EOC Pharma (Thaizhou) Co., Ltd.

Switzerland-based VectivBio Holding AG is acquiring privately-held Comet Therapeutics, which focuses on the development of drugs aimed at previously untreatable inherited metabolic diseases. With the acquisition, VectivBio will see a significant expansion of its rare disease pipeline. The CoMET platform gained through this acquisition is aimed at the treatment of inherited metabolic diseases that have a deficit of energy metabolism and depletion of functional Coenzyme A (CoA). The modular technology has the potential to address multiple previously untreatable IMDs by targeting the key cellular dysfunctions that underlie these conditions. This approach is expected to overcome important limitations of standard of care and has the potential to prevent the clinical progression of IMDs, VectivBio said in a statement. There are already four distinct programs currently in research, with plans to enter the clinic with the first program in the next 18 months, the company added. Under the terms of the agreement, VectivBio will acquire Comet Therapeutics in exchange for equity and cash, as well as additional milestone payments that were not disclosed. “The acquisition of the CoMET platform is in line with our core mission of developing disease-modifying treatments for rare severe diseases,” Luca Santarelli, founder and chief executive officer of VectivBio, said in a statement. “The platform’s potential to deliver a pipeline of medicines that target the fundamental molecular pathophysiology of IMDs by unlocking previously inaccessible pathways, would provide us with the opportunity to transform the lives of these patients. We are eager to begin work on our new programs and look forward to progressing our first candidate towards the clinic.” Elsewhere around the globe: AlzeCure Pharma – Sweden’s AlzeCure Pharma AB received approval from Swedish regulators to initiate a Phase I study of ACD856 focused on Alzheimer's disease. The Phase I study is AlzeCure's third clinical study with ACD856, the lead candidate drug within the company’s NeuroRestore platform. ACD856 is being developed as a symptom-relieving treatment for disease states where the cognitive ability is impaired. The primary study goal is to evaluate ACD856’s tolerability and safety after repeated dosing, as well as to examine early signals on brain activity. Meletios Therapeutics – French biotech Meletios Therapeutics announced a financial round that raised €3.8 million to accelerate its research programs aimed at identifying and developing a new generation of antiviral treatments. The financial infusion will allow Meletios to finalize a proof-of-concept study for its first product and will help the company to rapidly launch a first clinical trial, while pursuing the research and development of new innovative antiviral compounds. TISSIUM – Also based in France, TISSIUM closed a Series C financing round that brought in €50 million from new and existing international investors. The financing will allow TISSIUM to continue to execute on its development plan, funding the company up to the commercialization of its leading nerve repair, hernia repair and cardiovascular sealant products. CellCarta – Sweden-based CellCarta and Olink Proteomics AB announced a strategic collaboration that will provide Olink with Target 96 & Target 48 to pharmaceutical and biotech customers, advancing targeted protein biomarker quantification in clinical studies. With the acquisition of the first Olink Signature Q100 instruments and the collaborative support of Olink, CellCarta becomes the first global clinical CRO to offer the technology. The Olink platform offers a high-multiplex technique to quantify protein biomarkers that uses minimal clinical sample volume. AC Immune – Switzerland’s AC Immune SA announced that Roche subsidiary Genentech saw positive data with its licensed anti-tau monoclonal antibody, semorinemab, in mild-to-moderate Alzheimer’s disease. Semorinemab met one of its co-primary endpoints in a clinical study, although a second co-primary endpoint was not met. Safety data showed that semorinemab is well tolerated with an acceptable safety pro no unanticipated safety signals. Semorinemab demonstrated a statistically significant reduction in cognitive decline from baseline by 43.6% compared to placebo. Immutep Limited – Australia-based Immutep announced its Chinese partner EOC Pharma will expand its clinical trial pipeline for eftilagimod alpha in that country. EOC is preparing to initiate a clinical trial of efti in combination with an anti-PD-1 therapy. The new trial is expected to commence in the first half of calendar year 2022. The new trial builds on the latest promising data presented by Immutep at ASCO 2021 and on EOC’s previously announced Phase II trial evaluating efti in combination with chemotherapy in metastatic breast cancer patients. Relief Therapeutics – Switzerland’s RELIEF Therapeutics Holding announced additional findings in a Phase IIb/III study conducted by U.S. partner NRx Pharmaceuticals. The study assessed Zyesami (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. The new analysis shows that patients treated with Zyesami demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. NRx will seek Breakthrough Therapy designation from the U.S. Food and Drug Administration. If granted, RELIEF believes this could confer Priority Review to the aviptadil New Drug Application, when submitted. FairJourney Biologics – Portugal-based FairJourney Biologics S.A. has relocated into a larger, newly purpose-built research center in Portugal. The new premises support the company’s expansion and plans for further growth. FairJourney Biologics now occupies over 200,000 square feet, with the new premises containing 140 fully equipped laboratories, meeting rooms and social areas, as well as green spaces and leisure areas to promote employee well-being. The state-of-the-art facility will house more projects and industry-leading equipment, enabling the company to support more clients and carry out world-class research into antibody-based drugs.

