On June 22, 2021 TRexBio, a discovery stage company decoding human tissue immune biology to create revolutionary therapeutics, reported the successful close of the final tranche of a $59 million Series A financing (Press release, TRexBio, JUN 22, 2021, View Source [SID1234584249]). Proceeds from the financing will be used to expand the company’s unique discovery platform that maps human tissue regulatory T cell (Treg) behavior to dysregulation in disease, and to advance its six preclinical therapeutic programs. Investors include Eli Lilly and Company (Lilly), SV Health, Johnson & Johnson Innovation, Pfizer Ventures, and Alexandria Venture Investments.

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"The continued support from our investors further validates our approach to creating breakthrough therapeutics," said Carol Gallagher, Pharm.D., Executive Chair of TRexBio, and former President and CEO of Calistoga Pharmaceuticals. "We look forward to working with our investors and our academic and industry collaborators as we continue to create and advance a robust pipeline that addresses serious illnesses including cancer and auto-immune diseases."

TRexBio also announced the appointment of Johnston Erwin as Chief Executive Officer, and Ovid Trifan, M.D., Ph.D., as Chief Medical Officer, as part of the company’s plan to accelerate growth. Johnston, a seasoned industry veteran with experience in business development, venture investment, collaboration management, and clinical and regulatory development, joins TRexBio after a 36 year career with Lilly. He most recently served as VP of Corporate Business Development leading Lilly’s internal venture portfolio.

"TRex is at the forefront of one of the most exciting new areas in immunobiology and tissue homeostasis," said Johnston. "The company has a significant foundation in place, with a compelling vision, dedicated team and robust science. I am excited to lead the company into its next stage of development and ultimately transform the lives of patients by bringing a new generation of immune-based therapies to the world."

Dr. Trifan brings more than 20 years of medical research experience to TRexBio. Most recently he was the Chief Medical Officer and VP of Development at Apexigen, a clinical stage biotech company focused on immuno-oncology. Prior to Apexigen he held senior roles in clinical research at leading pharmaceutical companies including Bristol Myers Squibb and Johnson & Johnson, where he contributed to the development of multiple successful oncology drugs. Dr. Trifan will lead the advancement of TRexBio’s oncology programs into the clinic by the end of next year.

Mr. Erwin and Dr. Trifan are joined on the management team by Chief Scientific Officer Melanie Kleinschek, DVM, Ph.D., who has led the development of TRexBio’s unique ‘deep biology’ discovery platform. The platform uses high-resolution profiling of human tissue, modern computational biology tools, a proprietary system to generate tissue-like Tregs and disease-relevant phenotypic assays to generate novel insights into human tissue biology.

TRexBio’s accomplishments to date include:

Foundational collaborations with Lilly and the University of California San Francisco.
Advancement of six preclinical therapeutic programs across immuno-oncology and inflammation, two of which are on track to name development candidates in the next 12 months.
Identification of more than 20 novel tissue-focused targets from its proprietary ‘deep biology’ platform
The company works with an internationally recognized team of founding scientific advisors, including

Michael D. Rosenblum, M.D., Ph.D., Professor of Dermatology, Vice Chair of Research UCSF, and Co-Founder of Delinia Therapeutics;
Houman Ashrafian, BM Bch, DPhil, Managing Partner at SV Health Investors and former VP, Head of Clinical Science at UCB;
Adil Daud, M.D., Professor, Department of Medicine, Hematology/Oncology Director Melanoma Clinical Research, UCSF;
Diane Mathis, Ph.D., Professor in the Department of Immunology at Harvard Medical School, and holder of the Morton Grove-Rasmussen Chair in Immunohematology; and
Allison Simmons, M.D., Ph.D., Professor of Gastroenterology and Director of the MRC Human Immunology Unit at the University of Oxford.

On June 22, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, ("Transgene" or the "Company") reported the successful completion of its capital increase through the issuance of ordinary shares through a private placement with waiver of preferential subscription rights, via an accelerated bookbuilding pursuant to Articles L. 225-136 of the French Commercial Code and L. 411-2 1° of the French Monetary and Financial Code for an amount of approximately 34,1 million euros (the "Capital Increase") (Press release, Transgene, JUN 22, 2021, View Source [SID1234621817]).

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Hedi Ben Brahim, Chairman and CEO of Transgene, said: "We are very pleased to have concluded this successful fund raising, which has been supported by both historical shareholders and specialized healthcare investors, such as Invus. We are now well placed to execute on our ambitious corporate strategy of progressing our world leading myvac and Invir.IO technology platforms through first clinical validations of our personalized cancer vaccine TG4050 and our novel oncolytic virus BT-001 while advancing our randomized Phase II of TG4001. Transgene’s future has never looked brighter, and I am looking forward to the multiple key value-driving corporate milestones, we expect to announce over the next 18 months."

