On October 6, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Halozyme and argenx are expanding their existing global collaboration and license agreement that was signed in February 2019 (Press release, Halozyme, OCT 6, 2020, View Source [SID1234568121]).

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Under the newly announced expansion, argenx gained the ability to exclusively access Halozyme’s ENHANZE drug delivery technology for three additional targets upon nomination for a total of up to six targets under the existing and newly expanded collaboration. To date, argenx has nominated two targets including the human neonatal Fc receptor FcRn and complement component C2.

"We are pleased to be expanding the scope of our collaboration with Halozyme and to continue our productive relationship. We recognize that patients have different preferences and we want to secure our ability to offer subcutaneous delivery of our current and future candidates to reach as many patients as possible. We already have exclusive access to ENHANZE for our FcRn antagonist efgartigimod, which is in late stage development for multiple severe autoimmune diseases, and additionally have nominated our complement inhibitor targeting C2," said Keith Woods, Chief Operating Officer of argenx.

"We are delighted that argenx has agreed to expand our global collaboration and license agreement to include up to six targets," said Dr. Helen Torley, president and chief executive officer. "argenx has made rapid progress in the clinic with efgartigimod utilizing ENHANZE since signing the original agreement, moving to a Phase 2 study initiation for an indication being developed only as SC, within just fourteen months. argenx is also working to bring SC efgartigimod to patients suffering from myasthenia gravis following the successful ADAPT trial results."

On October 6, 2020 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, NEC Corporation (NEC; TSE: 6701), a leader in IT and network technologies, and BostonGene Corporation (BostonGene), a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported a strategic collaboration for two ongoing Phase 1 clinical trials of TG4050, an individualized therapeutic vaccine for ovarian and head & neck cancers based on Transgene’s proprietary myvac platform and NEC’s AI-driven Neoantigen Prediction System in Europe and the United States (Press release, NEC, OCT 6, 2020, View Source [SID1234568106]).

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Transgene’s myvac platform brings together a series of highly innovative technologies, such as viral genome engineering, to achieve high-speed modular manufacturing of bespoke immunotherapies.

TG4050 is an individualized cancer vaccine based on the myvac platform; it is based on an optimized viral platform for cancer vaccination and integrates NEC’s artificial intelligence capabilities. This therapeutic vaccine aims at stimulating the immune system of patients to induce a T-cell response against tumor-specific antigenic alterations, called neoantigens. These neoantigens are derived from genomic mutations and selected using NEC’s Neoantigen Prediction System, an advanced AI technology that has already been applied in the field of oncology. TG4050 has been designed to target up to 30 patient-specific neoantigens. Transgene is sponsoring two Phase 1 trials that are expected to deliver a first proof of concept of this virus-based individualized approach.

As part of the collaboration, BostonGene will conduct genomic and transcriptomic analyses of primary patient tumors collected from patients enrolled in these two clinical trials to identify predictors of response to TG4050 and the cancer cell-intrinsic and -extrinsic factors that may mediate each patient’s response to the vaccine. BostonGene’s platform integrates the genomic and transcriptomic analyses to simultaneously assess the activity of the tumor and the microenvironment through the identification of significant somatic alterations, evaluation of gene expression, estimation of tumor heterogeneity and classification of the microenvironment.

BostonGene generates a Tumor Portrait Report, involving the data-driven, visually appealing and self-explanatory tumor schematics elegantly depicting tumor activity, tumor cellular composition, and functionality of the immune-microenvironment and other tumor-associated processes. The comprehensive report will provide insights into the individual oncogenic state and immunogenicity of the patient’s tumor.

"BostonGene’s unique solution and deep expertise in Next Generation Sequencing (NGS) analysis provide us with the detailed profiles of a tumor and its micro-environment. These Tumor Portrait Reports will help us look at our patient data in light of the current published evidence and could help us accelerate the development of TG4050," said Éric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene. "This novel way of analyzing patient data is part of an ambitious translational program that supports the development of our myvac platform. By integrating these types of approaches into our studies, we seek to build an integrated framework for the use of viral-based immunotherapeutics."

