On July 25, 2024 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, reportedc that the Company will release the latest clinical data on its first-in-class fully human anti-B7H7/HHLA2 monoclonal antibody, HBM1020, for advanced solid tumors at the ESMO (Free ESMO Whitepaper) Congress 2024, taking place from September 13-17, 2024, in Barcelona, Spain (Press release, Harbour BioMed, JUL 25, 2024, View Source [SID1234645095]).

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HBM1020, generated from Harbour Mice H2L2 transgenic mice platform, is the first therapeutic monoclonal antibody against B7H7/HHLA2 to have entered clinical development globally. Data from the dose-escalation study of a phase I, multi-center, open-label trial (NCT05824663) demonstrated the promising safety and tolerability profiles of HBM1020 in patients with advanced solid tumors.

The findings will be displayed as a poster presentation during the ESMO (Free ESMO Whitepaper) Congress 2024. Details of the presentation are as follows:

Title: Ph I Dose-Escalation Study of HBM1020, a Novel Anti-B7H7 Antibody in Patients with Advanced Solid Tumors

Presentation Number: 1010P

Onsite Poster Display Date: Saturday, September 14, 2024

Speaker: Jason Henry

All accepted abstracts will be published online on the ESMO (Free ESMO Whitepaper) website.

About HBM1020

HBM1020 is a first-in-class fully human monoclonal antibody generated from Harbour Mice H2L2 transgenic mice platform, targeting B7H7/HHLA2.

B7H7, also known as HHLA2, is a novel immune modulatory molecule belonging to the B7 family. The B7 family is of central importance in regulating the T-cell response, making these pathways very attractive in cancer immunotherapy. Most of the validated targets in immune-oncology so far are related to B7 family, including PD-(L)1, and CTLA-4. The therapies against B7 family targets have already shifted the paradigm for cancer therapy with outstanding clinical benefits. As a newly discovered member of the B7 family, B7H7 expression is found non-overlapping with PD-L1 expression in multiple tumor types, which indicates an alternative immune evasion pathway besides PD-(L)1. In PD-L1 negative/ refractory patients, B7H7 potentially plays a critical role for tumor cells to escape immune surveillance. HBM1020 can enhance anti-tumor immunity by blocking the novel immune checkpoint target. Preclinical data demonstrated its immune activation and anti-tumor functional activities.

With its innovative biology mechanisms, HBM1020 presents a novel anti-tumor therapeutics complementary to PD-(L)1 therapeutics to patients, especially for PD-L1 negative/refractory patients.

On July 25, 2024 Bio-Thera Solutions Inc. (688177: SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that dosing has recently begun in an integrated Phase I / Phase III clinical study for BAT3306, a proposed biosimilar of Keytruda (pembrolizumab) (Press release, BioThera Solutions, JUL 25, 2024, View Source;phase-iii-clinical-trial-for-bat3306-a-proposed-biosimilar-of-keytruda-pembrolizumab-302206502.html [SID1234645094]). The clinical study is a randomized, double-blind, parallel group, active control study to compare the pharmacokinetics, efficacy and safety of BAT3306 to Keytruda in non-squamous non-small cell lung cancer (nsNSCLC) patients. The study is expected to enroll approximately 676 patients.

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"Keytruda is the most important innovative cancer therapy currently in use," said Shengfeng Li, CEO at Bio-Thera. "Bio-Thera is committed to expanding access to this important cancer therapy with the development of BAT3306."

Bio-Thera Solutions is developing a large pipeline of biosimilars that include BAT1806, a tocilizumab has been approved by FDA, EMA and NMPA, BAT1706, a bevacizumab has been approved by FDA and NMPA. BAT2206, a ustekinumab has been filed with FDA, EMA and NMPA. Bio-Thera Solutions is also pursuing biosimilar versions of golimumab, secukinumab, and mepolizumab.

On July 25, 2024 Nectin Therapeutics, Ltd., a biotechnology company developing novel immunotherapies and antibody drug conjugates (ADC) to address tumor resistance, reported a global, exclusive license agreement with Immunome Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies (Press release, Nectin Therapeutics, JUL 25, 2024, View Source [SID1234645093]). Under the terms of the license, Immunome received exclusive rights to a panel of antibodies targeting an undisclosed target.

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"This agreement allows Nectin to realize value while further pursuing and enabling the focus on our first-in-class anti-PVR program (NTX1088) through its ongoing clinical study in tumor types with high unmet need as well as advance our novel ADCs into clinical development. Immunome’s leadership team’s track record of developing and commercializing novel ADC therapies makes it an ideal partner to advance these promising assets," said Fabian Tenenbaum, Chief Executive Officer of Nectin Therapeutics.

"Immunome believes the next generation of transformative antibody drug conjugates will address novel targets by pairing high-quality antibodies with innovative linker-payload technology," said Clay Siegall, PhD, President and Chief Executive Officer of Immunome. "We appreciate the work Nectin has done on these antibodies and look forward to advancing them further."

Under the terms of the agreement, Nectin granted Immunome an exclusive, worldwide, all-fields license to monoclonal antibodies that are directed to a single undisclosed target. Immunome will be responsible for the research, development, manufacturing and commercialization of products incorporating these antibodies. Nectin will receive an upfront payment and will be eligible for milestones and royalties.

