On December 11, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit (IJB-CTSU) and Frontier Science Foundation (FS) reported data from a second interim overall survival (OS) analysis of the phase III APHINITY study, evaluating the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) as an adjuvant (after surgery) treatment for patients with HER2-positive early breast cancer (eBC) (Press release, Hoffmann-La Roche, DEC 11, 2019, View Source [SID1234552253]). This latest interim OS analysis was conducted after a median follow-up of approximately 74 months, compared to approximately 45 months for the primary analysis in 2017, and includes updated descriptive iDFS and cardiac safety data.1

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"The goal of adjuvant treatment is to give each person with early breast cancer the best chance of a cure," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "These new data with longer follow-up show the continued effect of the Perjeta-based regimen and an increased invasive disease-free survival benefit."

Martine Piccart, M.D., Ph.D., BIG co-founder and Scientific Director at Institut Jules Bordet, added: "These results demonstrate the importance of longer follow-up of APHINITY and further confirm the Perjeta-based regimen as the standard of care for people with HER2-positive early breast cancer at high risk of recurrence, such as those with lymph node-positive disease."

At this latest planned analysis, in the overall study population, the Perjeta-based regimen reduced the risk of breast cancer recurrence or death by 24%, compared to Herceptin, chemotherapy and placebo (HR=0.76; 95% CI 0.64-0.91). At six years, 90.6% of patients in the Perjeta arm have not seen their breast cancer return, compared to 87.8% in the placebo arm, an absolute benefit of 2.8%.1

Consistent with the primary analysis, the greatest effect continues to be observed in patients at high risk of recurrence, such as those with lymph node (LN)-positive disease. In these patients there was a 28% reduction in the risk of recurrence or death with the Perjeta-based regimen compared to Herceptin, chemotherapy and placebo (HR=0.72; 95% CI 0.59-0.87). This corresponds to an absolute improvement in iDFS at six years of 4.5% (87.9% vs. 83.4%). With longer follow-up, the treatment effect of the Perjeta-based regimen is seen regardless of hormone receptor (HR) status. The iDFS hazard ratio for HR-positive patients is 0.73 (95% CI 0.59-0.92). The iDFS hazard ratio for HR-negative patients is 0.83 (95% CI 0.63–1.10).1

Fewer deaths have been observed in the Perjeta-based regimen arm (125 vs. 147 [HR=0.85; 95% CI: 0.67-1.07]); however, data remain immature at this time. The APHINITY study continues as planned with the third interim analysis of OS scheduled for 2022. Continued follow-up of these patients is very important to determine a possible OS benefit.1

No new cardiac safety concerns emerged. The safety profile of the Perjeta-based regimen was consistent with that seen at primary analysis and in previous studies, with a low incidence of cardiac events. The percentage of primary cardiac events recorded in the Perjeta-based regimen arm was 0.8% vs. 0.3% in the placebo arm.1,2

Based on the primary study analysis in 2017, the clinical value of the Perjeta-based regimen for patients with HER2-positive eBC has been recognised by regulatory bodies around the world. This regimen is now approved for the treatment of eBC for people at a high risk of recurrence in more than 86 countries, including the US and across the EU. To date, more than 150,000 patients have been treated with the Perjeta-based regimen in this setting.3 The regimen has also been recognised in multiple international treatment guidelines, including those from St Gallen International Breast Cancer Conference, NCCN, ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper), which recommend it as an adjuvant standard treatment for patients with HER2-positive eBC at high risk of recurrence.4,5,6,7

These results from APHINITY will be presented in an oral session on Wednesday 11 December at 09.30 CT at the 2019 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas, US, by Dr Martine Piccart (Abstract #GS1-04). The data will also be featured in SABCS’ official press programme.

About APHINITY
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy, compared to Herceptin and chemotherapy, as adjuvant therapy in 4,805 people with operable HER2-positive eBC. The primary efficacy endpoint of the APHINITY study is iDFS, which in this study is defined as the time a patient lives without return of invasive breast cancer at any site, or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, OS, disease-free survival and health-related quality of life. The study will continue to follow participants for ten years.2,8

About Perjeta
Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is designed specifically to prevent the HER2 receptor from pairing (or ‘dimerising’) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival.9 Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different locations. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of HER signalling pathways, thus preventing tumour cell growth and survival.10

About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and metastatic HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients.11 Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test which identifies people who will likely benefit from these medicines at the onset of their disease.

