1stOncology™: Cancer Intelligence Service – Page 9970 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

InnoCare Announces Orphan Drug Designation of Gunagrabtinib by US FDA for Treatment of Cholangiocarcinoma

On June 16, 2021 InnoCare (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its pan-FGFR inhibitor gunagratinib (ICP-192) for the treatment of cholangiocarcinoma(Press release, InnoCare Pharma, JUN 16, 2021, View Source [SID1234584075]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

InnoCare’s ICP-192 is a highly selective pan-FGFR inhibitor targeting multiple solid tumors with FGFR gene aberrations. Currently, several clinical studies are ongoing in China and the United States.

According to the latest clinical data presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, as of February 2021, a total of 30 patients had received treatment of gunagratinib. Gunagratinib performed well in safety and tolerance, and the maximum tolerated dose (MTD) had not been reached. Among the 12 patients with FGF/FGFR gene aberrations who have completed at least one tumor assessment, the overall response rate (ORR) was 33.3%, including 1 patient (8.3%) of cholangiocarcinoma with complete response (CR), 3 patients (25%) with partial response (PR) and 7 patients having achieved stable disease (SD). The disease control rate (DCR) was 91.7%.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare, said, "We are very proud that our solid tumor drug has been granted ODD by the FDA following that for our blood cancer drug. Gunagratinib demonstrated anti-tumor activity for multiple tumor types, including cholangiocarcinoma, in patients with FGF/FGFR gene aberrations. We will rapidly advance the multi-center, multi-indication clinical trials in both the US and China in order to benefit patients early."

The Orphan Drug Designation by the US FDA originates from the Orphan Drug Act, which was enacted in 1983 to encourage the development of innovative drugs to treat rare diseases with a target patient population of less than 200,000 in the US. Upon marketing approval, drugs with ODD qualify for seven-year market exclusivity. In addition, US FDA also rewards ODD drugs with comprehensive incentives including tax credit for clinical trial cost, waiver of marketing registration application fee, waiver or reduced annual product fee, and other benefits, such as clinical protocol assistance and qualification for expedited development programs.

Last December, FDA granted ODD to InnoCare’s Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of mantle cell lymphoma (MCL).

New Equilibrium Biosciences Awarded Competitive Grant from the National Science Foundation

On June 16, 2021 New Equilibrium Biosciences reported it has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) for [$$$ AMOUNT] to conduct research and development (R&D) work on drug candidates that regulate intrinsically disordered proteins implicated in cancers and neurodegenerative disorders (Press release, New Equilibrium Biosciences, JUN 16, 2021, View Source [SID1234584055]).

New Equilibrium Biosciences is dedicated to developing new medicines through cutting edge sciences and cross-disciplinary collaborates. New Equilibrium combines big data, artificial intelligence, and biophysical experiments to accurately visualize the many different conformations that IDP’s, a class of shapeshifting proteins, may adopt. The overarching motivations for this work is to benefit the greater good by specifically targeting and drugging malfunction IDPs to restore normal cell function in those with cancer and neurodegenerative disorders.

"NSF is proud to support the technology of the future by thinking beyond incremental developments and funding the most creative, impactful ideas across all markets and areas of science and engineering," said Andrea Belz, Division Director of the Division of Industrial Innovation and Partnerships at NSF. "With the support of our research funds, any deep technology startup or small business can guide basic science into meaningful solutions that address tremendous needs."

Once a small business is awarded a Phase I SBIR/STTR grant (up to $256,000), it becomes
eligible to apply for a Phase II grant (up to $1,000,000). Small businesses with Phase II grants
are eligible to receive up to $500,000 in additional matching funds with qualifying third-party
investment or sales.

Startups or entrepreneurs who submit a three-page Project Pitch will know within three weeks if
they meet the program’s objectives to support innovative technologies that show promise of
commercial and/or societal impact and involve a level of technical risk. Small businesses with
innovative science and technology solutions, and commercial potential are encouraged to apply.
All proposals submitted to the NSF SBIR/STTR program, also known as America’s Seed Fund powered by NSF, undergo a rigorous merit-based review process. To learn more about
America’s Seed Fund powered by NSF, visit: View Source

About the National Science Foundation’s Small Business Programs: America’s Seed Fund
powered by NSF awards $200 million annually to startups and small businesses, transforming
scientific discovery into products and services with commercial and societal impact. Startups
working across almost all areas of science and technology can receive up to $1.75 million to
support research and development (R&D), helping de-risk technology for commercial success.
America’s Seed Fund is congressionally mandated through the Small Business Innovation
Research (SBIR) program. The NSF is an independent federal agency with a budget of about
$8.1 billion that supports fundamental research and education across all fields of science and
engineering.

