On March 20, 2019 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) and Eli Lilly and Company (NYSE: LLY) reported six projects that aim to improve the delivery of gastric and gastroesophageal junction (GEJ) cancer care in the United States (Press release, Eli Lilly, MAR 20, 2019, View Source [SID1234554022]). The quality improvement studies will focus on methods of intervention that can be implemented across a variety of different oncology practice settings. These projects are eligible to receiving funding from Lilly Oncology after completing contract negotiations. Forty-nine letters of intent were submitted in response to the RFP and subsequently 19 full proposals were requested for review.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"As part of our mission to facilitate care that helps patients live better lives, we’re honored to support research that enhances outcomes and experiences for people with gastric and gastroesophageal junction cancers," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "This project is intended to identify disparities in care between the community and academic setting, and define scalable, shareable solutions that will rapidly improve adherence to guidelines and quality of care."

The following studies were selected by the NCCN ORP:

Dan G. Blazer III, MD; Daniel P. Nussbaum, MD; Linda M. Sutton, MD; Duke University Health System and Duke Cancer Network Affiliates; The DCN Passport: A Novel, Patient-Centered Approach to Improve Care for Gastric/Gastroesophageal Junction Cancer Across an Academic-Community Oncology Network
Efrat Dotan, MD; Fox Chase Cancer Center; Improving the Approach to and Management of the Older Patient with Metastatic Gastric Cancer
Jae Kim, MD; City of Hope National Medical Center; Telehealth Intervention for Self-Management of Dietary Quality of Life After Gastric Cancer Surgery
Veena Shankaran MD, MS; University of Washington/Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center; Randomized Pragmatic Trial of a Proactive Financial Navigation Intervention in Patients with Newly Diagnosed Gastric and Gastroesophageal Junction Adenocarcinoma
Qiuling Shi, PhD; Loretta A. Williams, PhD; The University of Texas MD Anderson Cancer Center; Symptom Management Through an Automated Alert System to Improve Adherence During Systemic Therapy for Patients with Gastric/Gastroesophageal Junction (GEJ) Cancer
Kuang-Yi Wen, PhD; Sidney Kimmel Cancer Center (SKCC) at Jefferson; mChemoCoping – GC: A Text Messaging System Enabling Real-Time Monitoring and Management of Chemotherapy Side Effects Among Patients with Gastric Cancer (GC)
"NCCN ORP congratulates all of the collaborators, and looks forward to their contributions to the future of gastric and GEJ cancer care," said Dr. Koh.

"Lilly is proud to work with the NCCN ORP to research better ways for delivering high-quality cancer care to patients with this aggressive disease," said Maura Dickler, MD, Vice President of Late Phase Development, Lilly Oncology. "By utilizing novel approaches and advancing technology, these studies will help us to address some of the largest disparities in care that exist for patients undergoing treatment for gastric and GEJ cancers."

The NCCN ORP was responsible for the Request-for-Proposals (RFP) process, application review and evaluation. A committee led by NCCN and including a medical representative from Lilly determined which proposals would be eligible to receive funding. Project funding will be provided directly by Lilly upon mutual agreement of project terms and conditions.

The studies will be conducted over a period of two years.

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer by supporting investigator-initiated trials at NCCN Member Institutions and their affiliates. To date, it has supported more than 140 studies, with numerous publications in peer-reviewed journals. To learn more about the NCCN ORP and ongoing clinical trials, visit NCCN.org/ORP.

On March 20, 2019 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the full year ended December 31, 2018 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAR 20, 2019, View Source [SID1234534496]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Throughout 2018, we made great progress in pursuit of our mission of bringing innovative new RNAi nanoparticle therapeutics to cancer patients with high unmet medical need," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "This progress was highlighted by the recent updated interim analysis of our Phase 2 trial of prexigebersen in acute myeloid leukemia (AML). Of the 17 evaluable patients, 65% had a response, including 29% who achieved a complete response, one of which achieved a morphologic leukemia free state. With these interim results in hand, we are even more confident as we move this program forward in combination with venetoclax and decitabine."

