On December 7, 2021 METiS Therapeutics reported the company debut with $86 million Series A financing to harness artificial intelligence (AI) and machine learning to redefine drug discovery and delivery and develop optimal therapies for patients with serious diseases (Press release, METiS Therapeutics, DEC 7, 2021, View Source [SID1234648428]). PICC PE and China Life led the financing and were joined by Sequoia Capital China, Lightspeed, 5Y Capital, FreeS Fund and CMBI Zhaoxin Wuji Fund. The financing will be used to advance the company’s pipeline of novel assets with high therapeutic potential and the continued development of its AI-driven drug discovery and delivery platform.

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"METiS is well-positioned to change the drug discovery and delivery landscape with the creation of a proprietary predictive AI platform. We leverage machine learning, AI and quantum simulation to uncover novel drug candidates and to transform drug discovery and development, ultimately bringing the best therapies to patients in need," said Chris Lai, CEO, and Founder, METiS Therapeutics. "We are fortunate that our world-class roster of investors believes in our vision and today’s news represents the first of many significant milestones that we will be accomplishing throughout the next year."

The METiS platform (AiTEM) combines state-of-the-art AI data-driven algorithms, mechanismdriven quantum mechanics and molecular dynamics simulations to calculate Active Pharmaceutical Ingredient (API) properties, elucidate API-target and API-excipient interactions, and predict chemical, physical and pharmacokinetic properties of small molecule and nucleic acid therapeutics in specific microenvironments. This enables efficient lead optimization, candidate selection and formulation design. Founded by a team of MIT researchers, serial entrepreneurs and biotech industry veterans, METiS develops and in-licenses novel assets with high therapeutic potential that could benefit from its data-driven platform.

On December 7, 2021 Alvotech Holdings S.A. ("Alvotech"), a leading global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P. ("Oaktree"), reported that they have entered into a definitive merger agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol "ALVO (Press release, Alvotech, DEC 7, 2021, View Source [SID1234596548])."

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Company Overview

Alvotech, founded in 2013 in Reykjavik, Iceland, is a vertically integrated platform company focused exclusively on developing and manufacturing biosimilar medicines for the global market. Alvotech has a world class management team of proven and highly experienced pharmaceuticals executives with deep expertise in biologics and biosimilars, led by a visionary founder, Robert Wessman, who has a track record of building global biopharmaceutical companies.

Alvotech is dedicated to transforming patients’ lives by improving access to affordable biosimilar medicines and enhancing the sustainability of healthcare systems. A biosimilar medicine, offered at lower costs, is a biological product that is highly similar to and has no clinically meaningful difference from an existing approved biologic. Biologics are large complex molecules that have become the standard of care for many difficult-to-treat conditions. The global markets for biologic and biosimilar medicines have been rapidly growing over the last decade and are forecasted to grow at a 10%+ CAGR, reaching approximately $555 billion and approximately $80 billion by 2026, respectively1. By establishing the critical infrastructure needed to navigate the complexities inherent in developing biosimilar medicines at a global scale, Alvotech is uniquely positioned to succeed in the rapidly growing biosimilars market and to enable the global healthcare system to reduce the high cost of biologic medicines.

Alvotech aims to become a leading supplier of biosimilar medicines in all major markets around the world. To accomplish this objective, Alvotech has built a distinctive and comprehensive platform for developing and manufacturing biosimilars at scale over the past nine years with approximately $1 billion invested into the business to build critical elements of product development, including cell line development, process development and characterization, in addition to manufacturing, clinical development and conducting regulatory affairs, in-house to ensure the highest standards of product quality.

Alvotech currently has seven products in its pipeline across multiple therapeutic areas. Alvotech’s pipeline addresses originator products treating a diverse set of conditions across autoimmunity, ophthalmology, osteoporosis, and oncology, with total estimated peak originator sales of more than $80 billion combined.

Alvotech’s most advanced product is AVT02, the company’s biosimilar candidate to Humira. Humira is the world’s top selling pharmaceutical product with over $20 billion in global revenue in 2020. Alvotech was the first company to both file with the FDA for approval of its high-concentration adalimumab product and to have successfully conducted a switching study in support of an FDA designation of interchangeability. Alvotech’s other differentiated pipeline programs include biosimilar candidates to Stelara (ustekinumab), Eylea (aflibercept), Prolia/Xgeva (denosumab) and Simponi/Simponi ARIA (golimumab). In addition to its existing pipeline, Alvotech is also constantly evaluating new pipeline programs, both internally and through business development.

