Bellicum Pharmaceuticals to Participate in Jefferies 6th Annual IO Cell Therapy Summit

On March 27, 2019 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported participation in the Jefferies 6th Annual IO Cell Therapy Summit taking place in Boston (Press release, Bellicum Pharmaceuticals, MAR 27, 2019, View Source [SID1234534667]). Bellicum’s President & CEO Rick Fair and Head of Research, Aaron Foster, Ph.D., will provide an overview of the company and its development programs during a fireside chat on April 5, 2019 at 9:10 a.m. EDT.

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Theradiag reports its 2018 full-year results

On March 27, 2019 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specialized in in vitro diagnostics and theranostics, reported its consolidated full-year results for the financial year ended on December 31, 2018 approved by the Board of Directors on March 26, 2019 (Press release, Theradiag, MAR 27, 2019, View Source;utm_medium=rss&utm_campaign=theradiag-reports-its-2018-full-year-results [SID1234534665]).

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"The healthy increase in Lisa Tracker kit sales (up 17%) and the measures we took to reorganize the Company in late 2017 paid off in 2018, generating a major improvement in Theradiag’s performance. Before non-recurring items, we nearly broke even in 2018, with a net loss of €0.4 million. The brisk expansion in the Tracker business augurs very well for the future, and so the outlook for 2019 is bright. Innovation remains a top priority to support our growth, and we continue to hold discussions with pharmaceutical companies concerning further deals, including in the United States", commented Bertrand de Castelnau, Theradiag’s Chief Executive Officer.

2018 revenue
Theradiag’s consolidated revenue came to €8.9 million in FY 2018, down from €9.0 million in FY 2017 as a result of the contraction in theranostics revenue reflecting the fact that no non-recurring theranostics orders were logged in the first half of 2018. In contrast, a high level of activity was recorded in the same period of 2017 after Theradiag entered into several agreements with pharmaceutical companies.

Overall, 96% of theranostics revenue came from sales of kits for routine use. A steady increase over the past three quarters paved the way for an overall rise of 17% in FY 2018 sales compared to FY 2017.

IVD revenue remained stable, edging 1% higher.

Export sales of theranostics kits for routine use advanced by 19%.

Reduction in operating expenses, driving a 78% increase in operating income and almost eliminating the net loss before non-recurring items
The restructuring decisions made in late 2017 (shutdown of Prestizia’s operations and reorganization of the teams) and the favourable evolution of the product mix delivered benefits in FY 2018, including a 17% reduction in operating expenses.

As a result, the operating loss decreased by 78% from €2,515,000 in FY 2017 to €563,000 in FY 2018 and the net loss was cut from €5,959,000 to €787,000.

Before non-recurring items, Theradiag’s bottom line came close to breakeven in FY 2018, with a net loss of €372,000.

The FY 2018 net loss was adversely affected by a €415,000 restructuring charge.

Healthy cash position
At December 31, 2018, Theradiag’s available net cash stood at €3.43 million, compared to €5.16 million at December 31, 2017. Tight cost management helped to reduce Theradiag’s annual cash burn by one third.

"The company’s recovery is underway and its profitability is on track, with a sufficient cash position, allowing the Company to invest in its development." added Pierre Morgon, Chairman of the Board of Directors of Theradiag.

Highlights of 2018

Termination of the commercial agreements with HOB Biotech
As a result of HOB Biotech’s failure to comply with the contractual terms of the 2015 agreements between the two companies, Theradiag was unable to distribute the agreed products in Europe or to market its reagents in China. Legal proceedings were launched against HOB Biotech to remedy the loss suffered by Theradiag.

Partnership established with Biogaran
Theradiag entered into a partnership agreement with pharma group Biogaran to supply its Lisa Tracker kits with Biogaran’s biosimilar drugs. Theradiag’s monitoring kits are thus listed in France by Biogaran to support the biosimilar drugs it supplies. Theradiag will take responsibility for providing training to laboratories in how to use kits and follow up on clinician requests concerning monitoring.

