NantKwest to Participate in the 32nd Annual Piper Sandler Healthcare Conference

On November 18, 2020 NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, reported its participation in the virtual 32nd Annual Piper Sandler Healthcare conference, which takes place December 1-3, 2020 (Press release, NantKwest, NOV 18, 2020, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-participate-32nd-annual-piper-sandler-healthcare?field_nir_news_date_value[min]= [SID1234571353]). NantKwest Executive Chairman Patrick Soon-Shiong, M.D., and Chief Executive Officer Rich Adcock will participate in institutional investor meetings on Tuesday, December 1; meetings may be requested through Piper Sandler.

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Additionally, a pre-recorded fireside chat with Dr. Soon-Shiong and Mr. Adcock will be accessible beginning November 23, 2020 on the Piper Sandler conference site and in the Investors section of NantKwest’s website, NantKwest.com. The recording will be available on the NantKwest website through December 31, 2020.

CASI Pharmaceuticals Announces Partner Juventas Completes $65 Million Financing And Initiates Registration Study For CNCT19 (CD19 CAR-T)

On November 18, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported partner Juventas has completed the equivalent of $65 million financing and has initiated and enrolled the first patient in a Phase II registration study for CNCT19 (CD19 CAR-T) in China in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) (Press release, CASI Pharmaceuticals, NOV 18, 2020, View Source [SID1234571375]).

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Dr. Wei-Wu He, CASI’s Chairman, and CEO commented, "Initiating the Phase II B-NHL registration study and enrolling the first patient is an exciting milestone for the development of CNCT19. Our partner Juventas is also making good progress in the Phase I clinical trial for the treatment of relapsed or refractory acute lymphoblastic leukemia (B-ALL) and is expecting to start the Phase II study by the end of 2020. Its financing provides Juventas with resources to continue moving CNCT19 through registration and we remain excited about its potential as a first-line treatment for B-NHL. In addition, as a large (16%) shareholder of Juventas, we are pleased to see Juventas’ progress in their overall pipeline and expect its financing to help accelerate its development. Juventas is an example of CASI’s entrepreneurial partnership model that is built on two components, co-development and equity investment. We believe investment in our partners deepens our collaboration and provides additional potential return to our shareholders. With this approach, we will continue to grow CASI’s pipeline, one asset at a time."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program’s joint steering committee.

Immunicum AB and DCprime Combine Forces to Establish Leader in Cell-Based Cancer Immunotherapies

On November 18, 2020 Immunicum reported that it has entered into an agreement with Van Herk Investments B.V. to acquire all of the shares in DCprime B.V., a Dutch clinical stage company developing cancer relapse vaccines aimed to reduce tumor recurrence (the "Transaction") (Press release, Immunicum, NOV 18, 2020, View Source [SID1234623736]). Merging the complementary allogeneic dendritic cell biology approaches of both companies will enable Immunicum to further build and strengthen its position as a leader in cell-based cancer immunotherapies. Payment in the Transaction is effectuated through an issue in kind of 73,909,635 new shares in Immunicum representing 44 percent of the shares in Immunicum on a fully diluted basis. DCprime’s current majority shareholder, Van Herk Investments B.V., a leading European life science investor, will thereby become a significant shareholder of the combined entity. The issuance of the shares is subject to approval by an Extraordinary General Meeting (EGM) to be held on December 18th, 2020.

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Transaction Summary
The main objective of the combination is to establish a unified company built on decades of combined immuno-oncology and cell therapy expertise in the field of allogeneic dendritic cell biology. Moving forward, Immunicum’s scientific focus will continue to be on triggering immune responses against established tumors via intratumoral immune priming and expanded to include the reduction of tumor recurrence via relapse vaccination. To date Immunicum has established clinical proof of concept for its lead program, ilixadencel, which has been tested in a range of solid tumors. DCprime has produced equally encouraging clinical results for blood-borne tumors including interim data from its ongoing Phase II study in Acute Myeloid Leukemia (AML), which will be provided in an oral presentation at the upcoming ASH (Free ASH Whitepaper) 2020 conference. Together, the companies will advance a synergistic pipeline spanning both large and orphan indications in solid as well as blood-borne tumors, with two programs in Phase II clinical development and multiple near-term value inflection points as well as a portfolio of preclinical programs and research capabilities to fuel future pipeline expansion. Importantly, the combined process development and manufacturing expertise and specialized in-house research and development facilities will support the shared goal of becoming a leader in the development of cell-based immunotherapies.

The newly combined company will maintain its corporate headquarters in Stockholm, Sweden and consolidate research, process development and future manufacturing efforts at the location in Leiden, the Netherlands. Immunicum’s shares will continue to trade on the Nasdaq Stockholm.

