On September 16, 2020 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, reported its interim financial results for the six months ended June 30, 2020, and provided an update on its business activities (Press release, Inventiva Pharma, SEP 16, 2020, View Source [SID1234568610]).

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Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: "The first half of 2020 has been one of the most decisive periods since the founding of Inventiva in 2012. Looking at the development of our R&D portfolio, our lead drug candidate lanifibranor has shown very promising results in our Phase IIb clinical trial in NASH: with statistically significant results on both the FDA and European Medical Agency (EMA) primary endpoints relevant for seeking accelerated approval during Phase III clinical development, this trial has paved the way for lanifibranor to enter into pivotal Phase III In parallel, we have progressed in the development of odiparcil for the treatment of MPS VI: the recent acceptance of our IND application by the FDA will allow us to launch our first clinical trial with odiparcil in the USA and will lay the groundwork for its future development in this important market. I would also like to thank the whole Inventiva team who worked tirelessly over the last few months in a difficult context. I am proud of their work and commitment that contributed to these achievements. Looking ahead, we are now fully focused on moving forward with the clinical development of lanifibranor in NASH with the anticipated pivotal Phase III trial, while continuing to advance our different programs across MPS, psoriasis and oncology, in line with our multi-asset strategy."

Jean Volatier, Chief Financial Officer of Inventiva, added: "In addition to the significant progress of our R&D portfolio, especially in NASH, we were also able to considerably strengthen our financial position despite the challenging environment linked to the COVID-19 pandemic. Of particular note is our successful initial public offering on the Nasdaq Global Market in the U.S., which increases our visibility in this key market and has enabled us to extend our cash runway through the fourth quarter of 2022. Backed by a very solid financial position and important advances across our R&D portfolio, we are in an ideal position to pursue the development of our different drug candidates."

Key financial results for the first half of 2020

Revenues for the first half of 2020 reached €0.2 million compared to €1.3 million in the first half of 2019 and related primarily to research services in connection with Inventiva’s collaboration with Boehringer Ingelheim, which has since been terminated.

R&D expenses amounted to €12.6 million in the first half of 2020, down 36% compared to the first half of 2019. These expenses were mainly dedicated to the development of lanifibranor in NASH and odiparcil in MPS VI. The decrease compared to the previous year is mainly due to the halt in the clinical development of lanifibranor in the treatment of systemic sclerosis in February 2019 and the savings generated by the Employment Safeguard Plan subsequently introduced, with the first half of 2020 recording the full effect of the savings generated.

General and administrative expenses amounted to €3.4 million, compared to €3.1 million in the first half of 2019, up 8%, mainly due to increased labor costs.

Other operating income (expenses) amounted to (€1.4) million (compared with (€1.3) million in the first half of 2019). The first half of 2019 took into account the recording of a provision of €1.1 million relating to the Employment Safeguard Plan, while the first half of 2020 takes into account part of the expenses incurred as part of the Initial Public Offering in the United States.

Company’s net loss stood at (€15.7) million, compared to (€20.5) million in the first half of 2019.

Inventiva’s net cash flow amounted to €16.4 million in the six months ended June 30, 2020 compared to (€19.6) million in the first half of 2019. Net cash used in operating activities was (€7.2) million and (€18.7) million in the first half of 2020 and 2019, respectively.
In addition to the decrease in R&D expenses mentioned above, in the first half of 2020, cash flow from operating activities was positively impacted by the receipt in January 2020 of €4.2 million in respect of the 2018 Research Tax Credit (CIR), and the receipt in April and June 2020 of €4.2 million in total in respect of the 2019 CIR.
Net cash from financing activities amounted to €24.6 million in the first half of 2020, driven by: the issuance of €15 million (gross proceeds) of ordinary shares in February 2020 to certain existing investors in the Company and the entry into a €10.0 million credit agreement, guaranteed by the French State, with a syndicate of French banks.

