On July 21, 2020 Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, reported that the first patients have been dosed at clinical trial sites in its Phase 3 SPOTLIGHT clinical trial of rhPSMA-7.3 (18F), an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid PET imaging agent (Press release, Blue Earth Diagnostics, JUL 21, 2020, View Source [SID1234562182]). The SPOTLIGHT study is a Phase 3, multi-center, single-arm imaging study being conducted in the United States and Europe to evaluate the safety and diagnostic performance of rhPSMA-7.3 (18F) PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. The primary endpoints of the SPOTLIGHT study are to assess the Correct Detection Rate (CDR) and Positive Predictive Value (PPV) of rhPSMA-7.3 (18F) PET, using histopathology or confirmatory imaging as a standard of truth. U.S. clinical trial sites that have dosed patients, to date, include: Emory Healthcare, Atlanta, Ga.; John Wayne Cancer Institute, Santa Monica, Calif.; Urology San Antonio, San Antonio, Texas and Virginia Oncology Associates, Norfolk, Va. The first European patient was recently dosed at a clinical site in Finland.

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Blue Earth Diagnostics has two Phase 3 studies underway to investigate the use of rhPSMA-7.3 (18F) PET imaging in prostate cancer. The SPOTLIGHT study is designed to evaluate its safety and diagnostic performance in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. The LIGHTHOUSE trial is designed to evaluate the safety and diagnostic performance of rhPSMA-7.3 (18F) PET imaging in men with newly diagnosed prostate cancer. Further information, including a current list of clinical trial sites, can be found on www.clinicaltrials.gov (LIGHTHOUSE at NCT04186819, and SPOTLIGHT at NCT04186845).

"We are excited that both of our Phase 3 studies for rhPSMA-7.3 (18F) are well underway and enrolling patients, with the hope that our efforts can help inform more personalized clinical management to address the needs of men with prostate cancer," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Blue Earth Diagnostics continues to advance our comprehensive prostate cancer PET imaging portfolio that is built on approved, commercially available Axumin (fluciclovine F 18), and on the investigational agent, rhPSMA-7.3 (18F). Pending successful development and approval of rhPSMA-7.3 (18F), we will be in the unique position to offer complementary products to assist in the clinical management of men with known or suspected prostate cancer."

"Up to 40% of patients who undergo radical prostatectomy, and up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years," said David M. Schuster, MD, FACR, Emory University School of Medicine, and Coordinating Investigator for the SPOTLIGHT study. "An important consideration for physicians and their patients is the ability to determine the extent and location of recurrent prostate cancer in order to inform appropriate clinical management for these men. The Phase 3 SPOTLIGHT clinical study is designed to investigate the diagnostic performance of rhPSMA-7.3 (18F) PET imaging as a potential decision-making aid in assessing suspected biochemical recurrence of the disease. At Emory, we scanned our first patient in the SPOTLIGHT study in late June, and we are rapidly recruiting more patients in this exciting trial."

"The Investigational New Drug (IND) submission for the SPOTLIGHT trial included results from early clinical experience by the Technical University of Munich (TUM) with rhPSMA, including with rhPSMA-7.3 (18F), in more than 1,000 patients with prostate cancer," said Peter Gardiner, MB ChB, MRCP, FFPM, Chief Medical Officer of Blue Earth Diagnostics. "Blue Earth Diagnostics has also completed a Phase 1 clinical study in Turku, Finland to assess the safety, biodistribution and dosimetry of rhPSMA-7.3 (18F) in healthy volunteers and patients with prostate cancer."

"The investigational PET agent, rhPSMA-7.3 (18F), is a single isomer product, part of a family of theranostic rhPSMA compounds that BED exclusively acquired from TUM, via Scintomics Gmbh," said David Gauden, D.Phil., Chief Scientific Officer of Blue Earth Diagnostics. "In developing these compounds, we are initially focused on diagnostic PET imaging applications. We selected F18 as the radiolabeling isotope of choice for rhPSMA-7.3 PET based on important attributes, including: a positron energy that enables high resolution PET scans; high yielding chemistry for large batch, centralized manufacturing; and a half-life that enables efficient distribution across broad geographies, to be readily available for patients, independent of select individual hospitals."