Following the closing of the transaction, Erik Manting, Ph.D., currently CEO of DCprime, will join Immunicum’s leadership team as Chief Business Officer and deputy CEO. Jeroen Rovers, MD, Ph.D., currently Chief Medical Officer at DCprime, will have the role of the Managing Director of DCprime in the combination. Erik Manting brings several years of research experience in immunology as well as 15 years in commercial and management roles in banking. Jeroen Rovers brings 15 years of industry experience in a variety of medical roles, including CMO at Kiadis Pharma.

In addition, Immunicum will call for an EGM in order for the shareholders to resolve upon the proposed elections of Andrea van Elsas, Ph.D. and Dharminder Chahal to the Board of Directors of Immunicum. Andrea van Elsas is currently a venture partner at Third Rock Ventures, and his scientific career includes leading the anti-PD1 program that became leading immunotherapy, pembrolizumab (Keytruda). Dharminder Chahal is CEO and co-founder of an oncology diagnostics company, SkylineDx, and investment manager to Van Herk. Van Herk is a leading European investor in life science having made a number of successful investments including Zealand Pharma, Ablynx, Crucell and Galapagos. Van Herk is also the largest shareholder in Swedish listed biotech company, BioInvent, where Dharminder Chahal serves as a board member.

By way of the Transaction, Immunicum will acquire all outstanding shares in DCprime. Payment in the Transaction is effectuated through an issue in kind of 73,909,635 new shares in Immunicum to Van Herk. The share purchase agreement has been entered into with Van Herk Investment B.V. and has been adhered to by Van Herk Royalty B.V., which is a company within the Van Herk Group and the current shareholder of the shares in DCprime. Before closing the shares will be transferred to Van Herk Investments B.V. Further, prior to the closing of the Transaction, Van Herk will acquire the minority shareholders’ shares in DCprime and such minority shareholders will consequently partly be paid in cash and partly in Immunicum shares. As a result of the Transaction, Van Herk will be the largest shareholder in Immunicum, holding approximately 43 percent of the total outstanding shares after the Transaction. Customary lock-up provisions covering a period of twelve months have been put in place between Immunicum, Van Herk and DCprime minority shareholders receiving issued shares.

Van Herk Investments, together with Immunicum’s largest shareholder, Fourth Swedish National Pension Fund (AP4), have expressed their support to the new, combined entity. In addition, Van Herk Investments, Immunicum’s largest shareholder following the Transaction, intends to invest up to SEK 82.5 million in the company.

Closing of the Transaction is conditional upon approval of issuance of the shares by the EGM, with a two-thirds majority requirement for the approval of both the votes cast and the shares represented at the EGM,1 approval and publication of the prospectus, and Van Herk’s acquisition of the minority shareholders’ shares in DCprime. The closing of the Transaction is expected to take place at the end of December 2020.

Immunicum’s assessment is that the current funds available for the combined entity will be sufficient to finance operations into the beginning of 2022 based on immediate financial benefit from the companies’ operational synergies. Immunicum will further propose to the EGM the approval of a mandate for the Board of Directors to resolve to issue shares in a directed issue of up to 20 percent of the outstanding shares after the Transaction to facilitate financing activities.

Comments from Immunicum and DCprime
"As announced in the recent corporate and clinical update from September, one of Immunicum’s main goals is to expand the Company’s pipeline with the vision of becoming a leading cell therapy company. As such, joining forces with DCprime, an innovative company with extensive expertise in allogeneic dendritic cell biology, stands as an exciting opportunity with great potential for Immunicum that will build additional value for the Company, our shareholders and future patients," stated Sven Rohmann, MD, Ph.D., Chief Executive Officer of Immunicum. "Together, we can pursue the treatment of both solid tumor and blood-borne tumors by intratumoral priming as well as systemic boosting using the next-generation of allogeneic, off-the-shelf cell-based therapies. Our teams and our technologies are complementary and would significantly increase the potential of our pipeline and deliver more value-inflection points and potential partnering opportunities."

"DCprime has established a strong position in cell-based cancer therapy with a Phase II asset in blood-borne tumors. By integrating with the Immunicum team, we look forward to the continued advancement of our unique relapse vaccine approach in parallel to the ongoing clinical progress of Immunicum’s lead candidate, ilixadencel," stated Erik Manting, Ph.D., Chief Executive Officer of DCprime. "From a corporate perspective, DCprime’s and Immunicum’s lean and focused organizations and excellent teams are the perfect match to drive the development of the combined pipeline products and identify additional novel therapeutic solutions to address unmet medical needs in the field of cancer therapy."

"This transaction is a transformative milestone for Immunicum as it will bring additional value to the company and enable it to further establish itself as a leader in the development of cell-based immuno-oncology treatments," said Michael Oredsson, Chairman of the Board at Immunicum. "Together, we will have world class competence with in-house process development and manufacturing expertise and specialized research and development facilities as well as strengthened ownership by the addition of Van Herk, a renowned and committed life science investor known for their success stories in Galapagos and Zealand Pharma, BioInvent, Galapagos and successful trade sale exits in Ablynx (Sanofi), Crucell (J&J), among others."