Consequently, Inventiva’s cash and cash equivalents stood at €52.3 million as of June 30, 2020 compared to €35.8 million as of December 31, 2019.

The financial statements of the first half of 2020 were approved by the Board of Directors on September 15, 2020. The statutory auditors have issued a limited review report. For more details, Inventiva’s Half-Year Financial Report is available on the Company’s website at: www.inventivapharma.com.

Financial information after closing of the accounts

On July 15, 2020, Inventiva successfully closed its initial public offering on the Nasdaq Global Market of an aggregate of 7,478,261 new ordinary shares in the form of American Depositary Shares (ADSs), each representing one ordinary share, at an offering price of $14.40 per ADS. Aggregate gross proceeds of the initial public offering, before deducting underwriting commissions and estimated expenses payable by the Company, were approximately $107.7 million (€94.9 million2). All of the securities as part of the initial public offering were offered by Inventiva. The Company’s ADSs, listed under the symbol "IVA", began trading on the Nasdaq Global Market on July 10, 2020.

The Company believes its cash, cash equivalents, short-term investments and non-current financial assets, together with the net proceeds of its successful initial public offering on the Nasdaq Global Market and its cash flow from operations will be sufficient to fund its operations through the fourth quarter of 2022.

Main areas of progress in the R&D portfolio

Lanifibranor in non-alcoholic steatohepatitis (NASH)

Following the publication of the positive results from the NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH in June 2020, Inventiva has progressed with the analysis of the circulating biomarkers. The first results of this analysis have shown a positive and statistically significant decrease of some biomarkers under lanifibranor treatment. Of importance and in line with the mechanism of action of lanifibranor, patients treated with the drug candidate showed improvements on biomarkers of fibrosis (Pro-C3 – a marker of fibrogenesis and ratio TIMP-1/MMP2 – a ratio depicting the inhibition of matrix remodeling process), apoptosis (CK18-M30 – a marker of apoptosis) and inflammation (Ferritin and hs-CRP – markers of inflammation). These findings, including the table in appendix of this press release, will be presented in more detail during tomorrow’s webcast and conference call (see below for logistical details) – September 17, 2020

Following higher than expected observed effects of lanifibranor in reducing steatosis during the Phase IIb NATIVE clinical trial in NASH, Professor Kenneth Cusi, the investigator of the trial, decided to reduce the number of patients in the ongoing Phase II clinical trial evaluating lanifibranor in type 2 diabetes patients (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD); results are expected in 2021 – July 6, 2020

Publication of positive topline results from the Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial; decision to continue the clinical development of lanifibranor in NASH and enter into pivotal Phase III development – June 15, 2020

Inventiva announced positive topline results from the Phase IIb NATIVE clinical trial evaluating lanifibranor for the treatment of NASH on June 15, 2020.

In this 24-week clinical trial, lanifibranor met the primary endpoint with a statistically significant reduction of the Steatosis Activity Fibrosis score (SAF), which combines assessments of hepatocellular inflammation and ballooning, with no worsening of fibrosis in the Intention To Treat (ITT3) and Per Protocol populations (PP4). The drug candidate also met key secondary endpoints, including NASH resolution with no worsening of fibrosis5 and improvement of liver fibrosis with no worsening of NASH6 in both ITT and PP populations. With these results, lanifibranor is the first drug candidate to achieve statistically significant results on NASH resolution with no worsening of fibrosis and improvement of fibrosis with no worsening of NASH, the two Food and Drug Administration (FDA) and European Medicine Agency (EMA) primary endpoints relevant for seeking accelerated approval during Phase III clinical development. Based on these positive topline results, Inventiva has decided to continue with the clinical development of lanifibranor in NASH and enter into pivotal Phase III development.