The capital increase results in the issuance of 13,930,000 new ordinary shares at a subscription price of 2.45 euros (including issue premium), representing 16,6 % of the current share capital of the Company for a total amount of approximately 34,1 million euros. The subscription price represents a discount of 6.5% compared to the closing price of Transgene on June 21, 2021 (€2.62).

Institut Mérieux, which currently holds 99.5% through its subsidiary TSGH, 60% of the company’s share capital, and SITAM Belgium, which holds 4.9% of the company’s share capital, subscribed for new ordinary shares in the capital increase for a total amount of 25 million euros and 1,67 million euros, respectively. Several specialized healthcare investors, including Invus, also participated in the Offering.

As a result of the Capital Increase, the company’s share capital will be made up of 97,771,334 shares, each having a nominal value of €0.50, for a total share capital of 48,885,667 euros.

The funds raised in the Capital Increase will be used to strengthen the Company’s financial structure until the fourth quarter of 2023, in order to be able to conduct its clinical development plan, in particular on its new innovative product platforms myvac and Invir.IO, with the finalization of clinical studies, and to be able to serenely negotiate partnership and codevelopment agreements based on the results obtained from the end of 2021.

Funds will be directly used by descending order of strategic priority:
• circa €25m for the finalization of clinical studies and the obtention of data with TG4001, TG4050, BT-001 and TG6002;
• circa €4m to launch the clinical development of new oncolytic viruses based on the Invir.IO platform and currently undergoing preclinical evaluation;
• for the remainder, to finance, together with operational products of the Company, R&D and operational costs, as well as current cash consumption.

The transaction will be carried out under the 22nd resolution of the Combined General Shareholders’ Meeting of May 27, 2020. The Capital increase was the subject of a placement agreement entered into by the Company and the Global Coordinators on June 21, 2021. The placement agreement may be terminated by the Global Coordinators at any time up to (and including) the settlement date of the Capital Increase which is expected to take place on June 24, 2021, subject to certain customary conditions. Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Canada, Australia or Japan

To the Company’s knowledge, the breakdown of its share capital after the Capital Increase is as follows

(1): (1) On a non-diluted basis: before the potential exercise of the 41,352 stock-options outstanding as of the date of this press release and representing 0,0004% of both share capital and voting rights of Transgene.

SHAREHOLDERS’ SUBSCRIPTION AND LOCK-UP AGREEMENTS TGSH and SITAM Belgique have agreed with the Global Coordinators for the contemplated transaction that they will not sell or transfer its shares of Transgene for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to the customary exceptions. In connection with the Capital Increase, the Company will enter into a lock-up agreement with the Global Coordinators for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to the customary exceptions.

RISKS FACTORS Transgene draws the attention of the public to:
• The risk factors presented in the Universal Registration Document; the materialization of any or all of these risks is likely to have a detrimental effect on the activity, financial situation, or the results of Transgene or on its ability to achieve its objectives.
• The main risks associated with the Capital Increase are the following: o the market price of the Company shares may fluctuate and fall below the subscription price of the new shares; o due to stock market fluctuations, the volatility and liquidity of the Company shares may vary significantly; o the sale of Company shares may occur on the secondary market, after the capital increase, and have a negative impact on the Company share price; o regarding the use of the expected proceeds of the issuance within the context of the Capital Increase, the Company has room for maneuver as to the use of the funds raised and could use them in a way that the shareholders may not adhere to or that would not increase the value of their investment in the short term; and o a new market-based call by the Company, after the Capital Increase, could result in further dilution for the investors.

On June 22, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or Company), reported that it has received commitments for a A$60 million two-tranche private placement of new ordinary shares (New Shares) to professional, institutional and sophisticated investors (Placement) (Press release, Immutep, JUN 22, 2021, View Source [SID1234584214]).

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The first tranche of the Placement will be completed without shareholder approval. The second tranche of the Placement is subject to shareholders approval.

Use of Funds

The Company will use the proceeds received from the Placement to fund the expansion of its clinical programs and to commence the process characterisation and process validation for efti commercial manufacturing (2,000 litre scale). The proceeds received from the Placement will also be used for the offering costs and working capital purposes.

Placement

The Placement will involve the issue of New Shares at an issue price of A$0.52 per New Share (representing a 12.9% discount to the volume weighted average price (VWAP) of the Company’s ordinary shares as traded on ASX over the 30 days up to and including June 16, 2021). The New Shares issued under the Placement will rank equally with existing Immutep ordinary shares on issue with effect from their date of issue.

Settlement of the first tranche of the Placement is expected to occur on June 25, 2021, with the issuance of New Shares expected to occur on June 28, 2021.

