Curaleaf to Enter European Cannabis Market with Acquisition of EMMAC Life Sciences Limited – Europe’s Leading Independent Cannabis Company

On March 10, 2021 EMMAC Life Sciences Group, Europe’s largest independent cannabis company, reported that it is has signed a definitive agreement to be acquired by Curaleaf Holdings, Inc. (CSE: CURA) (OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading U.S. provider of consumer products in cannabis, for a base consideration of approximately US$285 million to be paid in 85%/15% Curalfeaf shares and cash (Press release, EMMAC Life Sciences, MAR 10, 2021, View Source [SID1234576609]). Contingent consideration of up to $57 million will be paid in Curaleaf shares and cash in the same ratio based upon the successful achievement of performance milestones. The proposed transaction provides Curaleaf with a developed platform for entry into the European cannabis market.

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As Europe’s largest vertically integrated independent cannabis company, EMMAC’s platform brings cultivation, EU-GMP processing, distribution, and R&D operations across several key European medical cannabis markets, including the United Kingdom, Germany, Italy, Spain and Portugal. EMMAC also has an operational presence and partnerships in European Union countries that are enacting new medical cannabis access programs. EMMAC’s Portugal based cultivation facility is an industry leader in cannabis flower production cost.

Boris Jordan, Curaleaf Executive Chairman, stated, "Curaleaf’s acquisition of EMMAC, announced today, provides an advanced base to reach scale within the nascent European cannabis market and transform Curaleaf into a truly international cannabis consumer packaged goods company. The consumer and political liberalization trends around cannabis that are sweeping the U.S. are also increasingly taking hold in Europe. Curaleaf will seek to leverage our branded cannabis consumer packaged goods strategy across Europe, a market which provides for cross-border cannabis distribution. The European cannabis market has the potential to exceed the U.S. cannabis market over the long-term and will help fuel our growth for years to come."

Antonio Costanzo, Chief Executive Officer of EMMAC, said, "Curaleaf’s acquisition of EMMAC is not only a significant milestone for EMMAC, but for the European cannabis market as a whole. As part of Curaleaf, a well-capitalized leader of the U.S. cannabis market, EMMAC is poised to exploit the rapid pace of growth of the European market, driven by regulatory change and the increasing demand for access to premium quality cannabis products. The combination of Curaleaf and EMMAC creates a global platform to address these large new opportunities across Europe. With EMMAC’s science-led approach, wealth of local market experience, as well as our network of supply and distribution partnerships throughout Europe, we are now uniquely positioned to reinforce our place as one of Europe’s leaders in the production and supply of medical cannabis, wellness CBD, hemp and other derivative products."

Transaction Terms & Approvals

Curaleaf will acquire EMMAC for base consideration of £0.50 per share, comprised of approximately GBP£35 million in cash, approximately 16.774 million subordinate voting shares of Curaleaf (based on the exchange ratio of Curaleaf share for each EMMAC share agreed by the parties). At yesterday’s Curaleaf closing share price on the CSE, the base consideration is valued at $285 million2. An additional US$57 million3 consideration will be paid subject to performance-based earn-outs. Post-transaction, the former shareholders of EMMAC will have approximately 3% pro forma ownership of Curaleaf on a fully-diluted basis, before factoring in the performance-based earn-outs. The Curaleaf share consideration will be subject to a statutory four-month hold period as well as a lock-up agreement with each recipient restricting trading of the share received, with release of 5% from such restrictions at the end of each calendar quarter following the closing. The proposed transaction is expected to close early in the second quarter of 2021, subject to customary closing conditions and regulatory approval. The transaction has been unanimously approved by the boards of directors of both EMMAC and Curaleaf, with Mr. Boris Jordan abstaining from the voting.

Transaction Advisors

Stikeman Elliott LLP and Memery Crystal LLP acted as legal advisors to Curaleaf. Eight Capital acted as financial advisors and provided a fairness opinion to the Special Committee. Canaccord Genuity Group acted as financial advisor and provided a fairness opinion to EMMAC, and Norton Rose Fulbright acted as legal advisor to EMMAC. EMMAC’s European legal team was led by Hill Dickinson LLP in the United Kingdom.

