On April 20, 2021 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, reported financial results for the full year ended December 31, 2020, as well as recent clinical progress (Press release, Akari Therapeutics, APR 20, 2021, View Source [SID1234578285]).

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"2020 saw us successfully complete a Phase II study in BP and align with the FDA and the European Medicines Agency (EMA) on a regulatory pathway to initiate a Phase III pivotal study in BP. In addition, we have initiated a Phase III study in HSCT-TMA. We have also seen further positive data support development of our back of the eye and surface of the eye programs," said Clive Richardson, Chief Executive Officer of Akari Therapeutics. "In 2021, we look forward to progressing our Phase III studies and advancing development of our ophthalmology, lung and trauma programs as we continue to leverage nomacopan’s unique bifunctional action as a dual highly specific inhibitor of LTB4 and complement C5."

Full Year 2020 and Recent Clinical Highlights

Akari’s two lead programs – in BP and HSCT-TMA – are in Phase III development. The Company also has early-stage programs addressing ophthalmology, pulmonary diseases and trauma.

PHASE III TRIALS

Phase III clinical trial in patients with BP

Initiation of a multicenter Phase III study of nomacopan for the treatment of BP with nomacopan following opening of FDA IND. Clinical sites expected to open for recruitment mid-2021.
The FDA and EMA have granted orphan drug designation for nomacopan for the treatment of BP.
Phase III clinical trial in pediatric patients with HSCT-TMA

Phase III study in pediatric HSCT-TMA is now open for enrollment at sites in the U.S. and Europe, subject to the ongoing impact of COVID-19 related restrictions.
Akari has FDA fast track and orphan drug designations for pediatric HSCT-TMA patients.
PNH – long term data

Long-term data from 19 PNH patients treated for over 30 cumulative patient-years showed that self-administered nomacopan:
Is well-tolerated with no reported major adverse vascular events and only a single reported serious adverse event (urinary tract infection) in one patient that was considered possibly related to nomacopan.
Induces transfusion independence (defined as at least six months without transfusion) in 79% (n = 14) PNH patients treated with nomacopan for at least six months, who were transfusion dependent prior to treatment. This compares favorably to the treatment of PNH patients on long-term eculizumab therapy where between 50-60% of transfusion dependent patients become transfusion independent in a 12-month period (Brodsky et al., 2008, SHEPHERD study on eculizumab, Hillmen et al 2013) and supports ongoing studies in other hematological diseases where the role of complement is implicated, such as HSCT-TMA.
EARLY-STAGE PROGRAMS

Ophthalmology program

Interim data from a first-in-eye Phase I/II study in atopic keratoconjunctivitis (AKC), a surface of the eye inflammatory disease, showed nomacopan was comfortable and well tolerated. Akari has opened an IND and is looking to expand its program in the surface of the eye.
Recently presented data points to the potential role of nomacopan as a treatment for AMD. This includes recent articles in the journal CELLS and the American Journal of Pathology, which highlights the causative role LTB4 plays in the induction of vascular endothelial growth factor (VEGF) and associated retinal inflammation. Taken together the data supports a potential therapeutic role for long acting PAS-nomacopan, inhibiting both complement and VEGF in sight threatening retinal diseases.
In a model of choroidal neo-vascularization, PAS-nomacopan injected once during the 16-day treatment period was equivalent to Eyelea in reducing neo-vascularization. Work is ongoing to explore the likely human injection frequency for intravitreal (IVT) administration of PAS-nomacopan.
Given the specialist nature of the ophthalmology market, Akari is exploring opportunities to collaborate with potential partners to accelerate the development of these ophthalmology programs.
Lung program

In the UK, recruitment into the COVID-19 observational study is complete and a publication is in preparation. Initial data has identified elevated levels of LTB4 in COVID patients. In addition, other early disease biomarkers have been analyzed, which may allow for the potential to optimize patient selection for treatment with nomacopan.
In the U.S., the FDA has approved a randomized multi-center study in patients hospitalized with COVID-19 pneumonia with a new increased dosing schedule, following experience in Brazil. The clinical study in Brazil, as previously reported has been paused and may potentially now align with the new U.S. program.
Akari is exploring opportunities to expand its lung program to include other inflammatory diseases with exacerbations, limited treatment options and where both complement and leukotriene pathways are implicated. In this context an investigator led severe asthma study is being considered in the U.S.
Trauma