Keen interest from the scientific community in biotherapy monitoring evident at the ECCO Congress
At the 13th edition of the ECCO Congress, over 90 publications presented biotherapy monitoring data. Of these, around 20 included results obtained using Lisa Tracker kits, confirming the scientific community’s keen interest in biotherapy monitoring. The increasing volume of publications also reflects the more widespread use of monitoring kits in what is also a growing number of centers.

Changes in Theradiag’s governance
Pierre Morgon succeeded Gérard Tobelem at Chairman of the Board of Directors.

Bertrand de Castelnau replaced Michel Finance as Chief Executive Officer and was also co-opted as a director replacing Dominique Costantini.

Bertrand de Castelnau, 58, has over 25 years’ experience in diagnostics. He began his career as a commercial attaché in Islamabad, Pakistan. Subsequently, he joined Roche in Basle, Switzerland as a general auditor and was then offered a position in the Diagnostics division before being handed responsibility for Roche Diagnostics’ Asia-Pacific region (based in Singapore). Next Bertrand took charge of Guerbet’s operations for four years, then ran the Horiba ABX group and the Horiba Medical segment for ten years, before joining DiaSys as head of sales and marketing and Chief Financial Officer.

The Board of Directors now has the following members:

Pierre Morgon, Chairman of the Board of Directors
Sylvie Bratel, Independent director
Bertrand de Castelnau, Director
Vincent Fert, Director
John Li, Director
Dominique Takizawa, Independent director
Subsequent events

Award of the 12th CE mark to the Lisa Tracker range
Theradiag has been awarded a CE mark for the Cosentyx (secukinumab) monitoring kit used in the treatment of psoriasis, psoriatic arthritis and ankylosing spondylitis, reaffirming its leadership position in biotherapy monitoring, with the most extensive line available in the market.

FDA inspection
During February, Theradiag was inspected by the FDA. It was not informed of any non-compliance issues and did not receive any comments (no Form 483 observations).

Next financial press release

Interim 2019 revenue on Thursday, July 25, 2019, after market close

Aclaris Therapeutics to Attend Upcoming Investor Conference

On March 27, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on dermatological and immuno-inflammatory diseases, reported that management will attend the following conference (Press release, Aclaris Therapeutics, MAR 27, 2019, View Source [SID1234534664]):

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Management will host investor meetings during the William Blair & Company 3rd Annual Late-Stage Therapeutics Conference in New York, NY Thursday, April 4, 2019.

Cancer Research UK, Lifearc and Ono Pharma Form Cancer Immunotherapy Alliance

On March 27, 2019 New immunotherapy drug targets for cancer will be progressed through a multimillion-pound drug discovery alliance reported (Wednesday) between Cancer Research UK, LifeArc and Ono Pharmaceutical Co., Ltd (Press release, LifeArc, MAR 27, 2019, View Source [SID1234534663]).

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The multi-year partnership brings together Cancer Research UK’s network of world-leading scientists and drug discovery expertise, LifeArc’s renowned therapeutic antibody engineering and development expertise, and Ono’s considerable track record in developing cancer immunotherapies.

The collaboration will identify targets for the development of both antibody and small molecule therapeutics. Boosted by a multimillion-pound investment from Ono and a further investment from LifeArc, drug discovery experts will be pursuing targets within Cancer Research UK’s extensive portfolio of immuno-oncology research.

This new collaboration expands upon an existing alliance between Cancer Research UK and LifeArc announced in 2017. Ono’s investment and expertise will help identify new therapeutic targets, accelerate target validation within the alliance, and support validated targets through the drug discovery phase.

Under the terms of the deal, LifeArc will progress antibody projects via its antibody screening and development expertise. Small molecule projects will be taken forward by Cancer Research UK’s Therapeutic Discovery Labs.

Morphological changes in breast cancer cellsOno will have option rights to licence the outputs of the alliance and take on clinical development and commercialisation of successful projects with worldwide exclusive rights. Cancer Research UK and LifeArc will receive an upfront access fee for entering the alliance, as well as additional upfront, milestone, and royalty payments for licensed projects.

