On June 2, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) ("MorphoSys"), and Constellation Pharmaceuticals, Inc., (NASDAQ: CNST) ("Constellation") reported that they have entered into a definitive agreement whereby MorphoSys will acquire Constellation for $34.00 per share in cash, which represents a total equity value of $1.7 billion (Press release, Constellation Pharmaceuticals, JUN 2, 2021, View Source [SID1234583376]). The transaction has been unanimously approved by the management board (Vorstand) and the supervisory board (Aufsichtsrat) of MorphoSys, as well as the Board of Directors of Constellation and is expected to close in the third quarter of 2021.

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Constellation is a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics that address serious unmet medical needs in patients with various forms of cancer. Constellation’s two lead product candidates, pelabresib (CPI-0610), a BET inhibitor, and

CPI-0209, a second-generation EZH2 inhibitor, are in mid- to late-stage clinical trials and have broad therapeutic potential to offer meaningful benefits to patients with various hematological and solid tumors. Pelabresib has the potential to be a first- and best-in-class BET inhibitor and is currently in Phase 3 clinical trials for myelofibrosis, a bone marrow cancer that disrupts the body’s normal production of blood cells. CPI-0209 is currently in Phase 2 with best-in-class potential for treating hematological and solid tumors. Constellation’s pipeline also includes numerous preclinical compounds.

"This transformational acquisition represents a major step forward for MorphoSys as we bolster our position in hematology-oncology," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "Both pelabresib and CPI-0209 have broad potential and we look forward to unlocking their full benefits for cancer patients. Our existing clinical and commercial expertise is ideally suited to accelerate Constellation’s programs, enabling us to maximize Constellation’s potential and bring these novel therapies to market. With Constellation’s high-potential product candidates, complementary R&D capabilities, and outstanding team, we can further advance our mission in the fight against cancer."

"We are proud that MorphoSys has recognized the strength of our team, our expertise in epigenetics, and our high-potential oncology development pipeline and discovery programs," said Jigar Raythatha, President and Chief Executive Officer of Constellation. "Becoming part of MorphoSys creates an industry leader with commercial capabilities, a deep R&D pipeline and complementary small molecule and biologics discovery and translational capabilities, as well as the financial strength to compete to win. Our shareholders will receive attractive, immediate and certain cash value for their shares, the employees of the combined entity will have a broader platform and greater opportunities, and patients will potentially benefit from innovative new therapies that address serious unmet needs."

Strategic Funding Partnership with Royalty Pharma

MorphoSys also announced that it has entered into a long-term strategic funding partnership with Royalty Pharma plc (Nasdaq: RPRX) ("Royalty Pharma") (together with the Constellation transaction, the "Transactions"). The terms of the agreement between MorphoSys and Royalty Pharma provide for the following, under certain conditions and upon closing of the transaction with Constellation:

$1.425 Billion Upfront Payment: Royalty Pharma will make a $1.425 billion upfront payment to MorphoSys, supporting its growth strategy. The proceeds will be used to support the financing of the Constellation transaction and development of the combined pipeline.
$350 Million Development Funding Bonds: Royalty Pharma will provide MorphoSys with access to up to $350 million in Development Funding Bonds with the flexibility to draw over a one-year period.
Milestone Payments: Royalty Pharma will make additional payments of up to $150 million to MorphoSys upon reaching clinical, regulatory and commercial milestones for otilimab, gantenerumab and pelabresib.
Royalties: Royalty Pharma will have the rights to receive 100% of MorphoSys’ royalties on net sales of Tremfya, 80% of future royalties and 100% of future milestone payments on otilimab, 60% of future royalties on gantenerumab, and 3% on future net sales of Constellation’s clinical stage assets (pelabresib and CPI-0209).
Equity Investment: After completion of the transaction and subject to the required approvals of the management board (Vorstand) and the supervisory board (Aufsichtsrat) of MorphoSys, Royalty Pharma is expected to invest $100 million in a cash capital increase of MorphoSys under an authorization to exclude subscription rights of existing shareholders. The new MorphoSys shares will be listed on the Frankfurt Stock Exchange.
Jean-Paul Kress continued, "We are thrilled to announce this partnership with Royalty Pharma, which is providing more than $2 billion to fuel our proprietary drug development and commercialization. We are confident they will be a strong financial partner for years to come, enabling us to fund our growth and – with the addition of Constellation’s innovative pipeline – bring our attractive new candidates to patients."

