On July 21, 2020 Cytokinetics, Incorporated (Nasdaq:CYTK) reported the closing of its previously announced underwritten public offering of 8,385,417 shares of its common stock at a price to the public of $24.00 per share (Press release, Cytokinetics, JUL 21, 2020, View Source [SID1234562185]). This includes the exercise in full by the underwriters of their option to purchase up to 1,093,750 additional shares of common stock. The gross proceeds to Cytokinetics from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Cytokinetics, were approximately $201.3 million.

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Goldman Sachs & Co. LLC, Piper Sandler & Co. and Cantor Fitzgerald & Co. acted as joint book-running managers for the offering. Barclays Capital Inc. acted as an additional book-running manager for the offering. JMP Securities LLC acted as lead co-manager, and Raymond James & Associates, Inc. and H.C. Wainwright & Co., LLC acted as co-managers.

The securities described above were offered by Cytokinetics pursuant to a shelf registration statement (including a base prospectus) filed on November 6, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and can be accessed for free on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by phone at (866) 471‐2526 or by email at [email protected]; Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, New York 10022, or by email: [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone: 1-888-603-5847.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 21, 2020 Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported the launch of the Company with a $32.5M Series A financing, initiation of the Phase 2 CRESTONE study, and new partnerships with Next Generation Sequencing diagnostic providers including Ashion Analytics, Strata Oncology, and Tempus to explore innovative models for real-time identification, patient referral, and enrollment of patients with tumors driven by rare genomic alterations (Press release, Elevation Oncology, JUL 21, 2020, View Source [SID1234562184]). The Series A financing was led by Aisling Capital and a syndicate of investors including Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners.

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"At Elevation Oncology, we envision a future in which each unique genomic testing result can be matched with a purpose-built precision medicine and bring clarity to the patient treatment journey. Focused drug development paired with open collaboration will be instrumental for our industry to fully realize the potential of precision medicine for all patients with cancer," said Shawn Leland, PharmD, RPh, Founder and Chief Business Officer of Elevation Oncology. "With our lead development program, seribantumab, and the partnerships announced today, we are taking our first steps toward this future."

Seribantumab and the Tumor-agnostic CRESTONE Study

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (ERBB3 or HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner gene to create chimeric NRG1 "fusion proteins."

Seribantumab was acquired in 2019 by Elevation Oncology, and the development program builds on prior clinical experience from over 800 patients demonstrating consistent safety and tolerability. Previous clinical trials with seribantumab did not select for tumors with an NRG1 fusion. The CRESTONE study leverages seribantumab’s rational design with recent discoveries on the significance of the NRG1 gene fusion and improvements in diagnostic sensitivity. Novel preclinical data generated by Elevation Oncology demonstrating the ability of seribantumab to prevent the activation of HER3 signaling in NRG1 fusion models are supportive of CRESTONE and are expected to be released in publications and at scientific conferences later this year.

Although rare, NRG1 gene fusions are oncogenic drivers that can be found in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, and neuroendocrine cancers, and sarcomas. Importantly, NRG1 gene fusions are mutually exclusive with other known driver mutations and are considered a unique oncogenic driver event essential for tumor cell survival. Following recent regulatory approvals of tumor-agnostic treatments associated with oncogenic drivers, CRESTONE is designed as a registration-enabling Phase 2 "basket trial" to evaluate the efficacy and safety of seribantumab in patients with any solid tumor that harbor an NRG1 fusion.

"Genomic testing and matched precision therapeutics are creating a revolution in oncology development and regulatory approval paths," said Lori Kunkel, MD, Chair of the Elevation Oncology Scientific Advisory Board and former Chief Medical Officer LOXO Oncology. "The FDA has recently approved several oncology therapeutics for tumor-agnostic indications. I am encouraged to see the evolution in our understanding of how to achieve better clinical outcomes to address the unmet clinical need among patients with a genomically defined cancer, regardless of its tissue of origin. The CRESTONE study potentially expands the actionability of genomic tests to tumors with an NRG1 fusion and is a promising approach for furthering this genomically-driven tumor-agnostic development pathway."

Innovative Models for Patient Enrollment

Sarah Cannon Research Institute (Sarah Cannon) has been selected as the first strategic site for CRESTONE and is open and enrolling patients today. Sarah Cannon’s world class clinical research leadership and insights as well as additional prospectively selected clinical sites are foundational to ensuring rigorous study conduct.

"Identifying potential driver alterations, such as NRG1 gene fusions, enables us to approach cancer treatment in a more targeted way," said David Spigel, MD, Chief Scientific Officer, Sarah Cannon Research Institute at Tennessee Oncology and one of the investigators of the CRESTONE study. "Today, all cancer patients facing a treatment decision without clear standard of care should consider comprehensive genomic testing for their tumor. Collaborations across the healthcare ecosystem help to ensure that the value of each genomic test is maximized and to expand access to critical treatment opportunities for patients."

Diagnostic partnerships will enhance traditional patient enrollment in the CRESTONE study through real-time, nationwide identification of NRG1 fusion positive patients within the Ashion, Strata Oncology, Tempus, and other partner networks. Through various partnership models, patients may also be enrolled in CRESTONE through active referral to current strategic sites or "just-in-time" site initiation.

These innovative models address specific challenges encountered by genomically-driven, tumor-agnostic trials such as the rarity of genomic driver alterations and the impracticality of comprehensive clinical site coverage by both geography and organ-system of study. In addition, these models may reduce the burden on patients by minimizing the number of diagnostic tests they may need and maximizing the treatment opportunities available to them, regardless of where they may live. Bringing clinical trials to patients using the "just-in-time" site initiation model can further help to minimize travel and keep patients safe in the face of ongoing travel restrictions due to COVID-19.