In order to give its products global reach, Alvotech has formed strategic commercialization partnerships covering 60+ countries with leading pharmaceutical companies. Alvotech’s partners, including Teva in the US and Stada in the EU, have licensed products in exchange for milestone payments and royalties. As of June 30, 2021, Alvotech had received license fee commitments of up to $1.15 billion under these partnerships, approximately 80% of which are still to be collected.

Management Comments

"We are delighted with this business combination and the long-term opportunities it will unlock for Alvotech," said Robert Wessman, Chairman and founder of Alvotech. "Through this important milestone, we believe that we are perfectly positioned to rapidly scale our portfolio with a like-minded partner who understands the intricacies of our business and our industry."

Howard Marks, Co-Chair of Oaktree, added, "Oaktree Acquisition Corp.’s strategy is guided by the same principles that are core to Oaktree’s broader investment philosophy, with a focus on long-term partnership and value creation. The Oaktree Acquisition Corp. franchise was formed to identify and partner with high-quality, growing companies that are making pivotal strides in their respective industries, and Alvotech is a clear fit with its meaningful contributions to sustainability within the healthcare ecosystem."

"Alvotech has built a highly attractive platform with a long-term view to lead the biosimilars market," said Zaid Pardesi, Managing Director at Oaktree and CFO & Head of M&A of Oaktree Acquisition Corp II. "The Company’s diverse pipeline and unique capabilities, in combination with its world-class distribution partners, set the stage for meaningful value creation and accelerated growth going forward."

Mark Levick, CEO of Alvotech, added, "Alvotech is in a unique position to impact the global healthcare ecosystem in a positive way and transform patient’s lives. Biosimilar medicines can increase access for patients whilst lowering cost for healthcare systems, and that helps to align our mission with all of our stakeholders. We believe this transaction will accelerate our ability to achieve our vision, and we could not be more excited about what the future holds for Alvotech."

Key Transaction Terms

The business combination is expected to deliver gross proceeds to Alvotech in excess of $450 million (assuming no redemptions). This includes cash proceeds of approximately $250 million from Oaktree Acquisition Corp. II’s trust account (assuming no redemptions); in excess of $150 million from private placement (PIPE) investors (the "PIPE Transaction"), including among others, funds managed by Suvretta Capital, Athos (the Strüngmann Family Office), CVC Capital Partners, Temasek, Farallon Capital Management, Sculptor Capital Management and premier Icelandic investors including Arctica Finance, Arion Bank, and Landsbankinn; and a $50 million equity commitment from existing shareholders to be funded prior to the end of 2021. The combined company will have an implied initial enterprise value of approximately $2.25 billion and will be well-positioned to continue investing in the growth of its biosimilar pipeline.

As part of the transaction, Alvotech’s existing equity holders have committed to roll 100% of their equity into the combined company. Leading existing institutional backers of Alvotech, including among others, Aztiq Pharma Partners, led by founder and Chairman Mr. Robert Wessman, Alvogen with CVC Capital Partners and Temasek as lead investors, Fuji Pharma from Japan, YAS Holdings from Abu Dhabi, Shinhan from Korea, Baxter Healthcare SA from the US, and Athos (the Strüngmann Family Office) from Germany intend to roll 100% of their shares into the combined company. Assuming no public shareholders of Oaktree Acquisition Corp. II exercise their redemption rights, current Alvotech equity holders will own approximately 80%, Oaktree Acquisition Corp. II shareholders will own approximately 11%, and PIPE investors will own approximately 7% of the issued and outstanding ordinary shares, respectively, of the combined company at closing.

The transaction also includes earn-out provisions tied to the trading price of the combined company’s shares, reflecting an alignment of interest with shareholders. Oaktree Acquisition Corp. II’s sponsor is deferring 1.25 million founder shares into an earn-out at share price hurdles of $12.50 and $15.00. The transaction also includes an earn-out to existing shareholders of Alvotech, consisting of 38.3 million shares, which will vest evenly at share price hurdles of $15.00 and $20.00.

The transaction, which has been unanimously approved by the boards of directors of each Alvotech and Oaktree Acquisition Corp. II, is subject to, among other customary closing conditions, approval by shareholders of Oaktree Acquisition Corp. II, and shareholders of Alvotech, with the holders of a majority of the votes required to approve the transaction having provided commitments to approve the transaction. The transaction is expected to close in the first half of 2022.

A more detailed description of the transaction terms and a copy of the Business Combination Agreement will be included in a current report on Form 8-K to be filed by Oaktree Acquisition Corp. II with the United States Securities and Exchange Commission (the "SEC"). Oaktree Acquisition Corp. II will file a registration statement (which will contain a proxy statement/ prospectus) with the SEC in connection with the transaction.

