On December 6, 2021 ITI reported that it will be attending the 2nd International Symposium on Merkel Cell Carcinoma (Press release, Immunomic Therapeutics, DEC 6, 2021, View Source [SID1234596484]).

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The focus of this symposium is to explore emerging data that may allow improvements in clinical guidelines, develop innovative approaches, and to understand the basic biology that drives this disease. We will include updates from the most recent clinical guidelines as well as emerging data highlighting MCC biology. This meeting will be partly in lecture format with talks from leaders in the field as well junior faculty and trainees. We will also include focused panel discussions and poster presentations to optimize real time feedback and collaboration. The educational purpose of this symposium is to disseminate emerging data and to advance MCC research by stimulating collaborative meeting.

On December 6, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it completed the repurchase of Roche shares that had been held by Novartis. On 4 November 2021, Roche and Novartis had announced this repurchase (Press release, Hoffmann-La Roche, DEC 6, 2021, View Source [SID1234596483]). The Extraordinary General Meeting of Roche Holding Ltd passed the resolutions required for the repurchase and the capital reduction on 26 November 2021. In accordance with the respective resolution of the Extraordinary General Meeting of 26 November 2021, the 53,309,000 shares have now been repurchased by Roche and the corresponding consideration has been transferred to Novartis. The repurchased shares will be cancelled upon completion of the corresponding procedure.

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Christoph Franz, Chairman of the Board of Directors of Roche: "With this transaction, we regain full strategic flexibility without compromising our operational scope of action. Rating agencies have confirmed the high quality of our ratings. On the basis of an unchanged dividend policy, all holders of Roche equity securities will benefit from the repurchase and the resolved capital reduction by cancellation of the repurchased shares and the earnings accretion resulting therefrom."

As previously announced, the transaction does not change the communicated outlook for the full year. Roche expects a mid-single-digit sales growth at constant exchange rates. Core EPS growth at constant exchange rates is targeted to be broadly in line with sales growth. Furthermore, Roche is aiming at increasing the dividend in Swiss francs also for 2021.

On December 06, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that new data from the ongoing Phase 1 study of SRF617, an antibody targeting CD39, will be presented in a scientific poster at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO), to be held virtually from December 8-11, 2021 (Press release, Surface Oncology, DEC 6, 2021, View Source [SID1234596482]).

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"Results from this first-in-human dose-escalation study of SRF617 show promising signs of activity, both as a monotherapy and in combination with chemotherapy and pembrolizumab in both immune checkpoint naïve and experienced patients," said Alison O’Neill, M.D., chief medical officer. "We are currently enrolling Phase 2 cohorts for patients with PD-1 naïve gastric cancer and patients with PD-1 relapsed/refractory gastric or non-small-cell lung cancer (NSCLC) and look forward to opening first-line pancreatic cancer cohorts soon."

Safety Overview

The recommended Phase 2 dose for SRF617 monotherapy has been determined to be 1400 mg Q2W based on aggregate review of safety, clinical PK/PD and preclinical data.
No instances of dose-limiting toxicity were observed through dose escalation to the 1400 mg dose level.
Monotherapy Highlights

PK are linear and correlate strongly with PD target occupancy. SRF617 is well-tolerated at doses that sustain full target occupancy throughout the dosing interval and demonstrate dose-dependent loss of CD39 on B cells. Early data from a patient undergoing paired tumor biopsy show marked decrease of CD39 expression in the tumor microenvironment following SRF617 treatment.
Ten of 32 evaluable patients (31%) receiving SRF617 as a monotherapy had disease stabilization at eight weeks, with four (12%) persisting beyond 16 weeks.
One patient with NSCLC whose disease previously progressed on chemotherapy and PD-1 blockade had prolonged disease stabilization beyond 24 weeks.
Combination Highlights

The recommended Phase 2 dose for SRF617 in combination with pembrolizumab has also been determined to be 1400 mg Q2W.
Of patients treated with SRF617 in combination with pembrolizumab (KEYTRUDA), four of eight evaluable patients (50%) had disease stabilization at six weeks, with three of the eight exhibiting disease control at 12 weeks and one beyond 20 weeks.
Of patients treated with SRF617 in combination with gemcitabine/albumin-bound paclitaxel (Abraxane), there was one confirmed partial response in a patient with pancreatic cancer whose disease had progressed on prior chemotherapy. The SRF617 1400mg dose cohort is currently enrolling.
About the SRF617-101 Clinical Trial:

The trial is a Phase 1, open-label, multicenter, first-in-human dose-escalation trial of SRF617, a monoclonal antibody that binds and inhibits CD39 activity, in patients with advanced solid tumors. The monotherapy dose escalation portion of the study evaluates the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of SRF617 as a monotherapy in patients with advanced solid tumors. The combination therapy dose escalation portion of the study evaluates the safety, tolerability, PK and preliminary efficacy of SRF617 in combination with gemcitabine + albumin-bound paclitaxel, or SRF617 in combination with pembrolizumab, in patients with locally advanced or metastatic solid tumors.

