On June 10, 2020 AbbVie (NYSE: ABBV) and Genmab A/S (Nasdaq: GMAB) reported that AbbVie and Genmab have signed a broad collaboration agreement to jointly develop and commercialize three of Genmab’s early-stage investigational bispecific antibody product candidates and enter into a discovery research collaboration for future differentiated antibody therapeutics for cancer (Press release, AbbVie, JUN 10, 2020, View Source [SID1234560959]). The companies will partner to develop Genmab’s next-generation bispecific antibody programs, epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4. The collaboration combines Genmab’s world-class discovery and development engine and next-generation bispecific antibody therapeutic candidates with AbbVie’s deep clinical expertise, innovative antibody-drug conjugate (ADC) platform and global commercial leadership in hematological cancers.

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The discovery research collaboration will combine proprietary antibodies from both companies along with Genmab’s DuoBody technology and AbbVie’s payload and ADC technology to select and develop up to four additional differentiated next-generation antibody-based product candidates, potentially across both solid tumors and hematological malignancies. Genmab’s DuoBody-CD3 technology engages and directs cytotoxic T cells selectively to tumors to elicit an immune response towards malignant tumor cells. AbbVie’s ADC technology allows the delivery of a therapeutic toxin directly to cancer cells while sparing normal, healthy cells, providing for a more targeted, less toxic treatment approach.

"This transformative collaboration will allow us to accelerate, broaden and maximize the development of some of our promising early-stage bispecific antibodies, including epcoritamab, with the ultimate goal of bringing these potential therapies much faster to cancer patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Today’s announcement marks the beginning of a new journey for Genmab that combines our world-class knowledge in antibody biology and deep expertise in truly innovative next-generation antibody technology platforms, with AbbVie’s R&D prowess and their leadership position in hematological cancers."

"Epcoritamab is a strong fit for our robust hematological oncology franchise", said Michael Severino, M.D., Vice Chairman and President, AbbVie. "By combining the strengths of our two organizations, we can advance the treatment landscape for patients battling cancer."

Collaboration Details
This collaboration will provide for the joint development and commercialization of the three bispecific antibody therapeutic candidates. For epcoritamab, the companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Genmab will book net sales in the U.S. and Japan and receive tiered royalties on remaining global sales. For DuoHexaBody-CD37, DuoBody-CD3x5T4 and any product candidates developed as a result of the companies’ discovery research collaboration, Genmab and AbbVie will share responsibilities for global development and commercialization in the U.S. and Japan. Genmab retains the right to co-commercialize these products, along with AbbVie, outside of the U.S. and Japan. For the discovery research partnership, Genmab will conduct Phase 1 studies for these programs. AbbVie retains the right to opt-in to program development.

Financial Terms
Under the terms of the agreement, AbbVie will pay Genmab USD 750 million in upfront payment with the potential for Genmab to receive up to USD 3.15 billion in additional development, regulatory and sales milestone payments for all programs as well as tiered royalties between 22% and 26% on net sales for epcoritamab outside the U.S. and Japan. Except for these royalty-bearing sales, the parties share in pre-tax profits from the sale of products on a 50:50 basis. Included in these potential milestones are up to USD 1.15 billion in payments related to clinical development and commercial success across the three existing bispecific antibody programs. In addition, if all four next-generation antibody product candidates developed as a result of the discovery research collaboration are successful, Genmab is eligible to receive up to USD 2.0 billion in option exercise and success-based milestone payments.

