to commercial rollout.

“Our decision to take only $40 million of the $60 million upfront will
ensure we have the cash to support our operations while minimizing
interest payments.

“I believe Unilife’s growing base of customers will view our long-term
partnership with OrbiMed as a positive development, as it further
strengthens our business position and capacity to meet their future
needs.”

During the six year term of the agreement, Unilife will make
interest-only payments to OrbiMed currently calculated at a rate of
10.25 per cent per annum, with the principal to be repaid by 12 March
2020.
 
OrbiMed will also receive a tiered royalty payment based on net sales
generated by Unilife during each fiscal year of the agreement. The
maximum royalty rate is 2.75 per cent of annual net sales.

The royalty rate decreases as annual net sales increases. Total
royalties paid to OrbiMed under the agreement are capped as Unilife has
the option to buy out the royalty payment, which is at a reduced amount
at any time on or before the fourth anniversary of the agreement.

This Week in The Pharmacy

THE PHARMACY: There’s a great deal of interest in the Bio-tech sector at the moment, so we have opened our own Pharmacy to keep our readers up to speed.

 

OncoSil Medical commences Pivotal Clinical Trial

OncoSil Medical (ASX: OSL) has commenced its Pivotal Clinical Trial for its OncoSil™ localised radiation therapy for the treatment of pancreatic cancer. READ MORE…

Bionomics receives BNC105 Phase II trial results

Bionomics Limited (ASX: BNO) has announced the results of the DISRUPTOR-1 trial of BNC105 in patients with metastatic renal cancer. READ MORE…


Antisense Therapeutics commences stem Cell mobilisation trial

Antisense Therapeutics (ASX: ANP) has commenced dosing in its Phase I Stem Cell Mobilisation (SCM) Human Proof of Concept trial of ATL1102, the company’s second generation antisense drug targeting the VLA-4 receptor. READ MORE…

Viralytics announces International Institutional ownership

Viralytics Limited (ASX: VLA) has completed a $27.1 million equity offering that included a number of new institutional investors who specialize in healthcare. READ MORE…

Unilife Secures $60M debt financing

Unilife Corporation (ASX: UNS) has entered into a $60 million debt financing agreement with an affiliate of healthcare sector investment firm OrbiMed. READ MORE…


VivaGel®‐coated condom approved for marketing in Japan.

Starpharma (ASX: SPL) has been granted regulatory certification for marketing of the company’s VivaGel®‐coated condom in Japan. READ MORE…

VivaGel®-coated condom approved for marketing in Japan.

THE ROADHOUSE PHARMACIST: Starpharma (ASX: SPL) has been granted
regulatory certification for marketing of the company’s VivaGel®‐coated
condom in Japan.

Starphama explained VivaGel® is licensed to Okamoto Industries as a condom coating for the Japanese market.

Japan is the world’s second largest condom market and Okamoto is the
market leader for condoms sold in the country with an approximate 60 per
cent share of the Japanese market.

Under Starpharma’s commercial licence agreement with Okamoto, Okamoto
has exclusive Japanese marketing rights for the VivaGel®‐coated condom.

VivaGel®‐coated condoms sold in Japan are to carry the VivaGel® brand
and Starpharma will receive royalties based on sales of these condoms.

“This receipt of the world’s first marketing approval for a
VivaGel®‐coated condom in Japan marks a major milestone for this product
and for our strategically important partnership with Okamoto,”
Starpharma chief executive officer Dr Jackie Fairley said in the
company’s announcement to the Australian Securities Exchange.

“We greatly appreciate Okamoto’s support and assistance in achieving
this certification and we look forward to a long and mutually profitable
commercial relationship.

“Following this certification Starpharma looks forward to the
introduction of its innovative, patented VivaGel®‐coated condom to this
key market in partnership with Okamoto, one of the world’s leading
condom companies,”

Starpharma said the value of the Japanese condom market has been estimated to be in the order of US$500 million.

In addition to its dominant position in the Japanese condom market,
Okamoto also holds strong market positions in several other Asian
markets, including Korea, Taiwan, Malaysia, Singapore and China.

Earlier this year Okamoto’s senior managing director Seiji Takeuchi said
condoms with functional coatings and gels represent the next wave of
innovation in the Japanese condom market following on from a
decades‐long focus on condom thinness.

“We are very pleased to be in a partnership with Starpharma for this product,” Takeuchi said.

Raising funds across the Boards

THE FUND RAISER: There’s been some happy explorers boosting their coffers this week.