"Beyond prexigebersen, we continue to make headway across our development pipeline. We are on track to submit our Investigational New Drug application to begin a Phase 1 study of our second drug candidate, BP1002, which targets the Bcl-2 protein. This trial will seek to treat both Non-Hodgkin’s Lymphoma and chronic lymphocytic leukemia patients that have failed Venetoclax. We recently strengthened our balance sheet through a $18.5 million registered direct offering and we now have the resources to achieve a number of key milestones that should significantly enhance shareholder value. We entered 2019 on strong footing and expect to build on that momentum throughout the balance of the year as we continue to advance these important programs," continued Mr. Nielsen.

Recent Corporate Highlights

·Reported Updated Interim Analysis from Phase 2 Clinical Trial of Prexigebersen for the Treatment of AML. In March 2019, Bio-Path reported updated interim data from 17 evaluable patients showing that 11 patients (65%) had a response, including five patients (29%) who achieved CR, one of which was a morphologic leukemia free state (MLFS), and six patients achieving stable disease. Importantly, after further analysis by the principal investigators, it was observed that 68% of these patients were secondary AML patients, an extremely difficult class to treat. As a result of these updated data, Bio-Path now intends to enroll two registration-directed cohorts of the triple combination of prexigebersen + decitabine + venetoclax in untreated AML and high risk MDS patients, and refractory/relapsed AML and high risk MDS patients. In December 2018, earlier data from this program were presented in a poster at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

·Raised $18.5 Million in Registered Direct Offering. In March 2019, Bio-Path issued 712,910 shares of its common stock at a price of $25.95 per share, for gross proceeds of approximately $18.5 million.

Financial Results for the Full Year Ended December 31, 2018

·The Company reported a net loss attributable to common stockholders of $8.6 million, or $14.38 per share, for the year ended December 31, 2018, compared to a net loss attributable to common stockholders of $8.1 million, or $15.99 per share, for the year ended December 31, 2017.

·Research and development expenses for the year ended December 31, 2018 decreased to $4.6 million, compared to $5.5 million for the year ended December 31, 2017 primarily due to decreased salaries and benefits expense.

·General and administrative expenses for the year ended December 31, 2018 decreased to $3.4 million, compared to $3.5 million for the year ended December 31, 2017 primarily due to decreased professional and consulting fees.

·As of December 31, 2018, the Company had cash of $1.0 million, compared to $6.0 million at December 31, 2017. Net cash used in operating activities for the year ended December 31, 2018 was $6.1 million compared to $8.0 million for the comparable period in 2017. Net cash provided by financing activities for the year ended December 31, 2018 was $1.2 million.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these full year 2018 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 1794629. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On March 20, 2019 Trizell Ltd (Trizell) reported that it has opened a Phase 3 Study of its novel gene therapy TR002, an adenovirus-mediated interferon alfa 2b, in patients with malignant pleural mesothelioma (MPM) who have failed first-line standard of care chemotherapy (Press release, Trizell, MAR 20, 2019, View Source [SID1234561809]). TR002 is given to trigger the pleiotropic anti-tumour effects of interferon, a naturally occurring protein the body uses to fight cancer, and is followed by gemcitabine chemotherapy. This study will include sites in the United States, Europe, Australia, and Russia.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Malignant pleural mesothelioma is an aggressive and devastating form of cancer affecting the outer (pleural) membrane of the lungs. The disease is usually triggered by inhalation of asbestos fibres that slowly make their way from the alveoli to the outer surface of the lung in the pleural cavity. The fibres then induce a cancer which grows on the outside of the lung into the pleural space, eventually invading surrounding thoracic tissues leading to death. There is a clear association between occupational or environmental asbestos and mineral fibre exposure and MPM development.
A previous Phase 2 study of TR002 at the Abramson Cancer Center included 40 MPM patients who were newly diagnosed or failed standard chemotherapy (Pemetrexed/ Platin) showed an overall disease control rate of 87.5%. The second line treatment cohort showed an almost doubling of median survival time compared to historical study controls (17 months vs. 9 months) with approximately 25% of patients living at least 2 years and approximately 20% at least 3 years.

MPM prognosis is poor and following failure of standard of care first line treatment, median life expectancy is around 9 months, with very few cases surviving past 18 months. With a prevalence of around 200,000 cases worldwide, there are around 3000 and 5000 new cases diagnosed every year in the EU and US alone. Dust from the September 11th attacks in New York is predicted to cause a rise in the number of future cases in the US, although the extent of the future rise is currently unclear.
"This is an exciting trial. The results that we noted in our previous study showed significant prolongation of life expectancy and particularly so for about 25 percent of these refractory patients who have gone on to live two and in some cases three years and more," said Daniel H. Sterman, MD, Director of the Multidisciplinary Pulmonary Oncology Program at NYU Langone Health. "We will work hard to get this potentially ground-breaking clinical trial completed."

