On February 20, 2020 VBL Therapeutics (Nasdaq: VBLT) reported the launch of a phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo), an immune checkpoint inhibitor, in the treatment of metastatic colorectal cancer (Press release, VBL Therapeutics, FEB 20, 2020, View Source [SID1234554547]). The National Cancer Institute (NCI) will serve as the Investigational New Drug (IND) sponsor for this study and the IND application has been approved by the U.S. Food and Drug Administration (FDA). This new study will investigate if priming with VB-111 can drive immune cells into the tumor and turn the colorectal tumor from immunologically "cold" to "hot." The addition of nivolumab to VB-111 may further boost the anti-tumor immune response.

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"This phase 2 study is part of our strategy to broaden the potential indications for VB-111 and to explore its activity as part of combination therapies," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We look forward to collaborating with NCI on this clinical trial, as we continue to generate data which adds to our understanding of VB-111’s mechanism of action and therapeutic potential. We were particularly encouraged by results in ovarian cancer demonstrating the recruitment of infiltrating T cells into a tumor following treatment with VB-111, turning the tumor ‘hot’. This important finding suggests that VB-111 may be applied to other ‘cold’ tumors, in which checkpoint inhibitors show limited or no efficacy, including colorectal cancer, for which there remains a major unmet need."

VBL and the NCI have entered into a Cooperative Research and Development Agreement (CRADA) under the direction of Tim F. Greten, M.D., Deputy Branch Chief & Senior Investigator of the Thoracic and GI Malignancies Branch (TGMB) and Co-Director of the NCI Center for Cancer Research (CCR) Liver Cancer Program. The goal of this open-label, single-arm phase 2 study is to evaluate VB-111 in combination with an anti-PD-1 inhibitor, nivolumab, in patients with metastatic colorectal cancer. In addition to safety and tolerability, this study will evaluate efficacy endpoints including Best Overall Response, as well as immunological and histologic readouts from tumor biopsies. For additional information refer to View Source

For patients interested in enrolling in this clinical study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web site: View Source

On February 20, 2020 Galectin Therapeutics Inc. (NASDAQ:GALT), a leader in the field of NASH therapeutics, reported the appointment of Pol F. Boudes, M.D. to the position of Chief Medical Officer (Press release, Galectin Therapeutics, FEB 20, 2020, View Source [SID1234554564]). In this position, Dr. Boudes will oversee Galectin’s global advanced clinical development of belapectin (GR-MD-02) for NASH cirrhosis, as well as all other company clinical and scientific initiatives. Dr. Boudes brings more than 25 years of experience in clinical drug development in liver-related diseases — most recently NASH — and immunology, endocrine, metabolic and orphan diseases.

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"Strengthening our executive team is a key development for the company, enhancing our future growth trajectory as we near launch of our NASH-RX trial, an adaptively-designed Phase 3 trial in NASH cirrhosis," said Dr. Harold H. Shlevin, CEO. "Dr Boudes’s diverse background in drug development, especially his experience in NASH and in related diseases, adds an important layer of expertise in relevant therapeutic areas and bolsters our ability to advance the development of our galectin-3 product assets. We are excited to have him join our team."

Chairman of Galectin, Mr. Richard E. Uihlein said, "On behalf of myself and the entire board, we are extremely pleased to have such a high quality Chief Medical Officer joining our excellent team. We believe the hiring of Dr. Boudes demonstrates the continued optimism and focus we collectively have on advancing our drug candidate through the planned upcoming trial in an effective and efficient manner."

Dr. Boudes will report directly to Galectin’s CEO Harold Shlevin, PhD. and serve as a member of the company’s executive management team.

"I am very excited to join at such an important moment," said Dr. Boudes. "The team at Galectin has done a remarkable job to advance the belapectin program with the planned initiation of a well-designed and innovative late-stage adaptive study. The drug candidate is anchored on a well-understood mechanism of action, and its effect in preventing the development of esophageal varices, if confirmed, could constitute a breakthrough for patients suffering from NASH cirrhosis and; potentially, other types of liver cirrhosis and other organ fibrosis." Dr. Boudes added, "It will also be an honor to work under the guidance of such an experienced and supportive board of directors."