On July 25, 2024 Presage Biosciences, a biotechnology company that directly measures activity of oncology drugs within human tumors, reported the Phase 0 dosing of the first cancer patient with Pure Biologics’ PBA-0405, an antibody that targets ROR1 (Press release, Presage Biosciences, JUL 25, 2024, View Source [SID1234645092]). PBA-0405 has been engineered to induce tumor cell killing by cytotoxic immune cells. This exploratory study is designed to study the biological effects of PBA-0405 within the human tumor microenvironment.

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In January, Presage and Pure Biologics announced the U.S. Food and Drug Administration issued a Study May Proceed notification for Phase 0 testing of a pre-GMP first-in-human drug candidate with Presage’s Comparative In Vivo Oncology (CIVO) platform. CIVO enables microdosing directly in a human tumor that is planned for surgical removal. Extensive molecular profiling technologies determine drug effectiveness in the tumor microenvironment by analysis of the expression of thousands of genes.

"With the dosing of the first patient in our exploratory Phase 0 study, PBA-0405 is the first ROR1-targeting compound with a unique mode of action to enter studies in patients. We’re encouraged by the preclinical data we’ve seen so far and are eager to evaluate its pharmacodynamic activity in human studies", said Dr. John Weinberg, Chief Medical Officer of Pure Biologics. ROR1 is a tumor-associated antigen expressed on many solid tumors and B cell malignancies.

"We are very excited to partner with Pure Biologics to evaluate their pre-GMP oncology drug in a first-in-human Phase 0 CIVO study" said Dr. Patrick Gray, Presage CEO. "Testing of pre-GMP compounds in human tumors in situ simplifies and speeds up the drug development process. Our Phase 0 studies can determine tumor killing activity, synergism with approved or investigational drugs, and immuno-oncology activity."

About CIVO
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables multiplexed intratumoral microdosing and generation of detailed tumor profiling. The CIVO device can deliver up to eight different drugs or drug combinations simultaneously into trackable drug columns. Presage’s CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with immunohistochemistry, in situ hybridization, and molecular profiling technologies in both preclinical and Phase 0 trials to inform and de-risk oncology drug development.

On July 25, 2024 Sanofi reported strong performance with 10% sales growth; 2024 guidance upgraded (Press release, Sanofi, JUL 25, 2024, View Source [SID1234645091]).

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Q2 sales growth of 10.2% at CER and business EPS(1) of €1.73

Dupixent sales up 29.2% to €3,303 million; target of ~€13 billion in 2024 unchanged
Pharma launches up 80.4% to €689 million, led by ALTUVIIIO, Nexviazyme, Rezurock, and Sarclisa
Vaccines sales -4.8% due to COVID-19 sales in 2023
Opella (former Sanofi Consumer Healthcare) up 9.6%, driven by the Qunol acquisition
Research and Development expenses grew 5.5%
Selling, general and administrative expenses grew 4.9%, substantially less than sales growth
Business EPS(1) of €1.73, down 0.6% reported and up 4.0% at CER
IFRS EPS of €0.89, down 22.6% reported
Q2 pipeline progress

Three regulatory approvals; Dupixent COPD (EU, July), Kevzara pJIA (US), Altuvoct hemophilia A (EU)
Four regulatory submissions, including fitusiran in hemophilia A/B and Sarclisa in multiple myeloma
Increasing pipeline news flow over 2024-2025, including 12 phase 3 data readouts

Other key updates

Sanofi ranked world’s 7th most sustainable company by TIME Magazine
Opella (Consumer Healthcare) intended separation on track with previously communicated timelines*
2024 business EPS guidance upgraded

2024 business EPS(1) to be stable at CER(2), an upgrade from a low single-digit percentage decrease previously, underpinned by accelerated delivery of Sanofi’s pipeline-driven transformation. Applying the average July 2024 exchange rates, the currency impact on 2024 business EPS is c.-5.5% to -6.5%.

Paul Hudson, Chief Executive Officer, commented:

"We are continuing our strong performance in 2024 and delivered broad-based, double-digit sales growth in the second quarter. We also made important progress in our pipeline of new medicines, including approvals for Dupixent in COPD, Kevzara in pediatric arthritis and ALTUVIIIO (EU) in hemophilia A. With the EU approval in COPD, Dupixent is the first-ever biologic medicine approved in this debilitating disease impacting hundreds of thousands of patients globally. As we accelerate our focused mid- and late-stage pipeline, we started a number of new phase 2 and phase 3 studies that will benefit patients in the future. We are well on track, delivering on our strategic priorities for Sanofi to become a development-driven, tech-powered biopharma company committed to serving patients and accelerating growth. Underpinned by accelerated delivery of Sanofi’s transformation, we upgrade our earnings per share guidance for 2024."

Q2 2024 Change Change
at CER H1 2024 Change Change
at CER
IFRS net sales reported € 10,745 m +7.8% +10.2% € 21,209 m +5.1% +8.4%
IFRS net income reported € 1,113 m -22.4% — € 2,246 m -34.5% —
IFRS EPS reported € 0.89 -22.6% — € 1.80 -34.3% —
Free cash flow(3) € 854 m -46.4% — € 545 m -82.6% —
Business operating income € 2,813 m +3.2% +8.3 % € 5,656 m -6.7% +1.4%
Business net income(1) € 2,161 m -0.7% +4.0 % € 4,380 m -10.2% -2.3%
Business EPS(1) € 1.73 -0.6% +4.0% € 3.51 -10.0% -2.3%