The Phase 3 study is an open-label, randomized, parallel group study in up to approximately 300 patients who have failed chemotherapy. TR002 is given by catheter directly into the pleural cavity as a single dose of 3 x 1011 viral particles. Gemcitabine chemotherapy commences 14 days later and continues until disease progression.

"It is very exciting to see a therapeutic approach developed at the University of Pennsylvania being moved to an international, randomized trial, as it is a career milestone for any academic researcher to see their work tested in this way," said Steven M. Albelda, MD, William Maul Measey Professor of Medicine, Perelman School of Medicine, University of Pennsylvania.

TR002 was pioneered by Drs. Albelda and Sterman, and by Dr. Evan W. Alley, MD, PhD, whose current appointment is at Cleveland Clinic Florida but who was involved in the trial during his time at Penn.

About TR002
TR002 (nadofaragene firadenovec) is an investigational gene therapy consisting of an adenovirus containing the gene interferon alfa-2b. It is administered by catheter into the pleural cavity, where the virus enters the cells lining the pleural cavity. Inside the cells, the virus breaks down leaving the active gene to do its work. The internal gene/DNA machinery of the cells picks up the gene and translates its DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach turns the patient’s own pleural cavity cells into multiple interferon microfactories, enhancing the body’s natural defences against the cancer.

About Malignant Pleural Mesothelioma
Malignant pleural mesothelioma is usually triggered by inhalation of asbestos fibres. These slowly make their way from the alveoli to the outer surface of the lung in the pleural cavity where they induce a cancer which grows on the outside of the lung into the pleural space, eventually invading surrounding thoracic tissues leading to death. Prognosis is poor and following failure of standard of care first-line treatment, median life expectancy is around 9 months, with very few cases surviving past 18 months.

WHO estimates that 43,000 people die of MPM each year; annually in North America, Western Europe, Japan, and Australia, there are 10,000 cases each year1. With the passage of the Clean Air Act, asbestos use was banned in the US in 19702, and the incidence of mesothelioma in the US was predicted to steadily decline. However, dust from the September 11th attacks in New York is predicted to cause a rise in the number of future cases although the extent of the future rise is currently unclear3. In contrast, asbestos use continued in Australia until 2003 and in Europe until 2005. As a result, the incidence of mesothelioma in European countries continues to rise and is projected to peak in 2020 and may account for as many as 250,000 European deaths in the next 35 years. In 2020, it is estimated over 18,000 Australian cases will be diagnosed4.

On March 20, 2019 Abbott (NYSE: ABT) reported that it will announce its first-quarter 2019 financial results on Wednesday, April 17, 2019, before the market opens (Press release, Abbott, MAR 20, 2019, View Source [SID1234534498]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

SOURCE Abbott

For further information: Abbott Media: Elissa Maurer, (224) 668-3309; Abbott Financial: Scott Leinenweber, (224) 668-0791
Abbott Logo

On March 20, 2019 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies to transform the fight against solid tumors and infectious diseases, publishes its financial results for 2018 and provides an update on its clinical and preclinical portfolio, and its technology platforms (Press release, Transgene, MAR 20, 2019, View Source [SID1234534517]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Philippe Archinard, Chairman and Chief Executive Officer of Transgene, commented:
"2018 was a year of intense activity for Transgene resulting in significant progress across all aspects of the business. We continued to advance our promising clinical assets and look forward to announcing data from our key clinical trials in the second half of 2019.

Our R&D efforts were focused on our two cutting-edge technology platforms: oncolytic viruses and therapeutic vaccines, engineered to deliver a step change improvement in the treatment of solid tumors.

With the Invir.IOTM platform, we design a new virus with a more potent oncolytic effect and are arming it with strong immune-modulating agents to treat tumor which are today resistant to existing therapies. Positive data were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2018. We have an ambitious program and we are currently evaluating several preclinical Invir.IOTM candidates which we expect to bring to the clinic in H1 2020.

