Quince Therapeutics Details Strategic Growth Plan with Launch of New Corporate Name

On August 1, 2022 Quince Therapeutics, Inc. (Nasdaq: QNCX), a biopharmaceutical company advancing innovative precision therapeutics targeting debilitating and rare diseases, reported an overview of its strategic growth plan in conjunction with its corporate name change (Press release, Quince Therapeutics, AUG 1, 2022, View Source [SID1234619483]). The launch of Quince Therapeutics marks a strategic shift in focus as the company prioritizes the clinical development of its highly differentiated bone-targeting drug platform and lead precision bone growth molecule, NOV004, to address major, unmet medical needs across multiple skeletal therapeutic indications. Quince also announced that the company plans to pursue the strategic expansion of its development pipeline through opportunistic in-licensing and acquisition of clinical-stage assets targeting debilitating and rare diseases, in addition to disclosing the company’s intent to out-license its legacy neuroscience and antiviral assets.
Dirk Thye, M.D., Quince’s chief executive officer, said, "We are eager and enthusiastic about launching Quince Therapeutics and introducing our new corporate strategy focused on the development and acquisition of innovative precision therapeutics for patients suffering from debilitating and rare diseases. Our proprietary bone-targeting drug platform and novel lead molecule, NOV004, are positioned to establish Quince as an important new leader in underserved therapeutic areas with major and unmet medical needs in a setting of historical underinvestment and few competitive companies. Our core technology is based on more than 10 years of extensive preclinical research and can be applied to a broad variety of skeletal diseases and indications as we look to expand our proprietary pipeline.

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!

"We also benefit from a highly experienced management team with a long track record of drug development success and value creation. This team is empowered by a cash runway extending into the second half of 2025, providing us near-term financial security in a period of economic uncertainty in the biotech sector. This strong financial position is expected to enable us to not only fully fund reaching NOV004’s human proof of concept clinical development milestone, but also allow Quince to pursue strategic in-licensing and acquisition of additional clinical-stage assets. We intend to aggressively leverage the advantages of our strong team and balance sheet to build a highly impactful and valuable company," Thye concluded.

Strategic Growth Plan Highlights

Today, Quince embarks on a fundamental shift in its strategic growth plan that now centers on advancing innovative precision therapeutics targeting debilitating and rare diseases. Key highlights of the company’s strategic growth plan include:

Addressing major, unmet medical needs across multiple skeletal therapeutic indications

Major, unmet medical needs have been estimated to include more than 18 million fractures in the U.S. each year that have led to more than $50 billion in direct medical costs.
Underserved bone fracture opportunity compounded by a growing aging population experiencing higher rate of life-threatening fractures.
No treatments currently approved for lead indication, osteogenesis imperfecta, which has been estimated to affect as many as 50,000 people in the U.S. alone.
Positioned as a lead innovator in underserved therapeutic areas with few competitive companies.
Discovery pipeline positioned for rapid expansion across multiple skeletal therapeutic indications, including osteogenesis imperfecta, fractures, spinal fusion, and other severe bone diseases.
Strong and well-protected intellectual property with robust portfolio of precision bone therapeutics.
Highly differentiated bone-targeting drug platform and broad applicability of lead molecule NOV004

Proprietary drug-targeting technology designed to enable precise delivery of small molecules, peptides, or large molecules directly to the site of bone fracture and disease.
Development pathway de-risked by more than 10 years of extensive preclinical studies demonstrating that concentrated drug-targeting promotes more rapid healing with fewer off-target safety concerns compared to non-targeted therapeutics.
Lead precision bone growth molecule NOV004 is an anabolic peptide engineered to precisely target and concentrate at the bone fracture site, resulting in rapid increases in bone density, strength, and healing as demonstrated in preclinical studies.
NOV004 expected to enter Phase 1 clinical studies in 2023.
Future development plans include progression of NOV004 to Phase 2 clinical study to evaluate safety and efficacy for the treatment of planned lead indication, osteogenesis imperfecta.
Strategic pipeline expansion through opportunistic in-licensing and acquisition of clinical-stage assets

Proactively evaluating potentially actionable clinical-stage assets targeting debilitating and rare diseases for in-licensing and acquisition.
Potential asset targets must have compelling clinical data and commercial opportunity and offer clear operational synergy and value creation.
Intend to be opportunistic and disciplined in approach with ability to be selective and competitive in evolving biotech environment.
Strong cash position expected to fund operations and clinical activities into the second half of 2025

Strong cash position of approximately $105 million in cash, equivalents, and marketable securities as of June 30, 2022 is expected to fund capital and operating expenditures into the second half of 2025.
Expect to fully fund achievement of lead molecule NOV004’s human proof of concept clinical development milestone.
Corporate restructuring in first half of 2022 optimized organization for operating efficiency.
Out-licensing legacy neuroscience and antiviral assets