§ Approval of a new patent directed at the use of lanifibranor for the treatment of several fibrotic diseases, including NASH, in China until June 2035 by the China National Intellectual Property Administration (CNIPA) – May 25, 2020

Odiparcil in mucopolysaccharidosis type VI (MPS VI)

§ Acceptance of the Investigational New Drug (IND) application for odiparcil in MPS VI by the U.S. Food and Drug Administration (FDA) – August 10, 2020

On August 10, 2020, the FDA accepted Inventiva’s IND application for odiparcil for the treatment of MPS VI, allowing the Company to initiate clinical trials with this drug candidate in the United-States.

Decision by Inventiva to extend the duration of the Phase I/II SAFE-KIDDS (SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study) clinical trial evaluating odiparcil in MPS VI children from 6 to 12 months following a scientific advice meeting with the EMA in July; launch of the trial is expected in the first half of 2021 – July 23, 2020

Publication of Inventiva’s latest research on odiparcil’s mechanism of action in the leading peer-reviewed scientific journal PLOS ONE, showing that the drug candidate was associated with decreased glycosaminoglycan (GAG) accumulation and increased GAG excretion, and highlighting its distribution in MPS VI disease-relevant tissues and organs – May 18, 2020

Other significant milestones

§ Appointment of Dr Arun J. Sanyal to Inventiva’s Scientific Advisory Board (SAB), further strengthening the Board’s expertise in the field of NASH – July 29, 2020

Inventiva has further reinforced its SAB in the field of NASH with the appointment of Dr Arun J. Sanyal on July 29, 2020. Professor of Medicine, Physiology and Molecular Pathology in the Division of Gastroenterology at Virginia Commonwealth University (VCU) Medical Center in Richmond, Virginia, Dr Sanyal’s research focuses on all aspects of NAFLD and NASH as well as complications of cirrhosis and End-stage Liver Disease. He also serves as Chairman of the National Institutes of Health (NIH) NASH Clinical Research Network, the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) consortium and the Liver Forum for NASH and Fibrosis. In addition to his participation in the SAB, Dr Sanyal is involved in preparing the protocol of the Phase III clinical trial for the development of lanifibranor in NASH.

Entry into a €10.0 million non-dilutive loan facility guaranteed by the French State ("Prêt Garanti par l’Etat"), with the support of Bpifrance, Crédit Agricole Champagne-Bourgogne and Société Générale, contributing to strengthening the Company’s cash position in the context of the COVID-19 pandemic – May 19, 2020

Capital increase of €15 million subscribed by BVF Partners L.P., New Enterprise Associates (NEA), Novo Holdings A/S and Sofinnova Partners – February 11, 2020

COVID-19 update

Following the updated recommendations of domestic public health authorities and a continuous risk assessment of the COVID-19 pandemic situation, Inventiva is pursuing the implementation of measures to minimize risks for its employees and support their health and safety in this unprecedented time. As of today, the R&D internal and support activities are not expected to be significantly impacted in the future.

The global pandemic of COVID-19 continues to evolve, and its ultimate impact remains uncertain. The Company cannot predict the full extent of potential delays or impacts on its clinical trials, or potential impact on its business. Inventiva is committed to continuing to implement measures aimed at minimizing any further potential business impact from the COVID-19 pandemic and continue to comply with the updated guidance documents of the regulatory authorities. The Company continues to closely monitor, assess and respond to the situation as it evolves overtime and continues to work closely with authorities, its contract research organizations, trial sites and investigators to critically reassess all its existing programs and communicates further when and if appropriate.

···

Next expected key milestones

End of NATIVE Phase IIb clinical trial meeting with the FDA and Scientific Advice meeting with the EMA – planned for fourth quarter of 2020
AbbVie’s completion of its ongoing Phase I clinical trial with ABBV-157 in psoriasis patients – expected fourth quarter of 2020
Preparation for commencement of the Phase III clinical trial evaluating lanifibranor in NASH – planned for the first half of 2021
Initiation of the Phase I/II SAFE-KIDDS (SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study) clinical trial evaluating odiparcil in MPS VI children – planned for the first half of 2021
Initiation of the Phase IIa extension clinical trial with odiparcil in MPS VI patients who completed the prior Phase IIa clinical trial (iMProveS) – planned for the first half of 2021