In September we launched myvacTM, a highly innovative viral vector-based, individualized immunotherapy approach combining the use of the tumor’s neoantigens with Transgene’s viral Page 2 / 13 vector expertise to create a completely novel patient specific treatment option for solid tumors. We signed a strategic collaboration with NEC to leverage its artificial intelligence capabilities to identify candidate neoantigen targets. With the know-how and highly skilled experts at NEC as well as Institut Curie, HalioDx and Traaser, we are targeting to initiate two clinical trials in H2 2019 with our lead myvacTM candidate TG4050.

This is an exciting time for Transgene as we advance our viral-vector based immunotherapies to transform the fight against solid tumors."

Clinical Pipeline Review

Transgene has made significant progress with its key clinical trials, the majority of which are designed to produce proof-of-concept clinical data. Positive results from these trials would create significant value and partnering opportunities.
TG4010 + Opdivo (ICI) (nivolumab) +chemotherapy Phase 2 Non-small cell lung cancer (NSCLC) – 1 st line Trial of TG4010 in combination with nivolumab and chemotherapy in patients whose adenocarcinoma cells express low or undetectable levels of PD-L1. ✓ Recruitment is progressing well in US and EU with the opening of additional centers in EU; recruitment completion expected in Q2 2019 ✓ Bristol-Myers Squibb supplying nivolumab through a clinical collaboration  Data on the study’s primary endpoint (ORR) on all evaluable patients(n=35) expected in H2 2019 Pexa-Vec + sorafenib (PHOCUS) Phase 3 Advanced liver cancer (hepatocellular carcinoma-HCC) – 1 st line ✓ Clinical trial being conducted by Transgene’s partner, SillaJen, Inc. (sponsor) ✓ Ongoing global recruitment  Futility analysis expected mid-2019  First efficacy readout expected in 2020 Pexa-Vec + Opdivo (ICI) (nivolumab) Phase 1/2 Advanced liver cancer (hepatocellular carcinoma-HCC) – 1 st line ✓ Several active trial sites in France and Italy ✓ Safety confirmed by Safety Review Committee (SRC) in February 2019, Phase 2 part on-going ✓ US sites to be activated in Q2 2019  Interim analysis on 15 patients expected 2H 2019 (primary endpoint: ORR) ✓ TG4001 + Bavencio (ICI) (avelumab) Phase 1/2 HPV-positive cancers including oropharyngeal head and neck cancer – 2 nd line ✓ Clinical collaboration agreement with Merck KGaA and Pfizer, for the supply of avelumab ✓ Following positive SRC the Phase 2 part is ongoing and additional sites are being activated in Europe  Next clinical readout expected in H2 2019 Page 3 / 13 TG6002 Phase 1/2a TG6002 is the first candidate from Transgene’s next generation oncolytic platform which is based on an improved viral backbone. This oncolytic virus, given in combination with the prodrug 5-FC, has been designed to produce the cytotoxic 5-FU locally in the tumor Gastro-intestinal adenocarcinoma (colon cancer for Phase 2) – IV route ✓ Multi-center trial on-going in Belgium, France and Spain  First clinical readout expected in H2 2019 Metastatic colon cancer (liver metastasis) – IHA route ✓ Coordinating investigator: Adel Samson, St James’s Hospital, Leeds (UK) ✓ Multi-center trial in UK; INDs submitted in UK  First patient expected to be treated in Q4 2019 TG1050 + Standard of care Phase 1 Chronic hepatitis B ✓ Trial completed  Positive results from Phase 1 clinical trial of TG1050 in Chronic Hepatitis B presented at the AASLD Liver Meeting 2018: confirmation of safety, and immunogenicity  Transgene is looking for partner to further advance this product TG4050 Two Phase 1 in preparation ✓ TG4050 is a therapeutic vaccine developed for individual patients, based on the specific mutations identified in the patient’s own tumor ✓ Collaboration with NEC; Transgene and NEC will co-finance 2 trials in: Ovarian cancer (after first line surgery and adjuvant therapy)  First patient expected Q4 2019 (evaluation of safety and immunogenicity)  Trial will be conducted in the US and France HPV-negative head & neck cancer (after surgery and adjuvant therapy)  First patient expected in Q4 2019 (evaluation of safety and immunogenicity)  Trial will be conducted in the UK and France

Transgene’s Cutting-edge Oncolytics and Vaccine Platforms Poised to Change the Treatment of Solid Tumors In 2018, Transgene significantly reinforced its preclinical capabilities, capitalizing on its global leading viral vector expertise in two of the most attractive fields of onco-immunotherapy: oncolytic viruses (OV) and therapeutic vaccines.

