On August 29, 2019 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers reported that Management will participate in the upcoming investor events set out below:

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H. C. Wainwright Annual Global Investment Conference: September 9 & 10, 2019 – New York, USA
Portzamparc Biotech Conference: September 10, 2019 – Paris, France
Large & Midcap Event: October 14 & 15, 2019 – Paris, France
Bryan Garnier Annual Healthcare Conference: November 12, 2019 – Paris, France
Actionaria: November 21 & 22, 2019 – Paris, France
Eigenkapital Forum: November 26 & 27, 2019 – Frankfurt, Germany

On August 29, 2019 Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, reported financial results for the second quarter ended June 30, 2019 and recent clinical progress (Press release, Akari Therapeutics, AUG 29, 2019, View Source [SID1234539160]).

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"We are pleased with the progress we have made advancing our BP, HSCT-TMA and AKC programs and are encouraged by the initial data we have received to date in these programs," said Clive Richardson, Chief Executive Officer of Akari Therapeutics. "Both AKC and BP have further planned clinical readouts this year, providing a potential opportunity for advancing both programs into pivotal trials in 2020 and further supporting the novel therapeutic role of combined C5 and LTB4 treatment. In addition, we are planning to start a pivotal clinical trial for HSCT-TMA in the fourth quarter of this year."

Second Quarter 2019 and Recent Business Highlights

Pediatric HSCT-TMA
The Company continues to progress towards a pivotal trial for HSCT-TMA with nomacopan, which is expected to start in the fourth quarter of 2019. This condition has an estimated 80% mortality rate in children with this severe disease, with currently no approved treatments. In a March 2019 meeting, a framework for the trial design was agreed with the U.S. Food and Drug Administration (FDA). In August 2019, the FDA granted Fast Track designation for nomacopan for the treatment of HSCT-TMA in pediatric patients.
Phase II clinical trial in patients with BP
Initial results from the first three patients with mild-to-moderate BP in the ongoing Phase II trial with nomacopan demonstrated a rapid reduction in BP Disease Area Index (BPDAI) score and blistering of 52% and 87%, respectively, by day 42. There were no drug related serious adverse events. The Company anticipates new safety and efficacy data in mild-to-moderate patients from this study to be given as an oral presentation at the the 28th European Academy of Dermatology and Venereology (EADV) Congress, October 10, 2019.
In early August, the Company announced new data demonstrating synergistic benefits of nomacopan’s dual C5 and LTB4 inhibitory activity in pemphigoid disease, generated by Dr. Christian Sadik’s group at University of Lubeck, Germany, and published in the August 2019 edition of JCI Insight [link].
Phase I/II clinical trial in patients with AKC
Successfully completed Part A of TRACKER, a Phase I/II clinical trial evaluating the safety and efficacy of topical nomacopan in patients with moderate-to-severe AKC. Results showed a rapid response and an overall improvement of 55% in the composite clinical score, which was composed of an improvement in symptoms of 62% and signs of 52% by Day 56. Three patients were treated with twice daily nomacopan eye drops in addition to standard of care for up to 56 days, with one patient completing 14 days and then withdrawing for reasons unrelated to the study. All patients had been on maximal topical cyclosporine, the standard of care, for at least three months prior to entry. The nomacopan eye drops were found to be comfortable and well tolerated with no serious adverse events. Enrollment in the Part B placebo-controlled efficacy arm in 16 patients continues to progress, with data read out planned for the fourth quarter of 2019.
Clive Richardson has been appointed permanent Chief Executive Officer of Akari after having served as interim Chief Executive Officer since May, 2018
Upcoming Events and Milestones

HSCT-TMA pivotal clinical trial expected to start in the fourth quarter of 2019.
Mild-to-moderate BP trial data to be presented at EADV Congress, October 10, 2019.
Completion of Part B of AKC Phase I/II trial by the fourth quarter of 2019.
Second Quarter 2019 Financial Results

