On October 29, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported two new academic collaborations with Columbia University and Mount Sinai (Icahn Mount Sinai) to translate cutting-edge research discoveries into potential therapies for patients with genetic diseases and genetically driven cancers (Press release, BridgeBio, OCT 29, 2021, View Source [SID1234592174]).

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"Columbia University and Mount Sinai are known for bringing together some of the most talented scientists to develop breakthroughs for patients. By partnering with these world-class research institutions, we are hopeful that together we will be able to help patients in need," said BridgeBio founder and CEO Neil Kumar, Ph.D.

BridgeBio has initiated 25 collaborations with leading institutions around the world that are focused on providing therapeutic options to patients with unmet need as quickly and safely as possible. To learn more about some of the institutions BridgeBio is proud to partner with, please visit Our Partners page.

Collaborating with academic institutions to identify early discoveries is a core pillar of BridgeBio’s efforts to reach patients more quickly. The goal of these collaborations is to revolutionize the relationships between drug development companies and biomedical research institutions by moving away from one-off interactions in favor of engaging and creative partnerships.

More than two-thirds of BridgeBio’s 30+ pipeline programs have come from partnerships with academic institutions and research centers. For example, BridgeBio’s clinical trial of encaleret, which is being investigated for the treatment of autosomal dominant hypocalcemia type 1 (ADH1), has been enabled by a Cooperative Research and Development Agreement with the National Institute for Dental and Craniofacial Research at the National Institutes of Health. BridgeBio’s investigational medicine acoramidis, which is being developed for the treatment of transthyretin (TTR) amyloidosis (ATTR), originated in a lab at Stanford University. BridgeBio partnered with the Stanford researchers and advanced acoramidis from the lab to Phase 3 clinical development in less than three years.

With a diverse pipeline encompassing investigational therapies in Mendelian diseases, precision cardiorenal, precision oncology and gene therapy, BridgeBio provides the insights and support needed to rapidly progress therapeutic research from labs to clinical development. BridgeBio intends to develop similar long-term partnerships based on trust, engagement, science and respect to support its mission of developing potentially life-changing medicines for patients with genetic diseases and cancers as quickly and safely as possible.

On October 29, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it will report third quarter 2021 financial results after the U.S. financial markets close on Thursday, November 4, 2021 (Press release, Oncternal Therapeutics, OCT 29, 2021, View Source [SID1234592190]). Oncternal’s management will host a webcast at 2:00 p.m. PT (5:00 p.m. ET) to provide a comprehensive business update and discuss the Company’s financial results.

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The live webcast of the call will be available online at investor.oncternal.com and the call will be archived there for at least 30 days.

On October 29, 2021 IMPACT Therapeutics reported that its ATR inhibitor IMP9064 has received the IND clearance from the U.S. Food and Drug Administration (FDA) for the Phase I/II clinical study, which will begin soon in the U.S (Press release, Impact Therapeutics, OCT 29, 2021, View Source [SID1234592206]). This will be the first in human study for the ATR inhibitor of IMPACT Therapeutics, representing a major leap of the company’s global development strategy for its synthetic lethality pipelines.

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This study is designed as a Phase I/II, dose escalation and expansion study, including individual arms to evaluate the safety, pharmacokinetics, and anti-tumor activities of IMP9064 as monotherapy and in combination with PARP inhibitor Senaparib in patients with advanced solid tumors.

IMP9064 is an ATR inhibitor discovered and developed by IMPACT Therapeutics, with worldwide intellectual property rights. In preclinical studies, IMP9064 was found to be a highly potent ATR inhibitor and is selective against other kinases. Additionally, IMP9064 has demonstrated high activities in several ATM-deficient cell lines and more active than reference compound in xenograft in vivo models, which could potentially lead to a wider therapeutic window, better tolerability in long-term administration as a single agent, and providing more flexibility in combination therapy. Senaparib, a PARP inhibitor developed by IMPACT Therapeutics, has been explored in several clinical studies worldwide. IMP9064 in combination with Senaparib will be evaluated in this clinical study to explore the combination therapy of an ATR inhibitor and a PARP inhibitor, which is highly anticipated in the DNA Damage Response (DDR) research field.