Most recently, Dr. Boudes was CMO at CymaBay Therapeutics, where he worked on the company’s proprietary NASH compound and was instrumental in inventing and launching programs in rare liver diseases. Prior to CymaBay, Dr. Boudes was CMO at Amicus Therapeutics, a company focusing on rare lysosomal storage disorders. Following this experience, Dr. Boudes became a board member of Protalix BioTherapeutics, a company developing plant cell expressed recombinant proteins with improved therapeutic profiles, notably for lysosomal disorders. Additionally, he’s held positions of increased responsibilities in clinical development at Bayer HealthCare Pharmaceuticals, Wyeth Research, Hoffman-La Roche and Pasteur Merieux. Dr. Boudes has contributed to the approval of multiple drugs, both in the US and globally, across a variety of therapeutic indications.

A dual citizen of the US and France, Dr. Boudes earned his MD at the University of Marseilles, France. He completed his internship and residency in Marseilles and Paris and was an Assistant Professor of Medicine at the University of Paris. In this capacity he also participated in multiple clinical research programs as an investigator. He is certified by the Educational Commission for Foreign Medical Graduates (US) and board-specialized in endocrinology and metabolic diseases, internal medicine, as well as in geriatric diseases (Paris).

Dr. Boudes holds several records of invention and has contributed to multiple peer-reviewed publications, notably on improving the clinical development process. He served on the editorial review board for La Revue Prescrire, a leading European Drug Therapeutic Bulletin, and on several scientific advisory boards for drug development. He is a member of several professional organizations, including the American Association for the Study of Liver Disease, the European Association for the Study of Liver (Geneva, Switzerland), the American Diabetes Association, the Royal Society of Medicine (London, U.K.), and the American Medical Association.

On February 20, 2020 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) reported that the Company plans to release its fourth quarter and year-to-date 2019 financial results on Thursday, February 27, 2020, before the opening of the U.S. financial markets (Press release, ANI Pharmaceuticals, FEB 20, 2020, View Source [SID1234554582]). The earnings press release will be accessible through the Investor Relations section of the Company’s website, www.anipharmaceuticals.com.

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Arthur S. Przybyl, President and Chief Executive Officer, and Stephen P. Carey, Vice President, Finance, and Chief Financial Officer, also plan to host a conference call to review those results starting at 10:30am Eastern Time on Thursday, February 27, 2020. The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875. The conference ID is 4783883.

A recording of the conference call will be available within two hours of the completion of the call and will remain accessible for a period of seven days following the call. To access the replay, dial (800) 585-8367. The access code for the replay is 4783883.

On February 20, 2020 Immatics Biotechnologies GmbH, a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting cancer immunotherapies, reported it has entered into a strategic collaboration agreement with GSK to develop novel adoptive cell therapies targeting multiple cancer indications (Press release, immatics biotechnologies, FEB 20, 2020, View Source [SID1234554549]).

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The companies will collaborate on the identification, research and development of next-generation T-Cell Receptor (TCR) Therapeutics with a focus on solid tumors. The parties will initially develop autologous T-cell therapies with the option to add allogeneic cell therapies using Immatics’ ACTallo approach. The companies intend to utilize proprietary TCRs identified by Immatics’ XCEPTOR TCR discovery platform and directed against two proprietary targets, which were discovered and validated by Immatics’ XPRESIDENT technology.

Under the terms of the agreement, Immatics will receive an upfront payment of 45 Million € (~$50 million) for two initial programs and is eligible to receive over $550M in development, regulatory and commercial milestone payments for each product as well as additional royalty payments. GSK obtains an option to select additional target programs to include in the collaboration. For each additional program, Immatics is entitled to option, milestone and royalty payments.

Immatics will have primary responsibility for the development and validation of the TCR Therapeutics up to designation of a clinical candidate. GSK will assume sole responsibility for further worldwide development, manufacturing and commercialization of the TCR Therapeutics with the possibility for Immatics to co-develop one or more TCR Therapeutics including the conduct of the first-in-human clinical trial upon GSK’s request.

"We are delighted to enter into this strategic collaboration with GSK – a partner who is already committed to adoptive cell therapies and TCR-T approaches," said Harpreet Singh, Chief Executive Officer of Immatics. "By combining Immatics’ world-leading target and TCR discovery platforms with GSK’s advanced manufacturing, development capabilities and a commitment to next-generation TCR-T technologies, both companies are joining forces to enable the development of effective novel therapies for cancer patients with high unmet medical need."

