iCo Therapeutics Inc. Agrees to a Business Combination with Satellos Bioscience Inc.

On March 22, 2021 iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo") and Satellos Bioscience Inc. ("Satellos"), a private Canadian corporation, reported to announce the execution of a definitive agreement, dated March 21, 2021 (the "Arrangement Agreement"), providing for the business combination of iCo and Satellos by way of a plan of arrangement (the "Arrangement") in accordance with Section 192 of the Canada Business Corporations Act (the "CBCA") (Press release, iCo Therapeutics, MAR 22, 2021, View Source [SID1234576951]). Pursuant to the Arrangement, Satellos will become a wholly-owned subsidiary of iCo, and the parties expect to complete an amalgamation of iCo and Satellos, with the resulting entity named "Satellos Bioscience Inc." (the "Resulting Issuer"), operating in the life sciences industry. Following the Arrangement, and the Concurrent Financing (described below) shareholders of iCo will hold an approximately 27.7% ownership interest, and the shareholders of Satellos will hold approximately 58.8.% of the outstanding common shares of the Resulting Issuer (the "Resulting Issuer Common Shares"). Prior to completion of the Arrangement, iCo, which is formed under the Business Corporations Act (British Columbia) is expected to continue under the CBCA and the Resulting Issuer will exist as a CBCA corporation. The completion of the Arrangement will result in a reverse takeover of iCo as defined in the policies of the TSX Venture Exchange (the "Exchange"). Completion of the Arrangement is subject to, among other things, the approval of the Exchange and approval from iCo and Satellos’ shareholders.

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Recommendation of the Board of Directors and Support Agreements

The board of directors of each of iCo and Satellos have: (a) determined that the Arrangement is in the best interests of iCo and Satellos, respectively; (b) recommended that its respective shareholders vote in favour of the resolutions approving the Arrangement; and (c) authorized the execution of the Arrangement Agreement and the performance of iCo’s and Satellos’ respective obligations under the Arrangement Agreement.

The directors and officers of iCo and Satellos, and certain other shareholders of iCo and Satellos representing an aggregate of 1,692,756 (0.9%) iCo common shares ("iCo Shares") and 8,138,400 (66.7%) Satellos common shares ("Satellos Shares"), respectively, in each case on a non-diluted basis, entered into voting support agreements pursuant to which they agreed to vote their eligible securities in favour of the Arrangement.

Bloom Burton & Co. Inc. ("Bloom Burton") is acting as exclusive financial advisor to iCo on the Arrangement. Bloom Burton, through Bloom Burton Development Corp., owns approximately 31.4% of the outstanding Satellos Shares on a fully diluted basis and certain Bloom Burton employees are directors of Satellos. For the purposes of considering and approving the Arrangement, such Bloom Burton directors have declared their conflict and recused themselves from the activities of the Satellos board in accordance with the requirements of the CBCA.

In coming to its recommendation with respect to the Arrangement, the board of directors of iCo reviewed and considered a fairness opinion from Evans & Evans, Inc., financial advisors to the board of directors of iCo in connection with the Arrangement, which report provides that, as of the date of such opinion, and subject to the assumptions, limitations and qualifications set forth therein, the consideration to be received by the iCo shareholders pursuant to the Arrangement is fair from a financial point of view.

In addition, in coming to its recommendation with respect to the Arrangement, the board of directors of Satellos also reviewed and considered a fairness opinion from Leede Jones Gable, financial advisors to the board of directors of Satellos in connection with the Arrangement, which report provides that, as of the date of such opinion, and subject to the assumptions, limitations and qualifications set forth therein, the consideration to be received by the Satellos shareholders pursuant to the Arrangement is fair from a financial point of view.

Transactions in connection with share buy-back program

On March 22, 2021 Genmab A/S reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAR 22, 2021, View Source [SID1234576950]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from March 15, 2021 to March 19, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 167,477 shares as treasury shares, corresponding to 0.26% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

ProMIS Neurosciences Completes US$7M (CDN$8.75M) Financing with Distinguished Group of Boston Based Investors

On March 22, 2021 ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported that the completion of an US$7M (CDN$8.75M) private placement of convertible unsecured debentures (the "Debentures") (Press release, ProMIS Neurosciences, MAR 22, 2021, View Source [SID1234576949]).

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The investors include Mike Gordon of Fenway Sports Group, the Kraft Group, Henry McCance, co-founder of the Cure Alzheimer’s Fund, and Jeremy Sclar of WS Development Group. "After conducting diligence with a number of experts in the field, we are impressed with the tremendous potential of ProMIS Neurosciences and its unique platform of drug candidates to have a profound impact in the fight against Alzheimer’s and other neurodegenerative diseases. Our group is pleased to provide funding for the next phase of the company’s exciting future", stated Mike Gordon of Fenway Sports Group.