Advisors

Morgan Stanley & Co. LLC and Credit Suisse served as financial advisors to Alvotech. Deutsche Bank Securities served as financial advisor and capital markets advisor to Oaktree Acquisition Corp. II. Deutsche Bank Securities and Morgan Stanley & Co. LLC served as lead private placement agents, and Citigroup Global Markets Inc. and Credit Suisse also served as private placement agents, for Oaktree Acquisition Corp. II in connection with the PIPE Transaction. Cooley (UK) LLP served as lead legal counsel to Alvotech. Kirkland and Ellis LLP and King & Spalding served as legal counsel to Oaktree Acquisition Corp. II. Shearman & Sterling LLP served as legal counsel to the placement agents.

Management Presentation

A presentation made by the management teams each of Alvotech and Oaktree Acquisition Corp. II regarding the transaction will be available on the websites of Oaktree Acquisition Corp. II at View Source and Alvotech at View Source Oaktree Acquisition Corp. II will also file the presentation and transcript of related remarks with the SEC as an exhibit to a Current Report on Form 8-K, which can be viewed on the SEC’s website at www.sec.gov.

On December 7, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported that members of management will participate in a fireside chat hosted by Cantor Fitzgerald Analyst Brian Cheng on Wednesday, December 8, 2021 at 1:00 p.m. ET (Press release, Immunome, DEC 7, 2021, View Source [SID1234596567]).

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The live call is reserved for institutional clients of Cantor Fitzgerald. A replay of the webcast can be accessed from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available at the conclusion of the live presentation for approximately 30 days.

On December 7, 2021 Race Oncology Limited ("Race") reported additional interim results from the Zantrene (bisantrene dihydrochloride) preclinical heart safety research program led by eminent cardiotoxicity researchers, Associate Professors Aaron Sverdlov and Doan Ngo, in collaboration with cancer scientist Associate Professor Nikki Verrills, at The University of Newcastle (ASX announcement: 28 April 2021) (Press release, Race Oncology, DEC 7, 2021, View Source [SID1234596735]).

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This research has found that Zantrene is able to also protect heart muscle cells from a new class of anti-cancer drug (carfilzomib) induced cell death while improving the carfilzomib-mediated killing of cancer cells.

Carfilzomib (trademark Kyprolis) is a highly effective anti-cancer drug used in the treatment of multiple myeloma (a dangerous blood cancer), but it can cause serious and permanent damage to the heart in many patient1. The risk of cardiac damage is so great that its use in older patients with pre-existing heart disease is often contraindicated2.

"Carfilzomib is a highly effective anti-cancer drug, but it’s use is limited due to cardiotoxicity. Our laboratory has tested numerous drug candidates over the years, we observe that Zantrene has: 1. potent anti-cancer effects; 2. synergistic anti-cancer effects with both carfilzomib and doxorubicin; and 3. cardioprotective effects against both carfilzomib and doxorubicin-induced cardiotoxicity. Zantrene was shown to salvage over 30% of carfilzomib-induced human heart cell from death. These results are genuinely remarkable, as with other clinically used cardioprotective drugs, we only observe a 10-15% protection from heart cell damage.

Zantrene is the first anti-cancer agent that we have found to exhibit a cardioprotective profile while being synergistically effective as an anti-cancer treatment. These results give hope to the millions of patients living with cancer that once they survive cancer, they may not have to live with heart disease."

Associate Professor Doan Ngo
While Zantrene’s improved heart safety compared to anthracyclines was demonstrated in more than 50 human clinical trial3,4, and has been shown in preclinical studies to protect heart muscle cells from anthracycline-induced death (ASX Announcement: 22 November 2021), the question as to whether Zantrene could help prevent cardiac damage caused by other classes of heart damaging cancer drugs had not been addressed.

"The expansion of Zantrene’s cardio-protection and anti-cancer synergy beyond the anthracyclines into the completely new drug class of proteasome inhibitors is unexpected. This discovery opens new clinical development pathways and partnering opportunities for Zantrene beyond those already identified by Race."

CSO Dr Daniel Tillett
"This additional result further underscores the potential patient utility and commercial applicability for Zantrene. We will be allocating additional resources to ensure this discovery can be comprehensively addressed."

Chief Executive Officer, Mr Phillip Lynch
Study Background
Multiple Myeloma
Multiple myeloma is dangerous leukaemia caused by the uncontrolled proliferation of the plasma white blood cells. It usually occurs in people aged over 60 and is more common in men. Multiple myeloma accounts for 10% of all blood cancers and is responsible for 1.8% of all new cancer cases in the United States, with a lifetime risk of 0.8% and a 5-year survival of 55.6% in 20215.