In March 2021, Akari announced CRADA with the USAISR, working to evaluate the potential for use of nomacopan in battlefield trauma. This follows positive pre-clinical data with nomacopan in a range of pre-clinical models.
Trauma is a global burden disease. In the U.S., there are approximately 500,000 trauma hospital discharges a year which are defined as severe and might benefit from early drug intervention to reduce multi-organ dysfunction following trauma. Akari is actively exploring other opportunities in trauma in the civilian population.
New histamine inhibition development program

Akari added to its pipeline a novel tick derived histamine inhibitor ‘votucalis’, which has a similar structure to nomacopan. Votucalis uniquely prevents activation of all four histamine G-protein coupled receptors creating new therapeutic opportunities in pain management. As such, votucalis potentially provides the opportunity to expand the Company’s existing dermatology franchise with other modes of administration (local topical delivery) and into other diseases such as atopic dermatitis.
The histamine program is supported by positive pre-clinical data in neuropathic pain and itch models.
Full Year 2020 Financial Results

As of December 31, 2020, the Company had cash of approximately $14.1 million, compared to cash of $5.7 million as of December 31, 2019.
In June 2020, Akari entered into a securities purchase agreement (Purchase Agreement) with Aspire Capital Fund, LLC (Aspire Capital) whereby Aspire Capital is committed to purchase up to an aggregate of $30 million of the Company’s ADSs. During the year ended December 31, 2020, the Company sold to Aspire Capital a total of approximately $6.0 million of ordinary shares. As of April 15, 2021, approximately $24.0 million of the original purchase commitment remains available for draw down under the Purchase Agreement.
Research and development (R&D) expenses for full year 2020 were approximately $8.8 million, as compared to approximately $8.7 million in 2019.
General and administrative (G&A) expenses for the full year 2020 were approximately $9.2 million, as compared to approximately $8.2 million in 2019. The increase was primarily due to a one-time non-cash financing expense related to the 2020 Purchase Agreement with Aspire Capital.
For the full year 2020, total other income was approximately $899,000 as compared to approximately $117,000 in 2019. This change was primarily due to higher income related to the change in the fair value of warrant liabilities in 2020 than in 2019, and foreign exchange gains in 2020 as compared to foreign exchange losses in 2019.
Net loss for full year 2020 was approximately $17.1 million, as compared to approximately $16.8 million for the prior year. The slight decrease in net income was primarily due to the aforementioned one-time non-cash financing expense related to the 2020 Purchase Agreement with Aspire Capital.
As part of the 2020 audit, the Company discovered an error in its accounting treatment of certain options (RPC options) from 2015 that should have been accounted for as an equity instrument as opposed to a liability. Accordingly, the Company concluded that the financial statements contained in the Company’s Annual Reports on Form 20-F for the years ended December 31, 2015 through 2019, as well as the interim condensed consolidated financial statements contained in the quarterly reports on Form 6-K for each quarter within these years, as well as the quarterly periods ended March 31, 2020, June 2020 and September 2020, should be restated and therefore not relied upon. This is a non cash re-statement and the RPC options do not constitute a legal liability to the Company and will not affect the Company’s financial statements upon settlement. The Company has included restated financial statements and notes thereto and any other appropriate revisions in its Annual Report on Form 20-F for the year ended December 31, 2020 and for more information please refer to Note 3 of our Annual Report on Form 20-F for the year ended December 31, 2020.
A copy of the Company’s Annual Report on Form 20-F for the year ended December 31, 2020 has been filed with the Securities and Exchange Commission and posted on the Company’s website at View Source

On April 20, 2021 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, reported financial results for the full year ended December 31, 2020, as well as recent clinical progress (Press release, Akari Therapeutics, APR 20, 2021, View Source [SID1234578285]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"2020 saw us successfully complete a Phase II study in BP and align with the FDA and the European Medicines Agency (EMA) on a regulatory pathway to initiate a Phase III pivotal study in BP. In addition, we have initiated a Phase III study in HSCT-TMA. We have also seen further positive data support development of our back of the eye and surface of the eye programs," said Clive Richardson, Chief Executive Officer of Akari Therapeutics. "In 2021, we look forward to progressing our Phase III studies and advancing development of our ophthalmology, lung and trauma programs as we continue to leverage nomacopan’s unique bifunctional action as a dual highly specific inhibitor of LTB4 and complement C5."

Full Year 2020 and Recent Clinical Highlights

Akari’s two lead programs – in BP and HSCT-TMA – are in Phase III development. The Company also has early-stage programs addressing ophthalmology, pulmonary diseases and trauma.