Research and development (R&D) expenses in the second quarter of 2019 were $3.6 million, as compared to R&D expenses of $5.1 million in the same quarter the prior year. This decrease was primarily due to lower manufacturing expenses as the Company had previously manufactured clinical trial material for supply through 2019, which was slightly offset by higher clinical trial costs and personnel expenses. R&D expenses for the six months ended June 30, 2019 were $1.3 million reflecting the receipt of a Q1 R&D tax credit of $4.9 million.
General and administrative (G&A) expenses in the second quarter of 2019 were $2.4 million, as compared to $2.9 million in the same quarter last year. This decrease was primarily due to lower expenses associated with professional services, personnel and rent, partially offset by higher stock-based non-cash compensation expenses.
Total other income for the second quarter of 2019 was $1.9 million, as compared to total other expense of $43,000 in the same period the prior year. This change was primarily due to $2.0 million of higher income related to the change in the fair value of the stock option liabilities in 2019 compared to 2018, and to higher foreign exchange gains of approximately $39,000 in 2019 as compared to 2018.
Net loss for the second quarter of 2019 was $4.1 million, compared to a net loss of $8.0 million for the same period in 2018. The decrease in net loss in the second quarter of 2019 was due primarily to the change in the fair value of the stock option liabilities and foreign exchange gains previously cited, accompanied by lower operating expenses in the second quarter of 2019.
As of June 30, 2019, the Company had cash of $2.7 million, as compared to cash of $5.4 million as of December 31, 2018. On July 3, 2019, the Company sold to certain institutional investors, accredited investors and an existing shareholder, RPC Pharma Ltd., an affiliated entity of Dr. Ray Prudo, Akari’s Chairman, an aggregate 2,368,392 registered American Depository Shares (ADSs) of Akari at a purchase price of $1.90 per ADS, resulting in gross proceeds of approximately $4.5 million. Additionally, for each ADS purchased by investors, the investors received an unregistered warrant to purchase one-half ADS. The warrants have an exercise price of $3.00 per ADS, were exercisable upon their issuance and will expire five years from the issuance date.
As of June 30, 2019, the Company has sold to Aspire Capital Fund, LLC (Aspire Capital) a total of $2.0 million of ordinary shares. Subsequent to June 30, 2019, the Company sold to Aspire Capital a further $3.5 million of ordinary shares and approximately $14.5 million remains available for draw down under the purchase agreement entered into with Aspire Capital.

On August 29, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥1%) and who have not received prior chemotherapy for metastatic disease (Press release, Hoffmann-La Roche, AUG 29, 2019, View Source [SID1234539107]). Roche’s VENTANA PD-L1 (SP142) Assay is now CE marked and commercially available in the European Union as an aid for identifying patients with TNBC eligible for treatment with the Tecentriq combination.

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"For the past 30 years, we have been dedicated to transforming the lives of people with breast cancer. Now, we are pleased to build on this foundation with the news that the first immunotherapy treatment for triple-negative breast cancer is available to people in Europe with PD-L1-positive, metastatic triple-negative breast cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The European approval of this Tecentriq combination represents a significant step forward in the treatment of this aggressive breast cancer, where the unmet medical need is great."

This approval is based on the results from the Phase III IMpassion130 study. Progression-free survival (PFS) results demonstrated a statistically significant benefit for Tecentriq in combination with nab-paclitaxel and showed that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 38% compared with nab-paclitaxel alone (median PFS=7.5 vs 5 months; hazard ratio [HR]=0.62, 95% CI: 0.49-0.78, p<0.0001) in people who were tested positive for PD-L1 expression on tumour-infiltrating immune cells. At the second interim analysis, Tecentriq and nab-paclitaxel showed a clinically meaningful overall survival (OS) improvement of seven months vs placebo and nab-paclitaxel in the PD-L1-positive population (median OS=25.0 vs 18.0 months; HR=0.71, 95% CI: 0.54 –0.93). OS results in the PD-L1-positive population were not formally tested due to the hierarchical design of the study as statistical significance was not met for OS in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72–1.02, p=0.078).