Carfilzomib mechanism of action and use
Carfilzomib is an intravenous drug for treating multiple myeloma in patients with relapsed or refractory disease after at least one previous therapy. It is given in combination with dexamethasone or with lenalidomide and dexamethasone6.

Originally developed by Proteolix before being acquired by Onyx Pharmaceuticals in 2009, carfilzomib is currently owned by Amgen after their acquisition of Onyx in 20137. Carfilzomib’s patent protection is expected to expire in 2025.

Carfilzomib is a 20S proteasome inhibitor that works by interfering with the system for breaking down proteins within cells. One of the hallmarks of cancer is the loss of control of normal protein synthesis and an increase in misfolded and damaged proteins that need to be removed. Inhibition of the 20S proteasome prevents these damaged proteins from being degraded, ultimately resulting in death of the cancer cells8.

Carfilzomib is administered to multiple myeloma patients in 28-day cycles. An intravenous infusion is given on two consecutive days each week for three weeks followed by a 12-day rest period. The annual cost of carfilzomib for a multiple myeloma patient is over US$300,000, with many patients treated for two or more years9.

Carfilzomib-induced cardiotoxicity
While effective in treating multiple myeloma, carfilzomib comes with significant risk of permanent heart damage. An analysis of the Phase 2 carfilzomib studies found of the 526 patients treated, 22% (n=116) of patients developed cardiac side-effects, 13.3% (n=70) showed arrhythmia, mainly atrial fibrillation, 7.2% (n=38) exhibited heart failure, 2% (n=9) developed treatment-associated cardiomyopathy, and 3% (n=18) suffered from ischemic heart disease2. Most cardiovascular events occurred early, with the first few doses administered10.

A history of atrial fibrillation/flutter or heart failure was more prevalent in patients experiencing cardiovascular events, emphasizing the importance of closely monitoring patients given carfilzomib11. Ionising radiation of the chest and/or anthracycline treatment also increases the risk of carfilzomib-induced cardiotoxicity, while biomarkers and echocardiography are not able to identify the patients most at risk for cardiovascular events12.

Study Highlights
1. Zantrene protects cardiomyocytes from carfilzomib-induced cell death
This study found Zantrene was able to protect or rescue primary human heart muscle (cardiomyocyte) cells from carfilzomib-induced cell death. Incubation of cardiomyocytes in the presence of 1000 nM carfilzomib for 72 hours resulted in 80% cell death (Fig. 2). Protection from cardiomyocyte cell death was observed upon the addition of 250 nM Zantrene and increased further with higher concentrations, reaching 50% survival (2.5-fold increase) at 1000 nM, a concentation that is less than 15% of the maximium achievable and tolerated dose in humans13.

Figure 2. Primary human cardiomyocyte cell viability when cultured in the presence of 0-5000 nM of Zantrene and 1000 nM carfilzomib for 72 hours. Data is the average of five independent replicates, each performed in triplicate. Bars show the standard error.

2. Zantrene is highly active in killing multiple myeloma cancer cells
Zantrene was found to be highly active in killing the multiple myeloma cell line H929, with an IC50 below 15 nM (Fig. 3). Addition of only 10 nM carfilzomib to 15 nM of Zantrene resulted in 100% cell death (data not shown). Experiments are currently underway to determine the optimal synergistic combinations of these two drugs in multiple myeloma cell lines.

Figure 3. H929 Multiple Myeloma cell viability when cultured in the presence of 0-5000 nM of Zantrene for 72 hours.

3. Zantrene synergises with carfilzomib to better kill breast cancer cells
While carfilzomib has shown preclinical promise as a treatment for solid tumours including breast cancer, it has proven too toxic in patients to be used in the clinic8. This study examined potential synergy between Zantrene and carfilzomib. Inclusion of low concentrations of Zantrene (< 125 nM) resulted in significant breast cancer cell death in the presence of low concentrations of carfilzomib (Table 1). This synergy was not limited to the MB-231 cell line as similar results were seen using MCF7 cells (data not shown).

Table 1. MB-231 breast cancer cell viability (%) when cultured in the presence of increasing concentrations of Zantrene and carfilzomib. Red shows drug combinations that result in high cell killing.

On December 6, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported the presentation of interim clinical data from the company’s ongoing Phase 1/2 study of BDC-1001, the company’s lead immune-stimulating antibody conjugate (ISAC) in a poster session at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021, being held virtually from Dec. 6-11, 2021 (Press release, Bolt Biotherapeutics, DEC 6, 2021, View Source [SID1234596478]). The lead author for the poster is Manish Sharma, M.D., START Midwest, with contributions from Ecaterina Dumbrava, M.D., MD Anderson Cancer Center, and other colleagues from the U.S. and South Korea.