Conference Call
Genmab will hold a conference call in English to discuss this news today, Wednesday, June 10, 2020, at 6:00 AM CDT / 7:00 AM EDT / 1:00 PM CEST. The dial in numbers are:

+1 855 857 0686 (US participants)
+44 3333000804 (international participants)

Confirmation code: 48035919

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

About Epcoritamab (DuoBody-CD3xCD20)
Epcoritamab (DuoBody-CD3xCD20) is a bispecific antibody created using Genmab’s proprietary DuoBody technology. Epcoritamab is designed to target CD3, which is expressed on T cells and is part of the T cell receptor signaling complex, and CD20, a clinically well validated therapeutic target. CD20 is expressed on a majority of B cell malignancies, including chronic lymphocytic leukemia (CLL), diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL). In a number of laboratory models, epcoritamab has shown highly effective killing of CD20+ tumors and induced potent tumor cell lysis across a panel of B cell tumor lines. Epcoritamab is currently evaluated in a Phase 1/2 study for multiple hematological B cell malignancies.

Complete dose escalation data for epcoritamab was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program. The data and preliminary activity from the Phase 1/2 study of subcutaneous epcoritamab in patients with relapsed / refractory B-cell non-Hodgkin lymphoma (B-NHL) are highly encouraging showing substantial single-agent activity for epcoritamab with a manageable safety profile. In the study, epcoritamab induced rapid and deep responses in heavily pretreated patients with B-NHL across different subtypes and no dose-limiting toxicities were observed.

On June 9, 2020 JW Therapeutics, reported the completion of a US$100 million Series B round financing, the investment was co-led by CPE and Mirae Asset, jointed by CR-CP Life Science Fund and Oriza Holdings, as well as existing investors including Loyal Valley Capital, Temasek, Sequoia Capital China, ARCH Venture Partners, Juno Therapeutics, a Bristol Myers Squibb company, and WuXi AppTec (Press release, JW Therapeutics, JUN 9, 2020, View Source [SID1234560971]). This round of financing brings the total capital raised to over US$200 million.

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JW Therapeutics plans to use the proceeds to further advance its lead product JWCAR029 (a CAR-T cell product targeting CD19 in clinical phase II), further build-out a pipeline, and gear up to establish commercialization capabilities to support product launch.

James Li, Co-Founder and CEO of JW Therapeutics, commented: "We are very pleased to welcome our new investors and, by working together, we hope to accelerate our product development and serve Chinese Patients."

On June 9, 2020 Voltron Therapeutics, Inc. reported that it has entered into a Sponsored Research Agreement (SRA) with the Vaccine and Immunotherapy Center (VIC) of the Massachusetts General Hospital (MGH). Leveraging VaxCelerate, a self-assembling vaccine (SAV) platform licensed exclusively to Voltron Therapeutics by Partners HealthCare, the goal of the collaboration is to optimize the dosing and development of potent compounds that inhibit tumor growth in mice in the treatment of Human Papilloma Virus (HPV) induced malignancy and Ovarian cancer (Press release, Voltron Therapeutics, JUN 9, 2020, View Source;immunotherapy-center-at-the-massachusetts-general-hospital-to-advance-the-development-of-a-personalized-cancer-vaccine-301073035.html [SID1234560957]).

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In prior research, the SAV, when combined with a checkpoint inhibitor in a model of HPV-induced cancer, demonstrated a significant improvement in survival over either agent alone or combined. Based on these preliminary findings, several aspects of the protein core of the vaccine construct were re-engineered to optimize its ability to bind targets on cancer cells. These new Voltron Therapeutics sponsored preclinical studies set out to underscore the SAV’s safety and efficacy track record and position it for human trials.

Dr. Mark Poznansky, Director, Vaccine and Immunotherapy Center, MGH stated, "The self-assembling vaccine, co-invented with my colleague Dr. Jeffrey Gelfand, has been designed to be highly adaptable, designed for safety and allows for seamless modifications in order to target specific proteins found in tumor cells. Leveraging the protein HSP70, we are able to determine the quantity and timing of vaccination that best induces T-cell responses and explore the maximized benefit from vaccine induced anti-tumor immunity."

The SAV program has intellectual property surrounding composition of matter. The vaccine incorporates a heat shock protein that activates the immune system, bound to targeting peptides. The base core technology relies on synthesizing the heat shock protein with Avidin. Biotinylated immunogenic peptides are then bound to the HSP to customize the vaccine.