"We are honored to have the support of such a distinguished group of investors, all of whom are accomplished leaders in the business and life sciences arenas" said Gene Williams, ProMIS Executive Chairman.

Debenture Terms

The Debentures are convertible into ProMIS common shares at the option of the holder at a conversion price of US$0.10 per share and accrue interest at 1% per annum, which is payable annually. At the company’s election, accrued interest may be paid in cash or common shares (such number of shares determined by dividing the interest due by the 5-day volume-weighted average trading price or "VWAP" of the common shares).

The Debenture mature on March 22, 2026. Prior to the maturity date, the Company may force conversion of the Debentures at the conversion price upon raising US$50M in equity and/or debt cumulatively. On the maturity date, the Company may redeem the outstanding principal amount of the Debentures in either cash or common shares (at the then 5-day VWAP less a 10% discount) or a combination thereof at its election. Amounts redeemed in common shares on the Maturity Date will be subject to TSX acceptance.

The investors were granted a right to participate, on a pro rata basis, in subsequent company offerings of equity securities for cash consideration pursuant to a public offering or a private placement.

The Debentures and any common shares issued on conversion are subject to a four-month hold period that expires on July 22, 2021. Net proceeds will be used for working capital and general corporate purposes.

ProMIS plans to accelerate progress toward a number of top priorities, including:

Advancing the PMN310 monoclonal antibody, our potential "best in class" next generation Alzheimer’s treatment, into clinical testing;
Enhancing our partnering prospects for programs under active discussion by allowing us to invest in additional validation data;
Expanding our portfolio of products and intellectual property into new target areas, using our proprietary discovery platform;
Advancing our partnered diagnostic programs;
Achieving NASDAQ listing;
Expanding our Board of Directors; and
Expanding our management team, capitalizing on the talent pool in Boston, to support a growing and ambitious scope of activity.
Retirement of our CEO

Finally, a note of great appreciation for our CEO, Dr. Elliot Goldstein. Elliot, who just turned 70, has announced his intention to retire from a full time role by the end of 2021. Even though Elliot is irreplaceable, ProMIS has initiated a search for a new CEO to help us achieve our potential. "Elliot has been a close friend and valued business partner for decades," said Gene Williams, "without his significant contributions, we would not have been able to take ProMIS from just a great science idea to a company with a growing portfolio of therapies that have the potential to be life-altering for patients. On behalf of the entire ProMIS community, and patients who in the future may benefit from our therapies, I offer Elliot our sincere thanks and gratitude".

"ProMIS Neurosciences was launched six years ago based on a world class scientific platform from our CSO and scientific founder, Dr. Neil Cashman. Playing a key role in this endeavor has been one of the most challenging yet rewarding experiences of my 40 odd years in pharmaceutical drug development. I am delighted for this exciting new phase of the Company", stated Dr. Elliot Goldstein, ProMIS CEO.

ImmunityBio Announces NIH-Led Research Affirming that PD-L1 T-haNK Therapy Overcomes T-Cell Escape in Multiple Types of Resistant Tumors

On March 22, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported the publication of preclinical data in the Journal for ImmunoTherapy of Cancer (JITC) highlighting efficacy of ImmunityBio’s PD-L1 t-haNK natural killer cell-based therapy in combination with T cell-based immunotherapy against heterogeneous tumors (Press release, NantKwest, MAR 22, 2021, View Source [SID1234576948]). ImmunityBio’s novel PD-L1 t-haNKs are derived from a human, allogeneic NK cell line (NK-92) that has been engineered to express IL-2, CD16, and a chimeric antigen receptor (CAR) that recognizes PD-L1.

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Human solid tumors are made of multiple clones of tumor cells, some of which harbor genomic alterations that make them invisible to T cells. These resistant clones accomplish this "cloaking ability" by preventing the presentation of the tumor antigens on MHC-I receptors, thus "hiding" from killer T cells. For these patients, maximum activation of T cells with immunotherapy is unlikely to lead to durable tumor control or a cure. However, when NK cells are activated, tumor recognition and targeting is restored. The study shows that when subpopulations of tumors cells escape T cell detection or killing, they upregulate PD-L1 in the process because of interferon in the tumor microenvironment. This increase in tumor cell PD-L1 expression sensitizes them to killing by PD-L1 t-haNKs.

"Our results suggest that sequential treatment, first with T cell immunotherapy to kill the sensitive tumor cells and upregulate PD-L1 on the remaining cells, followed by PD-L1 t-haNK treatment, may overcome the issue of tumor heterogeneity and enhance rates of durable tumor control in patients with relapsed solid cancers," said Clint T. Allen, M.D., Principal Investigator, Section on Translational Tumor Immunology in the National Institute on Deafness and Other Communication Disorders (NIH) and corresponding author of the publication.

