SynOx Therapeutics raises €37M in Series A Financing

On November 19, 2020 SynOx Therapeutics Ltd ("SynOx"), a clinical stage biopharmaceutical company, reported the closing of a €37 million Series A financing co-led by HealthCap and Medicxi and joined by investors Forbion and Gimv (Press release, SynOx Therapeutics, NOV 19, 2020, View Source [SID1234571398]).

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SynOx, a spin out of Celleron Therapeutics Ltd ("Celleron"), secured exclusive world-wide rights for the clinical development, manufacturing and commercialization of emactuzumab under a licence agreement with Roche. The financing will enable SynOx to continue the development of emactuzumab, for the treatment of diffuse tenosynovial giant cell tumours ("TGCT"), also known as pigmented villonodular synovitis ("PVNS"), and other indications.

Emactuzumab is a clinical-stage humanised IgG1 CSF-1R targeted antibody designed to target and deplete macrophages in the tumour tissue. It has shown a favourable safety profile in patients and encouraging efficacy for TGCT, a rare disease characterised by the proliferation of macrophages in the synovial tissue in the joint and tendon sheath.

Professor Nick La Thangue, Chief Executive Officer of SynOx, commented: "We are very excited to be developing emactuzumab as a breakthrough treatment for the extreme and debilitating effects of TGCT. SynOx will be focused on generating all necessary data to register this new therapy in a time- and cost-efficient way."

Jacob Gunterberg, Partner at HealthCap, said: "With the objective to develop a new therapy for TGCT patients who suffer from a significantly reduced quality of life, the involvement in the establishment and investment in SynOx fits very well with our investment strategy."

Francesco De Rubertis, Partner at Medicxi, commented: "We are excited to support SynOx in its continued development of emactuzumab, an agent which has demonstrated profound efficacy in over 60 TGCT patients treated to date."

The SynOx Board will consist of Jacob Gunterberg (HealthCap), Francesco De Rubertis (Medicxi), Dirk Kersten (Forbion), Michaël Vlemmix (Gimv), Declan Doogan (chairman of Celleron) and Nick La Thangue.

Nordic Nanovector completes enrolment into second safety cohort of follicular lymphoma patients in Archer-1 Phase 1b Betalutin®/rituximab combination trial

On November 19, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it enrolled the final two patients into the second safety cohort of its Phase 1 Archer-1 (LYMRIT 37-07) trial investigating safety and preliminary efficacy of Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab in 2nd-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, NOV 19, 2020, View Source [SID1234571374]).

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The dosing regimen in this cohort is a single administration of 15 MBq/kg Betalutin preceded by 40mg lilotomab, followed by 375 mg/m2 rituximab once per week for four weeks.

Data from this cohort is expected in H1’2021 and will be analysed alongside the data generated from the first cohort of patients receiving 10 MBq/kg Betalutin/40mg lilotomab.

As announced in April 2020, Archer-1 is expected to be paused pending this analysis, which is expected to inform plans for the further development of Betalutin development in 2L FL. The Company’s primary focus for its resources is on the timely completion of the pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line FL (3L FL).

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said: "We are pleased to complete patient enrolment into the second safety cohort of Archer-1. We look forward to the results from this cohort in H1’2021, which will add to our understanding of Betalutin use in FL patients. The data will also inform our thinking towards further development strategies for Betalutin in broader FL populations than that being investigated in our PARADIGME trial in 3L FL."

About Archer-1

Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial designed to assess the safety and preliminary activity of combining the CD37-targeted radioimmunoconjugate Betalutin with the CD20-targeted immunotherapy rituximab in patients with relapsed/refractory (2L) FL who have received one or more prior therapies.

Rituximab was approved for the treatment of non-Hodgkin’s lymphoma (NHL), including FL, more than 20 years ago and is the current standard of care. It is administered to patients with newly diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to rituximab, thus alternative targets and new treatments are important.

Carina Biotech signs agreement with Bionomics Ltd to create cancer-busting CAR-T cells targeted at a cancer stem cell marker abundant in solid tumours

On November 19, 2020 In this worldwide exclusive agreement, Carina Biotech reported that it will create Chimeric Antigen Receptor T cells (CAR-T cells) and other adoptive cell therapies to the leucine-rich repeat-containing G-protein coupled receptor 5 (LGR5) using the first-in-class humanised antibody BNC101 developed by Bionomics Limited (Press release, Carina Biotech, NOV 19, 2020, View Source [SID1234571346]).

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LGR5 is a molecular marker that is highly expressed on cancer stem cells within solid tumours including colorectal, breast, pancreatic, ovarian, lung, liver and gastric cancers.

This will be Carina’s latest CAR-T cell candidate in a growing pipeline, underpinned by its proprietary platform that produces "supercharged" CAR-T cells. CAR-T cell therapy is a revolutionary new treatment option for cancer that harnesses the power of the immune system. CAR-T cells are genetically modified immune cells (T cells) that are targeted at certain molecular markers found on cancer cells.

Carina Biotech’s CEO Dr Deborah Rathjen said, "Cancer stem cells, or CSCs, seem to have some kind of resistance to anti-cancer therapies. Anti-cancer drugs can kill proliferating cancer cells but CSCs survive – hence some cancers will respond to initial treatment but inevitably the cancer returns".

"We are excited to have done this deal with Bionomics given the wealth of clinical data available on BNC101. By creating a CAR-T cell that targets CSCs, we will be able to get to the core of some cancers, to kill those cells that enable cancers to keep bouncing back. We hope that LGR5-targeting CAR-T cells will go a long way to achieving our vision – a future that defeats cancer."

This is the third commercial deal for Carina in three months, following the sale of its first proprietary CAR-T cell to UK company Biosceptre, and a deal with Sydney immuno-oncology company Glytherix.

"Our serial-killing CAR-T cells do what so far has been very difficult to do – travel to the site of the cancer and disrupt the immunosuppressive tumour microenvironment. This allows for our CAR-T cells to get up close to cancer cells for potent and repeated killing action," says Dr Rathjen.

Carina’s platform also enables efficient CAR-T manufacture – reducing manufacturing time, improving yield and quality with CAR-T delivery efficiency of more than 90%.

Under the worldwide, exclusive License Agreement, Carina will fund all research and development activities. Bionomics is eligible to receive up to A$118 million in clinical and development milestones plus royalty payments if Carina fully develops and markets the new therapy. In the event that Carina sub-licenses the CAR-T treatment, Bionomics is eligible to receive sub-licensing revenues.

Supernus to Participate in Annual Piper Sandler Healthcare Conference

On November 19, 2020 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company’s management will participate in a fireside chat as part of the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held December 1-3, 2020 (Press release, Supernus, NOV 19, 2020, View Source [SID1234571343]). The Company will also host investor meetings on Thursday, December 3, 2020.

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The pre-recorded fireside chat can be accessed beginning November 23, 2020 by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of this fireside chat will be available for 60 days on the Company’s website after the conference.

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]