On October 21, 2016 CEL-SCI Corporation (NYSE MKT: CVM) reported: following up on our press release issued on September 26, 2016, we have received the Partial Clinical Hold letter from the U.S. Food and Drug Administration (FDA) (Press release, Cel-Sci, OCT 21, 2016, View Source [SID1234515949]). CEL-SCI has started working on a response to the FDA and will work diligently with the FDA to seek to have the partial clinical hold lifted.

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On October 20, 2016 Unum Therapeutics, a clinical stage biopharmaceutical company developing a universal cellular immunotherapy to treat multiple cancers, reported that the Company has been selected for two poster presentations on its Antibody-Coupled T-Cell Receptor (ACTR) platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Tumor Immunology and Immunotherapy 2016 Meeting (Press release, Unum Therapeutics, OCT 20, 2016, View Source [SID1234515935]). The conference will take place on October 20-23, 2016 at the Boston Marriott Copley Place in Boston, MA.
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Presentation Details:
Presentation Title: Efficient targeting of HER‐2‐positive cancers by Antibody‐Coupled T cell Receptor (ACTR) engineered autologous T cells
Presenter: Casey B. Judge
Presentation Date: Friday, October 21, 2016
Presentation Time: 5:15 p.m.‐7:45 p.m.
Room: Back Bay Room
Abstract Number: A77
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Presentation Title: High throughput triage of the ACTR platform demonstrates broad activity across multiple tumor targets
Presenter: Eugene Choi
Presentation Date: Saturday, October 22, 2016
Presentation Time: 6:00 p.m.‐8:45 p.m.
Room: Back Bay Room
Abstract Number: B60
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The posters will be posted on Unum’s website following the presentations.
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About Antibody-Coupled T-cell Receptor (ACTR) Technology and ACTR087
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Unum’s proprietary ACTR is a chimeric protein that combines components from receptors normally found on two different human immune cell types – natural killer (NK) cells and T-cells – to create a novel cancer cell killing activity. T-cells bearing the ACTR receptor protein can be directed to attack a tumor by combining with a monoclonal antibody that binds antigens on the cancer cell surface.
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In contrast to other T-cell therapy approaches for cancer that are limited to a single cancer cell surface target and, therefore, treat a narrow set of tumors, Unum’s approach is not restricted by a specific tumor cell antigen and, thus, may have applications for treating many different types of cancers when combined with the right antibody.
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Unum is developing ACTR in combination with a range of tumor-targeting antibodies for use in both hematologic and solid tumor indications. ACTR087, Unum’s most advanced product candidate, combines Unum’s proprietary ACTR, with rituximab, an anti-CD20 antibody. The ACTR087 study will be the first clinical trial using a viral vector to permanently insert the ACTR gene into the genome of patient T-cells.

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On October 20, 2016 Transgene (Euronext Paris:TNG), a company focused on discovering and developing targeted immunotherapies for the treatment of cancer and infectious diseases, reported its quarterly financial results as of September 30, 2016 (Press release, Transgene, OCT 20, 2016, View Source [SID1234515936]). The Company also announced today the launch of a share capital increase with shareholders’ preferential subscription rights for a total gross amount of c. €48.1 million.

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Operating revenue:

The following table summarizes the third quarter operating revenue1 for 2016 compared to the same period in 2015:

Q3 First Nine Months
In million euros 2016 2015 2016 2015

Revenue from collaborative and licensing agreements 0.1 0.4 2.0 1.1
Government financing for research expenditures 1.4 1.9 4.4 6.4

Operating revenue 1.5 2.3 6.4 7.5

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1 Excluding revenue from discontinued operations

During the third quarter of 2016, revenue from collaborative and licensing agreements was mainly composed of research services and royalties.

As of September 30, 2016, government financing for research expenditures mainly consisted of 75% of the research tax credit expected for 2016 (€4.4 million in the third quarter of 2016 versus €6.2 million over the same period in 2015). This decrease was due to lower eligible research and development expenses, explained by the restructuring of the Company.

Cash, cash equivalents, available-for-sale financial assets and other financial assets:

Cash, cash equivalents, available-for-sale financial assets and other financial assets stood at €25.4 million as of September 30, 2016, compared to €31.7 million as of December 31, 2015.

In the first nine months of 2016, Transgene’s cash burn was €16.3 million (excluding EIB loan), compared to €19.8 million for the same period in 2015. Cash burn was €8.2 million in the first half of 2016 and €8.1 million in the third quarter of 2016.

Net cash outflows linked to the restructuring plan amounted to €4.2 million over the period. Excluding the above disbursements, cash burn stood at €12.1 million in the first nine months of 2016, reflecting the positive effects of the reorganization plan.