Immunocore Announces Upcoming Presentations at the American Association for Cancer Research (AACR) 2021 Annual Meeting

On March 10, 2021 — Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, reported that four abstracts highlighting the Company’s lead program, tebentafusp, were accepted at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, which will be held virtually from April 10-15, 2021 (Press release, Immunocore, MAR 10, 2021, View Source [SID1234576524]). Two abstracts will be presented as oral presentations including, in the plenary session, Phase 3 data comparing tebentafusp (IMCgp100) with investigator’s choice in first line metastatic uveal melanoma (mUM). A second oral presentation will feature data on the kinetics of radiographic response for tebentafusp in previously treated mUM patients. Two abstracts will be poster presentations.

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PLENARY AND ORAL PRESENTATIONS

Title: Phase 3 randomized trial comparing tebentafusp with investigator’s choice in first line metastatic uveal melanoma

Date and Time: Plenary session presentation (CT002), Saturday April 10th at 11:30am – 1:30pm ET
Presenter: Jessica C. Hassel (PI), University Hospital Heidelberg, Heidelberg, Germany
Abstract #: 5342
Session Title: Phase III Clinical Trials
Title: Kinetics of radiographic response for tebentafusp (tebe) in previously treated metastatic uveal melanoma (mUM) patients (pts) achieving prolonged survival

Date and Time: Oral presentation (CT038), Monday April 12th at 1:30pm – 3:15pm ET
Presenter: Marcus O. Butler (PI), Princess Margaret Cancer Centre, Toronto, ON, Canada
Abstract #: 5338
Session Title: Disease-Oriented Innovative Clinical Research and Trials
POSTER PRESENTATIONS

Title: Uveal melanoma study patients with low CD163:CD3 ratio in tumor biopsy and low serum IL-6 showed enhanced tumor shrinkage (TS) and overall survival (OS) on tebentafusp

Poster #: 1673
Presenter: Jessica Hassel (PI)
Title: Tebentafusp induces transient systemic inflammation and modifies the micro-environment to sensitize uveal melanoma tumors to cytotoxic CD8 cells

Poster #: 517
Presenter: Marcus O. Butler (PI)
Presentations and posters will be available for registered attendees for on-demand viewing on the AACR (Free AACR Whitepaper) website beginning on April 10th 2021.

Turning Point Therapeutics to Present New Preclinical Data For Three Drug Candidates at American Association For Cancer Research Annual Meeting

On March 10, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that four abstracts featuring three of its drug candidates will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, which will convene virtually from April 10-14 (Press release, Turning Point Therapeutics, MAR 10, 2021, View Source [SID1234576523]).

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For lead drug candidate, repotrectinib, two poster presentations will highlight new preclinical combination data with MEK and MEK/Raf inhibitors, as well as repotrectinib’s potency against wildtype and TRKC A/B/C as compared to approved TRK inhibitors. For MET/SRC/CSF1R inhibitor, TPX-0022, the company will present preclinical data demonstrating potential utility in combination with immune checkpoint inhibitors. For its newest drug candidate, ALK-inhibitor TPX-0131, Turning Point will present preclinical potency data against ALK resistance mutations and in-vivo data demonstrating brain tissue penetration.

The four posters to be presented are:

Title: Repotrectinib increases effectiveness of MEK inhibitors in KRAS mutant cancer models
Abstract Number: 1104

Title: Molecular characteristics of repotrectinib that enable potent inhibition of TRK fusion proteins and broad mutant selectivity
Abstract Number: 1119

Title: TPX-0022, a potent MET/SRC/CSF1R inhibitor that modulates the tumor immune microenvironment in preclinical models
Abstract Number: 1444

Title: TPX-0131, a potent inhibitor of wild type ALK and a broad spectrum of both single and compound ALK resistance mutations
Abstract Number: 1469

AACR plans to make poster presentations available via its website on Sat., April 10, the first day of the virtual Annual Meeting.

Iovance Biotherapeutics to Present Updated Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Therapy Lifileucel in Advanced Melanoma at American Association for Cancer Research (AACR) 2021 Annual Meeting

On March 10, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that long-term interim data from Cohort 2 in the C-144-01 clinical study (NCT02360579) in advanced melanoma has been accepted as an oral presentation in a Clinical Trials Plenary Session at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting (Press release, Iovance Biotherapeutics, MAR 10, 2021, View Source [SID1234576522]).