"In acquiring Constellation, MorphoSys has a significant opportunity to drive clinical and commercial success," said Pablo Legorreta, Chief Executive Officer of Royalty Pharma. "We are excited to join forces to further advance the combined company’s pipeline and positively impact patients."

Benefits of the Transaction

Accelerates Growth Strategy with Exciting Mid- to Late-Stage Product Candidates. The transaction accelerates MorphoSys’ strategy to grow through proprietary drug development and commercialization. Constellation’s lead product candidates, pelabresib and CPI-0209, have broad potential, with expected approvals across a range of oncology indications in the coming years. Constellation’s lead compounds fit well with MorphoSys’ proven clinical development, regulatory and commercial capabilities, and MorphoSys is well positioned to rapidly advance and unlock the potential of the Constellation portfolio.
Bolsters Position in Hematology-Oncology and Expands into Solid Tumors. Constellation adds an attractive, complementary pipeline of highly innovative late- to early-stage cancer therapy candidates, augmenting MorphoSys’ existing pipeline in hematologic malignancies and expanding into potential therapies for solid tumors.
Strengthens Cutting-Edge Research and Technology Organization. The transaction leverages MorphoSys’ expertise in biologics and Constellation’s expertise in epigenetics and small molecule discovery platforms to develop a broad range of oncology therapies. Constellation adds exciting, pioneering science and attractive preclinical compounds targeting epigenetic regulators. Together, MorphoSys’ and Constellation’s highly talented research and development teams will strengthen earlier stage and emerging science to bring exciting new cancer therapies to patients.
Anchored by Strategic Funding Partnership. Royalty Pharma’s strategic funding partnership will fuel the expansion of the combined company’s capabilities to help accelerate the development, approval and commercial reach of breakthrough cancer treatments. This long-term commitment will help deliver significant value to all stakeholders.
Transaction Details

Under the terms of the merger agreement, an indirect wholly-owned subsidiary of MorphoSys will promptly commence a tender offer to acquire all of the outstanding shares of Constellation’s common stock at a price of $34.00 per share in cash. Following successful completion of the tender offer, MorphoSys will acquire all remaining shares not tendered in the offer through a second step merger at the same price as in the tender offer.

MorphoSys plans to pay an all-cash consideration for the transaction. The tender offer is not subject to a financing condition.

The purchase price of $34.00 per share in cash represents a premium of approximately 70% to Constellation’s volume-weighted average price for the last five trading days.

Consummation of the tender offer is subject to various conditions including a minimum tender of at least a majority of outstanding Constellation shares, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the receipt of any approvals or clearances required to be obtained under the applicable antitrust laws, and other customary conditions. The transaction is expected to close in the third quarter of 2021.

Following close, MorphoSys will remain headquartered in Munich, Germany, and will maintain a significant commercial and R&D presence in Boston, Massachusetts.

Advisors

Goldman Sachs Bank Europe SE acted as financial advisor to MorphoSys and Skadden, Arps, Slate, Meagher & Flom LLP as its legal advisor. Centerview Partners LLC acted as financial advisor to Constellation and Wachtell, Lipton, Rosen & Katz as its legal advisor. Goodwin Procter LLP acted as legal advisor to Royalty Pharma.

Conference Call

MorphoSys will host a conference call and webcast to discuss the transaction on June 2, 2021 at 2:00 p.m. CEST, or 8:00 a.m. EDT. The webcast and accompanying slides can be accessed in the Media and Investors section, under Conferences, of MorphoSys’ website at View Source or at View Source After the call, a slide-synchronized audio replay of the conference will be available at the same location.