About SRF617:

SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39 in the tumor microenvironment, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. A substantial body of research supports a role for CD39 in allowing cancer to evade immune responses. For example, pancreatic cancer stromal cells within the tumor micro-environment express high levels of CD39, which may inhibit anti-cancer immune responses. In preclinical studies, SRF617 has exhibited strong affinity for and inhibition of CD39, the ability to reduce adenosine and increase ATP levels and anti-tumor activity both as a single agent and in combination with multiple therapeutic agents. SRF617 has been granted Orphan Drug designation for the treatment of advanced pancreatic cancer by the FDA.

On December 6, 2021 Odyssey Acquisition S.A. ("Odyssey"), a Euronext Amsterdam-listed special-purpose acquisition company, and BenevolentAI, a leading clinical-stage AI drug discovery company, reported that they have entered into a definitive agreement for a business combination (the "Combination") (Press release, BenevolentAI, DEC 6, 2021, https://finance.yahoo.com/news/odyssey-announces-agreement-combine-benevolentai-060000260.html [SID1234596481]). The terms of the Combination value BenevolentAI at a pre-money valuation of €1.1 billion and a post-money valuation of up to €1.5 billion. Net transaction proceeds are expected to be up to €390m[1] including €135m of fully-committed PIPE and €300m of gross cash held in escrow by Odyssey. The funds will be used to accelerate BenevolentAI’s development, scale-up its clinical pipeline, continue investment in its technology platform, consolidate its leadership position in AI-enabled drug discovery and deliver multiple value inflection points in the near future.

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Joanna Shields, Chief Executive Officer, BenevolentAI, said: "We have built BenevolentAI into a category defining business by pioneering a revolutionary approach to drug discovery and development. Our AI platform empowers scientists to leverage biomedical and experimental data at scale to understand the underlying causes of disease and develop more effective medicines, faster. Every drug in our pipeline of 20+ programmes has been generated by the Benevolent Platform which has a proven track record of scientifically validated discoveries, both in-house and in partnership with leading pharmaceutical companies. The combination with Odyssey will allow us to scale our vision and ambition of uniting purposeful technology and cutting-edge science to discover life-changing medicines."

Dr François Nader, Chairman of BenevolentAI, said: "BenevolentAI stands out at the forefront of the emerging sector of AI-driven drug discovery, with its innovative R&D platform and focus on mechanism-based drug discovery. Through its impressive track record, BenevolentAI has demonstrated the value of its platform in facilitating new discoveries for challenging diseases that have defied conventional research efforts. BenevolentAI is a company with significant growth potential, and the combination with Odyssey will further accelerate the company’s ambitious plans to scale its platform and broaden its pipeline. Investments from existing shareholder Temasek, our strategic partner AstraZeneca and new shareholders Ally Bridge and Invus are a clear vote of confidence in BenevolentAI and its growth prospects."

Michael Zaoui, Chairman of Odyssey, said: "We established Odyssey with the objective of supporting and bringing to the European capital markets promising European growth companies in the healthcare and/or technology sectors. BenevolentAI is positioned at the convergence of these two sectors, is a proven leader in the emerging area of AI-driven drug discovery, and is led by a very experienced management team. We are convinced BenevolentAI offers superior growth prospects in a sector which itself is at an inflection point. We see our combination with BenevolentAI as a compelling investment opportunity and are convinced that this transaction will create value for all our shareholders."

Dr Olivier Brandicourt, healthcare expert to Odyssey, said: "BenevolentAI, leveraging its Knowledge Graph technology, is very well positioned to unlock a new phase of growth in the pharmaceutical R&D industry. BenevolentAI has already produced substantial evidence of the potency and efficiency of its platform, notably through the quality of its existing pipeline of candidates and its strong and expanding collaboration with AstraZeneca. We are confident in the ability of BenevolentAI to sustainably generate a pipeline of first- and best-in-class programmes and to become a key player in the global drug discovery sector."