Highlights Sydney, AUSTRALIA, April 19, 2021 (GLOBE NEWSWIRE) --  Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, provides an update on the ongoing development of its product candidates, eftilagimod alpha (“efti” or “IMP321”) and IMP761, and the activities of its partners for the quarter ended March 31, 2021. “We continue to lead the world in the development of different LAG-3 related therapies, with a robust pipeline of exciting clinical stage programs and promising data. Throughout the quarter ended 31 March 2021, we have been extremely active advancing and expanding upon these clinical programs, building upon our data generated last year” said Marc Voigt, CEO of Immutep. “We are well-positioned for long-term success, as we have a steady stream of positive data advancing our clinical studies, and decades of experience across our clinical team, which includes the discoverer of the LAG-3 immune control mechanism, as well as a strengthened balance sheet.” “There has recently been broad industry coverage of positive Phase II/III data from another company’s LAG-3 program to treat melanoma, which we’re pleased to say further validates targeting the LAG-3 pathway to enhance the immune response. While they have additional data to announce, what has been discussed to-date further supports our knowledge of the LAG-3 mechanism and is in line with our MSD collaboration to develop a combination of KEYTRUDA® with efti. This year is shaping up to be an exciting period for the clinical development of LAG-3 therapies,” added Dr. Frederic Triebel, CSO/CMO of Immutep. Efti Development Program Updates Intellectual PropertyImmutep recently further strengthened its IP profile for lead active immunotherapy candidate efti, which is a soluble LAG-3 fusion protein (LAG-3Ig). In particular, in March 2021, the United States Patent & Trademark Office granted a new patent number 10,940,181, which is entitled “Combined Preparations for the Treatment of Cancer or Infection”. The patent was filed as a divisional application and follows the grant of the parent patent announced on 30 December 2020. The claims of this new patent build on the protection provided by the parent patent and are patent protecting Immutep’s methods of treating cancer by administering efti and a PD-1 pathway inhibitor: either pembrolizumab (KEYTRUDA®) or nivolumab. The expiry date of the patent is 20 January 2036 (including a patent term adjustment of 12 days). TACTI-002 (Two Active Immunotherapies, also designated KEYNOTE-798) - Phase II clinical trial The TACTI-002 study is evaluating the combination of efti with KEYTRUDA® (pembrolizumab), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada), in first and second line non-small cell lung cancer (NSCLC) and second line head and neck squamous cell carcinoma (HNSCC). This study is being conducted in collaboration with MSD, which refers to the study as “Keynote-798”. Patients participate in one of three parts: Part A - First Line NSCLC, PD-X naiveRecruitment of an additional 74 first line NSCLC patients was initiated in accordance with Part A of the TACTI-002 collaboration trial expansion plans announced on 19 November 2020, adding to the 36 patients already enrolled prior to the expansion. Immutep and MSD expanded Part A of the TACTI-002 study following the encouraging results presented at the Society for Immunotherapy of Cancer's (SITC) Congress in November 2020. Part B - Second Line NSCLC, PD-X refractoryImmutep decided to expand Part B of TACTI-002, under the study’s Simon’s two-stage clinical trial design. The Company recently commenced recruitment of an additional 13 second line NSCLC patients, forming Stage 2 of Part B. The decision follows a preliminary safety and efficacy review by the Data Monitoring Committee and its recommendation, based on the patients recruited in Stage 1 of Part B. Part C - Second Line HNSCCThe last patient was safely dosed for Stage 2 of Part C of TACTI-002. This completes recruitment for Part C of the study. The Company continues to be excited by this study, as it recently announced encouraging interim data from TACTI-002 at the SITC 2020 Congress. Specifically, the data from second line HNSCC patients was very robust and forms an excellent basis for additional clinical development in this cancer type. Additional data from TACTI-002 is expected in H1 2021. TACTI-003 (Two Active Immunotherapies) - Phase IIb clinical trial - First Line HNSCCImmutep will also conduct a new randomised, controlled Phase IIb clinical study in approximately 160 first line HNSCC patients, which is a more commercially relevant indication than second line HNSCC. This study will evaluate the safety and efficacy of efti when given in combination with MSD’s KEYTRUDA®, compared to KEYTRUDA® alone. TACTI-003 