"The combination of Immunicum and DCprime creates a well-positioned company with a broad pipeline with two programs in the clinical phase as well as several preclinical opportunities," said Dharminder Chahal, Chairman of the Board at DCprime and representative for Van Herk. "We look forward to supporting Immunicum as the company further advances its innovative immuno-oncology projects."

Consideration
The purchase price for all outstanding shares in DCprime will be paid through the issuance of 73,909,635 shares (the "Consideration Shares") in Immunicum, representing a dilution of 44.48 percent (44.0 percent on a fully diluted basis considering outstanding warrants). Based on the closing price of Immunicum’s shares on 17 November, SEK 8.10, the consideration for the capital contributed in-kind corresponds to a total of SEK 598,668,043.50. Through issuance of the Consideration Shares, the number of shares in Immunicum will increase to a total of 166,167,166. The share capital will increase by SEK 3,695,481.75, from SEK 4,612,876.55 to a total of SEK 8,308,358.3. The dilution has been calculated as the number of issued new shares, divided by the total number of shares following the new issue.

The issuance of the Consideration Shares is subject to approval by an EGM. Further, the issuance of the Consideration Shares requires publication of a prospectus in connection with admission for trading of the newly issued shares on Nasdaq Stockholm.

The Consideration Shares that Van Herk and DCprime minority shareholders receive are subject to a lock-up arrangement of twelve months following closing of the Transaction, with certain exemptions that can be granted by the company.

Van Herk will, through the issuance of the Consideration Shares, achieve a shareholding in Immunicum representing at least three tenths of the voting rights for the total number of shares in Immunicum. According to Chapter 3, Section 1 Stock Market (Takeover Bids) Act (Sw. Lag (2006:451) om offentliga uppköpserbjudanden på aktiemarknaden) Van Herk would be obligated to make a public offer for all shares in Immunicum within four weeks thereafter (so-called mandatory bid). Van Herk has applied for and been granted an exemption from such mandatory bid obligation by the Swedish Securities Council. The granting of the exemption by the Swedish Securities Council is conditional upon (i) Immunicum informing its shareholders of the share capital and voting shares, respectively, in Immunicum that Van Herk receives through the Transaction and (ii) the approval of the issue of the Consideration Shares by the EGM in Immunicum supported by shareholders representing at least two-thirds of both the votes cast and the shares represented at the EGM.

The Swedish Securities Council’s full statement (AMN 2020:57) is available at www.aktiemarknadsnamnden.se.

EGM
Issuance of the Consideration Shares is subject to approval by an EGM to be held on 18 December 2020. Notice to the EGM will be made through a separate press release. In light of Covid-19, the Board of Immunicum has decided that shareholders of Immunicum at the EGM shall be able to exercise their voting rights by mail and e-mail in accordance with Section 3 of the Swedish Act (2020:198) on temporary exceptions to facilitate the execution of general meetings in companies and other associations.

Indicative Time Plan
December 18th, 2020 Extraordinary General Meeting in Immunicum
December 21st, 2020 Closing of the Transaction

Financial and Legal Advisors
Erik Penser Bank is acting as financial advisor, Asperion is acting as strategic advisor and Advokatfirman Delphi is legal advisor to Immunicum in relation to the Transaction. Kempen & Co is acting as financial advisor and Advokatfirman Cederquist and Allen & Overy are acting as legal advisor to DCprime.

Presentation
Representatives of Immunicum and DCprime will hold a live webcast on Thursday, November 19th at 8:00 a.m. CET in order to further describe the Transaction.

The audio cast will be streamed via this link: View Source

Participant dial in numbers:
SE: +46850558351
UK: +443333009267
US: 18335268382

For further information, please visit Immunicum’s webpage (www.immunicum.com).

The information is such information that Immunicum is obliged to make public pursuant to EU Market Abuse Regulation. The information was released for public disclosure through the contact persons detailed below on 18 November 2020 at 11:30 pm CET.

For more information, please contact:

Sven Rohmann, CEO
Telephone: +46 8 732 8400
E-mail: [email protected]

INVESTOR RELATIONS

Jonas Rodny and Carolin Wiken
Paues Åberg Communications
Telephone: +46 190 90 51
E-mail: [email protected]

Media Relations

Joanne Tudorica and Sophia Hergenhan, Ph.D.
Trophic Communications
Telephone: +49 171 351 2733
E-mail: [email protected]

Neurologist and Psychiatrist Prof. Johannes Rolf Streffer, MD Joins AC Immune SA as Chief Medical Officer

On November 18, 2020 AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, reported that Prof. Johannes R. Streffer, an authority on neurology and psychiatry, was hired as the Company’s Chief Medical Officer, and he is expected to join the Company in January 2021 (Press release, AC Immune, NOV 18, 2020, View Source [SID1234571322]).