Placement and Entitlement Offer to raise $18.2 million

Phoenix Gold (ASX: PXG) signalled its intention to raise new equity of up to $18.2 million (before costs) via an institutional placement of approximately 60 million shares to raise up to approximately $7.8 million and a 1 for 3 pro-rata non-renounceable entitlement offer to raise up to approximately $10.4 million.

The combined proceeds of the Offer will be used to fund the staged mine development plan, continue lateral and depth extensions at Castle Hill and Broads Dam projects and to provide working capital and pay for offer costs.

In the event the company does not receive any monies from the Entitlement Offer, the staged mine development will still be commenced using the funds raised from the Placement and the company’s cash on hand.

LionGold increases stake in Unity

Unity Mining (ASX: UML) announced the company’s major shareholder, LionGold has entered into a binding subscription agreement to acquire additional shares by way of a share placement to increase its stake to 19.9 per cent.

In February 2014 LionGold committed to sub-underwrite Unity’s Share Purchase Plan (SPP) in line with its then current holding of 13.2 per cent.

Unity agreed to allow LionGold an opportunity to increase its interest in the company up to a maximum of 19.9 per cent via a subsequent placement.

Under the terms of the subscription agreement, LionGold will now acquire an additional 87.8 million shares via this placement at the same price as set for shares offered under the SPP at 2.7 cents per share, for a total consideration of $2.37 million.

“We welcome this further commitment from LionGold, which builds on its recent agreement to escrow for 12 months its current 92.3 million shares in Unity,” Unity Mining managing director Andrew McIlwain said.

“LionGold has continued to demonstrate its confidence in Unity and is distinguishing itself as a partner of choice in the Australian junior gold space.”

$5.3m to drive Browns Range HRE project

Northern Minerals (ASX: NTU) is looking to raise $5.3 million through a Placement to sophisticated investors at 18 cents per share for its Browns Range heavy rare earth (HRE) project in northern Western Australia.

The funding initiative will include a Share Placement which has been supported by NTU’s major shareholder Australia Conglin International Investment Group (ACIIG).

“This funding increases the certainty and flexibility for Northern Minerals as we take Browns Range through the current feasibility studies towards production,” Northern Minerals managing director George Bauk said.

“We are pleased to have the ongoing support from our major shareholder ACIIG, which has reinforced its long term commitment to the project and development strategy.

The funding will be directed to a number of work programs as part of the feasibility study, as well as for general working capital.

As at 17 March 2014 the company had a cash position of $6.5 million, with the additional $5.3 million allowing the company to maintain momentum along its pathway to production.

The proposed sale of NTU’s Gardiner-Tanami gold assets to ACIIG for $2 million will now no longer proceed.

The gold asset sale was proposed as part of a funding package announced in February 2013, to raise a total of $58 million, with the backing of ACIIG.

During 2013, the company successfully raised $30 million through that funding initiative.

The proposed $26 million acquisition of a 16 per cent stake in the Browns Range HRE project by ACIIG (as announced in 2013) remains under consideration and subject to Northern Minerals Board and shareholder approval.

$1.7M Raising to advance Swedish graphite-graphene projects

Talga Resources (ASX: TLG) has received commitments to raise up to $1.7 million (before costs) via a placement.

The offer of 20 million ordinary shares has been made to sophisticated investors at an offer price of 8.5 cents per ordinary share.

Proceeds of the Placement are intended to be applied to graphite and graphene metallurgy, upscaling tests, economic studies, exploration and working capital.

“The proceeds will ensure the momentum already evident early in 2014 continues as we are now at the exciting stage of upscaling tests on graphene produced from our supergrade Nunasvaara deposit, as well as further metallurgical testwork on both the Nunasvaara and Raitajärvi graphite projects, both in Sweden,” Talga Resources managing director Mark Thompson said.

“We look forward to using the results to complete the preliminary economic study underway on Nunasvaara with a dual graphite-graphene focus.”

$4 million to advance Balama North

Triton Minerals (ASX: TON) has raised $4 million through a placement of shares to key sophisticated and institutional investors in Australia and internationally.

Funds raised from the Placement will be used to fund the first phase of the drilling and exploration program on the company’s graphite Balama North project in Mozambique.

A total of $4m was raised through the Placement, which will consist of the issue of just over 36.3 million shares at 11 cents per share.

Triton is now fully-funded to progress the first phase of the drilling program, exploration activities and studies at its Balama North graphite project in Mozambique.

As a result of the recent announcement about the substantial expansion in the exploration potential of the Balama North project, the RC and Diamond drilling programs have also been extended to drill test these new areas.

The exploration program will consist of completing the first phase of the exploration drilling, moving into potential resource definition drilling and modelling at the Nicanda Hill prospect.