will be executed in 20+ clinical sites in the United States, Australia and Europe, and study is expected to start in mid-2021. This is Immutep’s second collaboration with MSD for a combination of KEYTRUDA® and efti. EAT COVID - Phase II clinical trialThe investigator-initiated Phase II clinical trial being conducted by the University Hospital Pilsen in the Czech Republic advanced from the safety run and into the randomised portion of the study, which is evaluating efti in up to 110 hospitalised patients with COVID-19. In January 2021 Immutep reported that the independent Data Safety Monitoring Board (DSMB) had completed a safety run-in data review of the first six patients from the Phase II clinical trial of Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease (EAT COVID). Following this data review, the DSMB recommended that the study advance with enrolment for the randomised portion of the study. All six patients (age range, 50-83 years; 2 women and 4 men) received the three planned 10 mg efti injections and were since discharged from hospital with no adverse events reported. Partner Updates GlaxoSmithKline As announced in January 2021, GSK stopped its Phase II clinical trial evaluating GSK2831781 (derived from Immutep’s IMP731 antibody) in ulcerative colitis based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. Immutep’s collaboration with GSK remains in place and GSK2831781 continues to be under an exclusive license with GSK. Other PartnersSelected for its in-depth LAG-3 expertise and knowledge, Immutep entered into a Licence and Collaboration Agreement with Laboratory Corporation of America Holdings, known as LabCorp, to support its development of immuno-oncology products or services in October 2020. LabCorp co-authored with Bristol Myers Squibb an abstract released in March 2021 on the distribution and prevalence of LAG-3 expression in samples of melanoma and gastric/gastroesophageal junction cancer for the American Association for Cancer Research Annual Meeting 2021. Immutep’s other licensing partnerships with Novartis, EOC Pharma and CYTLIMIC continue to progress well. Financial Summary - Q3 FY21 Cash receipts from customers for the quarter was $59k, compared to $336k in Q2 (i.e. the quarter ended 31 December 2020). The net cash used in G&A activities in the quarter was $242k compared to $1.82 million in Q2. The significant decrease compared with last quarter is mainly due to the prepayment of certain annual expenses in Q2. G&A costs for the quarter includes $125k in payment of Non-Executive Director’s fees and Executive Director’s remuneration. The net cash used in Research and Development activities in the quarter was $1.74 million, compared to $3.18 million in Q2. Year to date cash flow used in R&D activities for the 9 months from July 2020 to March 2021 was $7.0 million compared to $16.1 million for the 9 months from July 2019 to March 2020. The decline is mainly due to the declining AIPAC expenses since patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase. The cash used in R&D activities is expected to increase with the commencement of the new Phase IIb TACTI-003 clinical trial. Total net cash outflows used in operating activities in the quarter was $3.05 million. In comparison, total net cash outflows from operating activities in Q2 was $5.58 million. The cash and cash equivalent balance as at 31 March 2021 was $51.7 million compared to a balance of $54.9 million as at 31 December 2020. Immutep is in an excellent financial position with a cash runway into calendar year 2023 and beyond several significant data read-outs. About Immutep Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer, infectious disease and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States. Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 protein, which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners. Further information can be found on the Company’s website or by contacting: Australian Investors/Media:Catherine Strong, Citadel-MAGNUS+61 (0)406 759 268; cstrong@citadelmagnus.com U.S. Media:Tim McCarthy, LifeSci Advisors+1 (212) 915.2564; tim@lifesciadvisors.com