Upcoming investor conference participation

H.C. Wainwright 22nd Annual Global Investment Virtual Conference, September 15-16, 2020
Roth Analyst Management Talk Series, September 21, 2020
20th Annual Biotech in Europe Forum, September 21-24, 2020
KBC Securities Virtual Life Sciences Conference, September 22-23, 2020
Lyon Pôle Bourse Investment forum, Lyon, September 30, 2020
Portzamparc Health/Biotech Virtual Seminar, October 1, 2020
HealthTech Innovation Days, Paris, October 5-6, 2020
European Midcap Hybrid Event, Paris, October 19-20, 2020
Stifel Healthcare Conference 2020, New York, November 17-18, 2020
Jefferies 11th Global Healthcare conference, London, November 17-19, 2020
Piper Sandler 32nd Annual Healthcare Conference, New York, December 1-3, 2020

Upcoming scientific conference presentations

§ Presentation of the Phase IIb NATIVE clinical trial results at The Liver Meeting of the AASLD (American Association for the Study of Liver Diseases), November 13-16, 2020

Conference call

A conference call in English will be held on Thursday, September 17, at 2:00 pm (Paris time). To join the conference call, please use the code 6617599 after dialing one of the following numbers:

The presentation accompanying this conference call will be available on Inventiva’s website in the "Investors" – "Results & Presentations" section at the same time and can be followed live at: View Source

A replay of the conference call and the presentation will be available from 6:00 pm (Paris time) onwards at: View Source

Next financial results publication

§ Q3 2020 Revenues and cash position: Thursday, November 12, 2020 (after market close)

Appendix

Measure of circulating biomarkers in NATIVE Phase IIb trial: significant decrease under lanifibranor treatment compared to placebo after 24-weeks

(1) Level where it is estimated that fibrogenisis is active and corresponding to F2/F3 patients
FAS (Full Analysis Set) population with available data at baseline (pre-treatment) and at week 24 (post-treatment)
* Median change under lanifibranor are statistically significantly different compared to placebo, using the common threshold of 5% (Exploratory Wilcoxon test)

On September 16, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,774,150 which covers compositions of matter directed to Alligator’s bispecific drug candidate ATOR-1015 (Press release, Alligator Bioscience, SEP 16, 2020, View Source [SID1234565215]). The granted patent’s earliest expiry year is 2036.

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"ATOR-1015 constitutes a new concept, a tumor-localizing bispecific CTLA-4 antibody. Our invention addresses one of the key challenges within immuno-oncology, i.e. the narrow therapeutic window of CTLA-4 drugs. This is now protected by a granted US patent", commented Per Norlén, CEO at Alligator Bioscience.

ATOR-1015 is developed for the treatment of metastatic cancer. Promising safety data from the ongoing ATOR-1015 Phase I clinical study was presented at ASCO (Free ASCO Whitepaper) in June 2020. The Phase I dose escalation study is planned to be completed during the fourth quarter 2020 and the subsequent Phase Ib efficacy study in malignant melanoma is due to start in 2021.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CEST on September 16, 2020.

On September 16, 2020 Vedanta Biosciences, a leading clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria, reported the appointment of Jeffrey Silber, M.D., as chief medical officer (Press release, Vedanta Biosciences, SEP 16, 2020, View Source [SID1234565238]). An accomplished leader in drug development, Dr. Silber brings deep experience across multiple therapeutic areas at Merck, AbbVie and EMD Serono and will guide the advancement of the company’s clinical programs. Nancy Chiu Wilker, Ph.D., J.D., also joins as vice president of legal, where among other responsibilities, she will oversee and expand the company’s foundational portfolio of patents around live biotherapeutic products.