"NEC looks forward to strengthening its collaboration with BostonGene through these trials of TG4050. BostonGene’s advanced analysis of NGS among cancer patients provides excellent profiling that we believe will add important insight into the understanding of each patient’s tumor environment and how it reflects on the clinical outcomes of our treatment," said Osamu Fujikawa, Senior Vice President at NEC Corporation.

"BostonGene is proud to support Transgene and NEC during these critical Phase 1 clinical trials," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "This collaboration represents our ongoing commitment to improve immunotherapy options and transform personalization of treatment for cancer patients."

About TG4050
TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence (AI) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences.

TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed for each patient and can be produced in a very short time frame.

This best-in-class candidate is being evaluated in two Phase 1 clinical trials for patients with ovarian cancers (new windowNCT03839524) and HPV-negative head and neck cancers (new windowNCT04183166).

About myvac
myvac is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac-derived products are designed to stimulate the patient’s immune system, recognize and destroy tumors using the patient’s own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded "Investment for the Future" funding from Bpifrance for the development of its platform myvac. TG4050 is the first myvac-derived product being evaluated in clinical trials.

About NEC’s Neoantigen Prediction System
NEC’s neoantigen prediction utilizes its proprietary artificial intelligence (AI), such as graph-based relational learning, which is combined with other sources of data to discover candidate neoantigen targets. NEC comprehensively evaluates the candidate neoantigens with a primary focus placed on its in-house major histocompatibility complex (MHC) binding affinity prediction trained on public and proprietary datasets. These allow NEC to effectively prioritize the numerous candidate neoantigens identified in a single patient.

On October 5, 2020 BridgeBio Pharma, Inc. (Nasdaq: BBIO), a company focused on genetic diseases, and Eidos Therapeutics, Inc. (Nasdaq: EIDX), a company focused on transthyretin (TTR) amyloidosis (ATTR), reported they have entered into a definitive agreement under which BridgeBio has agreed to acquire all of the outstanding common stock of Eidos it does not already own, representing approximately 36.3% of Eidos’ outstanding shares (Press release, BridgeBio, OCT 5, 2020, View Source [SID1234576224]). Eidos stockholders will have the right to receive in the transaction, at their election, either 1.85 shares of BridgeBio common stock or $73.26 in cash per Eidos share in the transaction, up to an aggregate maximum of $175 million of cash. The agreement was unanimously approved by BridgeBio’s Board of Directors and was approved by Eidos’ Board of Directors based upon the unanimous recommendation of a special committee of independent directors of Eidos.

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With this transaction, BridgeBio fully and formally welcomes Eidos back into its vibrant ecosystem of innovation. Eidos is developing acoramidis, a potential best-in-class TTR stabilizer, for patients with ATTR cardiomyopathy and polyneuropathy.

"With the completion of screening in the Phase 3 ATTRibute-CM study of acoramidis and expected enrollment of more than 600 participants, now is the time to begin laying the groundwork for a global launch. This transaction removes the operational complexity of the current ownership structure and allows us to fully unlock the potential of this investigational medicine for patients and investors," said Neil Kumar, Ph.D., founder and CEO of BridgeBio and CEO of Eidos. "Bringing Eidos fully back to BridgeBio positions us to invest in all opportunities around acoramidis, including subsequent studies to potentially broaden the evidence for its usage, and accelerate its commercial development using BridgeBio’s established infrastructure. We are excited to welcome acoramidis back into an ecosystem where cutting-edge science is being done across inherited diseases and targeted oncology."

BridgeBio applies its discover, create, test and deliver platform to target well described genetic diseases at their source. Using this platform Eidos will be able to capitalize on BridgeBio’s global clinical development and regulatory expertise, its developing commercial infrastructure, and its broader capital base to reach more patients more effectively. BridgeBio will be able to invest in novel formulations and studies of acoramidis to maximize its long-term potential benefit to ATTR patients, as well as developing its commercial infrastructure.