TRANSACTION HIGHLIGHTS

The combination of Odyssey, a €300m Euronext Amsterdam-listed special-purpose acquisition company focused on European healthcare and TMT growth companies, and BenevolentAI, a leading clinical-stage AI drug discovery company, represents the largest European SPAC merger announced to date and one of the largest Euronext Amsterdam biotech listings ever.

Founded in 2013, BenevolentAI has built a proprietary AI-based drug discovery platform that, combined with the scientific expertise of approximately 300 world-class scientists and technologists and full wet-lab capabilities, enables the delivery of novel drug candidates with a higher probability of clinical success than those developed using traditional methods. BenevolentAI has a consistently proven track-record of scientifically validated discoveries.

AI-driven drug discovery is at an inflection point and represents a significant growth opportunity.

AI-led drug discovery is becoming a powerful tool to accelerate biomedical innovations and discoveries, with the potential to achieve materially higher clinical success rates and drive efficiencies across the drug discovery process through the use of data-driven insights and analysis.

The sector is now at an inflection point and is increasingly becoming a strategic focus area for pharma companies, attracting significant capital and investment.

BenevolentAI is a leader in AI-enabled drug discovery with a highly promising pipeline.

BenevolentAI is a recognised industry leader in AI-enabled drug discovery; its existing pipeline alone could potentially address a patient base of over 260 million people with a current market opportunity above $30 billion.

Through the combined capabilities of its leading Knowledge Graph, AI-enabled BenevolentAI Platform and wet-lab facilities, BenevolentAI is well-positioned to not only identify new drug targets for complex and intractable diseases, with higher success rates than traditional drug discovery methods, but also to develop these targets at pace while generating experimental data at scale to fuel continuous innovation.

BenevolentAI has a proven scientific and commercial track-record.

All of BenevolentAI’s 20+ in-house drug programmes are platform-generated, discovered and developed using the company’s AI and machine learning tools. This includes a novel target for treating ulcerative colitis and an atopic dermatitis programme in the clinic. BenevolentAI’s multi-target commercial collaboration with AstraZeneca delivered the first novel AI-generated target for chronic kidney disease into AstraZeneca’s portfolio, and this collaboration is now being expanded. BenevolentAI also successfully identified Eli Lilly’s baricitinib as a treatment for COVID-19, which is now FDA emergency-use approved.

BenevolentAI has a highly versatile and diversified business model.

BenevolentAI is highly versatile and diversified, combining work across multiple therapeutic areas with the ability to develop pre-clinical and early-stage clinical assets in-house, to out-license or to collaborate with partners on new drug discovery and development.

BenevolentAI has an experienced management team supported by industry-leading Board members and scientific advisors.

BenevolentAI is led by an experienced management team with an outstanding track record in healthcare and technology, supported by industry-leading Board members and scientific advisors.

Highly attractive value proposition with significant and tangible upside.

Odyssey believes the investment opportunity represents an attractive value proposition with significant upside, as evidenced by the extensive pipeline of drug candidates and the potential of the BenevolentAI Platform.

TRANSACTION OVERVIEW

Odyssey has agreed to combine with BenevolentAI at a pre-money valuation of €1.1 billion and a post-money valuation of up to €1.5 billion, prior to any redemptions. The combination will be effected by way of a share exchange. BenevolentAI shareholders will receive Class A ordinary shares (the "Ordinary Shares") of Odyssey in exchange for their shares of BenevolentAI. Their BenevolentAI options and RSUs will convert into options and RSUs of Odyssey. As a result of the share exchange, BenevolentAI will become a wholly-owned subsidiary of Odyssey, which, following the closing of the transaction, will change its name to BenevolentAI. BenevolentAI is expected to benefit from a strong cash position, including €135m fully-committed PIPE, €300m of gross cash held in escrow by Odyssey (prior to any redemptions) and an estimated €56m of cash on BenevolentAI’s balance sheet as at 30 November 2021. Assuming that no Odyssey shareholders elect to redeem their Ordinary Shares in connection with the transaction, current BenevolentAI shareholders are expected to own 67.4% of the combined company (including vesting RSUs and options), Odyssey shareholders (including the Sponsor) 23.5%, and PIPE investors 9.1% of the post-transaction pro-forma equity, respectively. None of the current shareholders of BenevolentAI will sell stock as part of the transaction, and BenevolentAI’s core shareholders and current members of the board of directors of BenevolentAI, representing collectively approximately 86% of the current capital of BenevolentAI, will be subject to a lock-up of 180 days, subject to limited market standard exceptions.