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"We are thrilled to welcome Jeff to Vedanta. Jeff’s depth of experience in the full lifecycle of product development and across therapeutic areas will be very important to our team as we continue to advance our pipeline of defined bacterial consortia," said Bernat Olle, Ph.D., co-founder and chief executive officer of Vedanta Biosciences. "We are also delighted to welcome Nancy, whose extensive experience in building IP portfolios of innovative biotechs will fill a crucial role."

Dr. Silber comes to Vedanta Biosciences from EMD Serono, where he served as senior vice president of global development. While there, he was a member of the portfolio-level governance and franchise leadership committees, and he co-chaired the committee overseeing the design for all clinical studies. He previously served as vice president of strategic portfolio development at AbbVie. Dr. Silber started his industry career in clinical development at Merck, where he assumed multiple strategic roles including leading anti-infective clinical development programs, the vaccine therapeutic area, and the neuroscience pipeline and program management team. During his career, Dr. Silber has overseen multiple regulatory submissions and approvals worldwide and held departmental head responsibilities spanning clinical research, project management, program leadership, pharmacovigilance, biostatistics, epidemiology and translational medicine. He has been recognized with numerous academic and professional awards, including the highest honors awarded by Merck Research Laboratories and by Merck & Co. Dr. Silber earned his B.A. in biology from Harvard University and his M.D. from Albert Einstein College of Medicine of Yeshiva University. He received additional academic training in internal medicine at New York University/Bellevue Hospital and infectious diseases at the University of Pennsylvania. He began his career as an assistant professor of medicine at the Robert Wood Johnson Medical School.

"I see tremendous potential for microbiome-based therapeutics to address serious unmet needs across multiple therapeutic areas," Dr. Silber said. "Vedanta has led the way in harnessing the power of the microbiome for drug development and pioneering a new class of live biotherapeutic products. I’m excited to join the team and to help guide the advancement of the impressive pipeline."

Dr. Wilker previously served as vice president and lead IP counsel for Fog Pharmaceuticals, where she was responsible for the company’s intellectual property portfolio. She has also held IP counsel roles at Biogen and Seqirus and was a partner at the legal firm Sunstein LLP, where she served as IP counsel for numerous biotech companies. Dr. Wilker received her B.S. in biology and biochemistry from Colorado State University, her Ph.D. in immunology from Harvard University and her J.D. from Suffolk University Law School.

"Vedanta has built a leading IP position in microbiome therapeutics based on live bacteria," said Dr. Wilker. "I’m looking forward to joining the team as we continue to protect and expand our foundational patent portfolio."

Vedanta Biosciences also secured a $15 million loan facility from Oxford Finance to support its pipeline development, which includes four clinical-stage product candidates currently being evaluated for the treatment of high-risk C. difficile infection, inflammatory bowel disease (IBD), food allergy and advanced and metastatic cancers (in combination with Bristol Myers Squibb’s checkpoint inhibitor, Opdivo).

On September 16, 2020 Novartis reported data from the Phase III COMBI-AD study were published today in The New England Journal of Medicine (Press release, Novartis, SEP 16, 2020, View Source [SID1234565239]). The study shows more than half of high-risk patients with resected, stage III BRAF V600-mutated melanoma treated with Tafinlar (dabrafenib) + Mekinist (trametinib) were alive and relapse-free at 5 years1 . Research suggests the majority of relapses in high-risk stage III melanoma generally occur within 5 years1,2.

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"Findings published today offer confidence that treatment with dabrafenib and trametinib following surgery provides a durable, long-term relapse-free survival benefit for those at high risk of cancer recurrence," said Prof. Reinhard Dummer, M.D., Vice Chairman of the Department of Dermatology, University Hospital of Zurich. "These findings add to the growing body of evidence demonstrating the clinical value of dabrafenib and trametinib in the adjuvant setting."