On June 2, 2021 Genmab A/S (Nasdaq: GMAB) and Bolt Biotherapeutics, Inc. (Nasdaq: BOLT) reported that the companies have entered into an oncology research and development collaboration (Press release, Bolt Biotherapeutics, JUN 2, 2021, View Source [SID1234583375]). Together, the companies will evaluate Genmab antibodies and bispecific antibody engineering technologies in combination with Bolt’s proprietary Boltbody immune-stimulating antibody conjugate (ISAC) technology platform, with the goal of discovering and developing next-generation, immune-stimulatory, antibody-based conjugate therapeutics for the treatment of cancer. This research collaboration will evaluate multiple bispecific ISAC concepts to identify up to three clinical candidates for development. Genmab will fund the research, along with the preclinical and clinical development of these candidates through clinical proof of concept.

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"This exciting collaboration will provide a unique opportunity to combine Genmab’s innovative bispecific antibody technologies with Bolt’s powerful, advanced ISAC technology to develop targeted antibody products with the potential to transform cancer treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Genmab’s partnership approach is part of our DNA and we are pleased to be collaborating with Bolt to develop and deliver potential next-generation cancer therapeutics to patients in need of novel treatment options."

Randall Schatzman, Ph.D., Chief Executive Officer of Bolt, explained, "Our joint vision is to leverage Genmab’s and Bolt’s innovative technologies to develop a completely new type of ISAC with the aim to transform the way cancer is treated. Creating bispecific ISACs turbo-charged with potent immune stimulants is a novel concept that has tremendous potential for patients. We are delighted to be collaborating with the Genmab team and to have their deep expertise in discovering and developing bispecific antibodies brought to bear on this approach as we continue our mission to develop treatments that address key unmet needs for patients with cancer."

Financial Terms
Under the terms of the agreement, Genmab will pay Bolt an upfront payment of USD 10 million. Genmab will also make a USD 15 million equity investment in Bolt. Bolt is eligible to receive total potential milestone payments of up to USD 285 million per therapeutic candidate exclusively developed and commercialized by Genmab, along with tiered royalties. Genmab will fully fund pre-clinical and early clinical development of all candidates. If a candidate is co-developed, development costs will be split 50:50 between the two companies, and the companies will be solely responsible for commercialization costs in their respective territories and shall pay each other royalties on product sales.

On June 2, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that presentations at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in a virtual format from June 4 to 8, 2021 (Press release, Blue Earth Diagnostics, JUN 2, 2021, View Source [SID1234583374]). The two abstracts outlined the launch of studies investigating the use of Axumin (fluciclovine F 18, also known as FACBC) PET in the management of oligometastatic, recurrent prostate cancer, and its role, as assessed by the impact on radiographic progression-free survival, in guiding radiotherapy planning for patients with recurrent disease. Details of the presentations to be given by Blue Earth Diagnostics’ collaborators are listed below.

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NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a registered trademark of Blue Earth Diagnostics, Ltd., or its related companies. All other marks are the property of their respective owners.

Highlighted Axumin (Fluciclovine F 18) Scientific Presentations

All ASCO (Free ASCO Whitepaper) presentations are available beginning Friday, June 4, 2021, at 9:00 a.m. ET.

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Subtrack: Prostate Cancer – Local-Regional Disease

Title: The fluciclovine (FACBC) PET/CT site-directed therapy of oligometastatic prostate cancer (Flu-BLAST-PC) trial

Author(s): Risa Liang Wong, Sarah K Holt, Jing Zeng, Laura Graham, Rachel Kang, Nathan Conrad, Andrea Toulouse, Zoya Bauer, Michael Lai, Todd Yezefski, Jonathan L. Wright, Emily Steinberger Weg, Andrew Caleb Hsieh, Heather H. Cheng, Jean H Lee, Delphine L. Chen, Daniel W. Lin, Evan Y. Yu

Session: Poster session

Abstract: TPS5099

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Subtrack: Prostate Cancer – Local-Regional Disease

Title: Phase III study of local or systemic therapy INtensification DIrected by PET in prostate

CAncer patients with post-prostaTEctomy biochemical recurrence (INDICATE): ECOGACRIN EA8191

Author(s): Neha Vapiwala, Yu-Hui Chen, Steve Y. Cho, Fenghai Duan, Christos Kyriakopoulos, Daniel H. Shevrin, Rana R. McKay, Bridget F. Koontz, Evan Y. Yu, Volkan Beylergil, David A. Mankoff, Jonathan McConathy, Glenn Liu, Terence Z. Wong, Michael Anthony Carducci

Session: Poster session

Abstract: TPS5098

Blue Earth Diagnostics invites participants at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting to attend the above presentations and to learn more about the Company at www.blueearthdiagnostics.com. For full session details and scientific presentation listings, please see the ASCO (Free ASCO Whitepaper) online program here.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full U.S. Axumin prescribing information is available at:

View Source
About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including in neuro-oncology.

