On January 5, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that it has signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in radiopharmaceuticals and radiopharmaceutical technologies, and the Technical University of Munich (TUM) (Press release, Blue Earth Diagnostics, JAN 5, 2021, View Source [SID1234573475]). Under terms of the agreement, Blue Earth Diagnostics has exercised an option to acquire exclusive, worldwide rights to therapeutic applications of novel radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) technology in prostate cancer. Blue Earth previously acquired exclusive rights to rhPSMA imaging technology in 2018 and now has two investigational Phase 3 clinical trials underway to investigate the use of lead candidate 18F-rhPSMA-7.3 for PET imaging in prostate cancer ("LIGHTHOUSE," NCT04186819 and "SPOTLIGHT," NCT04186845).

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"This agreement supports Blue Earth’s overall strategic focus and marks a significant step in advancing our mission to develop and deliver products that address significant unmet medical needs in prostate cancer," said Jonathan Allis, D. Phil., Executive Chairman of Blue Earth Diagnostics. "Acquisition of this advanced therapeutic rhPSMA technology provides Blue Earth with a comprehensive, one-of-a-kind portfolio in prostate cancer. The company’s robust platform already includes two complementary and technologically advanced PET imaging agents, approved and commercially available Axumin (fluciclovine F 18), and investigational 18F-rhPSMA-7.3, each having unique mechanisms of action. With access to therapeutic applications of the rhPSMA technology platform, Blue Earth has the potential to optimize and personalize treatment options for men with prostate cancer like no other company in the industry."

The agreement further expands Blue Earth’s oncology portfolio and builds on the company’s proven track record and depth of expertise in the rapid development and global commercialization of PET radiopharmaceuticals for cancer. Blue Earth Diagnostics will drive development of a lead radiolabeled rhPSMA therapeutic compound and continue to collaborate with TUM to identify further optimized therapeutic candidates for future development.

Scintomics’ theranostic radiohybrid technology allows for the efficient labelling of PSMA-targeted agents with imaging radioisotopes such as 18F, or therapeutic radioisotopes such as 177Lu or 225Ac, providing the ability for potential use as a prostate cancer imaging agent or as a therapeutic agent. If approved, these innovative compounds offer the possibility of personalized medicine for men with prostate cancer, by effectively directing therapies using PSMA as the disease target.

"We are very pleased to enter into this therapeutic license agreement with Blue Earth Diagnostics, as their experience in the successful development and commercialization of radiopharmaceuticals will accelerate this first class of exciting "rh" technology based therapeutic agents towards use worldwide," said Saskia Kropf, CEO of Scintomics GmbH. "Early clinical experience with 177Lu-rhPSMA radioligand therapy at the Technical University of Munich has been very encouraging and justifies further development to advance a lead candidate into formal clinical studies," added Dr. Matthias Eiber, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. The radiohybrid technology and rhPSMA originated from Prof. Hans J. Wester´s group at the Institute for Pharmaceutical Chemistry at Technical University of Munich, Germany. rhPSMA has been utilized clinically under German legislation at the Department of Nuclear Medicine for the diagnostic imaging of men with both primary and recurrent prostate cancer, and is in early evaluation for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, followed by acquisition of exclusive rights to therapeutic applications in 2020. Blue Earth Diagnostics has two Phase 3 clinical studies underway to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with newly diagnosed prostate cancer ("LIGHTHOUSE," NCT04186819) and in men with recurrent disease ("SPOTLIGHT," NCT04186845). rhPSMA compounds have not received regulatory approval.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved 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.

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

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.

On January 5, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that it will participate in the 10th Annual LifeSci Partners Corporate Access Event, January 6-8 and 11-14, 2021 (Press release, Vaccinex, JAN 5, 2021, View Source [SID1234573492]).

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Maurice Zauderer, Ph.D., President and CEO, will host 1×1 meetings and will present a corporate update on Wednesday, January 6th at 11am EST.

To register to listen to the presentation or to request a meeting, visit: View Source

On January 5, 2021 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported that President and CEO, Usman "Oz" Azam, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 3:10 pm ET (Press release, Tmunity Therapeutics, JAN 5, 2021, View Source [SID1234573509]).