Results showed 52% of patients (95% CI, 48-58%) treated with Tafinlar + Mekinist were alive and relapse-free at 5 years compared to 36% of patients (95% CI, 32-41%) who received placebo. Median relapse-free survival (RFS) was not reached in the Tafinlar + Mekinist arm (95% CI, 47.9 months-NR) compared to 16.6 months (95% CI, 12.7-22.1 months) in the placebo arm. Treatment with Tafinlar + Mekinist reduced the risk of relapse or death by 49% compared to placebo (hazard ratio, HR, 0.51 [95% CI, 0.42-0.61])1. These findings were presented at the 2020 ASCO (Free ASCO Whitepaper) Virtual Scientific Program.

A subgroup analysis showed a generally similar RFS benefit across all substages, as assessed by AJCC-7 criteria. The five-year distant metastasis-free survival (DMFS) rate, a secondary endpoint, was 65% (95% CI, 61-71%) in patients treated with Tafinlar + Mekinist compared to 54% (95% CI, 49-60%) in patients who received placebo. COMBI-AD is ongoing to assess the secondary endpoint of overall survival (OS); the OS analysis at the first interim analysis showed a 3-year OS rate of 86% in the Tafinlar + Mekinist arm compared to 77% in the placebo arm. Overall survival results favored the combination therapy with Tafinlar + Mekinist over placebo, but the prespecified interim significance threshold of P = 0.000019 was not met.

"Reaching the five year mark without relapse is a profound moment for a patient living with high-risk, stage III melanoma," said Jeff Legos, Ph.D., MBA, Senior Vice President, Head of Oncology Drug Development, Novartis Oncology. "Tafinlar + Mekinist has helped patients and clinicians reimagine what is possible for patients living with advanced melanoma. We are proud of the deep and durable benefit demonstrated in COMBI-AD and remain grateful to the patients, investigators and their families who participated in this clinical trial."

During the extended follow-up, all patients had completed therapy. There was no clinically meaningful difference between the Tafinlar + Mekinist and placebo arms in the rate or severity of serious adverse events reported during the follow-up period.

More than 285,000 cases of melanoma are diagnosed every year globally and about half of these have a BRAF mutation3,4. Patients who receive surgical treatment for stage III melanoma may have a risk of recurrence because melanoma cells may remain in the body after surgery5.

About the COMBI-AD Study
COMBI-AD is a pivotaI Phase III study evaluating Tafinlar (dabrafenib) + Mekinist (trametinib) in patients with stage III, BRAF V600E/K-mutant melanoma without prior anticancer therapy. It is the longest follow-up, at 60 months, and largest dataset to date of patients with stage III melanoma receiving targeted therapy for adjuvant treatment1,6.

It is a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc as per AJCC 7th edition] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) combination therapy or two placebos for up to one year. The primary end point is recurrence-free survival, and secondary endpoints include overall survival, distant metastasis-free survival, freedom from relapse analysis and safety1,7.

About Tafinlar + Mekinist Combination
Tafinlar and Mekinist are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma:

That has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and
That has a certain type of abnormal "BRAF" (V600E or V600K mutation-positive) gene
Tafinlar and Mekinist are prescription medicines that can be used in combination to help prevent melanoma that has a certain type of abnormal "BRAF" gene from coming back after the cancer has been removed by surgery.

Tafinlar and Mekinist are prescription medications that can be used in combination to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic NSCLC), and that has a certain type of abnormal "BRAF V600E" gene.

Tafinlar and Mekinist are prescription medications that can be used in combination to treat a type of thyroid cancer called anaplastic thyroid cancer (ATC):

That has spread to other parts of the body and you have no satisfactory treatment options, and
That has a certain type of abnormal "BRAF" gene
Tafinlar, in combination with Mekinist, should not be used to treat people with wild-type BRAF melanoma. Mekinist should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma and it did not work or is no longer working.

Your health care provider will perform a test to make sure that Tafinlar and Mekinist , in combination, are right for you.

It is not known if Tafinlar and Mekinist are safe and effective in children.