The publication by first author Maxwell Lee et al., "Chimeric antigen receptor engineered NK cellular immunotherapy overcomes the selection of T cell escape variant cancer cells," describes the development of preclinical models with heterogenous cancers containing T cell escape variant tumor cells. T cell-based immunotherapy administered in these preclinical models resulted in IFNγ production that in turn upregulated PD-L1 expression in T cell escape variants. Subsequent administration of irradiated PD-L1 t-haNKs targeted and eliminated the tumor cell populations that had evolved to be resistant to T-cell immunotherapy alone, resulting in synergistic anti-tumor activity.

"We are excited to see this preclinical study that affirms our hypothesis of ‘Quantum Oncotherapeutics,’ which is currently being studied in Phase1/2 QUILT trials across multiple tumor types. The theory we hold is that our treatment itself induces changes in the tumor immune microenvironment. By anticipating these dynamic cellular changes, we can administer and activate NK cells at the optimal time and, ultimately, outsmart the tumor. These spatial-temporal insights informing treatment, have the potential to change the paradigm of cancer care with modernized immunotherapy protocols, beyond the standard-of-care therapy and beyond checkpoint therapy alone. Late-stage, randomized controlled trials in pancreatic and lung cancers that orchestrate NK cells and T cells are underway at ImmunityBio to confirm this hypothesis," said Patrick Soon-Shiong, M.D. Founder and Executive Chairman of ImmunityBio.

Sonnet BioTherapeutics Appoints Richard Kenney as Chief Medical Officer and Manuel Dafonseca as Head of Clinical Operations

On March 22, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported the appointment of Richard Kenney, M.D. as Chief Medical Officer and Manuel Dafonseca, as Head of Clinical Operations, effective March 22, 2021 (Press release, Sonnet BioTherapeutics, MAR 22, 2021, View Source [SID1234576945]).

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"I am pleased to welcome Richard and Manuel to Sonnet at such an exciting time as we prepare to enter SON-1010, our proprietary fully human Interleukin 12 (IL-12) therapeutic candidate configured with our Fully Human Albumin Binding (FHAB) technology, into the clinic," said Pankaj Mohan, Ph.D., Founder and CEO. "Richard is a seasoned industry leader with a demonstrated track record of overseeing clinical development teams and managing regulatory affairs. Manuel will bring to Sonnet his expertise in clinical operations and project management that comes at an opportune time as we continue to prepare our FHAB platform for its first clinical study."

Dr. Kenney has more than 20 years of experience in translational-stage development of biologics, as well as the commercialization strategy and corporate management of preclinical, clinical-stage and commercialized vaccines and immunotherapies. As President of ClinReg Biologics, he has provided strategic consulting in clinical and regulatory affairs of biologics, medical monitoring and pharmacovigilance in several capacities. Dr. Kenney most recently served as Chief Development Officer at X-VAX Technology and previously held Chief Medical Officer roles at Immune Design and Crucell Holland, where he led the clinical development and regulatory affairs groups. Dr. Kenney was a researcher/reviewer for the FDA for over six years and did post-graduate training at Duke and NIH. Dr. Kenney received a B.S. in Chemistry from George Washington University and his M.D. from Harvard Medical School.

"I am thrilled to join Sonnet to continue to build upon the important work of the team," commented Dr. Kenney. "I believe the FHAB platform has the potential to address difficult-to-treat solid tumors in broad cancer populations and at various stages of the disease. I look forward to applying my skillset as we advance our FHAB programs, as well as the low-dose IL-6 programs, through the clinic."

Mr. Dafonseca has over 30 years of experience in pharmaceutical development, ranging from discovery stage programs to post approval activities. Most recently he served as Director of Global Clinical Trial Operations – Oncology at Merck where he was responsible for the successful execution, enrollment and quality of his assigned portfolio within the company’s oncology portfolio. Prior to his time at Merck, Mr. Dafonseca served as the Director of Clinical Operations at Ipsen Biopharmaceuticals, where he led the North America clinical operations group, including the strategic planning, execution and management of Dysport and Somatuline to support global regulatory submissions. Mr. Dafonseca received his B.S in Medical Technology and M.S. in Zoology and Physiology from Rutgers University.

"This is a dynamic time for Sonnet’s FHAB platform, as the Company prepares its lead candidates for the clinic, and I am excited to be joining the team," stated Manuel Dafonseca. "The recent non-human primate (NHP) data is very encouraging and I look forward to applying my experiences in clinical trial management, from early stage to pre-approval activities, to bring Sonnet’s innovative treatments to cancer patients."