With Invir.IO, its new and more potent oncolytic virus platform Transgene is designing multi-functional OVs that it believes will deliver a step change in the treatment of advanced solid tumors. This is still an area of significant medical need despite the rapid growth in the use of immune checkpoint inhibitors either alone or in combination with other anti-cancer agents.

With myvacTM its individualized immunotherapy platform, Transgene is developing therapeutic vaccines designed for each individual patient which are expected to deliver improved outcomes in patients with less advanced solid tumors, as an adjuvant therapy following surgery for the first proof of concept trials. The lead candidates from both platforms are expected to enter clinical development in the next 12 months. Page 4 / 13 Invir.IOTM: the next generation of multifunctional oncolytic viruses to treat advanced solid tumors With Invir.IOTM, Transgene is making good progress in the increasingly attractive field of novel oncolytic viruses (OVs). Oncolytic viruses are an emerging class of targeted anticancer therapies designed to selectively infect, replicate in, and lyse malignant cells without causing harm to normal, healthy tissues. In addition to direct oncolytic activity, OVs have shown dual promise as immunotherapeutic agents: the viral infection leads to an immunogenic tumor cell death, triggers innate and adaptive immune responses that mediate further tumor destruction and these viruses can also deliver very potent immunotherapeutic agents selectively in the tumor micro environment. Transgene expects its Invir.IO viruses to deliver a step change on these two fronts.

The Invir.IO platform is designed to generate novel multifunctional oncolytic virus that has a more potent oncolytic viral backbone and incorporate several transgenes encoding for a range of specific anticancer weapons that are capable of better modulating the tumor micro-environment, with the aim of improving the treatment outcomes of patients with solid tumors.

In November 2018, Transgene presented positive data of its antibody-armed oncolytic vaccinia virus at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). This oncolytic vaccinia virus has demonstrated its ability to ensure the expression of BioInvent’s anti-CTLA-4 antibody in the tumor with low systemic exposure. It also showed improved efficacy and a better safety profile compared to the combination of the antibody and the non-armed corresponding oncolytic virus in pre-clinical models.

The Company is progressing very well in developing its large preclinical portfolio of candidates. We are committed and on track to bring to the clinic the OV encoding an anti-CTLA-4 antibody (collaboration with BioInvent), as well as at least one other OV encoding for an anti-cancer agent in H1 2020.

myvacTM: New generation of individualized immunotherapy using Transgene’s unique MVA based platform

In September 2018, Transgene announced the launch of its myvacTM platform, which has been designed to produce individualized, MVA-based immunotherapies that stimulate and educate the immune system of patients to recognize and destroy tumor cells.

The personalized immunotherapy product is based on the mutations that are identified in the patient’s own tumor. These mutations are highly relevant targets since they lead to the expression of tumor neoantigens which are known to trigger a stronger immune response than tumor associated antigens.

In March 2019, Transgene formalized its strategic collaboration with NEC aimed at treating cancer patients. NEC’s artificial intelligence algorithms will be used to predict which of the tumor neoantigens identified by sequencing in a given patient’s solid tumor are the most appropriate neoantigens to integrate into the genome of the viral vector (MVA). Transgene will design and manufacture a personalized vaccine for the treatment of this specific patient using the myvacTM technology.

NEC will co-finance the first two clinical studies that Transgene will conduct with the lead myvac vaccine TG4050. These two clinical trials will be conducted in Europe and in US, in patients with HPV-negative head and neck cancers and ovarian cancer. Both trials are expected to start in Q4 2019.

Transgene has developed and validated its PilotClin manufacturing unit in order to efficiently produce GMP batches of its personalized vaccines. Several research tracks are also being pursued to optimize further the immunogenicity of the myvacTM therapeutic vaccines. Page 5 / 13

In March 2019, the NEOVIVA project which supports the industrial development of the myvacTM platform, was awarded a grant from Bpifrance’s ‘Investments for the Future’ program. Under the agreement, Transgene will receive €2.6 million over the five-year duration of the program from Bpifrance. The NEOVIVA project aims to further develop this innovative technology in collaboration with its three partners: HalioDx, Traaser and the Curie Institute. The NEOVIVA project complements the already existing collaboration between Transgene and NEC.