On December 11, 2019 AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) reported positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody drug conjugate (ADC) and potential new medicine, in patients with HER2-positive metastatic breast cancer who received two or more prior HER2-targeted regimens (Press release, AstraZeneca, DEC 11, 2019, View Source [SID1234552252]).

The primary endpoint of objective response rate (ORR), confirmed by independent central review, was 60.9% with trastuzumab deruxtecan monotherapy (5.4mg/kg). Patients had a median of six prior therapies for metastatic disease (2-27).

Patients achieved a disease control rate (DCR) of 97.3% with a median duration of response (DoR) of 14.8 months and median progression-free survival (PFS) of 16.4 months. The median overall survival (OS) has not yet been reached, with an estimated survival rate of 86% at one year. The results were consistent across subgroups of patients.

José Baselga, Executive Vice President, Oncology R&D, said: "The clinically meaningful and durable responses seen among these patients illustrate the potential of trastuzumab deruxtecan to establish a new standard of care. These results are impressive, as women with this advanced stage of breast cancer have already endured multiple prior therapies for HER2-positive metastatic breast cancer."

Antoine Yver, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, said: "The strength of the pivotal results and the consistency with previously reported trastuzumab deruxtecan data further underscore that this specifically engineered HER2-targeted antibody drug conjugate is delivering on its intent of enhancing efficacy for patients with HER2-positive metastatic breast cancer."

Ian E. Krop, a principal investigator of the DESTINY-Breast01 trial and Associate Chief, Division of Breast Oncology, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute, said: "These results are particularly striking as trastuzumab deruxtecan prompted a high level of durable tumour reduction among patients, the majority of whom had exhausted most if not all standard therapies for HER2-metastatic breast cancer. We are excited by these results and their potential to help patients with this advanced stage of breast cancer."

Summary of resultsi
Efficacy measure
Total evaluable (n=184) ii

ORR (%) (95% CI)
60.9 (53.4-68)
CR (%)
6.0
PR (%)
54.9
SD (%)
36.4
PD (%)
1.6
DCR (%) (95% CI)iii
97.3 (93.8-99.1)
CBR (%) (95% CI)iv
76.1 (69.3-82.1)
Median DoR (95% CI)
14.8 months (13.8-16.9)
Median PFS (95% CI)
16.4 months (12.7-NE)
Estimated OS at 12 months (%) (95% CI)
86 (80-91)
CI, confidence interval; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; NE, not estimable.
i As assessed by independent central review.
ii 5.4mg/kg.
iii DCR is (CR + PR + SD)
iv CBR is (CR + PR + SD for ≥6 months)

The data were included as part of the press programme at the 2019 San Antonio Breast Cancer Symposium and simultaneously published online in The New England Journal of Medicine.

Prior therapies included trastuzumab emtansine (100%), trastuzumab (100%), pertuzumab (65.8%), other anti-HER2 therapies (54.3%), hormone therapies (48.9%) and other systemic therapies (99.5%). Median treatment duration for trastuzumab deruxtecan was 10 months (0.7-20.5) with a median duration of follow-up of 11.1 months (0.7-19.9). As of data cut-off on 1 August 2019, 42.9% of patients remained on treatment.

The safety and tolerability profile of trastuzumab deruxtecan in DESTINY-Breast01 was consistent with that observed in the Phase I trial. The most common Grade 3 or higher treatment-emergent adverse events were decreased neutrophil count (20.7%), anaemia (8.7%), nausea (7.6%), decreased white cell count (6.5%), decreased lymphocyte count (6.5%) and fatigue (6.0%). Overall, 13.6% of patients had confirmed interstitial lung disease (ILD) related to treatment as determined by an independent review. The events were primarily Grade 1 or 2 (10.9%) in severity with one Grade 3 (0.5%) and no Grade 4 events. Four deaths (2.2%) were determined to be due to ILD.

Regulatory submission of trastuzumab deruxtecan for the treatment of patients with HER2-positive metastatic breast cancer was recently accepted with Priority Review by the US Food and Drug Administration. A regulatory submission has also been made to Japan’s Ministry of Health, Labour and Welfare.