Dr Hamish Ryder, director of Cancer Research UK’s Therapeutic Discovery Labs, said: "We’re thrilled to welcome Ono to join and expand our successful collaboration with LifeArc and create one of our most ambitious alliances to date. This unique alliance is a melting pot of world-leading cancer research and each organisation’s extensive expertise in oncology drug discovery.

"As we enter into a new age of immuno-therapeutic approaches to cancer care, we hope that this partnership will accelerate the development of new treatments, bringing them to patients with cancer much faster."

LifeArc CEO, Melanie Lee, noted; "At LifeArc, we are committed to translating medical innovation to benefit patients with new therapies, diagnostics or by building on the understanding of disease. This collaboration with Cancer Research UK and Ono is an example of how shared goals and collaboration can create real value."

"We greatly appreciate Cancer Research UK’s network of scientists, drug discovery expertise together with LifeArc’s antibody development capabilities," said Dr. Toichi Takino, Ph.D., Corporate Officer and Executive Director, Discovery and Research of Ono.

"We are very pleased to join in the successful collaboration between Cancer Research UK and LifeArc and we believe that we together will successfully identify novel drug candidates for new cancer treatment in the immuno-oncology field, which will be further developed and commercialized by us throughout the world and fulfil unmet medical needs."

Enterome to present data on its innovative microbiome-derived molecular mimicry approach to cancer immunotherapy at AACR 2019

On March 27, 2019 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the key functional and molecular interactions between the gut microbiome and the human body to develop targeted therapeutics, reported it will present data on its innovative microbiome-based approach for the development of therapeutic peptide cancer vaccines for the first time in a poster at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA, USA (March 29 to April 3) (Press release, Enterome, MAR 27, 2019, View Source [SID1234534662]).

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Enterome’s innovative approach is based on the concept of "molecular mimicry" whereby microbiome-derived bacterial antigens show molecular similarity with Tumor-associated Antigens (TAAs) and Tumor-specific Neoantigens (TSNAs). Based on this similarity, bacterial antigens ("onco-mimics") mimic key tumor antigens that are highly expressed by tumors to trigger tumor-specific cytotoxic T cell immune responses.

Enterome has developed a proprietary discovery platform to identify such bacterial onco-mimics from the human gut microbiome. The data to be presented at AACR (Free AACR Whitepaper) 2019 demonstrate that onco-mimics identified by Enterome elicited strong immune responses against self-peptides that were, by themselves, not immunogenic. While mice vaccinated with TAAs did not generate an immune response, vaccination with onco-mimics were observed to result in a strong immune response against both bacterial peptides and selected TAAs. Furthermore, adoptive transfer of T cells from mice immunized with onco-mimics into tumor-engrafted nude mice led to tumor control in the presence of checkpoint inhibitors.

Dr. Christophe Bonny, CSO of Enterome, commented: "We are very excited by these data that we believe represent an early validation of our innovative approach to cancer immunotherapy. It is now well recognized that the gut microbiome plays an important role in driving the development of T cells and the presence of commensal-specific memory T-cells. We believe our approach, based on bacterial molecular mimicry, has the potential to open up opportunities to develop new targeted therapies against tumor cells that are not detected as non-self by the immune system."

Enterome’s first product candidate developed using its molecular mimicry approach, EO2401, comprises three onco-mimics that are highly homologous to solid tumor antigens. Enterome expects to initiate a Phase 1b/2a clinical trial of EO2401 in 2019 as a potential new immunotherapy for glioblastoma multiforme (GBM), for which no curative treatments exist.

The presentation details are:

Poster title: Microbiome derived peptides stimulate strong immune response against tumor associated antigens and trigger in vivo tumor regression after vaccination
Session Title: Cancer Vaccines and Intratumoral Immunomodulation
Abstract ID#: 1475 (poster board 30)
Poster presentation: April 1, 8 am – 12 pm EST, Georgia World Congress Center, Exhibit Hall B, Poster Section 22