BridgeBio Pharma and the University of California, San Diego Announce Collaboration to Advance Treatments for Genetically Driven Conditions

On April 13, 2021 BridgeBio Pharma, Inc. (NASDAQ: BBIO), and the University of California, San Diego (UC San Diego) reported a partnership to translate research in genetically driven conditions into potential therapeutic applications for patients, with a focus on oncology and neurology (Press release, BridgeBio, APR 13, 2021, View Source [SID1234577970]).

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"UC San Diego is a leading research institution with a top pharmacology department and a strong profile in neurology and oncology. By leveraging their expertise through our collaboration partnership, we hope to advance discoveries into potential treatments as quickly and safely as possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

Under this partnership, BridgeBio and UC San Diego will collaborate on identifying research programs with strong potential for therapeutic applications that address areas of unmet need. BridgeBio will potentially sponsor research programs and support the development of identified programs toward potential clinical investigation through its licensing and affiliate development model.

"Our world-renown scientists have deep knowledge into genetically driven conditions. Coupling our cross-disciplinary, flexible approach to advancing research with BridgeBio’s developmental expertise and collaborative model presents tremendous opportunity to realize the potential of our work," said UC San Diego Associate Vice Chancellor for Innovation and Commercialization Paul Roben. "I look forward to seeing our collaboration advance around our shared mission to develop life-changing therapies and give patients new hope."

BridgeBio partners with top academic and research institutions, including UC San Diego, to support early, promising research in genetically driven diseases and cancers with clear genetic drivers. Today BridgeBio also announced formal partnerships with Brown University, GlycoNet, The Lundquist Institute, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center and University of California, Davis – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to date. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

With trust, respect and science at the forefront of all collaborations, BridgeBio continuously seeks long-term partnerships with similar institutions that are rooted in trust, engagement, science and respect in order to drive forward its mission of developing life-changing medicines for patients with genetically driven conditions, including in oncology and neurology, as quickly and safely as possible.

Repare Therapeutics to Present at the 2021 Bloom Burton & Co. Virtual Healthcare Investor Conference

On April 13, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported that members of its senior management team will present at the 2021 Bloom Burton & Co. Virtual Healthcare Investor Conference on Tuesday, April 20 at 9:30 a.m. ET (Press release, Repare Therapeutics, APR 13, 2021, View Source [SID1234577987]).

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A live webcast of the presentation can be accessed in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 30 days.

April 9, 2021 – Cancer Advances, Inc. Announces Minisymposium Presentation at AACR

On April 13, 2021 Cancer Advances, Inc., a clinical stage biopharmaceutical company developing therapeutics for gastrointestinal cancers, reported that its abstract entitled, "Vaccination with Polyclonal Antibody Stimulator (PAS) prevents pancreatic carcinogenesis in the KRAS mouse model" has been selected for presentation in a minisymposium at the AACR (Free AACR Whitepaper) Annual Meeting 2021 (Press release, Cancer Advances, APR 13, 2021, View Source [SID1234577972]).

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Jill Smith, MD of the Georgetown Lombardi Comprehensive Cancer Center, will present the results of this study during the week of April 10-15, 2021. The pre-recorded presentation will be available for viewing during the meeting. A live Q&A session will be held April 12, 1:30 pm EDT. In addition, attendees have the opportunity to contact Dr. Smith via a networking portal to discuss the research further.

Details of the abstract and minisymposium are below:

Abstract Title: Vaccination with Polyclonal Antibody Stimulator (PAS) prevents pancreatic carcinogenesis in the KRAS mouse model

Abstract Number: 109

Q&A Session: April 12, 1:30 pm EDT

Abstract/Session Link: View Source!/9325/presentation/1168

LintonPharm Announces Authorization from China Health Authority (NMPA) to Proceed with a Phase 1/2 Trial Evaluating Catumaxomab for the treatment of Non-Muscle Invasive Bladder Cancer

On April 13, 2021 LintonPharm Co., Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T cell engaging bispecific antibodies for cancer immunotherapy, reported that China’s health authority, National Medical Products Administration (NMPA) authorized the company to proceed with a Phase 1/2 clinical trial (clinicaltrials.gov: NCT04799847) evaluating the safety and efficacy of catumaxomab in patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) whose tumors have recurred due to Bacillus Calmette-Guerin (BCG) vaccine failure (Press release, Lintonpharm, APR 13, 2021, View Source [SID1234577988]). This is LintonPharm’s second clinical program evaluating catumaxomab. In July 2020, the company announced authorization of a Phase 3 trial in advanced gastric cancer which screened its first patient in October 2020.

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Recently, Lindis Biotech, partner of LintonPharm, initiated a dose-finding Phase 1 trial with catumaxomab in NMIBC patients in Germany (clinicaltrials.gov: NCT04819399) and reported an excellent safety profile, which supports the conduct of the Phase 1/2 trial in China.

"Regulatory clearance to move forward with our clinical program evaluating catumaxomab in bladder cancer is another significant milestone for LintonPharm and supports our goal of exploring the potential for this targeted therapy in a broad range of cancers," said Robert Li, Ph.D., DABT, Co-founder and CEO of LintonPharm. "Patients with NMIBC BCG failure have high rates of tumor recurrence and often face a lifetime of surgical intervention which may impact bladder function. New treatment options are needed and we are hopeful that this study puts us one step closer toward helping these patients."