PHASE III TRIALS

Phase III clinical trial in patients with BP

Initiation of a multicenter Phase III study of nomacopan for the treatment of BP with nomacopan following opening of FDA IND. Clinical sites expected to open for recruitment mid-2021.
The FDA and EMA have granted orphan drug designation for nomacopan for the treatment of BP.
Phase III clinical trial in pediatric patients with HSCT-TMA

Phase III study in pediatric HSCT-TMA is now open for enrollment at sites in the U.S. and Europe, subject to the ongoing impact of COVID-19 related restrictions.
Akari has FDA fast track and orphan drug designations for pediatric HSCT-TMA patients.
PNH – long term data

Long-term data from 19 PNH patients treated for over 30 cumulative patient-years showed that self-administered nomacopan:
Is well-tolerated with no reported major adverse vascular events and only a single reported serious adverse event (urinary tract infection) in one patient that was considered possibly related to nomacopan.
Induces transfusion independence (defined as at least six months without transfusion) in 79% (n = 14) PNH patients treated with nomacopan for at least six months, who were transfusion dependent prior to treatment. This compares favorably to the treatment of PNH patients on long-term eculizumab therapy where between 50-60% of transfusion dependent patients become transfusion independent in a 12-month period (Brodsky et al., 2008, SHEPHERD study on eculizumab, Hillmen et al 2013) and supports ongoing studies in other hematological diseases where the role of complement is implicated, such as HSCT-TMA.
EARLY-STAGE PROGRAMS

Ophthalmology program

Interim data from a first-in-eye Phase I/II study in atopic keratoconjunctivitis (AKC), a surface of the eye inflammatory disease, showed nomacopan was comfortable and well tolerated. Akari has opened an IND and is looking to expand its program in the surface of the eye.
Recently presented data points to the potential role of nomacopan as a treatment for AMD. This includes recent articles in the journal CELLS and the American Journal of Pathology, which highlights the causative role LTB4 plays in the induction of vascular endothelial growth factor (VEGF) and associated retinal inflammation. Taken together the data supports a potential therapeutic role for long acting PAS-nomacopan, inhibiting both complement and VEGF in sight threatening retinal diseases.
In a model of choroidal neo-vascularization, PAS-nomacopan injected once during the 16-day treatment period was equivalent to Eyelea in reducing neo-vascularization. Work is ongoing to explore the likely human injection frequency for intravitreal (IVT) administration of PAS-nomacopan.
Given the specialist nature of the ophthalmology market, Akari is exploring opportunities to collaborate with potential partners to accelerate the development of these ophthalmology programs.
Lung program

In the UK, recruitment into the COVID-19 observational study is complete and a publication is in preparation. Initial data has identified elevated levels of LTB4 in COVID patients. In addition, other early disease biomarkers have been analyzed, which may allow for the potential to optimize patient selection for treatment with nomacopan.
In the U.S., the FDA has approved a randomized multi-center study in patients hospitalized with COVID-19 pneumonia with a new increased dosing schedule, following experience in Brazil. The clinical study in Brazil, as previously reported has been paused and may potentially now align with the new U.S. program.
Akari is exploring opportunities to expand its lung program to include other inflammatory diseases with exacerbations, limited treatment options and where both complement and leukotriene pathways are implicated. In this context an investigator led severe asthma study is being considered in the U.S.
Trauma

In March 2021, Akari announced CRADA with the USAISR, working to evaluate the potential for use of nomacopan in battlefield trauma. This follows positive pre-clinical data with nomacopan in a range of pre-clinical models.
Trauma is a global burden disease. In the U.S., there are approximately 500,000 trauma hospital discharges a year which are defined as severe and might benefit from early drug intervention to reduce multi-organ dysfunction following trauma. Akari is actively exploring other opportunities in trauma in the civilian population.
New histamine inhibition development program

Akari added to its pipeline a novel tick derived histamine inhibitor ‘votucalis’, which has a similar structure to nomacopan. Votucalis uniquely prevents activation of all four histamine G-protein coupled receptors creating new therapeutic opportunities in pain management. As such, votucalis potentially provides the opportunity to expand the Company’s existing dermatology franchise with other modes of administration (local topical delivery) and into other diseases such as atopic dermatitis.
The histamine program is supported by positive pre-clinical data in neuropathic pain and itch models.
Full Year 2020 Financial Results