"With the strong backing of a dynamic and experienced investor syndicate, Elevation Oncology is well positioned to execute on our mission of delivering precision medicines to physicians and their patients with cancer," said Steve Elms, Chairman and Interim Chief Executive Officer of Elevation Oncology and Managing Partner of Aisling Capital. "Our development approach to seribantumab sets the stage for our broader vision: the elevation of precision medicine to the forefront of every patient journey through building a collaborative industry-wide ecosystem. Together with diagnostic developers, clinical researchers, patient advocates, and the Elevation Oncology team, we are looking to build a pipeline of precision oncology medicines that can amplify each other’s efforts towards our shared goal of improving patient outcomes."

On July 21, 2020 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and Theranostics, reported its consolidated half-year revenue and cash position at June 30, 2020, data that is currently being audited (Press release, Theradiag, JUL 21, 2020, View Source [SID1234562183]).

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Consolidated H1 2020 revenue of €4.9 million

Over the six months to June 30, 2020, Theradiag generated revenue of €4.9 million, versus €5.0 million in the first half of 2019 highlighting the robustness and quality of the products marketed despite a delicate economic and health situation.

The Theranostics business posted another half of solid growth, with revenue up +16.5%, primarily driven by sales of LISA TRACKER kits in routine use whose sales exceeded €2.4 million in the first half of 2020 (vs. €2.0 million at June 30, 2019). As has been the case for a number of semesters now, the Theranostics represents the Company’s recurring business, thus providing it with enhanced visibility.

The highly degraded context since mid-March 2020, notably with the implementation of the plan blanc emergency plan in French hospitals, disrupted activity in all regions. Nevertheless, Theradiag posted a decent performance in France with particularly satisfactory Theranostics sales of €1.0 million, up 13% compared with the first half of 2019. Activity in the United States generated revenue of €0.4 million, up 42%. In its export business, the Company maintained a highly acceptable level of activity (+10%).

The IVD (In Vitro Diagnostics) activity recorded an 18.6% fall in revenue to €2.4 million at June 30, 2020, compared with €2.9 million in the first half of 2019. This decrease was a result of the impact of the exceptional sales to former partner HOB Biotech recorded in the first half of 2019. Excluding this negative base effect, Theradiag has maintained a level of activity that is in line with its strategy despite the global economic situation.

Cash position

At June 30, 2020, Theradiag had net available cash of €1.7 million, versus €2.9 million at December 31, 2019. This cash position is in line with the Company’s roadmap despite weak second-quarter activity and late payments. Moreover, Theradiag has prepared the necessary paperwork to apply for a State-guaranteed loan.

Bertrand de Castelnau, Theradiag’s CEO, commented: "I’m particularly pleased with the work undertaken by Theradiag’s teams and their unwavering commitment during this turbulent semester. This commitment has enabled us to generate remarkable results in our Theranostics business, which is our strategic priority and is generating increasingly patent recurring performances each semester. As well as these successes in our flagship activity, we have been able to activate the necessary levers to address the diagnostics market within the framework of the battle against the Covid-19 pandemic. Our actions have led to the certification of four CE-marked tests, two of them manufactured by Theradiag. Despite this success, which allows these tests to be marketed in France and abroad, it is important to remain cautious regarding the economic impact of this milestone on our 2020 financial year. We are very closely monitoring the ongoing public health crisis we are facing, we will intensify our efforts to protect our employees and partners, and we will continue to focus on developing our sales, our partnerships and our R&D investments in order to maintain a positive momentum throughout 2020".

Pierre Morgon, Chairman of Theradiag’s Board of Directors, added: "The Theradiag team is continuing to deploy its strategy centering on Theranostics and has already generated a remarkable performance over the last semester despite the tumultuous economic situation. Beyond the half-year growth of our Theranostics activity, the teams have been able to capitalize on the Company’s DNA, innovation, to bolster its technological lead to help patients. Theradiag is still on a positive trajectory and is on course to balance its books again".

Update regarding the impact of the Covid-19 pandemic on Theradiag’s annual activity

Theradiag is continuing to assess the potential consequences of the Covid-19 pandemic on its business and is continuing to put required measures in place for its employees, clients and partners. As of the date of this press release, Theradiag is expecting 2020 revenue to probably be negatively impacted by around 10%, not including the potential effects of new business associated with the Covid-19 tests whose deployment has begun.

Reminder of the main H1 2020 highlights

– February 2020: Theradiag presents excellent results generated by its new i-Tracker kits in its TRACKER range at the ECCO Congress.

– February 2020: THERADIAG helps establish a new WHO international standard for biotherapy monitoring.

– March 2020: THERADIAG announces the CE Marking of the first four i-Tracker test kits in its TRACKER range.

– April 2020: Theradiag commits to fighting Covid-19 and assesses the likely impact on FYR 2020.

– May 2020: Theradiag announces the approval of a first Covid-19 test, ‘RT-PCR’.

– June 2020: Theradiag issues an update on its Covid-19 test activity, and the first Theradiag-labeled tests receive the CE mark.

– July 2020: The University of Tours and Theradiag sign two agreements simultaneously: an exclusive licensing agreement for the production of Covid-19 viral proteins and a global collaboration agreement that could lead to further partnerships in the future.

Next financial press release:

H1 2020 results, on Monday September 21, 2020

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.