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.

On February 20, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that Amit D. Munshi, President and Chief Executive Officer, will present at the upcoming investor conferences (Press release, Arena Pharmaceuticals, FEB 20, 2020, View Source [SID1234554583]):

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SVB Leerink 9th Annual Global Healthcare Conference – Presenting on Tuesday, February 25, at 3:00 PM ET, in New York City
Cowen and Company 40th Annual Healthcare Conference – Presenting on Wednesday, March 4, at 10:40AM ET, in Boston
A live audio webcast of the presentations will be posted under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.

On February 19, 2020 Elicio Therapeutics, a next generation immuno-oncology company, reported Peter DeMuth, PhD., Elicio Vice President of Research, will present "Targeting the Lymph Nodes to Enhance Mutant KRAS-Specific Vaccine Responses," at the upcoming RAS-Targeted Drug Discovery Summit in Vienna, Austria, from February 25 to 27, 2020 (Press release, Elicio Therapeutics, FEB 19, 2020, View Source [SID1234554495]).

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The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Elicio’s ELI-002 targets seven position 12 and 13 KRAS mutations, present in approximately 25% of all human solid tumors. Elicio believes that ELI-002 has the potential to become a multi-targeted mKRAS therapy with the ability to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal, lung, bile duct, endometrial, and ovarian.

"By precisely targeting the immune cells which orchestrate anti-tumor responses in lymph nodes, ELI-002 has been shown in preclinical studies to enhance the magnitude and functional characteristics of KRAS-specific immunity important for a robust anti-tumor effect" said Peter DeMuth, PhD, Vice President of Research of Elicio Therapeutics. "These responses were able to simultaneously target all 7 common KRAS mutants, indicating the potential to prevent tumor recurrence likely to arise from therapies specific to individual mutants."

At the conference Dr. DeMuth will discuss Elicio’s:

Amphiphile technology which allows "AMP KRAS-vaccine" ELI-002 to simultaneously generate immune response to the seven mutations commonly present in KRAS driven cancers by targeting peptides with a powerful adjuvant directly to the lymph nodes;
In vivo data showing the significant benefits of lymph node targeting versus systemic drug delivery;
Data showing induction of potent mKRAS-specific T cell responses using ELI-002, a first-in-class lymph node immunotherapy, and;
Plans for a prospective, multicenter First-in-Human Phase 1/2 Trial of ELI-002 Lymph Node Immunotherapy as Treatment for Minimal Residual Disease in Patients with KRAS mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors.
Elicio has demonstrated in multiple tumor models that improving the targeting of immunogens and cell-therapy activators to lymph nodes, where resident immune cells potently orchestrate immunity, can substantially amplify their ability to induce effective tumor-killing immune responses. ELI-002 is an "AMP KRAS-vaccine" containing seven Amphiphile mKRAS peptides and a proprietary Amphiphile adjuvant, administered subcutaneously.

KRAS mutations are present in 90% of pancreatic cancers, 40% of colorectal cancers, 30% of non-small cell lung, 30% of bile duct, 14% of endometrial, and 14% of ovarian cancers. ELI-002has completed preclinical validation, IND-enabling GLP toxicology studies, and a pre-IND meeting with the FDA. P1/2 trials will be multi-site, starting with an open label dose escalation, progression to expansion cohorts in KRAS mutated solid tumors, and seamlessly progressing into a randomized, controlled cohort.

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

On February 19, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its fourth quarter and full year 2019 financial results on Tuesday, February 25, 2020 (Press release, Iovance Biotherapeutics, FEB 19, 2020, View Source [SID1234554512]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. EST.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 4693108. The live webcast can be accessed in the Investors section of the Company’s website at www.iovance.com. The archived webcast will also be available for one year in the Investors section at www.iovance.com.