ATR is a synthetic lethality target of ATM mutations, which are commonly found in hematologic malignancies as well as a variety of solid tumors. ATR inhibitors have demonstrated proof-of-concept (POC) efficacy data in tumors harbored ATM mutations in previous clinical studies, and ATR is considered as one of the most promising synthetic lethality targets after PARP. Data from an ongoing ATR inhibitor clinical study presented at TRIPLE Conference 2021 showed that ATR inhibitor exhibits good efficacy as a monotherapy, but there is still significant room for improvement. This raised stronger interest to investigate combination of ATR inhibitor with other drugs. Among them, the combination of ATR inhibitor with PARP inhibitor is especially promising. In addition, the combination of ATR inhibitor with PARP inhibitor might overcome PARP inhibitor monotherapy resistance. As a company with both ATR inhibitor and PARP inhibitor in development, IMPACT Therapeutics is better positioned to study the combination therapy of ATR inhibitor with PARP inhibitor.

Combination therapy approach has been widely recognized as a major trend in the development of synthetic lethality-based therapeutics and targeted anticancer therapeutics to expand indications as well as to enhance anti-tumor activity. As a biopharmaceutical company dedicated to the discovery and development of novel therapeutics based on synthetic lethality, IMPACT Therapeutics has built extensive DNA Damage Response (DDR) pipelines including PARP, Wee1, ATR, and ATM inhibitors. IMPACT’s compounds were uniquely designed to have high activity and selectivity, which enables the company to target broader cancer indications and provide more opportunities for its in-house combination therapies.

Dr. Chih-Yi Hsieh, Senior Vice President and Chief Medical Officer said, "The pre-clinical data of IMP9064 has demonstrated its superiority among the same-class compounds. The clearance of this clinical program in the U.S. will enable us to validate the high potency, high selectivity, and robust anti-tumor activity of IMP9064 in the clinical study. IMPACT has formulated a differentiated clinical strategy for our ATR inhibitor which could advance the clinical development as efficient as possible, expand our synthetic lethality pipelines, and benefit more patients worldwide."

On October 29, 2021 Sprint Bioscience reported the the third quarter was an intense and news-dense period (Press release, Sprint Bioscience, OCT 29, 2021, View Source [SID1234592191]). Thanks to a licensing agreement and a rights issue, the company now finds itself in its strongest financial position to date and ready to take the next step in its development. BioStock contacted CEO Erik Kinnman to get his view on the past quarter and on the future.

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With three outlicensed drug programs, with a combined potential value of 747 million USD, plus potential royalties, the future has a lot to offer Sprint Bioscience. The latest in the line of license deals is the immunooncology program Vps34. During the third quarter, the company worked intensely on handover to American Deciphera Pharmaceuticals, that is now taking over the helm in the program.

Solid base for continued investments
A brand new new license agreement and a completed rights issue mean that Sprint Bioscience stands at a cash position of 85.7 million SEK at the end of the third quarter, ready to invest further in new preclinical drug programs.

And the company has not been slow to make use of this. Shortly after Vps34 was outlicensed, the company announced the next addition to the internal development portfolio, NIMA. The goal of the project is to develop a treatment for solid cancerous tumours. The candidate aims to inhibit the tumour’s ability to program the microenvironment around it, thus preventing tumour growth and facilitating attacks from the immune system. You can read more about the program here.

Great interest in the development projects
In addition, progress has also been made in the DISA development program, where the intended target protein has been announced. In connection with this, the marketing of the program began, with intensified dialogues with potential licensees. A first stop on the marketing journey was the partnering conference BIO-Europe, which took place during the past week, where Sprint Bioscience was met with great interest in both DISA and other development programs.

In parallel with the escalating marketing of DISA, work is also ongoing to find new interesting starting points for more drug development programs. One such program is carried out in collaboration with Dr Julian Walfridsson at Karolinska Institutet, a program that was recently awarded a research grant of 2.5 million SEK from the Swedish Foundation for Strategic Research. Read more.

