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]

Umoja Biopharma Launches with $53M Series A Financing to Develop Fully Integrated, Scalable, In Vivo Immunotherapy Platform

On November 18, 2020 Umoja Biopharma, a biotechnology company pioneering an integrated in vivo immunotherapy platform, reported the completion of its $53 million Series A financing led by MPM Capital and Qiming Venture Partners USA (Press release, Umoja Biopharma, NOV 18, 2020, View Source [SID1234575244]). Umoja was founded by a team of leading scientists and researchers with the vision of creating an entirely new approach to engineered immunotherapies. Umoja’s suite of innovations will re-engineer a patient’s own immune system to attack and destroy both hematologic and solid organ-based tumors with a simplicity and cost that enables widespread implementation.

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"Umoja has already made significant progress on its goal of delivering technologies that will address the limitations of current engineered immunotherapies," said Andy Scharenberg, M.D., co-founder and CEO of Umoja. "Our in vivo-based approach is scalable while also providing control, safety, and highly effective anti-tumor activity; our goal is to improve both access and outcomes."

Umoja’s platform incorporates three core components: the VivoVec delivery platform, RACR/CAR payload architecture, and the TumorTag platform. The VivoVec delivery platform acts in vivo to generate a population of cancer fighting cells, VivoCAR T cells, which can be exquisitely controlled by the RACR/CAR control system using exogenously administered, FDA approved drugs. TumorTag molecules can be used in combination with the VivoCAR T cells to direct cancer-killing T cells to the tumor and the critical supporting cells of the tumor. 2

"This represents an important step forward in delivering on a shared vision to develop transformational therapies for patients who need them, including the most vulnerable population affected by debilitating diseases – children," said Michael Jensen, M.D., co-founder, Umoja Biopharma, vice president, Seattle Children’s Therapeutics and chief therapeutics officer, Seattle Children’s. "We now have the opportunity to combine forces and move at light speed, eclipsing what could have been accomplished singularly or in a normal academic manner."

Umoja Biopharma was founded through an initial seed investment by MPM Capital and DCVC Bio, and its scientific founders from Seattle Children’s Research Institute and Purdue University, based on pioneering work in the laboratory of Philip Low, the Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry. The Series A financing will enable Umoja to advance its platform and therapeutic programs to early clinical development, attract talent and invest in research. "Umoja is comprised of a highly skilled and passionate team that brings together a unique complement of expertise with in vivo gene transfer, drug development and oncology," said Luke Evnin, Ph.D., co-founder and Managing Director of MPM Capital.

"We believe that Umoja’s approach represents the future of cancer treatment." "Umoja is working to create an entirely new approach to engineered immunotherapies that can pave the way for cancer therapies that are more accessible and effective for patients around the world," said John Hamer, Managing Partner, DCVC Bio. "We look forward to continuing to work with the exceptionally skilled Umoja team to support the development of their integrated and scalable VivoVec and TumorTag technology." "We believe that the combination of deep technical experience and integrated technology platform will put Umoja at the forefront of in vivo T cell engineering," said Anna French, Partner at Qiming Venture Partners USA. "Umoja’s universal CAR approach supports multi-antigen targeting which will be required for the development of solid tumor therapeutics."

Enosi Life Sciences Files Patent for TNF-Inhibiting Molecules EN1001, EN2001 and EN3001

On November 18, 2020 Enosi Life Sciences Corp. ("Enosi" or the "Company"), a drug research and development company focused on providing industry-leading therapeutics for autoimmune disease, cancer, and acute inflammation, reported it has filed a patent for its proprietary molecules (Press release, Enosi Life Sciences, NOV 18, 2020, View Source [SID1234572277]). These include EN1001 for autoimmune disease; EN2001 for autoimmune disease and cancer; and EN3001 for autoimmune disease and cancer.

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The EN1001 molecule blocks Tumor Necrosis Factor Receptor-1 (TNFR1), which is a principal culprit in autoimmune disease, acute inflammation and has a role in cancer. EN1001 will be a significant enhancement compared to existing TNF-blocking technologies which inhibit both TNFR1 and TNFR2, which have limited efficacy as a result of co-inhibition of the naturally anti-inflammatory TNFR2.

Enosi’s EN2001 molecule offers a completely different option for the treatment of rheumatoid arthritis. Inflammatory EGF-like growth factors stimulate the growth of the pannus, a tumor-like structure in a Rheumatoid Arthritis (RA) joint which contains cells that produce tumor necrosis factor (TNF) and other destructive cytokines. Enosi has shown that its lead molecule (EN2001), which traps these growth factors, can prevent tissue destruction by inhibiting the growth of cells that form the pannus. This is a new mechanism of action for autoimmune disease drugs. Since Enosi’s growth factor trap is not expected to have adverse immunosuppressive activity, it can be combined with other RA therapeutics without fear of increasing immunosuppression. This is important because all of the approved RA therapies are immunosuppressive and make the patient susceptible to infection, cancer and even cardiovascular problems. Its ability to inhibit the proliferation of diseased cells may allow Enosi’s growth factor trap EN2001 to also be useful in the treatment of solid tumors.

For cancer and fibrotic diseases where TNFR2 is a "bad actor" instead of a "good actor," Enosi’s proprietary EN3001 molecule will counter TNFR2 activation. The function of TNFR2 is to protect the body from the effects of inflammation, but too much TNFR2 occurs in tumors and leads to inactivation of immunity against cancer. TNFR2 does this by inducing the proliferation of regulatory T cells that suppress the immune response. Thus, EN3001 will act like a checkpoint inhibitor by increasing immunity, which will be particularly useful in the treatment of cancer.

Each Enosi therapeutic will offer use in multiple diseases. EN1001 will be tested in RA and a number of autoimmune diseases, however, research has shown that TNF-mediated inflammation is important in other diseases as well, ranging from acute inflammation associated with viral infections like COVID-19, to endometriosis and Alzheimer’s disease. These three therapeutics from Enosi; EN1001, EN2001 and EN3001 are still in development and are at least five years away from clinical trials.

The market for TNF inhibitor drugs is expected to reach $43 billion by 2023, and $115 billion by 2026. To capitalize on this high growth industry and meet a wide and unmet demand, Enosi Life Sciences recently announced its Regulation D offering, enabling investors the opportunity to invest in next generation therapeutics for autoimmune disease and cancer.

"The filing of this patent represents a key milestone for Enosi as we seek to firmly communicate our targeted therapeutic pipeline to potential partners, industry professionals and of course, the broader investment community," said Dr. H. Michael Shepard, President, CSO and CEO of Enosi Life Sciences. "Enosi is derived from the Greek word for combinations, and we are following that philosophy. The combination of Dr. Feldmann’s experience in autoimmune diseases and my experience with antibody therapies for cancer, together with Dr. Jim Woody’s experience in management and fundraising bring a depth of knowledge to our endeavor. In addition, the candidate therapeutics we discover will likely be useful for a combination of different diseases." We believe our unique, proprietary approach represents significant potential once commercialized, and we look forward to continued updates regarding its development."

Capital raised through the Regulation D 506(c) offering, and potentially a future Regulation A+ financing, will support Enosi’s efforts to progress the Company’s molecules that target autoimmune disease, cancer and acute inflammation toward clinical trials.