Key achievements:

Since June 2016, Transgene continued rolling out its clinical development program, in line with the strategy aimed at combining Transgene’s immunotherapies with other immunotherapy treatment approaches, in particular immune checkpoint inhibitors (ICIs).

The development programs have progressed as follows:

Therapeutic vaccines:
TG4010: strategy focused on combination trials with ICIs in lung cancer. Two Phase 2 clinical trials are being prepared, in 1st and 2nd line of treatment of non-small cell lung cancer. The 2nd line clinical trial of TG4010 in combination with Opdivo (nivolumab), conducted by UC Davis Medical Center (USA), is expected to start in H2 2016.
TG4001: Transgene signed an agreement with Merck KGaA, Darmstadt, Germany, and Pfizer, to evaluate TG4001 and Avelumab in HPV-positive, advanced head and neck cancers. This Phase 1/2 trial is expected to start in H1 2017.
TG1050: the Phase 1/1b clinical trial is moving forward with the recruitment of the first patients that will receive multiple doses of TG1050, a therapeutic vaccine against chronic hepatitis B. This step follows the positive recommendation of the Safety Review Committee in July 2016.
Oncolytic viruses:
Pexa-Vec: ongoing recruitment and first patient in Europe expected at the very end of the year for this Phase 3 clinical trial in 1st line of hepatocellular carcinoma (HCC). Two Phase 2 clinical trials combining Pexa-Vec with ICIs are in preparation. Transgene confirms that a Phase 2 trial evaluating Pexa-Vec in combination with ipilimumab in solid tumors will start in H2 2016. The initiation of the Phase 2 trial of this oncolytic virus associated with nivolumab in advance primary liver cancer (HCC) is expected for H1 2017.
TG6002: preparation of the Phase 1 clinical trial in glioblastoma, expected to start in H1 2017.
Also, early October 2016, at the 10th International Meeting on Replicating Oncolytic Virus Therapeutics (Vancouver, Canada), Transgene presented a new generation of replicative oncolytic virus with improved cytotoxic activity in resistant tumor cell lines thanks to the vectorization of intrabodies. This original approach opens new possibilities for engineering the next generation of armed oncolytic viruses and confirms Transgene’s innovation capabilities and unique R&D know-how.

Outlook:

Transgene confirms that it expects 2016 cash burn to be around €35 million.

The Company announced today the launch of a share capital increase with shareholders’ preferential subscription rights. Institut Mérieux, Transgene’s reference shareholder via its affiliate TSGH, has committed to participate in this transaction and to subscribe up to 75% of the total number of the new shares, materializing its commitment, made at the beginning of the year, to bring additional funding to the Company.

On October 12, 2016 Transgenomic, Inc. (NASDAQ:TBIO), and privately-held Precipio Diagnostics, LLC reported entry into a merger agreement, pursuant to which Precipio will become a wholly owned subsidiary of Transgenomic, and Transgenomic will be renamed Precipio, Inc (Press release, Transgenomic, OCT 20, 2016, View Source [SID1234515937]). In connection with the merger, it is anticipated that the original Precipio security holders will receive between 62% and 80% of the outstanding shares of the combined company, depending on the relative amount of outstanding liabilities of the parties at closing and prior to the investment of new capital. The merger is expected to close in 2016, pending approval by Transgenomic shareholders and other closing conditions set forth in the merger agreement. Simultaneous to the merger, the combined company will receive an investment of up to $7 million from a syndicate led by BV Advisory Partners in a private placement of preferred convertible securities, and $3.0 million of outstanding debt of each company is expected to convert into this same class of preferred convertible securities. This comprehensive transaction will provide the Company with a clean balance sheet and sufficient capital to achieve its planned expansion.

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Transgenomic has filed to complete a reverse stock split of between one-for-ten and one-for-thirty before the merger closes, and the company’s outstanding debt is expected to convert into common and preferred shares. The companies expect that shares of the combined company will be listed on the NASDAQ exchange and trade under the "PRPO" ticker (subject to filing and approval by NASDAQ). The merger agreement provides that, Ilan Danieli, Precipio founder and Chief Executive Officer, will serve as the Chief Executive Officer of the combined company. BV Advisory Partners is acting as advisor to the transaction.

Paul Kinnon, Transgenomic President and Chief Executive Officer, said "In recent years we have transitioned from a provider of conventional life science tools and diagnostic services into an innovative biotechnology enterprise focused on advancing precision medicine. We have done this through our revolutionary ICE COLD-PCR (ICP) technology, which enables accurate, non-invasive tumor profiling using circulating DNA in patient plasma. We have established a solid platform for commercialization of ICP, with leading global distributors and a solid pipeline of potential agreements with partners and customers. This is a good time to join forces with Precipio, which shares our commitment to accurate and timely advanced cancer diagnostics and has established an impressive infrastructure of academic experts and a growing customer base, validated by successful case studies. I look forward to working with my new colleagues to ensure a successful transition."