Björn Sjöstrand new Chairman of the Board
However, it was not only the coffers and portfolio that expanded during the quarter, Sprint Bioscience also took steps to strengthen the organisation. The company has appointed a new CFO in the form of Mattias Skalmstad and the board was joined by life science entrepreneur Björn Sjöstrand as its new chairman. You can read an interview with Sjöstrand where he talks about his entry into, and his view of, the company here.

CEO comments
Overall, it has been an eventful quarter for Sprint Bioscience. BioStock contacted the company’s CEO Erik Kinnman to get his view of the third quarter and to learn more about what he sees ahead as we move towards winter.

First of all, Erik, how would you like to sum up the past quarter?
– It’s been very intense and successful. We have outlicensed the VPS34 program to Deciphera Pharmaceuticals, a very strong partner that has already shown great commitment to taking the program further. This is our largest deal to date and together with the new share issue carried out in August, this means that we have greatly strengthened our financial position.

– With a strong financial position in place, we can look to the future and focus on continuing to develop the business and build values in both outlicensed and internal programs.

BIO-Europe was held this week, an important event for you where you had conversations about the DISA project. What is the interest in the project so far?
– There is a noticeable interest from a large number of different companies. Some are interested more generally in what we have to offer, others are more specifically interested in either the VADA or DISA programs. It is clear that the mechanisms we address are highly interesting. DISA is in the relatively early stages compared to the VADA programme and we have received valuable feedback and started new dialogues. The BIO-Europe meeting has been successful for us and provided us with good support for continued discussions and marketing of our pharmaceutical programs.

Looking ahead, what milestones do you see in the next year?
– We continue to work intensively with our partners and the outlicensed programs to reach the next milestone on the path to clinical development and market approval. Such successes will further validate our business model. Furthermore, we want to continue to build our internal portfolio of highly interesting cancer drug programs and we are constantly working to sign new licensing agreements with strong international partners.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

On October 29, 2021 Signet Therapeutics, a biopharmaceutical startup focusing on developing innovative targeted cancer drugs using novel disease models, reported it has completed seed-2 round of approximately 10 million US dollars (Press release, Signet Therapeutics, OCT 29, 2021, View Source [SID1234592207]).

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The new round was led by 5Y Capital (Morningside Venture), with participation from Yael Capital, Blue Ocean Capital, and existing investors Tiantu Capital and Sky9 Capital. The new funding will advance Signet’s two first-in-class oncology programs toward clinical trials. In addition, Signet plans to expand its platform of disease models to other cancer areas and empower target discovery and pharmacodynamics studies at other pharmaceutical companies on a greater scale. Founded in 2020, Signet has raised a seed round of ￥60 million in CNY (equivalent to approximately $10 million), totaling two rounds of around $20 million within its first year.

Dr. Haisheng Zhang, CEO of Signet Therapeutics, and his core team members were from Dana-Farber Cancer Institute, Harvard Medical School, one of the world’s leading cancer research institutions. Traditional in vitro studies use cell lines that cannot accurately model patient’s drug performance, often returning misleading bioactivity results that misguide the screening and optimization of lead compounds, which could result in clinical failure. Leveraging years of oncology and functional biology and genomic research expertise, Signet developed a unique platform of novel disease models based on real-world cancer genomics data to simulate drug effects in 3D organ tissues that bear a closer resemblance to human biology and produce pharmacodynamics data with higher relevance to clinical performance.

Gastric cancer is the third leading cause of cancer death in the world. Close to one-third of the cases are of the diffusive gastric cancer (DGC) subtype, which is associated with poor prognosis and a low response rate to existing cancer therapies and medicines. Using its novel disease models platform, Signet made the groundbreaking discovery of a promising new target for DGC. It launched a drug discovery program with the leading AI drug R&D company XtalPi and, in March 2021, announced the identification of a pre-clinical candidate in over six months.

As Signet quickly advance its first-in-class DGC pipeline toward clinical trials, it has recently expanded its drug discovery program with XtalPi to another novel cancer target discovered by Signet. The two companies hope to build upon their existing success in combining XtalPi’s AI drug discovery capabilities with Signet’s customized novel disease models to quickly discover and validate candidates with potent bioactivity and a desirable drug property profile that can translate to enhanced clinical performance.