Sale of the Rights of TG1050 and TG6002 in Greater China

On July 10, 2018, Transgene entered into a set of agreements with Tasly Biopharmaceuticals Co., Ltd. (‘Tasly’) under which Transgene sold both the T101 Greater China patent rights and its entire 50% stake in the Transgene Tasly (Tianjin) joint venture which already owned the T601 Greater China patent rights. Following these
agreements, Tasly now holds all rights to research, develop and commercialize T601 and T101 in Greater China.
In return, Transgene received a total of 27.4 million new Tasly shares valued at $48 million (€41 million) based on the subscription price in pre-IPO financing round of Tasly, which took place concurrently with the transaction with Transgene. Transgene’s stake represents 2.53% of Tasly’s expanded share capital. Tasly has announced its intention to list its shares on the Hong Kong Stock Exchange. The transactions were finalized in August 2018.

NB: T601 and T101 are products developed in China and respectively incorporating Transgene’s TG6002 and TG1050 patented technologies.

€20 million revolving credit facility secured with Natixis Transgene has recently secured a €20 million loan (revolving credit) facility with Natixis, the French Corporate and Investment bank. The interest-bearing facility will have a 30-month term and Transgene will be able to draw and reimburse the facility at its discretion during the term. Transgene has used its shares in the Chinese biotech company Tasly as collateral for this loan.

Key Financials-

Net profit of €8.0 million in 2018, compared to a loss of €32.3 million in 2017. The net profit that Transgene achieved in 2018 was mainly generated by the transaction with Tasly Biopharmaceuticals Co., Ltd.-Net operating expenses of €35.5 million in 2018, compared to €36.1 million in 2017-Net cash burn for 2018 was reduced to €24.5 million compared to €28.1 million in 2017-Cash available at year-end 2018: €16.9 million, compared to €41.4 million at the end of 2017 "In 2018 we were able to continue a high level of investment in our clinical and per-clinical programs while at the same time reducing our cash burn via prudent financial management. Operating costs remain under good control and following the recent financing agreement with Natixis we now have extended our financial visibility until mid-2020." said Jean-Philippe Del, Vice President, Finance.

The financial statements for 2018 as well as management’s discussion and analysis are attached to this press release (Appendices A and B). Page 6 / 13

Financial Outlook 2019 Transgene expects its cash burn for 2019 to be between €25 million and €30 million. The Company has the financial resources to execute its strategy through to mid-2020.

The Board of Directors of Transgene met on March 20, 2019, under the chairmanship of Philippe Archinard and closed the 2018 financial statements. Audit procedures have been performed by the statutory auditors and the delivery of the auditors’ report is ongoing. The Board will convene Transgene’s annual general meeting of shareholders for May 22, 2019 and proposes to renew all four directors whose terms are set to expire at that meeting. The Board of directors was informed of the decision of Mr Alain Mérieux to retire from his board seat effective as of the AGM on May 22, 2019. The Board thanks Mr Mérieux for his long-time continued support of Transgene and has named Mr Mérieux Honorary President of Transgene in recognition of his contributions. The Board has proposed the nomination of Mr Hedi Ben Brahim, Vice President for immunotherapy at Institut Mérieux, to fill the seat vacated by Mr Mérieux.

The Company’s registration document, which includes the annual financial report, will be available in April 2019 on Transgene’s website, www.transgene.fr.

A conference call in English is scheduled today, on March 20th at 6:30 p.m. CET Webcast link to English language conference call: View Source Participant telephone numbers: France: +33 (0) 1 7099 4740 UK (Toll Free): 0808 109 0700 US (Toll Free): +1 866 966 5335 Password: Transgene A replay of the call will be available on the Transgene website (www.transgene.fr) following the live event. Contacts Transgene: Jean-Philippe Del +33 (0)3 88 27 91 04 [email protected] Media contacts: Citigate Dewe Rogerson EU : David Dible/ Sylvie Berrebi US : Marine Perrier-Barthez + 44 (0)20 7638 9571 / +1 424 341 9140 [email protected]