About the SPOTLIGHT Phase 3 Clinical Trial for rhPSMA-7.3 (18F)

The SPOTLIGHT Phase 3 clinical trial is a prospective, Phase 3, multi-center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) in men with suspected prostate cancer recurrence based on elevated Prostate-Specific Antigen (PSA) following prior therapy. The study will enroll approximately 300 evaluable patients at clinical sites in the United States and Europe. The primary endpoints of the SPOTLIGHT study are to assess the Correct Detection Rate (CDR) of rhPSMA-7.3 (18F) PET, on a patient level, and the Positive Predictive Value (PPV), on a region level, of rhPSMA-7.3 (18F) PET using histopathology or confirmatory imaging as a Standard of Truth (SoT). Secondary endpoints will assess the safety rhPSMA-7.3 (18F) and determine inter- and intra-reader agreement of rhPSMA-7.3 (18F) scan interpretations by blinded independent readers. Additional information about the Phase 3 SPOTLIGHT trial is available at www.clinicaltrials.gov (NCT04186845).

About rhPSMA

rhPSMA-7.3 (18F) is an investigational agent that consists of a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds can also be labeled with radioisotopes such as 177Lu and 225Ac for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, with an option to therapeutic rights. rhPSMA originated from the Technical University of Munich, Germany, and has been utilized clinically under German legislation at the Department of Nuclear Medicine there for the diagnostic imaging of men with both primary and recurrent prostate cancer. 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 July 21, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that the Company has entered into a comprehensive partnership with the recently established QUANTRO Therapeutics GmbH ("QUANTRO"), a research-based biotech company based in Vienna, Austria, that strives to discover and develop novel therapeutics interfering with disease-causing transcriptional programmes in cancer and other diseases (Press release, Evotec, JUL 21, 2020, View Source;announcements/press-releases/p/evotec-enters-partnership-with-quantro-therapeutics-5955 [SID1234562181]).

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QUANTRO will combine and exploit innovative functional-genetic and transcriptomic technologies to generate an unprecedented drug discovery pipeline transforming the precision and scope of cell-based compound screens. By introducing "Transcriptional Fingerprinting" to drug discovery, QUANTRO intends to revamp the scope of pharmacologic interventions in a variety of cellular, target and disease contexts. A prime focus will be the discovery and development of drug candidates blocking the activity of oncogenic transcription factors, a class of particularly promising therapeutic targets that has so far been deemed "undruggable".

Founded by Dr Stefan Ameres and Dr Johannes Zuber as a spin-off of the Institute of Molecular Biotechnology ("IMBA") and the Research Institute of Molecular Pathology ("IMP"), QUANTRO is headed by Chief Executive Officer Dr Dieter Nachtigall.

Evotec will provide hit identification services for QUANTRO’s proprietary anti-tumour projects. Furthermore, Evotec joins Boehringer Ingelheim Venture Fund GmbH ("BIVF") in QUANTRO’s seed financing round. Both companies have acquired equal minority stakes in QUANTRO and will be represented on QUANTRO’s Supervisory Board by Dr Dirk Ullmann (Evotec) and Dr Sebastian Kreuz (BIVF), respectively.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "QUANTRO is a very promising academic spin-off company with great potential to lead the way in time-resolved RNA sequencing with a potentially ground-breaking technology to address ‘undruggable’ drug targets. Through our partnership and equity investment, we will further validate QUANTRO’s approach and hope to be able to open many new doors across a broad range of therapeutic modalities together in the future."

Dr Dieter Nachtigall, Chief Executive Officer of QUANTRO, said: "QUANTRO Therapeutics has designed and set up a new discovery approach and technology platform based on world-leading scientific expertise by our founders and excellent support from our highly committed corporate venture partners. We are extremely motivated and ambitious to start operations in our facilities at the Vienna StartUp Labs and turn our vision of identifying and developing new anti-cancer agents with breakthrough potential into a reality."

Dr Sebastian Kreuz, Boehringer Ingelheim Venture Fund, added: "The BIVF focuses on groundbreaking therapeutic approaches and technologies that have the potential to advance patient care in areas of high unmet medical need. We are looking forward to supporting QUANTRO and its dedicated founders to apply time-resolved RNA sequencing in an industrialised setting with the aim to unlock transcription factors as a highly promising target class for drug discovery in oncology and other disease areas."

No financial details of the agreement were disclosed.

On July 21, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported that it will invest $300 million to acquire a 49.9 percent equity interest in Tizona Therapeutics Inc., a privately held company developing first-in-class cancer immunotherapies (Press release, Tizona Therapeutics, JUL 21, 2020, View Source [SID1234562179]). Gilead will also receive an exclusive option to acquire the remainder of Tizona for up to an additional $1.25 billion, including an option exercise fee and potential future milestone payments.