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The company reported data from 57 subjects participating in an ongoing Phase 1/2 study of BDC-1001, across 16 different types of HER2-expressing solid tumors. BDC-1001 demonstrated a favorable safety and tolerability profile at all evaluated doses and schedules, showing early signs of clinical activity with corresponding biomarker changes in the tumor microenvironment of post-treatment tumor biopsies. BDC-1001 is an immune-stimulating antibody conjugate (ISAC) comprising a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to an innovative TLR7/8 agonist.

"The favorable safety profile and early indications of clinical disease control in the BDC-1001 study are encouraging," said Dr. Sharma, Associate Director of Clinical Research at START Midwest. "There is a clear need for well tolerated, durable treatments in the fight against cancer and I’m excited to see if BDC-1001 can deliver on that potential as we explore higher drug exposure levels."

The poster presentation at ESMO (Free ESMO Whitepaper) I-O reported new safety, pharmacokinetic/pharmacodynamic, and efficacy results for the ongoing Phase 1 dose-escalation portion of the BDC-1001 monotherapy trial. Fifty-seven subjects have been treated at increasing dose levels up to 20 mg/kg every three weeks and 12 mg/kg every two weeks, and data from these subjects demonstrate that:

BDC-1001 continues to have a favorable safety and tolerability profile with mild (grade 1/grade 2) infusion related reactions in some patients and no dose-limiting toxicities at dose levels up to 20 mg/kg every three weeks and 12 mg/kg every two weeks. There was no indication of cytokine release syndrome (CRS), and a maximum tolerated dose (MTD) has not been reached.

Early signs of clinical activity are noted in 13 of 40 tumor evaluable subjects with one durable partial response maintained through 52 weeks and multiple subjects achieving stable disease for >12 weeks.

The pharmacokinetic (PK) data demonstrate increasing peak drug levels with increasing dose, and linearity of PK above the 5 mg/kg dose level. Clinical PK modeling predicts that target exposure levels can be achieved with weekly dosing.

Plasma and tissue biomarker results show increase in multiple biomarkers indicative of myeloid cell and TLR 7/8 activation that is consistent with BDC-1001’s mechanism of action. Increasing drug exposure correlates with increases in plasma cytokines and corresponding biomarker changes in the tumor microenvironment of multiple post-treatment tumor biopsies, with intriguing signs of clinical disease control.

These encouraging data point to the need for increased drug exposure to optimize clinical benefit. The favorable safety profile of BDC-1001 allows for continued enrollment in the dose escalation portion of the study, and the Company’s refined PK model based on data from more than 50 patients predicts that weekly administration will provide BDC-1001 exposures at or above the target exposure threshold. The data also support initiation of the combination therapy study with nivolumab (PD-1 inhibitor).

"Bolt Biotherapeutics is committed to agile clinical development based on data. In this Phase 1/2 study of BDC-1001, we have gained tremendous insight into the ability of this novel candidate to mobilize the patient’s immune system in targeting the tumor and its microenvironment. The increases in myeloid cell infiltration and repolarization of macrophages we’ve seen in multiple post-treatment biopsies are provocative and consistent with our proposed mechanism of action," said Edith Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. "We look forward to exploring weekly dosing as we get closer to determining the recommended Phase 2 dose for BDC-1001 as monotherapy, and to initiating combination therapy with a checkpoint inhibitor."

Presentation Details

Title: Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors

Lead author: Manish R. Sharma, M.D.

Presentation Number: 164P

Timing: On-demand access beginning Dec. 6 at 12:00 p.m. CET.

The poster presentation will be available on the ESMO (Free ESMO Whitepaper) I-O conference website and on Bolt’s website.

Conference Call and Webcast Details

Bolt Biotherapeutics management will host a conference call for the investment community, in conjunction with the now virtual ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, to discuss emerging clinical data and insights from the ongoing Phase 1/2 study today, Monday, December 6, 2021, at 8:00 a.m. ET/5 a.m. PT.

The conference call can be accessed by dialing +1 (833) 665-0609 within the U.S. or Canada or by dialing +1 (929) 517-0400 from international locations. The passcode for the call is 2633068. A live webcast, including slides, will be available on the Events & Presentations page of Bolt Biotherapeutic’s website at www.boltbio.com. An archived replay can be accessed for 30 days following the webcast.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform

ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs comprise three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.