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Prof. Streffer joins AC Immune from UCB Biopharma SPRL where he currently holds the position of Vice President, Head of Translational Medicine Neuroscience. His expertise will further accelerate AC Immune’s progress in advancing its pipeline of therapies targeting neurodegenerative diseases.

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We welcome Prof. Streffer’s timely appointment, as his understanding of biomarkers and experience of clinical study design in Alzheimer’s disease (AD), and particularly preclinical AD, will positively impact AC Immune’s discovery efforts. His appointment is a further affirmation of our scientific leadership in the neurodegenerative disease field. Prof. Streffer’s significant expertise and standing in the scientific and medical community will be an invaluable asset as we work to develop innovative treatments for neurodegenerative diseases using our proprietary technology platforms."

Prof. Streffer commented: "I am humbled and proud to be invited to join AC Immune, an established pioneer at the forefront of discovering and developing treatments for neurodegenerative diseases. It is tremendously exciting to be involved at the cutting edge of research addressing an area with such a high unmet medical need and where my work on clinical studies and understanding early biomarkers in Alzheimer’s could play a critically important role. The existing and developing pipeline of AC Immune is very impressive. I look forward to working with the outstanding team at AC Immune and hope my own expertise will contribute to their continued success."

At UCB Prof. Streffer led the development of a translational space in neuroscience, integrating clinical and biomarker sciences. Prior to this he was a member of the Alzheimer Disease Area Leadership Team at Janssen, Pharmaceutical Companies of Johnson & Johnson. Here he gained experience in early experimental AD trials, including biomolecular modalities such as positron emission tomography (PET), volumetric and functional MRI, genetics, cognition and cerebrospinal fluid markers. As a member of the Experimental Medicine group and as leader of the Janssen

BACE inhibitor (BACEi) program targeting Alzheimer’s Disease he initiated a number of methodological and biomarker studies focusing on early diagnosis and translation. Prof. Streffer was also the industrial lead for European Medical Information Framework (EMIF)-AD. In the Innovative Medicines Initiative (IMI)-EMIF program researchers from 14 countries combined in a EUR 56 million project to integrate a wide variety of AD data cohorts to foster understanding of early biomarkers and change in the predementia AD spectrum.

Prof. Streffer is a graduate of the University of Tübingen, Germany, where he received his medical degree. He also completed graduate studies on neuro-oncology and is Board certified in psychiatry and neurology. He has published more than 70 manuscripts and is a visiting Professor in the Department of Biomedical Sciences at the University of Antwerp.

Agendia and Paige Announce Landmark Strategic Partnership to Revolutionize Treatment Planning in Breast Cancer

On November 18, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, and Paige, a global leader in AI-based digital diagnostics, reported a first of its kind strategic partnership that will redefine precision oncology (Press release, Agendia, NOV 18, 2020, View Source [SID1234571355]). The partnership will enable co-development of treatment planning tools that integrate the cloud-based Paige Platform with genomic information from Agendia’s proprietary MammaPrint and BluePrint diagnostic tests for patients with breast cancer. These new products will enable faster access to predictive and prognostic information along the entire continuum of care, from diagnosis and early intervention to metastatic treatment planning.

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"Paige’s digital pathology platform is truly transformational for oncology and will catapult diagnostics forward as a whole. This partnership defines the democratization of treatment planning tools by accelerating access to these tests and the essential insights they provide for more patients globally," said Mark Straley, Chief Executive Officer of Agendia. "Our goal is to provide same-day turnaround in most cases, enable earlier intervention, preserve limited biopsy or surgical tissue specimens, and extend key benefits to physicians and their patients with access to testing in countries where tissue ‘send out’ is not allowed. Whether a patient is in Manhattan or Mumbai, the ability to get real-time and accurate results from Agendia’s MammaPrint and BluePrint tests will improve how we are treating breast cancer today."

The initial focus of the collaboration will be the development of digital tests for early treatment planning where genomic testing has played an essential role in determining recurrence risk and tumor biology as doctors and their patients make decisions about the path ahead. This can be especially important for patients with operable breast cancer. Beyond early intervention, AI-derived biomarkers will be used to augment genomic testing in the metastatic setting where a multitude of therapeutic options can add to the complexity of treatment planning.

"As the first company to receive FDA clearance, FDA breakthrough designation and two CE marks for digital and computational pathology products, Paige is delivering next-generation digital diagnostics that redefine how we approach cancer care," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "By combining our unique capabilities with Agendia’s leadership in breast cancer, we believe this innovative partnership can achieve our shared goal of transforming clear and actionable information into precision treatment for better patient outcomes. It will be the first of many AI-based diagnostic tests to come."