Eidos and acoramidis will also become the keystone in BridgeBio’s growing cardiorenal portfolio, which includes drug development in autosomal dominant hypocalcemia type 1 (ADH1) and primary hyperoxaluria type 1 (PH1) as well as undisclosed precision cardiology drug discovery programs.

Eidos completed screening in September for its pivotal Phase 3 ATTRibute-CM clinical trial of acoramidis in patients with ATTR cardiomyopathy. The study is expected to enroll more than 600 subjects with either wild-type or variant TTR across more than 80 sites in 18 countries. Topline results from Part A are expected in late 2021 or early 2022 and from Part B in 2023. If Part A is successful, the company intends to file for regulatory approval of acoramidis in 2022.

BridgeBio expects to launch two drugs, if approved, in 2021 and is building the capabilities necessary to deliver genetic medicines to patients around the globe, which it can deploy for acoramidis.

"ATTR is a rapidly progressive and fatal disease when left untreated, so we know that every moment counts for the patients and families we aim to serve. With Eidos fully reunited with BridgeBio, we intend to move as quickly as possible to advance acoramidis through the development process and, if approved, into the marketplace," said Cameron Turtle, D.Phil., senior vice president of cardiorenal disease at BridgeBio.

"The special committee of Eidos’ Board believes that this transaction is in the best interest of the Eidos minority stockholders and offers them compelling value," said William Lis, chairman of the special committee of Eidos’ Board. "The transaction recognizes the significant current value of acoramidis and allows the Eidos minority stockholders to participate in the potential future value of both acoramidis and the broader BridgeBio pipeline of over 20 novel medicines in development for genetic diseases."

BridgeBio anticipates several meaningful upcoming milestones across its portfolio over the next 12-18 months, including topline Phase 3 Part A data from acoramidis in ATTR cardiomyopathy, Phase 2 data from low-dose infigratinib (FGFR inhibitor) in achondroplasia, Phase 1/2 data from AAV5 gene therapy in congenital adrenal hyperplasia, and Phase 2 data from encaleret (calcium sensing receptor antagonist) in autosomal dominant hypocalcemia type 1.

Additional Transaction Details

Under the terms of the agreement, Eidos stockholders will be entitled to elect to receive the consideration for each share of Eidos common stock in all-stock or all-cash, subject to proration such that the cash portion of the transaction will not exceed $175 million in the aggregate.

All-stock consideration: 1.85 shares of BridgeBio common stock per Eidos share; or

All-cash consideration: $73.26 in cash per Eidos share, subject to proration.
The merger consideration represents a 55% premium to the volume weighted average price of Eidos shares over the 30 trading days ending on October 2, 2020 and a 41% premium to the closing trading price of Eidos common shares on October 2, 2020, based on the closing trading price of BridgeBio shares on October 2, 2020.

Eidos stockholders who do not make an election will be deemed to have elected the all-stock consideration. The transaction is intended to be treated as a reorganization for U.S. federal income tax purposes, in which case gain would be recognized by the Eidos stockholders only to the extent of any cash consideration received. At closing, Eidos stockholders will own between 16% and 18% of BridgeBio, depending on the amount of cash Eidos stockholders elect to receive.

The transaction is not subject to a financing contingency. BridgeBio intends to fund the cash consideration with available cash on hand.

The transaction, which is expected to close in the first quarter of 2021, is subject to the approval of a majority of Eidos’ shares held by stockholders other than BridgeBio and its affiliates. In addition, in accordance with Section 203 of the Delaware General Corporation Law, the transaction is also subject to the approval of at least 66-2/3% of Eidos’ outstanding voting shares not currently owned by BridgeBio or its affiliates or associates (as such terms are defined in Section 203 of the Delaware General Corporation Law), as well as other customary closing conditions. The issuance of shares by BridgeBio will also need to be approved by the affirmative vote of a majority of the votes cast by BridgeBio’s stockholders voting on such matter. Directors of BridgeBio and their affiliates, collectively owning approximately 36% of the outstanding BridgeBio shares, have agreed to enter into voting and support agreements and have agreed to vote in favor of the share issuance. There is no filing requirement under the Hart-Scott-Rodino Antitrust Improvements Act for this transaction.