About HER2-positive breast cancer
Approximately one in five breast cancers are HER2-positive.1,2 Despite recent improvements and approvals of new medicines, there remains significant unmet needs for patients with advanced HER2-positive metastatic breast cancer.3,4 This disease remains incurable with patients eventually progressing after currently available treatments.3,4

About HER2
HER2 is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells that is associated with aggressive disease and poor prognosis in breast cancer patients.5 To be considered HER2-positive, tumour cancer cells are usually tested by one of two methods: immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH). IHC test results are reported as: 0, IHC 1+, IHC 2+, or IHC 3+.1 A finding of IHC 3+ and/or FISH amplification is considered positive.1

About DESTINY-Breast01
DESTINY-Breast01 is a pivotal Phase II, single-arm, open-label, global, multicentre, two-part trial evaluating the safety and efficacy of trastuzumab deruxtecan in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine. The primary endpoint of the trial is objective response rate, as determined by independent central review. Secondary objectives include duration of response, disease control rate, clinical benefit rate, progression-free survival and overall survival. Enrolment into DESTINY-Breast01 was completed in September 2018 with 184 patients at more than 100 sites globally.

About trastuzumab deruxtecan
Trastuzumab deruxtecan (DS-8201; fam-trastuzumab deruxtecan in the US only); is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise and the most advanced programme in AstraZeneca’s ADC scientific platform. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.

A comprehensive development programme is underway in North America, Europe and Asia, including five pivotal trials in HER2-expressing metastatic breast and gastric cancers, including a trial in patients with metastatic breast cancer and low levels of HER2 expression. Phase II trials are underway for HER2-expressing advanced colorectal cancer, as well as metastatic non-squamous HER2-overexpressing or HER2-mutated non-small cell lung cancer. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

About the collaboration between AstraZeneca and Daiichi Sankyo
In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise trastuzumab deruxtecan as a potential new medicine worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

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On December 11, 2019 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the appointment of Shehnaaz Suliman, M.D., MBA, M.Phil., as the company’s president and chief operating officer (Press release, Alector, DEC 11, 2019, View Source [SID1234552251]). In this new role, Dr. Suliman will oversee Alector’s day-to-day operations, including preclinical development, program management, and strategic and administrative functions. Dr. Suliman will report to Arnon Rosenthal, Ph.D., chief executive officer of Alector.

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"Shehnaaz’s background and expertise in drug development, strategy, portfolio management, and operational leadership uniquely position her to bring greater integration to our operations. Her strong track record of building and leading teams that can support the development of life-changing medicines comes at a key inflection point for Alector as we prepare to launch our first registrational trial in 2020," said Dr. Rosenthal. "Shehnaaz’s core leadership strengths will be invaluable to our entire organization, and we look forward to leveraging her insights as a thought partner and leader at Alector."

"Neurodegeneration affects millions of patients and families worldwide, and I am proud to be supporting Alector’s mission to find a cure for these diseases. As the leader in immuno-neurology, Alector has made substantial progress in rapidly advancing a broad clinical portfolio of novel and innovative programs," said Dr. Suliman. "As we advance our lead programs into late-stage clinical development and continue to progress our research pipeline, I look forward to partnering with the team to further our vision for finding cures for neurodegenerative diseases. I am excited to be joining the company at this important time and look forward to helping Alector execute our objectives and scale our organization effectively."

Dr. Suliman brings over 20 years of business development, drug development, strategic and operational expertise, and executive leadership skills to Alector. She joins Alector from Theravance Biopharma, where she served as senior vice president, corporate development and strategy, a position she held from July 2017 to March 2019. Prior to Theravance, Dr. Suliman worked for Genentech as a group leader and project team leader in the R&D Portfolio Management and Operations Group from September 2010 to May 2015 where she led and oversaw a number of neuroscience development programs. She was also vice president and global therapeutic head, Roche Partnering from June 2015 to July 2017. Dr. Suliman held various management roles of increasing responsibility at Gilead Sciences between January 2005 and September 2010. Before Gilead, Dr. Suliman was an investment banker with Lehman Brothers and Petkevich & Partners, advising public and private companies on buy- and sell-side transactions. She is a member of the board of directors of Ultragenyx Pharmaceutical, a biopharmaceutical company, and 10X Genomics, a life science technology company. Dr. Suliman received her M.D. from the University of Cape Town Medical School, South Africa, and holds an MBA, with distinction, and M.Phil. in development studies from Oxford University, where she was a Rhodes Scholar.

On December 11, 2019 Eli Lilly and Company (NYSE: LLY) reported the opening of the LIBRETTO-431 clinical trial [NCT04194944] for selpercatinib, also known as LOXO-292, for treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC) patients (Press release, Eli Lilly, DEC 11, 2019, View Source [SID1234552245]). Enrolled trial participants will be randomized to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET fusion-positive NSCLC.