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Gilead can exercise its option to acquire the remainder of Tizona following the readout of a Phase 1b study of Tizona’s investigational antibody, TTX-080, or earlier if Gilead decides to do so. TTX-080, discovered by Tizona, is a potential first-in-class medicine that targets HLA-G, a novel and emerging immune checkpoint expressed across multiple tumor types. The expression pattern of HLA-G often appears distinct from that of PD-(L)1, suggesting potential utility to address tumors that do not respond to current anti-PD-(L)1 treatments and to deepen responses in tumors that are sensitive to anti-PD-(L)1 therapies.

The U.S. Food and Drug Administration has cleared Tizona’s Investigational New Drug (IND) application for TTX-080, and in the third quarter of this year, Tizona plans to initiate a Phase 1 clinical trial evaluating TTX-080 both as a monotherapy and in combination with other agents in patients with advanced cancers.

"Tizona is pursuing first-in-class cancer immunotherapies that could make an important difference in oncology by helping patients who don’t respond to current checkpoint inhibitors," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "This agreement with Tizona adds to the significant progress we’ve made in the first half of this year in building out a strong and diverse immuno-oncology pipeline. We now have multiple opportunities to develop novel therapies that will improve the treatment of cancer."

"Gilead’s support will enable Tizona to accelerate and broaden our TTX-080 clinical program while also enabling us to rapidly advance our rich, first-in-class preclinical portfolio and target validation efforts," said Scott Clarke, Chief Executive Officer, Tizona. "Our mission is dedicated to translating novel scientific insights into first-in-class immunotherapies and Gilead is a partner that shares our passion for science and delivering breakthrough innovation to people with cancer."

TERMS OF THE AGREEMENT
Under the terms of the agreement, Tizona equity holders will receive $300 million upon closing. Gilead will obtain a 49.9 percent equity stake and an exclusive option to purchase the remaining equity exercisable following the completion of Phase 1b studies for TTX-080, or earlier if Gilead chooses. Tizona equity holders will be eligible to receive up to $1.25 billion in an option exercise fee and potential future milestone payments. Gilead will also provide funding to support Tizona’s ongoing research and development to advance its novel pipeline.

The transaction is expected to close in the third quarter of this year and is subject to antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

Gilead will have the right to appoint two individuals to Tizona’s Board of Directors upon closing of the transaction.

Tizona will spin off TTX-030, the company’s investigational, first-in-class anti-CD39 antibody partnered with AbbVie, into a separate entity prior to closing of this transaction. TTX-030 is not subject to this agreement.

TTX-080 is investigational and not approved anywhere globally. Its efficacy and safety have not been established.

Cowen is acting as financial advisor and Ropes & Gray is acting as legal counsel to Gilead. Latham & Watkins is acting as legal counsel and Squire Patton Boggs is acting as IP counsel to Tizona.

On July 21, 2020 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its second quarter 2020 financial results on Tuesday, August 4, 2020 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, JUL 21, 2020, View Source [SID1234562178]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

To register for the conference call and webcast, please use one of the methods below. Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

Online registration: View Source

Phone registration: (888) 869-1189 or (706) 643-5902

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to ir.invitae.com.

On July 21, 2020 Isofol Medical AB (Nasdaq First North Premier Growth Market: ISOFOL), reported that 330 patients now have been included in the global phase III-study AGENT (Press release, Isofol Medical, JUL 21, 2020, View Source [SID1234562170]). The interim analysis – which aims to evaluate efficacy data – will be initiated when these 330 patients have been evaluated after 16 weeks treatment and two tumor screenings. The result from the analysis is expected around year end.

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Isofol’s drug candidate, arfolitixorin, is evaluated for treatment among patients with first-line metastatic colorectal cancer (mCRC). The study is currently being conducted in Australia, Europe, Japan, Canada and the US on more than 90 clinics and is expected to include in total 440 patients.

A milestone has been reached as 330 patients now have been included in the AGENT-study and thereby the interim analysis will be initiated after 16 weeks of treatment and two tumor evaluations. The analysis is performed by an independent committee, the Data Safety Monitoring Board (DSMB) and the results are expected to be communicated around the turn of the year. The outcome is estimated to be either that the recruitment to the study ends after 440 patients or is increased to 660 patients to achieve statistical significance for PFS (Progression-Free Survival).

"We are pleased to have recruited 330 patients and now being able to initiate the interim analysis, which is a large milestone for Isofol. The team has done a fantastic job in these challenging times and we are looking forward to the result from the interim analysis which will decide the next step," says Ulf Jungnelius, M.D, CEO of Isofol.