Upon closing, Eidos will become a wholly owned subsidiary of BridgeBio and Eidos’ common stock will cease trading independently on The Nasdaq Global Select Market.

Advisors
Goldman Sachs & Co. LLC and J.P. Morgan Securities LLC are acting as financial advisors to BridgeBio, and Skadden, Arps, Slate, Meagher & Flom LLP is providing legal counsel. Centerview Partners LLC is acting as financial advisor to the special committee of Eidos’ Board, and Cravath, Swaine & Moore LLP is providing legal counsel to the special committee.

CONFERENCE CALL AND WEBCAST
BridgeBio and Eidos will discuss this transaction today on a conference call and webcast today at 8 a.m., ET. Institutional investors and analysts are invited to participate in the call by dialing (800) 379-2666, or (409) 937-8964 for international calls using conference ID: 7359337. Other interested parties, including individual investors, members of the media and employees of BridgeBio and Eidos, are encouraged to participate via webcast. The webcast may be accessed here View Source

On Oct 05, 2020 SpringWorks Therapeutics a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the company has entered into a clinical trial collaboration agreement with Pfizer Inc. (NYSE: PFE) to evaluate SpringWorks Therapeutics’ investigational gamma secretase inhibitor (GSI), nirogacestat, in combination with Pfizer’s anti-B-cell maturation antigen (BCMA) CD3 bispecific antibody, PF‐06863135, in patients with relapsed or refractory multiple myeloma. (Press release, Pfizer, OCT 5, 2020, View Source [SID1234574086]).

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Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, thereby enhancing the activity of BCMA-targeted therapies, including CD3 bispecific antibodies.

"This collaboration is another important step in continuing to advance our goal of developing nirogacestat as a best-in-class BCMA potentiator, and we are pleased to work with Pfizer to study nirogacestat in combination with PF‐06863135, which has recently demonstrated promising monotherapy clinical data," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We now have five collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities. We look forward to generating clinical data with our collaborators to further evaluate the ability of nirogacestat to improve outcomes for patients with multiple myeloma."

Under the terms of the agreement, Pfizer will sponsor and conduct the Phase 1b/2 study to evaluate the safety, tolerability and preliminary efficacy of the combination, and will assume all costs associated with the study, other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights. Pfizer and SpringWorks Therapeutics will also form a joint development committee to manage the clinical study, which is expected to commence in the first half of 2021.

"Entering into this clinical collaboration is a proud milestone in our strong relationship with SpringWorks," said Chris Boshoff, MD, PhD, Chief Development Officer for Pfizer Oncology at Pfizer. "We believe that studying nirogacestat in combination with PF-06863135 could hold significant therapeutic promise for patients with relapsed or refractory multiple myeloma, and we look forward to working together to advance this important area of research."

In addition to its ongoing clinical collaborations with BCMA-directed therapies, SpringWorks is also currently conducting a global Phase 3, double-blind, randomized, placebo-controlled clinical trial (the DeFi Trial) to evaluate nirogacestat in adults with progressing desmoid tumors.

On October 5, 2020 Nimble Therapeutics reported the company has entered into a strategic collaboration with Incyte to discover first-in-class peptide therapies across various disease areas (Press release, Nimble Therapeutics, OCT 5, 2020, View Source [SID1234569773]).

"This is an important collaboration for both companies to discover novel peptide based therapeutics," said Jigar Patel, Ph.D., CEO of Nimble Therapeutics. "We are excited to partner with Incyte, an organization with world-class drug discovery, development and commercialization capabilities, to ensure maximal patient impact across multiple disease indications."

The collaboration will leverage Nimble’s proprietary peptide synthesis, screening and optimization platform, coupled with its high chemical diversity and integrated suite of assays to enable faster discovery and optimization of promising compounds for intracellular and extracellular targets.

Under the terms of the agreement, Nimble will receive an undisclosed upfront payment, reimbursement of certain research program costs and may become eligible for downstream milestone payments and royalties. Incyte has exclusive rights to develop and commercialize any peptides discovered under the collaboration, and an option to further expand the collaboration to include additional targets.