"Voltron Therapeutics is excited to continue our groundbreaking work with the VIC by supporting ongoing research dedicated to our Oncology program and the advancement of the VaxCelerate platform to develop vaccines to fight a range of cancers," said Pat Gallagher, Chief Executive Officer, Voltron Therapeutics. "The resources at the VIC and MGH to support vaccine development and innovation are instrumental in helping us advance this important work. We are hopeful that further development, pre-clinical testing and additional proof of concept results could lead to first in human trials in 2021 and ultimately make a significant and lasting difference in the treatment of cancer patients."

Additionally, Voltron Therapeutics has closed on $3.5 million in a Series-A Preferred funding round. The funds raised will be used to accelerate the development of SAV technology and expansion of the Company’s vaccine portfolio.

"This funding for Voltron Therapeutics will allow the company to conclude preclinical work as it moves toward human trials with the self-assembling vaccine," added James Ahern, Founder of Laidlaw Venture Partners, and member of the Voltron Therapeutics Board of Directors. "We at LVP are committed to continuing to support Voltron as it progresses the SAV portfolio into clinical development, with financial sponsorship and leverage of our expert network."

Voltron Therapeutics and MGH have a longstanding relationship for the development of vaccines to fight infectious diseases and cancer. Recently, Voltron Therapeutics announced a separate joint agreement to advance an application of the VaxCelerate platform to develop a vaccine designed to protect patients at risk of Coronavirus (COVID-19) infection. This vaccine will be entering animal testing this quarter. Currently, preclinical data exists in two different infectious disease settings with encouraging results. The COVID-19 vaccine could be in humans by late 2020/early 2021.

On June 9, 2020 NFlection Therapeutics, Inc., a biopharma therapeutics developer dedicated to targeting disease pathways to uncover new approaches to fighting rare disease, reported the closing of a $20 million Series A financing round with investment from venBio Partners and F-Prime Capital (Press release, NFlection Therapeutics, JUN 9, 2020, View Source [SID1234560956]). The company also announced the initiation of the first clinical trial of its lead product, NFX-179 Gel, a topically applied therapy.

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The Phase 2a study, on the heels of the successful submission of their Investigational New Drug Application with the U.S. Food and Drug Administration, will be a safety, tolerability and pharmacokinetic/pharmacodynamic study of NFX-179 Gel in adult patients with cutaneous neurofibromatosis type-1 (NF-1). This study will evaluate three concentrations of NFX-179 Gel compared with its vehicle (placebo) in a randomized, double-blind, placebo-controlled, clinical trial of 48 patients with cutaneous neurofibromatosis type-1. The study will be conducted at five investigational centers across the United States.

"This study allows us to determine the drug’s ability to suppress key biomarkers involved in the progression of neurofibromas and will aid in the selection of doses for a larger Phase 2b study," said Christopher Powala, president & chief executive officer of NFlection. "There are no FDA-approved products for this condition, and NFX-179 Gel has the potential to address this unmet medical need."

"Almost all adults with neurofibromatosis type-1 develop cutaneous nerve tumors during their lifetime. The tumors form under the skin and manifest as nodules that can be stigmatizing and even painful," said Annette Bakker, Ph.D., President, Children’s Tumor Foundation. "We are pleased that NFlection has recognized the unmet need posed by cutaneous neurofibromas, and we are encouraged that topical NFX-179 may hopefully soon provide a life-changing solution for thousands of NF-1 patients."

About Cutaneous Neurofibromatosis Type-1
Cutaneous neurofibromas are tumors that grow from small nerves in the skin or just under the skin and appear as small or larger bumps, typically beginning around the time of puberty. It is less common to see this type of neurofibroma in young children with NF1. Individuals with NF1 commonly develop more cutaneous neurofibromas as they get older. They do not become malignant, but they may be disfiguring, itchy or painful when bumped. Despite their benign nature, cutaneous neurofibromas may cause significant problems, such as depression and a sense of isolation, and may require surgical removal.