Linnaeus Therapeutics Announces Expanded Clinical Collaboration with Merck to Include Multiple Additional Cohorts to Evaluate LNS8801 in Combination with KEYTRUDA® in Patients with Advanced Cancer

On June 15, 2021 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that the expansion of its ongoing clinical collaboration with Merck to include multiple additional phase 2 cohorts(Press release, Linnaeus Therapeutics, JUN 16, 2021, View Source [SID1234584073]). Based on promising preliminary safety, pharmacodynamic and efficacy data, this expanded agreement will allow the companies to further evaluate the combination of LNS8801 and Merck’s anti-PD-1 therapy, KEYTRUDA(pembrolizumab) in patients with selected advanced solid tumors.

LNS8801 is a first-in-class, orally bioavailable small molecule that is a highly specific and potent agonist of the G-protein estrogen receptor (GPER). GPER is widely expressed on cancers. Stimulating GPER rapidly and durably depletes the c-Myc oncoprotein, stops cancers from proliferating, and makes them more visible to the immune system.

Linnaeus and Merck are currently evaluating the combination of LNS8801 and KEYTRUDA in patients who had previously responded to PD-1/L1 therapy but have subsequently progressed on PD-1/L1 inhibitors. Additionally, Linnaeus is currently evaluating LNS8801 as a monotherapy in patients that cannot tolerate PD-1/L1 therapy due to serious immune-related adverse events.

Under the terms of the agreement, Linnaeus will conduct six additional Phase 2 cohorts evaluating the combination of LNS8801 and KEYTRUDA in several indications including NSCLC, head and neck cancer, cutaneous and uveal melanoma, among others.

"We are very pleased to expand our collaboration with Merck, the established leader in cancer immunotherapy, as we advance LNS8801 into Phase 2 clinical trials," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "Based on the encouraging signals we have seen so far in the advanced cancer patients treated with the combination of LNS8801 and KEYTRUDA as well as LNS8801 as monotherapy, we are optimistic that the combination of LNS8801 and KEYTRUDA will provide meaningful benefit to this patient population."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About LNS8801

LNS8801 is an orally bioavailable and highly specific, potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc oncoprotein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. In the ongoing phase human 1/2a study, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc oncoprotein depletion, and durable clinical benefit in patients with advanced cancer.

Inhibikase Therapeutics Prices Follow-On Public Offering of Common Stock

On June 15, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders inside and outside of the brain, reported that the pricing of an underwritten public offering of 15 million shares of its common stock at a public offering price of $3.00 per share for total gross proceeds of approximately $45 million (the "Offering) before deducting underwriting discounts and commissions and offering expenses payable by Inhibikase(Press release, Inhibikase Therapeutics, JUN 16, 2021, View Source [SID1234584072]). In addition, Inhibikase has granted the underwriters a 45-day option to purchase up to 2.25 million additional shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on June 18, 2021, subject to customary closing conditions.

Inhibikase intends to use the net proceeds from the public offering, together with existing funds, to fund the costs of a Phase 1b extension study for IkT-148009 in Parkinson’s patients and to validate target engagement markers in the central and peripheral nervous system; to fund production of IkT-148009 for Phase 1b and Phase 2 clinical studies and to fund a Phase 2 efficacy trial of IkT-148009 in Parkinson’s patients. This funding will further support the clinical dose calibration study(ies) of IkT-001Pro in healthy subjects to support approval under the Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act and to fund drug product production for IkT-001Pro. The balance will support general research and development activities, medicinal chemistry for additional molecules and IND-enabling studies, team building, and other general corporate activities

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering. JonesTrading Institutional Services LLC is acting as the co-manager for the offering.

The offering is being made pursuant to a registration statement on Form S-1 (File No. 333-257032) that was declared effective by the Securities and Exchange Commission (the "SEC") on June 15, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

ImmunoPrecise Attending the 6th Annual CART-CR Summit

On June 16, 2021 ImmunoPrecise reported that it will be attending The 6th Annual CAR-TCR Summit which returns in 2021 as the industry-leading comprehensive forum with one goal: to engineer a disease-free world(Press release, ImmunoPrecise Antibodies, JUN 16, 2021, View Source [SID1234584070]). At the event, over 150 speakers will lead discussions on many topics from commercial pipeline development to new innovations and approaches. The virtual event will be held from August 30 to September 2.