Seeking to out-license capital-intensive legacy neuroscience and antiviral assets, including COR588, COR388, COR852, and COR803.
Lysine gingipain inhibitor COR588 is Phase 2 ready for further evaluation in Alzheimer’s disease and other P. gingivalis associated diseases.
Antiviral 3CLpro irreversible inhibitor COR803 for coronavirus infection positioned at IND-enabling preclinical study phase.
Out-licensing effort to identify partners already underway with goal of concluding the process before the end of 2022.
Initiates Nasdaq Trading Under New Ticker Symbol "QNCX"

Quince’s ticker symbol on the Nasdaq Stock Market will begin to trade under "QNCX" effective at the open of market trading today, Monday, August 1, 2022. The corporate name change to Quince Therapeutics, Inc. does not affect the rights of the company’s stockholders with respect to the name change. Outstanding stock certificates are not affected by the name change and will not need to be exchanged.

Management to Participate at Upcoming Investor Conference

Quince’s chief executive officer Dirk Thye, M.D., will present at the Canaccord Genuity 42nd Annual Growth Conference taking place on Thursday, August 11, 2022 beginning at 2:30 p.m. Eastern Time. A webcast of the event will be accessible on the Investor Calendar page under the News & Events heading of Quince’s investor website at www.quincetx.com. The webcast will be archived at that location for 90 days.

Consolidated Financial Results for the First Three Months of the Fiscal Year Ending March 31, 2023

On August 1, 2022 JSR reported consolidated financial results for the First Three Months of the Fiscal Year Ending March 31, 2023 (Filing, 3 mnth, JUN 30, JSR, 2022, AUG 1, 2022, View Source [SID1234619297]).

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!


BioInvent Enrolls First Patient in Phase 1/2a Trial of BI-1607 in HER2 Positive Solid Tumors

On August 01, 2022 BioInvent International reported treatment of the first patient in a Phase 1/2a trial of its second anti-FcyRIIB antibody BI-1607 in combination with trastuzumab in HER2+ solid tumors (Press release, BioInvent, AUG 1, 2022, View Source [SID1234618934]).

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!

The first-in-human Phase 1 trial is a dose escalation study of BI-1607 combined with trastuzumab in HER2+ advanced or metastatic solid tumors. The selected dose of BI-1607 will be studied in a subsequent Phase 2a part of the trial along with trastuzumab in advanced breast, metastatic gastric and gastroesophageal junction HER2+ cancers.

The first patient has been recruited to the Phase 1 part of the study which is expected to recruit between 12 and 26 subjects. The Phase 2a aims to recruit 30 patients in two cohorts of 15 subjects each (one cohort in breast and one in gastric and gastroesophageal cancers). The study will be carried out at 7-12 sites in Spain, the UK, Germany, and in the U.S.

"This new study with our exciting anti-FcyRIIB antibody BI-1607 marks BioInvent’s fifth clinical trial, with four distinct drug candidates, and it is a further demonstration of the productivity of our technology platform. Preclinical data have shown that a BI-1607 surrogate antibody enhances the therapeutic efficacy of anti-HER2 antibodies, and we look forward to further investigating this effect in human subjects," said Martin Welschof, CEO of BioInvent.

Like BI-1206, BioInvent’s lead FcyRIIB antibody, BI-1607 is intended to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. Trastuzumab alone or in combination with chemotherapy significantly improves overall survival of HER2+ breast cancer patients. However, many patients remain uncured and develop resistance to trastuzumab resulting in relapse or progression of the disease. BI-1607 differs from BI-1206 in that BI-1607 has been engineered for reduced Fc-binding to FcyRs. This alteration generates a major differentiating factor between the two antibodies, and specifically with respect to the best combination partners.

Preclinical data presented at this year’s AACR (Free AACR Whitepaper), indicate that treatment with BI-1607 enhances the efficacy of current anti-HER2 regimens such as trastuzumab. HER2 is a driver of tumor formation and growth in approximately 20% of breast cancers, the most common cancer worldwide in women, and in gastric and gastroesophageal junction adenocarcinoma.

Consolidated Financial Results
for the First Quarter of the Fiscal Year Ending March 31, 2023

On August 1, 2022 Ono reported its consolidated financial results for the First Quarter of the fiscal year ending March 31, 2023 (Filing, 3 mnth, JUN 30, Ono, 2022, AUG 1, 2022, View Source [SID1234618753]).

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!


Prothena to Report Second Quarter 2022 Financial Results on August 8th

On August 1, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that it will report its second quarter and first six months of 2022 financial results on Monday, August 8, 2022 after the close of the U.S. financial markets (Press release, Prothena, AUG 1, 2022, View Source [SID1234617285]).

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!

Consistent with past practice, the Company will not be conducting a conference call in conjunction with this financial results release on August 8.