The assessment of PD-L1 on tumour-infiltrating immune cells is essential for identifying the patients with TNBC benefiting from this Tecentriq combination. PD-L1 expression status in the IMpassion130 study was assessed by the VENTANA PD-L1 (SP142) assay.

Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The nature and incidence of severe adverse events (SAEs) and Grade 3–4 adverse events (AEs) were consistent with the known safety profiles of the individual study drugs or the underlying disease. SAEs were reported in 23% of people receiving Tecentriq plus nab-paclitaxel compared to 18% of people receiving chemotherapy alone. Grade 3–4 AEs were reported in 49% of people receiving Tecentriq plus nab-paclitaxel compared to 42% of people receiving chemotherapy alone.

Currently, there are seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease.

About the IMpassion130 study
The IMpassion130 study is a Phase III, multicentre, randomised, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer. The study enrolled 902 people who were randomised equally (1:1). The co-primary endpoints are PFS per investigator assessment (RECIST 1.1) and OS in the ITT population and in the PD-L1-positive population. Performing a test for statistical significance for OS in the PD-L1-positive population is dependent upon OS results from all randomised patients. Secondary endpoints include objective response rate and duration of response.

About triple-negative breast cancer
Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year.1 TNBC represents ~15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.2-4 It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification.5 Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer.3

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.

Our targeted medicines Herceptin, Perjeta and Kadcyla are continuing to transform the treatment of early and advanced HER2-postive breast cancer and, through our Tecentriq and ipatasertib clinical programmes, we hope to bring new treatment combinations to people with breast cancer, ultimately improving outcomes.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source

On August 29, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that Robert Bazemore, president and chief executive officer, will participate in the following September investor conferences (Press release, Epizyme, AUG 29, 2019, View Source [SID1234539124]):

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Citi 14th Annual Biotech Conference’s "Focusing the Laser on Precision Oncology – Part 2" Company Panel on Thursday, Sept. 5, 2019 at 9:30 a.m. ET in Boston; and,
Morgan Stanley 17th Annual Global Healthcare Conference (fireside chat) on Monday, Sept. 9, 2019 at 3:40 p.m. ET in New York City.
Live webcasts will be available in the investor section of the company’s website at www.epizyme.com. The webcasts will be archived for 60 days following the presentations.

On August 29, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC PINK: IPATF) today reports its financial results for the year ended April 30, 2019 (Press release, ImmunoPrecise Antibodies, AUG 29, 2019, View Source [SID1234539109]). The financial statements and related Management’s Discussion and Analysis ("MD&A") can be viewed on SEDAR at www.sedar.com.

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Financial Highlights:

Revenue: ImmunoPrecise achieved record annual revenue of $10,926,268 in fiscal 2019 compared to $5,441,349 in fiscal 2018. This represents a 100% increase in revenue as a result of its completed acquisitions of IPA Europe (formerly ModiQuest Research), and IPA’s ability to grow its core business and expand into higher revenue service offerings in therapeutic discovery.

Gross Margin: ImmunoPrecise increased its gross margin to $5,294,634 from $2,451,026 in 2019. In percentage terms, the Company’s gross margin increased to 48% from 45% in 2018. The higher margin in 2019 was mostly attributable to the Company’s increased focus on larger programs with higher margins at its new B-cell lab, as well as increased efficiencies in operations.

Net Loss: ImmunoPrecise recorded a net loss of $7,617,467 during the year ended April 30, 2019, compared to net loss of $5,171,103 for the year ended April 30, 2018. The net loss increased in 2019, primarily as a result of the acquisitions of U-Protein and IPA Europe, which required higher expenses in all facets of the business in order to manage a global landscape. $1,312,403 of the costs incurred during the year ended April 30, 2019, were one-time costs which are not expected to be incurred again.