On June 9, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz Pharmaceuticals") reported the pricing of $850 million aggregate principal amount of 2.000% exchangeable senior notes due 2026 in a private offering (the "offering") by Jazz Investments I Limited, its wholly-owned subsidiary (the "Issuer"), to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Jazz Pharmaceuticals, JUN 9, 2020, View Source;301072646.html [SID1234560955]). The Issuer also granted the initial purchasers of the notes a 13-day option to purchase up to an additional $150 million aggregate principal amount of notes. The sale of the notes is expected to close on June 11, 2020, subject to customary closing conditions.

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The notes will be general unsecured obligations of the Issuer and will accrue interest payable semiannually in arrears on June 15 and December 15 of each year, beginning on December 15, 2020, at a rate of 2.000% per year. The notes will mature on June 15, 2026, unless earlier exchanged, repurchased or redeemed. Prior to March 15, 2026, the notes will be exchangeable only upon satisfaction of certain conditions and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be exchangeable for cash, ordinary shares ("ordinary shares") of Jazz Pharmaceuticals or a combination thereof, at the Issuer’s election. The initial exchange rate will be 6.4182 ordinary shares per $1,000 principal amount of notes (equivalent to an initial exchange price of approximately $155.81 per ordinary share, which represents approximately a 40.0% premium over the closing price per ordinary share on the Nasdaq Global Select Market on June 8, 2020), subject to adjustment in some events but not for any accrued and unpaid interest. The Issuer’s obligations under the notes will be fully and unconditionally guaranteed on a senior unsecured basis by Jazz Pharmaceuticals and will rank pari passu in right of payment with the Issuer’s existing 1.875% exchangeable senior notes due 2021 (the "2021 notes") and 1.500% exchangeable senior notes due 2024.

The Issuer may redeem the notes at its option, prior to June 15, 2026, in whole but not in part, in connection with certain tax-related events. The Issuer also may redeem the notes at its option on or after June 20, 2023 and prior to March 15, 2026, in whole or in part, if the last reported sale price of ordinary shares has been at least 130% of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending within the three trading days immediately preceding the date on which the Issuer provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

If Jazz Pharmaceuticals undergoes a "fundamental change," subject to certain conditions and limited exceptions, holders of the notes may require the Issuer to repurchase for cash all or part of their notes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date of the notes or upon the Issuer’s issuance of a notice of redemption, the Issuer will, in certain circumstances, increase the exchange rate for holders of the notes who elect to exchange their notes in connection with such a corporate event or exchange their notes called for redemption during the related redemption period, as the case may be. Jazz Pharmaceuticals estimates that the net proceeds from the offering will be approximately $833.6 million (or approximately $981.0 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discount and commissions and estimated offering expenses payable by the Issuer. The Issuer intends to use approximately $332.9 million of the net proceeds from the offering to repurchase for cash up to approximately $332.9 million aggregate principal amount of the 2021 notes through individual privately negotiated transactions concurrently with the offering of notes. The remaining net proceeds will be used for general corporate purposes, which may include additional repurchases of 2021 notes from time to time following the offering. Note repurchases occurring concurrently with the offering of the notes, and the potential related market activities by selling holders of the 2021 notes, could increase (or reduce the size of any decrease in) the market price of the ordinary shares concurrently with the pricing of the notes, resulting in a higher effective exchange price for the notes. Note repurchases that may occur from time to time following the offering of the notes could increase (or reduce the size of any decrease in) the market price of the ordinary shares or the trading price of the notes.

None of the notes, the guarantee or the ordinary shares issuable upon exchange of the notes, if any, have been registered under the Securities Act or the securities laws of any other jurisdiction, and, unless so registered may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.