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A live webcast of the presentation will be available on the "Events and Presentations" page of the Tmunity website at View Source Tmunity will maintain an archived replay of the webcast on the website for 30 days after the conference.

On January 5, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO) reported that leading proxy advisory firm Institutional Shareholder Services ("ISS") recommends that BridgeBio stockholders and Eidos Therapeutics, Inc. (Nasdaq: EIDX) stockholders vote "FOR" BridgeBio’s proposed merger with Eidos and each of the other proposals to be considered at both companies’ virtual special meetings to be held on January 19, 2021 (Press release, BridgeBio, JAN 5, 2021, View Source [SID1234576236]).

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Under the proposed merger agreement, 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. 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. Based on the closing price of $71.11 per share of BridgeBio common stock on the Nasdaq on December 31, 2020, the stock consideration represented approximately $131.55 per share of Eidos common stock.

The BridgeBio board of directors unanimously recommends that BridgeBio stockholders vote "FOR" the proposal to approve the issuance of BridgeBio shares in connection with the merger agreement.

In light of the fact that BridgeBio owns a majority of the issued and outstanding Eidos common stock and certain BridgeBio officers and directors also serve on the Eidos board, the Eidos board formed a special committee of independent directors (the "Eidos special committee") to consider and negotiate the terms and conditions of the merger and to make a recommendation to the Eidos board. The Eidos special committee recommends that Eidos stockholders vote "FOR" the proposal to approve the merger with BridgeBio as well as additional proposals to be considered at the Eidos special meeting.

The merger is expected to be consummated by the end of the first calendar quarter of 2021, subject to the receipt of the required approvals from both BridgeBio and Eidos stockholders and other customary closing conditions. Following the consummation of the merger, Eidos will become a wholly owned subsidiary of BridgeBio and Eidos’ common stock will no longer be listed on any public market.

On January 5, 2021 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) reported that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted the marketing authorization application (MAA) for tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody (Press release, MorphoSys, JAN 5, 2021, View Source [SID1234573457]). The MAA seeks approval for tafasitamab, in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The MAA will now enter the formal review process by Swissmedic.

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The Swissmedic MAA for tafasitamab will be reviewed as part of the U.S. Food and Drug Administration’s (FDA) modified Project Orbis, which provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators. Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries.

"Currently about 40% of DLBCL patients do not respond to initial therapy or relapse thereafter leading to a high medical need for new, effective therapies," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "The acceptance of the MAA for tafasitamab for review by Swissmedic is a pivotal step towards bringing tafasitamab in combination with lenalidomide to eligible patients in Switzerland."

"Tafasitamab in combination with lenalidomide may represent an important new targeted treatment option for patients with relapsed or refractory DLBCL," said Mike Akimov, M.D., Ph.D., Head of Global Clinical Development, MorphoSys. "We look forward to continuing to work with the regulatory authorities alongside our partners at Incyte to bring this novel therapeutic option to eligible patients with a high unmet medical need."

The Swissmedic application, submitted by Incyte in collaboration with MorphoSys, is supported by data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL and data from the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. If approved, Incyte will hold the marketing authorization, and have exclusive commercialization rights for tafasitamab in Switzerland.

Incyte has exclusive commercialization rights for tafasitamab outside the United States.

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide[1], characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter[2]. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL[3],[4],[5].

About L-MIND
The L-MIND trial is a single arm, open-label, multicenter Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant. The study’s primary endpoint is Overall Response Rate (ORR). Secondary outcome measures include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS). In May 2019, the study reached its primary completion.

For more information about L-MIND, visit View Source

About RE-MIND
RE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys’ L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory DLBCL patients in the U.S. and the EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective Response Rates (ORR) were validated based on this subset of 76 patients in RE-MIND and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.

For more information about RE-MIND, visit View Source

About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration (FDA) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi(R) is a registered trademark of MorphoSys AG.

XmAb(R) is a registered trademark of Xencor, Inc.