Ilan Danieli, Precipio founder and Chief Executive Officer, said "We are proud of Precipio’s progress in building a growing platform that provides unique services to cancer patients and their physicians by providing a demonstrated superior level of diagnostic accuracy, ensuring that patients receive the best possible treatment. Cancer misdiagnosis is an all too common and underappreciated problem, which frequently has a negative impact on patient treatment, and may cause needless loss of life. We provide both primary and second opinion screening, and our network of leading academic cancer researchers and advanced diagnostic technologies have proven to be an invaluable resource for patients and physicians. Our entire team is committed to ensuring that our services are made widely available. To that end we will continue building out our sales team to accelerate adoption and revenue growth. We believe Transgenomic’s ICP technology and commercial infrastructure fit well with our values and our business model, and look forward to this next stage of growth, as we work together to integrate our teams, technologies and services."

Keith Barksdale, Founder of BV Advisory Partners, commented, "Transgenomic and Precipio have complementary strengths with the potential to be a dynamic and strong competitor in the rapidly growing market for advanced cancer diagnostics. ICP is a revolutionary mutation detection technology that is now available through global distributors, and adoption by drug researchers and developers is ramping up. The technology is also available to help guide cancer diagnosis and treatment through Transgenomic’s CLIA laboratory. Precipio’s platform of leading academic cancer experts provides superior diagnostic accuracy level to oncologists and their patients; it represents a unique resource that can benefit from and leverage the power of ICE COLD-PCR. We look forward to working with the combined company going forward to help assure its growth and success."

Transgenomic’s ICE COLD-PCR offers major advantages over current sequencing technologies. It delivers at least a 100-fold improvement in sensitivity compared to standard methodologies, allowing detection of both known and previously unknown genetic alterations in any exon of any gene using a single assay. It is robust, easy to use and easily implemented, requiring minimal disruption to established sequencing workflows. It is available as ICEme Kits that deliver up to a 500-fold increase in mutation detection compared to most current methods, with levels of detection routinely achievable down to 0.01%. This ultra-high sensitivity enables detection of low level mutations and allows accurate patient monitoring as well as stratification of cancer sub-populations. ICEme Kits are compatible with most patient samples, including tissue, blood, plasma, urine and other biofluids. The kits are simple to use and work with most of the genomic analysis platforms available in laboratories today. They are easily customizable for use with single mutations or multiple mutations in combination. The current menu includes approximately 20 clinically relevant, actionable mutations that are associated with important cancers. The ICP range of mutation targets is being expanded on an ongoing basis.

ICE COLD-PCR was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology exclusively to Transgenomic.

On October 20, 2016 Dilaforette Holding AB, a clinical-stage drug development company, reported its name change to Modus Therapeutics Holding AB and its intention to undertake an Initial Public Offering ("IPO") (Press release, Modus Therapeutics Holding, OCT 20, 2016, View Source [SID1234517242]). A rights issue is planned in connection with the IPO in order to finance the further clinical development of the Company’s lead candidate sevuparin for the treatment of sickle cell disease ("SCD").

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Commenting on today’s announcement, Christina Herder, CEO of Modus Therapeutics, said: "Modus Therapeutics is entering an exciting phase with the opportunity to develop sevuparin in sickle cell disease in two separate uses based on promising data, recently published in the British Journal of Haematology (Telen et al, August, 2016). Sevuparin is now in Phase II clinical trials and we have a clear objective to advance this promising candidate through these trials to establish clinical proof of concept in both a hospital and a home setting over the next years."

Viktor Drvota, Chief Investment Officer at Karolinska Development and recently elected as new member of Modus Therapeutics Board of Directors, said: "Modus Therapeutics has established a strong basis with sevuparin in SCD from which to advance to the next value inflection milestones. The proposed IPO would provide further support to the Company to build on its encouraging clinical findings with sevuparin and develop a potentially best- and first-in-class treatment for SCD patients with few effective therapeutic options. Modus Therapeutics is one of several companies in our portfolio that are expected to deliver important milestones in the coming years and we are delighted with how this portfolio is maturing."

For further information: Christina Herder, CEO, Tel: + 46 70 374 71 56, [email protected]

David Dible or Pip Batty, Citigate Dewe Rogerson, Tel: +44 207 282 2049/1022, [email protected]