Tafinlar and Mekinist, in combination, may cause serious side effects such as the risk of new cancers, including both skin cancer and nonskin cancer. Patients should be advised to contact their health care provider immediately for any skin changes, including a new wart, skin sore, or bump that bleeds or does not heal, or a change in the size or color of a mole.

When Tafinlar is used in combination with Mekinist, it can cause serious bleeding problems, especially in the brain or stomach, that can lead to death. Patients should be advised to call their health care provider and get medical help right away if they have any signs of bleeding, including headaches, dizziness, or feel weak, cough up blood or blood clots, vomit blood or their vomit looks like "coffee grounds," or red or black stools that look like tar.

Mekinist, alone or in combination with Tafinlar, can cause inflammation of the intestines or tears in the stomach or intestines that can lead to death. Patients should report to their health care provider immediately if they have any of the following symptoms: bleeding, diarrhea (loose stools) or more bowel movements than usual, stomach-area (abdomen) pain or tenderness, fever, or nausea.

Tafinlar, in combination with Mekinist, can cause blood clots in the arms or legs, which can travel to the lungs and can lead to death. Patients should be advised to get medical help right away if they have the following symptoms: chest pain, sudden shortness of breath or trouble breathing, pain in their legs with or without swelling, swelling in their arms or legs, or a cool or pale arm or leg.

The combination of Tafinlar and Mekinist can cause heart problems, including heart failure. A patient’s heart function should be checked before and during treatment. Patients should be advised to call their health care provider right away if they have any of the following signs and symptoms of a heart problem: feeling like their heart is pounding or racing, shortness of breath, swelling of their ankles and feet, or feeling lightheaded.

Tafinlar, in combination with Mekinist, can cause severe eye problems that can lead to blindness. Patients should be advised to call their health care provider right away if they get: blurred vision, loss of vision, or other vision changes, seeing color dots, halo (seeing blurred outline around objects), eye pain, swelling, or redness.

Tafinlar, in combination with Mekinist, can cause lung or breathing problems. Patients should be advised to tell their health care provider if they have new or worsening symptoms of lung or breathing problems, including shortness of breath or cough.

Fever is common during treatment with Tafinlar in combination with Mekinist, but may also be serious. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Patients should be advised to call their health care provider right away if they get a fever.

Rash and other skin reactions are common side effects of Tafinlar in combination with Mekinist. In some cases, these rashes and other skin reactions can be severe or serious, may need to be treated in a hospital, or lead to death. Patients should be advised to call their health care provider if they get any of the following symptoms: blisters or peeling of skin, mouth sores, blisters on the lips or around the mouth or eyes, high fever or flu-like symptoms, and/or enlarged lymph nodes.

Some people may develop high blood sugar or worsening diabetes during treatment with Tafinlar in combination with Mekinist. For patients who are diabetic, their health care provider should check their blood sugar levels closely during treatment. Their diabetes medicine may need to be changed. Patients should be advised to tell their health care provider if they have increased thirst, urinate more often than normal, or produce an increased amount of urine.

Tafinlar may cause healthy red blood cells to break down too early in people with glucose-6-phosphate dehydrogenase deficiency. This may lead to a type of anemia called hemolytic anemia, where the body does not have enough healthy red blood cells. Patients should be advised to tell their health care provider if they have yellow skin (jaundice), weakness or dizziness, or shortness of breath.

Tafinlar, in combination with Mekinist, can cause new or worsening high blood pressure (hypertension). A patient’s blood pressure should be checked during treatment. Patients should be advised to tell their health care provider if they develop high blood pressure, their blood pressure worsens, or if they have severe headache, lightheadedness, blurry vision, or dizziness.