Highlights Sydney, AUSTRALIA, Jan. 22, 2021 (GLOBE NEWSWIRE) --  Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, provides an update on the ongoing development of its product candidates, eftilagimod alpha (“efti” or “IMP321”) and IMP761, and the activities of its partners. “Immutep has entered calendar year 2021 in a very strong financial and operational position, following the encouraging clinical results announced for our lead product candidate, efti, last year. We have increasing confidence in efti and accordingly, three new efti trials or trial extensions with up to 386 patients in different cancer indications were announced or started in the quarter. We advanced our business development activity with MSD and signed a new LAG-3 agreement with LabCorp. Our engagement with regulatory bodies has continued and our IP position has been significantly strengthened; in addition, we are upscaling the manufacturing of efti to prepare for the future. Immutep is advancing strongly towards another step change in calendar year 2021,” said Marc Voigt, CEO of Immutep. Eftilagimod Alpha UpdatesFollowing a succession of very encouraging clinical trial results for efti reported throughout 2020, Immutep prioritised the process of scaling up the drug candidate’s manufacturing, increasing the process from 200L to 2,000L capacity bioreactors. Manufacturing is taking place at the WuXi Biologics manufacturing plant in Mashan, Wuxi, China. The major scale up steps are taking place throughout 2021. AIPAC - Phase IIb clinical trialImmutep reported first Overall Survival (OS) data (based on approximately 60% of patient events) from the AIPAC phase IIb trial in a spotlight presentation at the San Antonio Breast Cancer Symposium 2020 in December. The results included a promising and improving overall trend in OS with a median survival benefit of +2.7 months from efti plus chemotherapy, compared to chemotherapy plus placebo. In addition, a statistically significant OS benefit was observed in the efti group in key pre-defined patient groups. In patients under 65 years of age, a +7.1 months survival benefit was observed in the efti group which reported a median OS of 21.9 months vs. 14.8 months in the placebo group, reflecting nearly 50% longer survival. Similarly, in patients with a low starting monocyte count, a +9.4 months survival benefit was observed in the efti group, with a median OS of 22.4 months vs. 12.9 months in the placebo group, 74% longer. Importantly there was a statistically significant increase of cytotoxic CD8 T-Cells in the efti arm versus the control arm and patients with those increased cells had, in general, a better OS. It is the first time that an antigen presenting cell activator (APC activator) has delivered meaningful OS data in a randomised, double blind setting. The proportion of patient events has advanced to ~ 68% currently and Immutep is on track to report final OS data and Overall Response Rates (ORR) by mid calendar year 2021. TACTI-002 - Phase II clinical trial In November 2020, Immutep presented very encouraging results from its TACTI-002 phase II trial of efti at the Society for Immunotherapy of Cancer's (SITC) Congress. TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada) and is called Keynote-798 by MSD. More mature ORRs for Parts A and C were reported at SITC and continued to be very favourable. Immutep reported a 39.4% ORR in patients with 1st line Non-small Cell Lung Cancer (NSCLC) and 43.5% in patients with 2nd line head and neck squamous cell carcinoma (HNSCC), on an evaluable patient basis. Five patients (two with 1st line NSCLC and three with 2nd line HNSCC) reported a complete disappearance of all lesions, known as a Complete Response. First data from patients with 2nd line NSCLC (Part B) who are PD-1 resistant was also reported at SITC. This group showed encouraging efficacy for low PD-L1 expressing patients who do not typically respond to immune checkpoint (PD-L1) therapy. Following the encouraging results presented at SITC, Immutep and MSD expanded the TACTI-002 study by 74 additional patients with 1st line NSCLC, creating a stage 3 for Part A. Recruitment for this new stage opened in late December 2020. In addition, Immutep completed recruitment of 2nd line HNSCC patients for Part C of the trial in early January 2021. Further data from TACTI-002 is expected in H1 2021. Phase II Clinical Trial in Head and Neck CancerThe encouraging results reported by Immutep at SITC in patients with 2nd line HNSCC prompted the Company to announce its intention to run a new randomised, controlled phase II clinical study in approximately 160 1st line HNSCC patients which is a more commercially relevant indication. Patients will be 1:1 randomised to receive efti in combination with an anti-PD-1 treatment, or anti-PD-1 monotherapy. The trial is intended to take place across clinical trial sites in the United States, Australia and Europe. Immutep is continuing planning for this new trial and will announce further details in due course. TACTI-mel - Phase I clinical trialThe results of Immutep’s phase I TACTI-mel trial were recently published in the peer-reviewed Journal for ImmunoTherapy of Cancer. TACTI-mel evaluated efti in combination with pembrolizumab in metastatic melanoma patients. EAT COVID – Phase II clinical trialThe University Hospital Pilsen in the Czech Republic has commenced an