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.

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"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.

Ipsen and Marengo Therapeutics announce strategic partnership to advance two precision immuno-oncology candidates from Marengo’s STAR Platform into the clinic

On August 1, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) and Marengo Therapeutics, Inc. reported a strategic partnership to advance two of Marengo’s preclinical STAR platform-generated candidates into the clinic (Press release, Ipsen, AUG 1, 2022, View Source [SID1234617166]). The collaboration will leverage Marengo’s proprietary R&D expertise of a novel mechanism of T cell activation with Ipsen’s global oncology footprint for clinical development and commercialization.

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Under the terms of the agreement, Ipsen will make an upfront payment of $45 million, together with potential payments up to a total of $1.592 billion if all milestones are met in addition to tiered sales royalty payments. Marengo will lead the preclinical development efforts and will expense related costs until the submission of an Investigational New Drug (IND) application to the U.S. FDA. Ipsen will assume responsibilities for clinical development and commercialization.

Collectively, the Ipsen and Marengo teams have a proven track record of successful oncology-medicine development and commercialization to maximize the potential of candidates across a large range of cancer indications.

"Marengo’s foundational discovery of activation of T cell subsets via TCR Vβ is unprecedented and highly differentiated from the current immuno-oncology technologies we have seen," said Howard Mayer, M.D., Executive Vice President and Head of R&D at Ipsen. "This partnership with Marengo provides a strong foundation for a productive and successful collaboration as we embark on a journey to develop novel and durable therapies that will strengthen our oncology pipeline and further enhance our commitment to people living with cancer".

"Our strategic partnership with Ipsen underscores our shared ambition to develop transformative medicines for people fighting cancer," said Zhen Su, M.D., MBA, CEO of Marengo Therapeutics. "Marengo brings a precision medicine approach to the field of Immuno-oncology with a focus on T cell activation and this collaboration is an important validation of our STAR platform beyond our lead candidate. Together this partnership is a demonstration of the strong progress and promise of our innovative scientific platform."

CORMEDIX INC. TO REPORT SECOND QUARTER 2022 FINANCIAL RESULTS AND PROVIDE A CORPORATE UPDATE ON AUGUST 11

On August 1, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it will report its financial results for the second quarter ended June 30, 2022, before the market open on Thursday, August 11, 2022, and will host a corporate update conference call at 8:30am Eastern Time (Press release, CorMedix, AUG 1, 2022, View Source [SID1234617183]).

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Precision BioSciences to Report Second Quarter 2022 Financial Results on August 8, 2022

On August 1, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that it will publish financial results for the second quarter 2022 and provide a business update on August 8, 2022 (Press release, Precision Biosciences, AUG 1, 2022, View Source [SID1234617199]).

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Last patient completed follow-up period in Phase II/III study of Amphera’s MesoPher cell therapy in mesothelioma

On August 1, 2022 Amphera B.V., a late-stage biotechnology company developing cell therapies to treat cancer, reported that the last patient has completed the active follow-up in the Phase II/III DENIM study of MesoPher cell therapy to treat pleural mesothelioma (Press release, Amphera, AUG 1, 2022, https://www.businesswire.com/news/home/20220801005324/en/Last-patient-completed-follow-up-period-in-Phase-IIIII-study-of-Amphera%E2%80%99s-MesoPher-cell-therapy-in-mesothelioma [SID1234617215]).

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Ilona Enninga PhD, COO of Amphera said: "Despite the challenges experienced during the pandemic, we were able to maintain strong enrolment to the study. The first patient was included in 2018, the last patient was included in June 2021 and completed the 12 month follow-up in June 2022. In total 176 patients were included. I would like to thank our investigators and the clinical study team for their exceptional efforts in keeping the study on track. We are now focused on database lock and subsequent statistical analysis."

Rob Meijer, CEO of Amphera said: "This is another significant milestone in the development of MesoPher after the promising efficacy results in pancreatic cancer reported earlier this year. The DENIM study is designed to be pivotal following discussions with the regulators. We plan to report topline results early in Q4 2022. The results are expected to be the basis for an EMA Marketing Authorization Application in H1 2023, starting the process of bringing this new therapy to mesothelioma patients."

The DENIM (DENdritic cell Immunotherapy for Mesothelioma) study is a randomised open-label Phase II/III study of patients with pleural mesothelioma. The objectives are to assess the efficacy and anti-tumour activity of MesoPher as maintenance treatment after chemotherapy. Patients received 3 bi-weekly injections of MesoPher, plus two further injections of MesoPher after 4 and 7 months. Patients in the control arm received best supportive care alone. The primary endpoint of the study is overall survival.

In Q4 2022, Amphera will also present the survival data of the expansion cohort of 28 patients in the Phase II REACtiVe study of MesoPher in resected pancreatic cancer. The promising results of the first cohort were recently published in the European Journal of Cancer (View Source(22)00159-9/fulltext).