About Immatics’ Adoptive Cell Therapies
Adoptive Cell Therapy (ACT) has the potential to cure cancer. ACT is a treatment that uses natural or engineered T cells to fight tumors. Immatics has developed three innovative, proprietary approaches to produce Adoptive Cell Therapies: ACTolog, ACTengine and ACTallo.

About ACTallo
The ACTallo approach is based on genetically engineering allogenic gd donor T cells to recognize cancer cell targets as identified by Immatics’ XPRESIDENT platform. This allogeneic approach enables the development of immunotherapies that can be used ‘off-the-shelf’, for immediate treatment of the cancer patient.

About Immatics’ Technology Platforms
Immatics has developed an extensive and diverse cancer immunotherapy portfolio based on its unique target (XPRESIDENT) and T-cell receptor (XCEPTOR) discovery capabilities. XPRESIDENT is the most sensitive, accurate and highest-throughput technology capable of identifying targets in virtually any type of cancer. Immatics’ innovative TCR platform XCEPTOR is enabling the fast and efficient discovery and qualification of a large number of high-affinity and high-specificity T-cell receptors that can be used in T-cell engineering for Adoptive Cell Therapies.

On February 20, 2020 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its Annual Report for 2019 (Press release, Bavarian Nordic, FEB 20, 2020, View Source [SID1234554565]). Below is a summary of business progress, financial performance for the year and financial outlook for 2020. The full report is attached as a PDF file and can be found on the company’s website, www.bavarian-nordic.com.

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A year of transformation
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "2019 was a decisive year for Bavarian Nordic with several important events that have reshaped the Company towards fulfilling our vision. In particular, the FDA approval of JYNNEOS and our acquisition of Rabipur/RabAvert and Encepur from GlaxoSmithKline were two significant game-changers for us as we are now transitioning into a commercial vaccine company with a solid cash flow generation, allowing us to continue investments in our pipeline to bring additional life-saving products to the market. By establishing commercial operations, we will become a full-fledged company leveraging our existing strengths in R&D and manufacturing with an ambition to deliver sustainable profitability. To succeed in this endeavor, we have strengthened our leadership team with experienced people in commercial and R&D and will also be inviting many new colleagues to join us on this exciting journey."

Important events after the balance sheet date

In January 2020, we completed the sale of the Priority Review Voucher, granted by the FDA in connection with the approval of JYNNEOS in 2019. Net proceeds from the sale were DKK 620 million.
In November 2019, we strengthened our leadership team with the appointment of Jean-Christophe (JC) May as Executive Vice President and Chief Commercial Officer, who took up his position in January 2020. Based in a newly established office in Zug, Switzerland, he is heading our commercial organization, which is being ramped up to secure a successful transition of sales and marketing responsibilities for the acquired vaccines, as well to grow the market for our monkeypox vaccine.
Our leadership team was further strengthened with the appointment in January 2020 of Laurence De Moerlooze as Executive Vice President and Chief Medical Officer, who will take up her position in April 2020. She is joining the Company from Takeda Vaccines where she currently serves as Vice President and Global Program Lead for vaccines against Zika virus and Norovirus and has previously worked at GSK for more than 15 years, holding various leading roles in medical affairs and vaccine development working with numerous life-saving vaccines including Rabipur/RabAvert and Encepur.
During the first quarter of 2020, we will transfer our headquarters to Hellerup near Copenhagen in order to allow for the further expansion of the manufacturing facility in Kvistgaard, as we scale up and expand our manufacturing activities to incorporate the acquired vaccines, as well as launch our new fill and finish facility.
Strategy and short-term goals
By 2025, we aspire to be one of the largest pure play vaccines companies, improving and saving lives by excelling in R&D innovation, manufacturing and commercialization. To drive forward our ambitions for growth, we have outlined the following three strategic pillars along with our mid- to long-term goals in the annual report:

A company driven by Commercial excellence
Develop Innovative and lifesaving vaccines
Best-in-class vaccine Manufacturer
The key strategic activities and milestones in 2020 for each strategic area include:

A company driven by Commercial excellence

Assume full sales and marketing responsibility for Rabipur/RabAvert and Encepur from GlaxoSmithKline
Establish a full commercial organization to support Rabipur/RabAvert, Encepur and JYNNEOS for the monkeypox indication
Take over physical distribution of Rabipur/RabAvert and Encepur in selected markets
Increase awareness and establish a new market for the monkeypox indication
Develop Innovative and lifesaving vaccines