investigator-initiated randomised phase II clinical trial evaluating efti in up to 110 hospitalised patients with COVID-19. Recruitment of patients commenced in October 2020. Initial results from the safety run in of the trial are expected to be reported in early 2021 with initial interim efficacy results in 2021. IMP761 Update IMP761, a LAG-3 agonist antibody, is Immutep’s preclinical candidate for autoimmune disease. The Company is continuing cell line and other preclinical development for IMP761 in preparation for clinical trials. Partner Updates EOC Pharma - Phase II clinical trialEOC Pharma announced its plans to conduct a new trial in December 2020, following Immutep’s announcement of encouraging first OS data from its Phase IIb study, AIPAC (see above). Approximately 152 patients will participate in EOC Pharma’s clinical trial which evaluates efti in combination with chemotherapy and is fully funded by EOC.  EOC Pharma is the exclusive licensee of efti for the Chinese market. The ethics committee of the leading clinical site has already approved the study. GlaxoSmithKline  As announced today, GSK has stopped its phase II clinical trial evaluating GSK2831781 (derived from Immutep’s IMP731 antibody) in ulcerative colitis based on the assessment of clinical data as part of a planned interim  analysis  conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program. Immutep’s collaboration with GSK remains in place and GSK2831781 continues to be under an exclusive license with GSK. The discontinuation of the GSK trial has no impact on Immutep’s three other product candidates all of which have different mechanisms of action, including its lead product candidate eftilagimod alpha. Immutep’s cash runway is also unimpacted. Other PartnersSelected for its in-depth LAG-3 expertise and knowledge, Immutep entered into  a  Licence  and  Collaboration Agreement with Laboratory Corporation of America Holdings, known as LabCorp, to support its development of immuno-oncology products or services in October 2020. Immutep’s other licensing partnerships with Novartis and CYTLIMIC continue to progress well. Intellectual Property During the quarter, Immutep was granted a new US patent for efti in combination with a PD-1 pathway inhibitor, such as pembrolizumab or nivolumab. The Company was also granted a new European patent for its pre-clinical candidate IMP761 and a new Australian patent for LAG525, a humanised form of Immutep’s IMP701 antibody which is out-licensed to Novartis. Financial Summary – Q2 FY21 Cash receipts from customers for the quarter was $336k, compared to $23k in Q1 (i.e. the quarter ended 30 September 2020). Cash receipts from government grants and tax incentives for the quarter was $34k, compared to $126k in Q1. The net cash used in G&A activities in the quarter was $1.82 million compared to $0.35 million in Q1. The significant increase compared with last quarter is mainly due to the prepayment of certain annual expenses. G&A costs for the quarter includes $248k in payment of Non-Executive Director’s fees and Executive Director’s remuneration. Total net cash outflows used in operating activities in the quarter was $5.58 million. In comparison, total net cash outflows from the operating activities in Q1 was $3.34 million. The net cash used in Research and Development activities in the quarter was $3.18 million, compared to $2.10 million in Q1. Year to date cash flow used in R&D activities for the 6 months from July to December 2020 was $5.3 million compared to $11.4 million for the 6 months from July to December 2019; the decline is mainly due to the declining AIPAC expenses since almost all patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase. In November 2020, the Company successfully raised $29.57 million via a placement which was supported by high-quality institutional investors in Australia and offshore. In December 2020, the Company received $10.66 million from the exercise of warrants over American Depository Shares. The cash and cash equivalent balance as at 31 December 2020 was $54.9 million compared to a balance of $22.7 million as at 30 September 2020. Immutep is in an excellent financial condition with a cash runway beyond end of calendar year 2022 and beyond several significant data read-outs. Its cash position is currently at its strongest since it started the LAG-3 developments. About ImmutepImmutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States. Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners. Further information can be found on the Company’s website or by contacting: Australian Investors/Media:Catherine Strong, Citadel-MAGNUS+61 (0)406 759 268; cstrong@citadelmagnus.com U.S. Media:Tim McCarthy, LifeSci Advisors+1 (212) 915.2564; tim@lifesciadvisors.com