Men (including those who have had a vasectomy) should use condoms during sexual intercourse during treatment with Tafinlar and Mekinist and for at least 4 months after the last dose of Tafinlar and Mekinist. For women of reproductive potential, Tafinlar and Mekinist, in combination, may harm your unborn baby. Use effective birth control (contraception) during treatment with Tafinlar and Mekinist in combination, and for 4 months after stopping treatment with Tafinlar and Mekinist. The most common side effects for patients with metastatic melanoma are: pyrexia, nausea, rash, chills, diarrhea, headache, vomiting, hypertension, arthralgia, peripheral edema, and cough. The most common side effects for patients with stage III melanoma receiving the combination as adjuvant therapy are: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia. The most common side effects for patients with NSCLC: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea.

On September 16, 2020 Canexia Health reported a new financing round from PacBridge Capital Partners (HK) Limited to propel the company’s long-term global growth and accelerate its roadmap to make cancer testing for treatment selection and monitoring accessible to all cancer patients (Press release, Contextual Genomics, SEP 16, 2020, View Source [SID1234565256]). The investment signals Canexia Health’s record-breaking growth in 2020 to date, with new customer collaborations and studies, product enhancements, and reimbursement progress.

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"This has been a year of incredible growth for Canexia Health. Since the beginning of 2020, we have welcomed new customers and collaborators, and we are well on the path to democratize how oncologists gain information about cancer treatment selection and monitoring"

Highlights include:

● New collaborations. In the first half of 2020, the company increased commercial partner agreements by 65%. One new collaborator is Genolife, a private clinic that provides access to personalized genetic tests and genetic counselling services. Genolife will offer Canexia Health’s circulating tumor DNA (ctDNA) assay, Follow It, in Quebec. Additional new commercial partner agreements include AstraZeneca Canada, the Eastern Ontario Regional Laboratory Association (EORLA), and Queen’s University. All are involved in Project ACTT, and EORLA and Queens University will adopt Canexia’s technology transfer model to bring ctDNA testing in-house. Project ACTT is a CAD $2.59M initiative led by Canexia Health and supported by Canada’s Digital Technology Supercluster to deploy and enhance Follow It for 2,000 patients during COVID-19 as an alternative to surgical tissue biopsies.

● Monitoring studies. Monitoring is a $15B market opportunity in the US alone. Adding to its portfolio of monitoring studies, Canexia Health is collaborating with Exactis Innovation, a pan-Canadian Networks Centres of Excellence comprising 14 oncology centers. The research study, led by Dr. Simon Turcotte at the Centre de Recherche Centre Hospitalier de l’Université de Montréal, will deploy Follow It to analyze ctDNA and investigate non-invasive early detection of treatment failure in patients with metastatic colorectal cancer who are undergoing systemic chemotherapy and liver resection. Following definitive surgery, disease recurrence is seen in 50-75% of patients within 2 years, highlighting the importance of recurrence risk prediction and disease monitoring in this patient population.

● Product enhancements. Canexia Health continues to expand the genomic content of its assays, including MSI and CNV content, as well as recently releasing updates to the Canexia Health Fusions panel. The company has also improved the sensitivity of its liquid biopsy assays for use in monitoring and leveraged tens of thousands of processed samples to improve its AI and machine learning algorithms.

● Reimbursement progress. Via partner Lab Genomics, Follow It has received a unique Z code, representing a key reimbursement milestone with the US Centers for Medicare and Medicaid.

● Corporate rebrand and growth. In July, the company rebranded from Contextual Genomics to Canexia Health to reflect the company’s deep focus on cancer patients and on building a community nexus to make precision oncology affordable and accessible. The company has also increased its full-time workforce by 35% since March 2020 with the addition of new hires in the laboratory, as well as in computational science, software, business development, and marketing.

"This has been a year of incredible growth for Canexia Health. Since the beginning of 2020, we have welcomed new customers and collaborators, and we are well on the path to democratize how oncologists gain information about cancer treatment selection and monitoring," said Michael Ball, CEO of Canexia Health. "Further, we have built a clinically focused molecular test specifically for those who want to bring this technology in-house. The faster you can get an individual on targeted therapy, the better their outcomes are likely to be. Building in-house capabilities and thus making cancer testing more accessible, that’s really the focus for our company moving forward."