Growth Initiatives in Fiscal 2020:

Asset Building: While CRO services remain the mainstay of the Company, ImmunoPrecise has worked continuously on building an intellectual property estate and portfolio of proprietary methods and physical assets through collaborations, joint ventures, acquisitions and in-licensing. The onboarding of existing assets with regard to equipment, technologies, IP and licenses within the Company’s EU operations has been compounded by active research and development at all operational sites this year. This includes the on-going development of new service offerings to be rolled out in the fiscal year 2020, but more notably, internal, discovery programs focused on novel, therapeutic antibodies, primarily in the field of immuno-oncology.

Talem Therapeutics: Recently, the Company formed Talem Therapeutics (Talem), based in Cambridge, Massachusetts, to support its internal, therapeutic, discovery programs. Talem is structured to secure assets during their discovery and development stage and seek out strategic partnerships with clinical-stage pharma and biotech companies, where it will aid in the out-licensing or sale of the therapeutics for clinical trials. The ability for investors to support individual assets or portfolios in Talem generates an asymmetrical opportunity for investments, while avoiding ImmunoPrecise’s shareholders dilution. The depth and speed of IPA’s offerings enables Talem to customize each program and leverages the Company’s expertise and technologies in antibody discovery.

Global Integration and Cost Synergies: ImmunoPrecise integrated IT services, including the global service desk, and decreased cost and risk while removing collaboration barriers, including tools that allow for communicating in different languages. They have also begun to capture synergies after the global integration of sales, marketing, R&D, management, and legal services. IPA has prepared for the integration of fundamental business services such as payroll, financial controls, and an Oracle suite of enterprise software. They will continue to enhance these integrations, as well as create synergies in additional areas such as M&A communications and tax integration.

B cell SelectTM and DeepDisplayTM : IPA Canada and IPA Europe have both been designated as approved CROs for the world’s leading, transgenic animal platform producing human antibodies, and exercised an advantage in optimizing services for various transgenic animal vendors. The Company made strategic investments in R&D activities to develop proprietary technologies enabling the application of their B cell SelectTM and DeepDisplayTM platforms to a broad range of transgenic animal species and strains.

The Market:

CRO Services and Therapeutic Development: In an attempt to streamline, many large pharmaceutical companies are limiting the number of external CRO vendors that can be contracted. This is particularly promising for those CROs that fill multiple niches in the discovery and manufacturing pipeline. The key players serving the monoclonal antibodies market are Pfizer, Inc., GlaxoSmithKline plc, Novartis AG, Merck & Co., Inc, Amgen, Inc., Abbott Laboratories, AstraZeneca, Eli Lilly and Company, Mylan N.V., Daiichi Sankyo Company, Ltd., Bayer AG, Bristol Myers Squibb Co., Johnson & Johnson Services, Inc., Biogen Inc., Thermo Fisher Scientific, Inc., Sanofi Genzyme, F. Hoffmann-La Roche Ltd., and Novo Nordisk A/S2. In 2016 alone, Novartis invested 9 billion USD and Pfizer invested 7.9 billion USD in R&D3. This is of little surprise given the global monoclonal antibody market was valued at USD 85.4 billion in 2015 and is expected to reach a value of USD 138.6 billion by 20241.

1 Healthcare Insights Life Sciences, CRO Sector Fundamentals Remain Hot for M&A Consolidation, July 3, 2019.
2Monoclonal Antibodies (mAbs) Market Size Worth $138.6 Billion By 2024, Nov. 2016
3Monoclonal Antibody Market 2019-2025 Growth, Key Players, Size, Demands and Forecasts, April 2019

"We continue to expand our therapeutic offerings as a global, full-service antibody provider to pharmaceutical and biotech companies internationally, and to accelerate our volume of large-scale, therapeutic programs. Simultaneously, IPA sets itself on a path of Antibody Discovery and IP estate-building through Talem Therapeutics, which will expand our clinical partnerships and continue to build our IP estate" commented Dr. Jennifer Bath, President and CEO of the Company.