On June 2, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the appointment of industry veteran Zelanna Goldberg, M.D., M.A.S. as its Chief Medical Officer (Press release, Alpine Immune Sciences, JUN 2, 2021, View Source [SID1234583373]). Dr. Goldberg joins Alpine from Iovance Biotherapeutics, where she was Senior Vice President, Clinical Science.

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"We are very enthusiastic about the addition of Zelanna to the Alpine team, particularly as we pursue an expanding scope of clinical development activities across oncology and inflammatory disease indications," said Stanford Peng, M.D., Ph.D., President and Head of Research and Development at Alpine. "Zelanna is an experienced clinical development executive with a commitment to helping patients with life-threatening and debilitating diseases."

"I am thrilled to join Alpine and lead the clinical strategy and development of the company’s extremely promising pipeline, including ALPN-101, ALPN-202, and ALPN-303," said Dr. Goldberg. "I look forward to integrating within the research and development team to continue to advance these unique therapies and those that are coming next from Alpine’s directed evolution platform to meaningfully improve the lives of patients with cancer and life-threatening auto-immune diseases."

Dr. Goldberg brings over 20 years of industry and clinical practice experience, including strategic and/or operational responsibility for multiple therapeutic products such as dacomitinib (Vizimpro), palbociclib (Ibrance), and avelumab (Bavencio). Most recently, Dr. Goldberg was Senior Vice President, Clinical Sciences at Iovance Biotherapeutics, where she oversaw multiple aspects of the clinical development program of lifileucel (LN-145). Prior to Iovance, Dr. Goldberg held roles of increasing responsibility at Sunesis, Oxigene and Pfizer, where she was the global clinical lead for multiple assets. Prior to entering industry, Dr. Goldberg was an Associate Professor in the Department of Radiation Oncology at the University of California, Davis Medical Center.

Dr. Goldberg received her M.D. degree from University of Toronto Faculty of Medicine. Dr. Goldberg completed her residency in Radiation Oncology at Ontario Cancer Institute/Princess Margaret Hospital-University of Toronto, and her post-doctoral training in radiosensitizing drugs at Stanford University.

Disclosure of Inducement Grant under Nasdaq Listing Rules

The compensation committee of Alpine’s board of directors granted Dr. Goldberg an option to purchase 160,000 shares of common stock. The option will vest with respect to 25% of the shares underlying the option on the one-year anniversary of Dr. Goldberg’s employment start date of June 1, 2021, and the remaining 75% of the shares underlying the option will vest in equal monthly installments over the 36-month period following the one-year anniversary of Dr. Goldberg’s employment start date, subject to her continued service to Alpine through each relevant vesting date. In addition, pursuant to the terms of Alpine’s change of control and severance policy, if there is a change of control and, upon or during the 12 months after the change of control, Dr. Goldberg’s employment is terminated either (i) by Alpine without cause or (ii) by Dr. Goldberg for good reason, the option will become fully vested and exercisable. The option has a ten-year term and an exercise price of $10.29, equal to the per share closing price of Alpine’s common stock as reported by Nasdaq on June 1, 2021.

The stock options were granted outside Alpine’s 2018 Equity Incentive Plan as an inducement material to Dr. Goldberg entering into employment with Alpine in accordance with Nasdaq Listing Rule 5635(c)(4). The terms and conditions of the option are generally consistent with those in Alpine’s 2018 Equity Incentive Plan.

On June 2, 2021 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported that Michael Amoroso, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 10:30 a.m. ET (Press release, Abeona Therapeutics, JUN 2, 2021, View Source [SID1234583372]).

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A live and archived webcast of the presentation will be available on the investor section of the Abeona Therapeutics website at www.abeonatherapeutics.com.