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Abstract Title: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced (unresectable or metastatic) melanoma: durable duration of response at 28-month follow up
Authors: Jason Alan Chesney, MD, PhD, et al.
Abstract Number: 5329
Presentation Number: CT008
Session Title: Immunooncology and Cell Therapy Trials
Session Date and Time: Saturday, April 10, 2021, 3:30 PM – 5:50 PM ET
Location: AACR (Free AACR Whitepaper) Virtual Annual Meeting 2021 at www.aacr.org

In addition to the oral presentation, three Iovance poster presentations at AACR (Free AACR Whitepaper) will highlight the design of clinical trials in progress in solid tumors and chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). These posters are intended to educate physicians about study design and will not include clinical data. Posters will be available from 8:30 a.m. ET on Saturday, April 10 through Monday, June 21, 2021 in the Virtual ePoster Hall at www.aacr.org.

Abstract Title: A Phase 2, multicenter study of autologous tumor infiltrating lymphocytes (TIL) (LN 144/LN-145/LN-145-S1) in patients with solid tumors
Authors: Scott Gettinger, MD, et al.
Abstract Number: CT235
Abstract Title: A Phase 1/2 study evaluating the safety and efficacy of IOV-2001 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Authors: Meixiao Long, MD, PhD, et al.
Abstract Number: CT244
Abstract Title: A phase 2 multicenter study of autologous tumor infiltrating lymphocytes (TIL; LN-145) cell therapy in patients with metastatic non-small cell lung cancer (mNSCLC)
Authors: Erminia Massarelli, MD, PhD, et al.
Abstract Number: CT246
The AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research—from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy—and highlights the work of the best minds in research and medicine from institutions all over the world. For more information, please visit the AACR (Free AACR Whitepaper) Annual Meeting page at www.aacr.org/meeting/aacr-annual-meeting-2021.

Affimed Announces Presentations at the AACR Annual Meeting 2021

On March 10, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that preclinical anti-tumor efficacy in vivo data from its innate cell engager (ICE) AFM24 have been accepted for e-poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, being held on April 10-15 (Press release, Affimed, MAR 10, 2021, View Source [SID1234576521]).

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In addition, early data from a Phase 1 study evaluating AFM13 preloaded CAR-like cord blood-derived NK cells followed by weekly AFM13 monotherapy in patients with recurrent or refractory CD30-expressing lymphomas at The University of Texas MD Anderson Cancer Center will be presented by Katy Rezvani during a Major Symposium on April 13th.

Poster details:

Title: AFM24 is a novel, highly potent, tetravalent bispecific EGFR/CD16A-targeting Innate Cell Engager (ICE) designed for the treatment of EGFR-positive malignancies

Abstract: 1881

Authors: Jens Pahl, Gabriele Hintzen, Uwe Reusch, Torsten Haneke, Christian Breunig, Sheena Pinto, Cassandra Choe-Juliak, Andreas Harstrick, Wolfgang Fischer, Arndt Schottelius, Joachim Koch, Erich Rajkovic

Poster Release: The e-poster website will be launched on April 10, 2021. All e-posters will be available for browsing on this date. The poster will also be available on the Company’s website – www.affimed.com

Major Symposium Details:

Session Title: Engineering and Modulating Natural Killer (NK) Cells for Cancer Immunotherapy

Session Number: SY30

Talk: CAR-NK, a Drive to the Future of Cell Therapy

Speaker: Katy Rezvani, MD, PhD, Sally Copper Murray Endowed Chair in Cancer Research Professor of Medicine, Chief, Section of Cellular Therapy, Director for Translational Research Medical Director, SCT Laboratory and the GMP Laboratory, Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson

Moderated 30-minute Panel Session for Q&A Date: Tuesday, April 13, 1:30-2:00 pm ET

More details about the programs for the AACR (Free AACR Whitepaper) Virtual Annual Meetings are available online at www.aacr.org.

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting, and additional details can be found at www.clinicaltrials.gov using the identifier NCT04101331.

In addition, Affimed is studying AFM13 in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive Hodgkin or non-Hodgkin lymphomas. The investigator-sponsored Phase 1 study, conducted at the MD Anderson Cancer Center in Houston, is administering a CAR-like, stable complex of AFM13 pre-loaded cord blood-derived allogeneic NK cells. The study can be found at www.clinicaltrials.gov using the identifier NCT04074746.

About AFM24

AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Affimed is evaluating AFM24 as a monotherapy for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24-101 is a first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450. In addition, Affimed is planning to initiate further studies evaluating AFM24 in combination with adoptive NK cell transfer and in combination with atezolizumab.