As of December 31, 2020, the Company had cash of approximately $14.1 million, compared to cash of $5.7 million as of December 31, 2019.
In June 2020, Akari entered into a securities purchase agreement (Purchase Agreement) with Aspire Capital Fund, LLC (Aspire Capital) whereby Aspire Capital is committed to purchase up to an aggregate of $30 million of the Company’s ADSs. During the year ended December 31, 2020, the Company sold to Aspire Capital a total of approximately $6.0 million of ordinary shares. As of April 15, 2021, approximately $24.0 million of the original purchase commitment remains available for draw down under the Purchase Agreement.
Research and development (R&D) expenses for full year 2020 were approximately $8.8 million, as compared to approximately $8.7 million in 2019.
General and administrative (G&A) expenses for the full year 2020 were approximately $9.2 million, as compared to approximately $8.2 million in 2019. The increase was primarily due to a one-time non-cash financing expense related to the 2020 Purchase Agreement with Aspire Capital.
For the full year 2020, total other income was approximately $899,000 as compared to approximately $117,000 in 2019. This change was primarily due to higher income related to the change in the fair value of warrant liabilities in 2020 than in 2019, and foreign exchange gains in 2020 as compared to foreign exchange losses in 2019.
Net loss for full year 2020 was approximately $17.1 million, as compared to approximately $16.8 million for the prior year. The slight decrease in net income was primarily due to the aforementioned one-time non-cash financing expense related to the 2020 Purchase Agreement with Aspire Capital.
As part of the 2020 audit, the Company discovered an error in its accounting treatment of certain options (RPC options) from 2015 that should have been accounted for as an equity instrument as opposed to a liability. Accordingly, the Company concluded that the financial statements contained in the Company’s Annual Reports on Form 20-F for the years ended December 31, 2015 through 2019, as well as the interim condensed consolidated financial statements contained in the quarterly reports on Form 6-K for each quarter within these years, as well as the quarterly periods ended March 31, 2020, June 2020 and September 2020, should be restated and therefore not relied upon. This is a non cash re-statement and the RPC options do not constitute a legal liability to the Company and will not affect the Company’s financial statements upon settlement. The Company has included restated financial statements and notes thereto and any other appropriate revisions in its Annual Report on Form 20-F for the year ended December 31, 2020 and for more information please refer to Note 3 of our Annual Report on Form 20-F for the year ended December 31, 2020.
A copy of the Company’s Annual Report on Form 20-F for the year ended December 31, 2020 has been filed with the Securities and Exchange Commission and posted on the Company’s website at View Source

On April 20, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that the Company has invested into OxVax, a new immuno-oncology company based on research from Oxford University, which enables the development of the next generation of cancer vaccines with the potential to overcome the limitations of the current approaches (Press release, Evotec, APR 20, 2021, View Source;announcements/press-releases/p/evotec-invests-into-oxford-cell-therapy-company-oxvax-6053 [SID1234578281]).

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OxVax is developing an innovative cancer vaccine platform based on a unique and proprietary population of dendritic cells capable of inducing a potent anti-tumour immune response. The company’s technology allows the bulk manufacture of these cells from donor blood derived stem cells. By ex vivo loading of these cells with tumour antigens, OxVax will be able to create a vaccine which can train the body to target and eliminate tumours.

The research is based on the work of Professor Paul J Fairchild and Tim Davies from the Sir William Dunn School of Pathology at Oxford University. The founders will be joined by Marcelo Bravo as Chief Executive Officer, a serial entrepreneur who has taken two companies public.

Evotec’s investment is co-led by the South Korean-based venture capital company Lead Compass Investment. Financial details were not disclosed.

Dr. Thomas Hanke, Head of Academic Partnerships at Evotec, said: ‘We are excited to work with the Oxford researchers and Lead Compass to support the development of next-generation dendritic cell therapies to treat tumours with a high unmet medical need in the future. This investment fits well with Evotec’s ambition to become a biotech powerhouse in off-the-shelf cell therapy offerings.’

Professor Paul J Fairchild, Associate Professor of the Immunobiology of Stem Cells at Oxford University, said: "Our research has shown how stem cells can be used to create potentially unlimited numbers of a rare cell type of the immune system responsible for orchestrating the immune response to solid tumours. We believe that access to these cells can open the field of cancer vaccination and transform the treatment of some of the most intractable cancers."

Marcelo Bravo, Chief Executive Officer at OxVax, added: "Our platform enables the manufacture at scale of an off-the-shelf highly potent vaccine which addresses the major limitations that have frustrated cancer vaccine development in the past. Our immediate focus will be the definition of the quality profile of the product and the industrialisation of the manufacturing protocol which will put us in a strong position to proceed towards the clinic."