Bladder cancer is the 10th most common cancer worldwide. In 2020, bladder cancer was diagnosed in approximately 573,278 patients globally and approximately 1.8 million people were living with this form of cancer over a five-year period [1]. NMIBC is a cancer found in the tissue that lines the inner surface of the bladder and accounts for approximately 75 percent of all bladder cancer [2]. Transurethral resection of bladder tumor (TURBT) is the current standard of treatment for NMIBC. Relapse is common after TURBT (up to 70 percent at five years) and as a result, patients often undergo multiple surgical procedures over a longer period [2]. Intravesical BCG is commonly used as an adjuvant treatment after TURBT. However, a large number of patients experience tumor recurrence, which is referred to as BCG failure [3]. Radical cystectomy (RC) is usually recommended after BCG failure, but many physicians and patients refrain from RC in favor of preserving bladder function.

About Catumaxomab

Catumaxomab was approved by the European Medicines Agency in 2009 for the treatment of malignant ascites. This bispecific antibody binds to a transmembrane glycoprotein on the tumor cell–the epithelial cell adhesion molecule (EpCAM)–and CD3 on the T cell, and also recruits immune accessory cells through FcγR binding. Catumaxomab destroys tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models.

Recently, catumaxomab was authorized by regulatory authorities in China, Taiwan (China) and South Korea to conduct a global Phase 3 clinical trial for treating patients with advanced gastric cancer.

Theseus Pharmaceuticals Debuts with $100M Series B Raise to Develop Pan-Variant Kinase Inhibitors

On April 13, 2021 Theseus Pharmaceuticals, a biotechnology company shaping the future of targeted oncology by developing best-in-class, pan-variant kinase inhibitors, emerged from stealth reported the close of a $100 million Series B financing led by Foresite Capital (Press release, Theseus Pharmaceuticals, APR 13, 2021, View Source [SID1234577973]). Theseus also announced data from a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, which demonstrated that the Company’s lead product candidate, THE-630, has potent activity against all major classes of activating and resistance mutations observed in patients with KIT-mutant gastrointestinal stromal tumors (GIST).

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OrbiMed incubated Theseus to develop therapies designed to outsmart treatment-resistant cancer mutations, funding the Company’s Series A in 2018. In addition to Foresite Capital, the Series B raise was supported by a syndicate of other new investors, including Adage Capital Management, Boxer Capital, Farallon Capital Management, Longitude Capital, Nextech Ventures, Omega Funds, Pontifax Venture Capital, Rock Springs Capital, and T. Rowe Price, as well as OrbiMed. In conjunction with the financing, Michael Rome, Ph.D., Managing Director of Foresite Capital, has joined the Theseus Board of Directors, which also includes Carl Gordon, General Partner at OrbiMed.

"We are thrilled by the validation of this discerning group of investors and welcome Michael to Theseus’ board of directors," said William C. Shakespeare, Ph.D., Co-founder and President of Research and Development at Theseus Pharmaceuticals. "For many driver-oncogene targets, current standard-of-care kinase inhibitors have insufficient activity to cover the broad array of variants that could lead to resistance, so they are limited by constantly mutating cancer. At Theseus, we take a pan-variant approach to targeting oncogenes with kinase inhibitors specifically designed to retain their effectiveness even as cancer mutates. Using sophisticated assays, we can predict how cancers will change, enabling new therapies to stay ahead of future mutations and overcome the demonstrated burden of treatment resistance."

Theseus is developing a pipeline of pan-variant tyrosine kinase inhibitors (TKIs) that can anticipate and inhibit new cancer mutations. The Company’s lead candidate, THE-630, is a next-generation pan-variant KIT inhibitor in development for the treatment of refractory GIST. The Company expects to file an IND before the end of the year. Theseus’ pipeline also includes a selective EGFR inhibitor to overcome C797S-mediated resistance to first- or later-line osimertinib treatment for patients with non-small cell lung cancer, and a third kinase target candidate for an undisclosed indication.

Iain Dukes, D. Phil., Co-founder and Interim CEO of Theseus Pharmaceuticals, and Venture Partner of OrbiMed, commented, "The scientific co-founders of Theseus are a team of distinguished drug discovery and development leaders who have pioneered the development of pan-variant kinase inhibitors. Together at ARIAD Pharmaceuticals, they discovered and developed multiple kinase inhibitors in areas of high clinical need, two of which they brought to market, ponatinib and brigatinib, and a third, mobocertinib, that is now in late-stage clinical development. With this foundation of expertise, combined with the backing of a top-tier syndicate of investors, Theseus is well positioned to develop best-in-class, pan-variant TKIs that provide durable benefit for people living with cancer."

At the AACR (Free AACR Whitepaper) meeting, Theseus presented preclinical data demonstrating that THE-630 has potent activity against all classes of activating and resistance mutations observed in KIT-mutated GIST. These data showed that THE-630 was highly efficacious in tumor models containing mutations that confer resistance to approved TKIs. These data highlight the potential for a pan-variant inhibitor such as THE-630 to deliver meaningful clinical benefit for patients with refractory GIST. The presentation can be found on Theseus’ website.