Continue preparations for initiation of the Phase 3 trial of MVA-BN RSV in the elderly in 2021
Advance the Phase 3 trial of smallpox MVA-BN freeze-dried formulation
Obtain successful marketing authorization of Ebola vaccine MVA-BN Filo in the EEA (partnered with Janssen)
Establish proof-of-concept for BN-Brachyury in chordoma
Explore intra-tumoral/intravenous administration within immunotherapy
Best-in-class vaccine Manufacturer

Complete the qualification and validation of the newly built fill and finish facility
Commence investment in expansion of vaccine bulk manufacturing
Commence the manufacturing technology transfer of Rabipur/RabAvert and Encepur
Financial performance
Bavarian Nordic achieved its planned goals for 2019 and outperformed compared to guidance on revenue and earnings before interest and tax (EBIT).

Revenues were DKK 662 million, compared to a guidance of DKK 600 million as more revenue was recognized on the BARDA funding to support qualification and validation of the new fill and finish facility. Revenue from product sales was DKK 324 million and revenue from ongoing development contracts was DKK 338 million.

The result before interest and tax (EBIT) was a loss of DKK 328 million, compared to a guided loss of DKK 360 million.

The cash preparedness at year-end was DKK 716 million, compared to a guidance of DKK 700 million, and was composed of DKK 472 million in cash, cash equivalents and investments in securities and DKK 244 million in undrawn credit lines.

For a detailed financial review, see the annual report.

DKK million USD million*
2019 guidance actual guidance actual
Revenue 600 662 90 99
EBIT (360) (328) (54) (49)
Cash preparedness, year-end** 700 716 105 107

* Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.68 per 1.00 USD, which was the exchange rate as of December 31, 2019.
** Cash preparedness includes cash, cash equivalents, investments in securities and the aggregate amount of undrawn credit lines.

Outlook for 2020
The acquisition of Rabipur/RabAvert and Encepur will have a significant positive impact on Bavarian Nordic’s revenue, as the vaccines will become the primary revenue driver. In 2019, GlaxoSmithKline posted revenues of approximately DKK 1,490 million from combined sales of the vaccines, compared to Bavarian Nordic’s estimate of approximately DKK 1,300 million. The higher revenue is primarily ascribed to better performance for Rabipur/RabAvert, which has benefitted from competitor stock-outs during 2019 and is not considered to reoccur in the short term. Bavarian Nordic does not anticipate stock-outs to affect the sales in 2020 and thus maintain expectations to grow combined sales of the new products by a low-to-mid single digit rate annually from the previous estimated 2019 level.

2020E (all numbers are approximate) DKK million USD million
Revenue 1,900 288
EBITDA 675 102
Cash and cash equivalents, year-end 1,350 205
In addition to sales from Rabipur/RabAvert and Encepur the guidance also assumes revenue from our smallpox vaccine business, a milestone payment from Janssen related to expected EMA approval of the Ebola vaccine and other revenue from contract work. The smallpox revenue mainly relates to sales from uncommitted contracts, but also includes committed contract work related to the ongoing Phase 3 study of the freeze-dried smallpox vaccine and validation of the new fill and finish facility. The revenue assumptions are based on currency exchange rates of DKK 6.60 per 1 USD and DKK 7.45 per 1 EUR.

Net proceeds of DKK 620 million from the sale of the Priority Review Voucher, granted to the Company by the FDA in connection with the approval of JYNNEOS in 2019, were received in January 2020 and will be recognized as other operating income in the consolidated financial statements for 2020.

Research and development costs of approximately DKK 500 million are expected for 2020, of which approximately DKK 150 million are expected to be recognized as production costs as the investment is deployed towards contract work.

See the annual report for a full description of assumptions for the 2020 guidance.

Rights issue in first half 2020
To support the acquisition of Rabipur/RabAvert and Encepur, including repayment of the bridge financing provided by Citi and Nordea, the Company is planning a rights issue on Nasdaq Copenhagen in the first half of 2020. The rights issue, which has been approved by the Company’s shareholders, is fully underwritten by Citi and Nordea as Joint Global Coordinators.

Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am EST) to present the annual results followed by a Q&A session. A listen-only version of the call can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 9168708.