Tae-erk Kim, Chief Executive officer at Lead Compass Investment, added: "We are excited to invest in OxVax’s technology since it addresses the low migration, cross-presentation, and T-cell activation problems of past dendritic cell cancer treatments. Promising results in an oncology setting would further pave the way for OxVax to expand its technology into other therapeutic areas and be the first company to have dendritic cells act as the true control tower of the immune system."

On April 20, 2021 Reify Health reported that AstraZeneca (LSE/STO/Nasdaq: AZN), a leading global biopharmaceutical company, has selected StudyTeam, a patient enrollment management platform, to accelerate clinical development across its breast cancer investigational therapy portfolio (Press release, AstraZeneca, APR 20, 2021, View Source [SID1234578273]). Reify Health’s leading cloud-based solutions connect and empower the clinical trial ecosystem, starting with effective patient recruitment and enrollment. With its use of StudyTeam, AstraZeneca reinforces its reputation as a global sponsor of choice at breast cancer research sites.

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Since 2019, AstraZeneca has deployed Reify Health’s StudyTeam across multiple large global oncology clinical trials. Sites using StudyTeam with AstraZeneca randomize more patients per site per month and provide overwhelmingly positive feedback; in fact, 100% of sites using StudyTeam in its trials choose to do so for subsequent studies. High site engagement, supercharged workflows, and more visibility and control went into AstraZeneca’s decision to expand usage of StudyTeam.

"We now use StudyTeam to track patient recruitment and patient enrollment for all of our studies," said Katherine Wall, senior data manager at clinical research site Redlands Hematology Oncology in Redlands, California. "StudyTeam is a huge game changer for us to track all our patients in the solid tumor and hematologic malignancy trials that we’re participating in, and we’re now able to be even more efficient with our prescreening, thanks to StudyTeam. We’re grateful for sponsors like AstraZeneca that focus on providing sites like ours the solutions we need to enroll effectively."

AstraZeneca will expand use of the StudyTeam platform, including deployment of the Smart Patient Discovery feature. Information from a sponsor’s protocol can now be used to suggest potential patients to any research site coordinator using the StudyTeam system, allowing sites to more effectively connect the right patient to the right trial.

"AstraZeneca is prioritizing the site experience and the patient experience in its breast cancer clinical research program," said Ralph Passarella, CEO and co-founder of Reify Health. "By empowering sites with easy-to-use technology that allows sites to manage patients across all trials, our technology enables AstraZeneca to overcome the traditional challenges of moving candidates effectively through the enrollment funnel. And as the sponsor, AstraZeneca is gaining real-time visibility into patient enrollment to make quick, informed decisions on key issues that reduce site burden, improve candidate identification, and ultimately accelerate enrollment timelines."

AstraZeneca and other top-20 global biopharma companies, including Amgen and Eli Lilly and Company, use Reify Health’s StudyTeam to work with over 3,000 research sites in over 100 countries.

On April 20, 2021 OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in kids and adults including ovarian, esophageal, endometrial and lung cancers, reported the closing of a $6 million Series A round of funding (Press release, OS Therapies, APR 20, 2021, View Source [SID1234578272]).

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The company’s lead product is OST-HER2 targeting Osteosarcoma in kids, which is a listeria cancer vaccine intended to prevent metastasis, increasing overall survival.

"Our primary focus is to get this done: to ensure that this leading technology is employed in a clinical trial, in order to bring new treatments for the deadly disease of Osteosarcoma to market," said Dr. Robert Petit, CMO/CSO of OS Therapies. "The OST-HER2 treatment has been highly successful in multiple trials in canine osteosarcoma, demonstrating 3X improvement in Overall Survival and Disease Progression – we hope to see that it works as well–or even better–in kids."

The completed private placement will also support the advancement of preclinical and toxicology studies for OS Therapies’ second major platform technology OST-TDC: a next generation Drug Conjugate Technology targeting large solid tumors and potentially other diseases. "With the combination of the OST-HER2 late-stage development, and the significant potential of the OST-TDC technology, we believe OS Therapies has found a balanced approach to significant growth potential," said Nathan Cali, Managing Director of Noble Capital Markets.

OS Therapies Executive Chair Colin Goddard, PhD. pointed out: "This funding gives OS Therapies the opportunity to execute on their clinical plan, while opening up funding options for the future corporate structure of what could likely be a fully-integrated biopharmaceutical company."

About Osteosarcoma
Osteosarcoma is a solid tumor of the bone that predominantly occurs in adolescent and young adults (AYA). Standard treatment includes radiation and chemotherapy, with a high recurrence rate and significantly poorer prognosis upon metastasis.