Assuming Shareholder Approval is obtained for the completion of the second tranche of the Placement, settlement is expected to occur on July 29, 2021, with the issuance of New Shares expected to occur on July 30, 2021.

Share Purchase Plan

Following completion of the issue of the first tranche of the Placement, Immutep will conduct an offer of New Shares under a non-underwritten share purchase plan (SPP) to existing shareholders in the Company with a registered address in Australia and New Zealand as at 7.00pm (Sydney, Australia time) on June 18, 2021.

The SPP will provide each Eligible Shareholder with the opportunity to apply for up to A$30,000 of New Shares at the price payable per New Share in the Placement. The SPP is targeting to raise approximately A$5 million. The SPP is expected to close at 5.00pm (Sydney, Australia time) on July 22, 2021.

On June 22, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it has rescheduled the Company’s fireside chat being hosted by H.C. Wainwright, which was previously scheduled for today, to July 12, 2021 at 11 a.m. Eastern Time (Press release, Phio Pharmaceuticals, JUN 22, 2021, View Source [SID1234584230]). Details regarding the rescheduled fireside chat will be forthcoming.

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On June 22, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the Phase 3 ORIENT-15 study met the predefined overall survival primary endpoint. ORIENT-15 is a global randomized, double-blind, multi-center clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, Innovent Biologics, JUN 22, 2021, View Source [SID1234584250]).

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Based on an interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy regardless of PD-L1 expression status. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab, and no additional safety signals were identified. These results will be presented at an upcoming medical meeting.

The principal investigator of the ORIENT-15 study, Prof. Shen Lin from Peking University Cancer Hospital and Institute stated, "More than half of new and fatal cases of esophageal cancer in the world occur in China every year. In China, esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer, and squamous cell carcinoma (ESCC) is the predominant histologic type. Treatment options for people with ESCC are limited. Chemotherapy is currently the main treatment for ESCC and, in recent years, immunotherapy has brought new hope in the treatment of this type of cancer, with some PD-1 inhibitors receiving approval as a second-line treatment for patients with ESCC in China. We are encouraged by these interim results of the ORIENT-15 study which demonstrated that sintilimab in combination with chemotherapy prolonged overall survival in the first-line treatment of patients with ESCC, regardless of PD-L1 status."

Dr. Zhou Hui, Senior Vice President of Clinical Development of Innovent, stated: "The treatment options for locally advanced or metastatic ESCC are limited and represent a significant unmet clinical need. ORIENT-15 is the largest clinical study of sintilimab conducted by Innovent to date. Despite the COVID-19 pandemic, the joint effort of the study’s investigators and broader team have enabled us to reach this milestone. We would like to express our sincere gratitude to all the patients who participated in the ORIENT-15 study. We hope these results can help to provide a new treatment option for patients with ESCC."

About the ORIENT-15 Study

ORIENT-15 is a global randomized, double-blind, multi-center Phase 3 clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil [5-FU]), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ClinicalTrials.gov, NCT03748134). At the time of interim analysis, a total of 659 eligible patients were enrolled and randomly assigned into the experimental group or control group in a 1:1 ratio. Patients were enrolled regardless of PD-L1 status. The primary endpoints included overall survival in all randomized patients and overall survival in PD-L1 positive (defined as CPS ≥10) patients.

About Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer is one of the most common malignant tumors worldwide that begins in the inner layer (mucosa) of the esophagus, which connects the throat to the stomach. Based on GLOBOCAN 2020 estimates, approximately 600,000 new cases of esophageal cancer are diagnosed and approximately 540,000 deaths result from the disease globally. Esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. More than half of new and fatal cases of esophageal cancer in the world occur in China. In China, it is estimated there were approximately 320,000 new cases of esophageal cancer diagnosed and approximately 300,000 deaths resulting from the disease in 2020. Esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer in China, which has a five-year survival rate of only 30 percent.

The two main types of esophageal cancer are squamous cell carcinoma (SCC) and adenocarcinoma. In China, SCC is the predominant histologic type – accounting for more than 90 percent of all esophageal cancer. Currently, first-line standard systemic therapy in China is chemotherapy based on platinum drugs for unresectable, locally advanced recurrent or metastatic ESCC. There have been a few PD-1 inhibitors recently approved for the second-line treatment of patients with ESCC.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for three indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
Additionally, Innovent currently has regulatory submissions under review in China for sintilimab:

In combination with BYVASDA (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma
The second-line treatment of squamous non-small cell lung cancer
Innovent also has two clinical studies that have met primary endpoint for sintilimab:

in combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma
The second-line treatment for esophageal squamous cell carcinoma
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.