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"Given the remarkable results of the LIBRETTO-001 trial, I am excited to open this important Phase 3 trial of selpercatinib, a highly selective and potent molecule that has previously demonstrated sustained responses with a well-tolerated safety profile," said Professor Ben Solomon, principal investigator at the Peter MacCallum Cancer Centre in Melbourne Australia. "This trial endeavors to generate outcome data that place patients with RET fusions alongside those with EGFR mutations and ALK fusions, as driver-positive populations that should be treated with targeted therapies in the first-line setting, rather than chemoimmunotherapy."

"This is an important milestone in the journey to further demonstrate the benefit of selpercatinib and the potential for people living with advanced or metastatic RET fusion-positive non-small cell lung cancer in the first-line setting against the current standard of care," said Anne White, president of Lilly Oncology. "Launching a trial of this size underscores the importance of now including RET fusions in the paradigm of genomic testing in lung cancer."

Trial Background
LIBRETTO-431 is a randomized Phase 3 clinical trial of patients with treatment-naïve RET fusion-positive NSCLC. The trial will enroll 400 patients with advanced or metastatic RET fusion-positive NSCLC who have received no prior systemic therapy for metastatic disease. Enrolled trial participants will be randomized 1:1 to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET fusion-positive NSCLC. RET fusions may be identified using local testing. This trial’s primary endpoint is progression-free survival (PFS) and secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR), and intracranial ORR. For patients randomized to the control arm, crossover is allowed at progression.

About Selpercatinib (LOXO-292)
Selpercatinib, also known as LOXO-292, is a highly selective and potent, oral investigational new medicine in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. Selpercatinib was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms.

Selpercatinib has received breakthrough designations in RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers.

About RET-Altered Cancers
Genomic alterations in RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2 percent of non-small cell lung cancer, 10-20 percent of papillary and other thyroid cancers and a subset of other cancers. Activating RET point mutations account for approximately 60 percent of MTC. RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

On December 10, 2019 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, reported it will be requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the drug development program for its Orphan Drug candidate HCC011, inhaled delta-9-tetrahydrocannabinol (THC), in the treatment of hepatocellular carcinoma (Press release, Tetra Bio Pharma, DEC 10, 2019, View Source [SID1234561119]).

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Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the most common form of liver cancer and is responsible for 80 percent of the primary malignant liver tumors in adults. In addition to quality of life benefits to cancer patients, based on preclinical research, HCC011 should also have antitumor effects. The Phase 2 study of HCC011 will target patients with disease progression on Sorafenib, have measurable disease, and Child-Pugh Class A liver impairment. The Phase 2 trial will consist of a single arm. Patients will receive the HCC011 by inhalation three times daily, in combination with Sorafenib, until disease progression or unacceptable toxicity. The study design is similar to the ones used by recent drugs seeking accelerated approval. The Disease control rate will be assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST); the overall survival and time to progression will be closely monitored over time. Patients will also beneficiate of the anti-emetic effect of HCC011, which will participate in improving their quality of life.

The company intends to file an NDA for HCC011 via the 505(b)(2) pathway. The FDA has three approval pathways by which drugs may gain approval and the 505(b)(2) new drug application (NDA) is one of the three ways created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a specific section of the U.S. Federal Food, Drug, and Cosmetic Act. The provisions of a 505(b)(2) provide manufacturers who have certain types of drugs with an opportunity to acquire FDA approval without performing all the work that’s required with a standard 505(b)(1) NDA.

Additionally, 505(b)(2) pathway allows for the ability to pursue additional designations such as fast track and accelerated approval to complement its already granted Orphan Drug Designation for HCC011 in HCC. Orphan drug designation provides certain benefits and incentives, such as seven-year marketing exclusivity, protocol assistance from the FDA, tax credits of 50% of the clinical drug testing cost awarded upon approval, and a waiver of the prescription drug user fee. The company fully intends to seek out additional designations where appropriate.

The HCC011 orphan drug candidate benefits from Tetra’s significant clinical data on the pharmacokinetics, safety and pharmacodynamics of inhaled cannabinoids. The company will also benefit from its previous investment in its GMP compliant manufacturing facility for these inhaled new drugs that holds an active Drug Establishment License (DEL) from Health Canada.

"We are very excited to bring HCC011 to clinical trials to help patients suffering from hepatocellular carcinoma and believe the 505(b)(2) pathway is the right approach for us, as we will be able to leverage our data and the data of others," said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. "This regulatory strategy combined with the Orphan status will provide major cost savings to shareholders. Post our meeting with FDA, we hope to gain clarity on our filing and marketing requirements, including input from the Agency on the design of our planned Phase 2 trial for HCC011 in HCC. We plan to provide an update once we have concurrence with the FDA."