The Board of Directors of Odyssey and the Board of Directors of BenevolentAI have each unanimously approved the proposed transaction. The closing of the transaction is subject to the satisfaction or waiver of customary closing conditions, including the approval by a general meeting of Odyssey’s shareholders and a minimum cash balance at closing (see "Conditions to Closing" below), and is expected to close in Q1 2022. Following the closing of the transaction, the combined company will be listed on Euronext Amsterdam and will trade under the ticker symbol "BAI". The combined company will be led by the current CEO of BenevolentAI, Joanna Shields, alongside BenevolentAI’s industry-leading management and research team. Olivier Brandicourt, healthcare expert to Odyssey, will join the combined company’s Board of Directors alongside Jean Raby, Odyssey’s current co-CEO. Dr Francois Nader, current Chairman of the Board of Directors of BenevolentAI, will assume the role of Chairman of the Board of Directors of the combined company. The combined company will be headquartered in London.

INVESTOR PRESENTATION

Odyssey and BenevolentAI will host an investor conference call today at 14:00 CET via webcast to discuss the proposed transaction. The webcast is accessible as an audio only livestream via BenevolentAI’s website (www.benevolent.com/investors), alternatively investors can join via phone to listen to the webcast and participate in a Q&A with management.

Further information about the transaction is available on BenevolentAI’s website (www.benevolent.com) and on the Odyssey website (www.odyssey-acquisition.com).

ADVISORS

Goldman Sachs International is serving as exclusive financial advisor to BenevolentAI in connection with the business combination. Goldman Sachs International is also acting as placement agent on the PIPE. Latham & Watkins (London) LLP, NautaDutilh Avocats Luxembourg S.a r.l. and NautaDutilh N.V. are serving as legal advisors to BenevolentAI.

J.P. Morgan AG and Zaoui & Co are serving as financial advisors to Odyssey. J.P. Morgan AG is also acting as placement agent on the PIPE. Skadden, Arps, Slate, Meagher & Flom (UK) LLP, ELVINGER HOSS PRUSSEN, société anonyme and Stibbe N.V. are serving as legal advisors to Odyssey.

Odyssey was supported in its due diligence by Oliver Wyman (commercial advisors), Accuracy (accounting advisors), Arsène-Taxand (tax advisors) and former DeepMind Health Research Lead Trevor Back (AI expert).

Linklaters LLP is serving as legal advisor to the placement agents on the PIPE.

[1]Prior to any redemptions, excluding €56m of cash on BenevolentAI’s balance sheet estimated as at 30 November 2021 and including transaction expenses.

On December 6, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC), a clinical-stage biotechnology company, reported that the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and the Alliance for Clinical Trials in Oncology, have completed enrollment of 267 patients in the Phase 2 portion of the adaptive Phase 2/3 trial evaluating whether uproleselan improves overall survival in newly diagnosed patients 60 years or older with acute myeloid leukemia (AML) (Press release, GlycoMimetics, DEC 6, 2021, View Source [SID1234596480]). The randomized, controlled trial is evaluating the addition of uproleselan, GlycoMimetics’ investigational, first-in-class, targeted antagonist of E-selectin, to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. Completion of enrollment now sets the stage for a planned evaluation of the Phase 2 portion of the trial to determine whether the prespecified threshold for continuing to Phase 3 has been met based on event-free survival (EFS). Geoffrey Uy, M.D., Professor of Medicine, Washington University School of Medicine in St. Louis, is the trial’s Principal Investigator. GlycoMimetics and NCI are collaborating on the development of uproleselan under a Cooperative Research and Development Agreement.

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This press release features multimedia. View the full release here: View Source

"I would like to thank the Alliance for completing the enrollment of the Phase 2 portion despite all of the logistical challenges associated with the pandemic. If the EFS analysis meets the preplanned metric, the data will be transferred confidentially to GlycoMimetics to support regulatory filings for uproleselan in AML, and enrollment will continue in the Phase 3 portion of the trial," said Harout Semerjian, GlycoMimetics Chief Executive Officer. "Together, the GlycoMimetics- and NCI-sponsored programs will constitute a large dataset of 650 patients with AML. We would anticipate filing with regulatory agencies for approval for treatment of patients in both the frontline and relapsed/refractory AML settings should both trials achieve positive readouts."

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration and the Chinese Health authority for the treatment of adult patients with AML who have relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance.