On April 3, 2023 Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immune-oncology and immunology, reported annual results of full year 2022 (Press release, Harbour BioMed, APR 3, 2023, View Source [SID1234629774]).

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!

"2022 has been our second financial year since listing on the Main Board of the Stock Exchange of Hong Kong in December 2020. With greater opportunities, the Company integrated enriched resources and significant additional efforts to drive the advancement of our portfolio and expand our collaboration worldwide, leveraging our unique global proprietary technology platforms and sustained discovery engine." said Jingsong Wang, Founder, Chairman and Chief Executive Officer.

"2022 was a year of high efficiency on portfolio development for HBM. The Phase III clinical study of batoclimab, through the joint efforts of the sponsor, investigators and patients, overcame all difficulties during the pandemic and completed enrollment of 132 subjects in 10 months, with the positive outcome achieved. This is the first successful pivotal Phase III study of myasthenia gravis clinical trials in China."

"2022 was a year of expansion in collaboration network for HBM. With innovative and agile business model as well as robust portfolio and proprietary technology , we have successfully partnered with top pharmaceutical companies such as AstraZeneca and CSPC Pharmaceutical Group for pipeline products in Harbour Therapeutics, and cooperated with innovative industry leaders such as Moderna and Dragonfly Therapeutics for cutting edge technology innovation with transformational business model of Nona sciences. Based on the continuous collaborations on Immune Cell Engagers globally, the Company has established itself as the leader in HBICE based bispecific antibody innovations. Leveraging on the cash income brought by varieties of global collaborations, the Company’s revenue increased by 846.5% year on year, and our capability to monetize technology and innovation has been strongly validated."

"2022 was a year of breakthrough in technology innovation for HBM. We have established a wholly-owned subsidiary, Nona Biosciences. It is the technology platform arm for HBM, and it’s mission is to focus on cutting-edge technology innovations and providing discovery solutions from ‘Idea to IND’ to partners around the world. The key value drivers for the company are industry leading technology platforms including Harbour Mice, HBICE and Antibody Plus in various therapies, with deep expertise and rich experience. Since its inception, Nona Biosciences has been endorsed by renowned partners, demonstrated its innovation engine power in next generation therapeutics. ."

"Moving forward, we will build upon these significant achievements and continue our mission to be the global leader in driving innovation in the next generation of antibody therapeutics, benefiting the patients around the world." Dr. Wang concluded.

Continued advancement of robust portfolio and differentiated pipeline

The Company is committed to discovering and developing innovative antibody therapeutics for oncology and immunology diseases and has a differentiated product pipeline that includes more than ten drug candidates, six of which are in clinical stages.

In 2022, the Company moved forward the global clinical development program of porustobart (HBM4003) in multiple indications. Porustobart, the next-generation anti-CTLA-4 antibody, is the first fully human heavy chain only antibody in the world that has entered into clinical development. This flagship program has advanced rapidly from candidate selection to Phase II with unprecedented clinical data released in 2022. The results showed an excellent safety profile with a strong positive signal on efficacy, with the potential to become the best-in-class treatment option for melanoma patients in China. In parallel, further clinical data of this combination therapy with PD-1 for patients with Neuroendocrine Neoplasms (NEN) will be released in 2023, which also show best-in-class potential for patients with high grade NEN. With more data collected and strong efficacy demonstrated in clinical trials, we are enabling the pivotal trial of porustobart.

Another flagship program is the exciting development for HBM7008, a novel product targeting B7H4 and 4-1BB,and generated from our immune cell engager platform HBICE. HBM7008 is also the only bispecific antibody against these two targets globally. This product entered into Phase I trials in the U.S. and Australia in 2022 with great potential on solid tumors. To maintain the leading position in the development of this first-in-class asset, the Company has entered into a co-development collaboration with Cullinan Oncology, to accelerate its development in the U.S., Europe and Australia.

The Company co-developed HBM9378 with Kelun-Biotech and drove this program into clinical stage in 2022. HBM9378 is a fully human monoclonal antibody against TSLP (thymic stromal lymphopoietin) generated from H2L2 platform. The long half-life optimization and outstanding biophysical properties solidify its favorable dosing and formulation advantages.

In the first quarter of 2023, HBM1020 (B7H7), HBM1022 (CCR8) and HBM1007 (CD73) obtained the IND clearance from the U.S. FDA to initiate clinical study. HBM1020 is a first-in-class fully human monoclonal antibody targeting B7H7 (HHLA2) generated from Harbour Mice platform and also the only product in IND stage globally. B7H7 is widely expressed in solid tumors and has low overlapping with PD-L1, especially stronger expression than PD-L1 in NSCLS. With excellent molecular design and target features, HBM1020 demonstrates the potential to address broad unmet medical needs on solid tumors.

In addition, HBM7022 (CLDN18.2xCD3), HBM7004 (B7H4x4-1BB), HBM9027 (PD-L1xCD40), HBM9033 (MSLN ADC), HBM1047 (CD200R1) and HBM9014 (LIFR) are all preclinical stage products in the company’s pipeline. With the efficient output of the technology platforms as well as the rich expertise of our R&D team, the Company aims to file at least one IND each year moving forward.

Platform-driven business model to maximize value creation

Out-licensing and co-development, as important business models of HBM, ascended great achievements. In 2022, the Company granted the global out-licensed of HBM7022 to AstraZaneca, and achieved a co-development partnership on HBM7008 with Cullinan Oncology. In addition, HBM9378 developed in collaboration with Kelun-Biotech, has entered the clinical stage. These achievements validate our platform value through multiple milestones on business development and will accelerate the development of our portfolio.

To maximize the value creation of our platform and enhance our influence in the industry through technology collaborations, the Company established Nona Biosciences to better empower the innovators and enable its collaborators from idea to IND (I to ITM). At the end of 2022, Nona Biosciences achieved significant success in its launch as it has landed numerous major deals, such as the collaboration with Moderna, a global biotechnology company well recognized for its capabilities in mRNA technology, and with Dragonfly Therapeutics, a cutting-edge developer on multiple therapies in relation to NK cells. As an original discovery engine, our platform allows Nona Bioscience to be a reliable partner for collaborations for diverse R&D needs in various therapeutic areas and modalities. Nona Biosciences is on a new path to expand the Company’s collaboration network and bring strong value growth in the future.

To give full play to the value of the unique platform technologies, the Company continues to explore the application of its platform in broader application scenarios with deep biology expertise, incubating several joint ventures focusing on next-generation innovation. HBM Alpha Therapeutics (HBMAT), an innovative biotechnology company incubated together with Boston Children’s Hospital, completed seed financing to advance its novel antibody therapies to treat congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS). Another incubation program, Shanghai NK Cell Technology Limited, completed its A round financing and raised a fund over RMB100 million to deepen its efforts in cutting-edge NK cell therapeutics.

Looking ahead to 2023, HBM will continue to focus on global innovation and cooperation, taking its core technology platform as the innovation fulcrum, accelerating the clinical development of the innovative pipeline products focusing on immune-oncology therapeutics, and actively embracing the first commercialization of our portfolio. Furthermore, through expansive business collaborations, we will accelerate the advancement of our portfolio and enable our partners to generate more cutting-edge target molecules through collaborations with Nona Biosciences. HBM aims to lead next-gen biotherapeutics innovation on a global basis, leveraging in-house unique technology platforms and strong research and development capabilities, and accelerate our mission to lead a healthy life with breakthrough medicines globally.

On April 3, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in upcoming investor relations event(s) (Press release, Ideaya Biosciences, APR 3, 2023, View Source [SID1234629773]).

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!

Cantor’s The Future of Oncology Virtual Symposium
Tuesday, April 4th, 2023 at 2:15 PM ET

Fireside chat with Yujiro Hata, Chief Executive Officer, hosted by Li Watsek, Vice President and Equity Research Analyst
A live audio webcast of conference events, as permitted by conference host, will be available at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source and/or through the conference host. A replay of available webcasts will be accessible for 30 days following the live event.

On April 3, 2023 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the availability of an additional tablet strength of ERLEADA (apalutamide) in the United States (Press release, Johnson & Johnson, APR 3, 2023, View Source [SID1234629771]). The introduction of the 240mg tablet provides the first-and-only option for a once-daily, single-tablet Androgen Receptor Inhibitor (ARI) approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

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!

With two strengths available, healthcare providers will have the flexibility to prescribe the approved 240mg once-daily dose of ERLEADA in either one 240mg tablet or four 60mg tablets. The single-tablet option may be preferable for patients in need of reducing their total number of daily pills.

ERLEADA remains the only ARI with labeling to include approved alternate methods of administration for patients who have difficulty swallowing tablets whole. The 60mg tablets continue to have an approved option for dispersing with applesauce, while the 240mg tablet is approved for dispersing in orange juice, water or applesauce. The 240mg tablet may also be administered through a feeding tube.

"Each person and their cancer are unique and, as such, there is no one-size-fits-all approach to treatment," said Luca Dezzani, M.D., Vice President, Medical Affairs, Solid Tumor, Janssen Scientific Affairs, LLC. "The availability of 240mg and 60mg strength options of ERLEADA demonstrates Janssen’s commitment to prostate cancer patients and provides prescribers flexibility in dosing and methods of administration to fit each patient’s unique needs."

Both tablet strengths are available via prescription through existing specialty pharmacy networks.

About ERLEADA

ERLEADA (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). ERLEADA received U.S. Food and Administration (FDA) approval for nmCRPC in February 2018, and received U.S. FDA approval for mCSPC in September 2019. To date, more than 100,000 patients worldwide have been treated with ERLEADA.

For more information, visit www.ERLEADA.com.

ERLEADA IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Cerebrovascular and Ischemic Cardiovascular Events — In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 3.7% of patients treated with ERLEADA and 2% of patients treated with placebo. In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4.4% of patients treated with ERLEADA and 1.5% of patients treated with placebo. Across the SPARTAN and TITAN studies, 4 patients (0.3%) treated with ERLEADA and 2 patients (0.2%) treated with placebo died from an ischemic cardiovascular event. Patients with history of unstable angina, myocardial infarction, congestive heart failure, stroke, or transient ischemic attack within 6 months of randomization were excluded from the SPARTAN and TITAN studies.

In the SPARTAN study, cerebrovascular events occurred in 2.5% of patients treated with ERLEADA and 1% of patients treated with placebo. In the TITAN study, cerebrovascular events occurred in 1.9% of patients treated with ERLEADA and 2.1% of patients treated with placebo. Across the SPARTAN and TITAN studies, 3 patients (0.2%) treated with ERLEADA, and 2 patients (0.2%) treated with placebo died from a cerebrovascular event.

Cerebrovascular and ischemic cardiovascular events, including events leading to death, occurred in patients receiving ERLEADA. Monitor for signs and symptoms of ischemic heart disease and cerebrovascular disorders. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Consider discontinuation of ERLEADA for Grade 3 and 4 events.

Fractures — In a randomized study (SPARTAN) of patients with nmCRPC, fractures occurred in 12% of patients treated with ERLEADA and in 7% of patients treated with placebo. In a randomized study (TITAN) of patients with mCSPC, fractures occurred in 9% of patients treated with ERLEADA and in 6% of patients treated with placebo. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.

Falls — In a randomized study (SPARTAN), falls occurred in 16% of patients treated with ERLEADA compared with 9% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. Falls occurred in patients receiving ERLEADA with increased frequency in the elderly. Evaluate patients for fall risk.

Seizure — In two randomized studies (SPARTAN and TITAN), 5 patients (0.4%) treated with ERLEADA and 1 patient treated with placebo (0.1%) experienced a seizure. Permanently discontinue ERLEADA in patients who develop a seizure during treatment. It is unknown whether anti-epileptic medications will prevent seizures with ERLEADA. Advise patients of the risk of developing a seizure while receiving ERLEADA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others.

Severe Cutaneous Adverse Reactions — Fatal and life-threatening cases of severe cutaneous adverse reactions (SCARs), including Stevens Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) occurred in patients receiving ERLEADA.

Monitor patients for the development of SCARs. Advise patients of the signs and symptoms of SCARs (e.g., a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy). If a SCAR is suspected, interrupt ERLEADA until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, or for other Grade 4 skin reactions, permanently discontinue ERLEADA [see Dosage and Administration (2.2)].

Embryo-Fetal Toxicity — The safety and efficacy of ERLEADA have not been established in females. Based on findings from animals and its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA [see Use in Specific Populations (8.1, 8.3)].

ADVERSE REACTIONS

The most common adverse reactions (≥10%) that occurred more frequently in the ERLEADA-treated patients (≥2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.

Laboratory Abnormalities — All Grades (Grade 3-4)

Hematology — In the TITAN study: white blood cell decreased ERLEADA 27% (0.4%), placebo 19% (0.6%). In the SPARTAN study: anemia ERLEADA 70% (0.4%), placebo 64% (0.5%); leukopenia ERLEADA 47% (0.3%), placebo 29% (0%); lymphopenia ERLEADA 41% (1.8%), placebo 21% (1.6%).

Chemistry — In the TITAN study: hypertriglyceridemia ERLEADA 17% (2.5%), placebo 12% (2.3%). In the SPARTAN study: hypercholesterolemia ERLEADA 76% (0.1%), placebo 46% (0%); hyperglycemia ERLEADA 70% (2%), placebo 59% (1.0%); hypertriglyceridemia ERLEADA 67% (1.6%), placebo 49% (0.8%); hyperkalemia ERLEADA 32% (1.9%), placebo 22% (0.5%).

Rash — In 2 randomized studies (SPARTAN and TITAN), rash was most commonly described as macular or maculopapular. Adverse reactions of rash were 26% with ERLEADA vs 8% with placebo. Grade 3 rashes (defined as covering >30% body surface area [BSA]) were reported with ERLEADA treatment (6%) vs placebo (0.5%).

The onset of rash occurred at a median of 83 days. Rash resolved in 78% of patients within a median of 78 days from onset of rash. Rash was commonly managed with oral antihistamines, topical corticosteroids, and 19% of patients received systemic corticosteroids. Dose reduction or dose interruption occurred in 14% and 28% of patients, respectively. Of the patients who had dose interruption, 59% experienced recurrence of rash upon reintroduction of ERLEADA.

Hypothyroidism — In 2 randomized studies (SPARTAN and TITAN), hypothyroidism was reported for 8% of patients treated with ERLEADA and 1.5% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. Elevated TSH occurred in 25% of patients treated with ERLEADA and 7% of patients treated with placebo. The median onset was at the first scheduled assessment. There were no Grade 3 or 4 adverse reactions. Thyroid replacement therapy, when clinically indicated, should be initiated or dose adjusted.

DRUG INTERACTIONS

Effect of Other Drugs on ERLEADA — Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties. No initial dose adjustment is necessary; however, reduce the ERLEADA dose based on tolerability [see Dosage and Administration (2.2)].

Effect of ERLEADA on Other Drugs

CYP3A4, CYP2C9, CYP2C19, and UGT Substrates — ERLEADA is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9 in humans. Concomitant use of ERLEADA with medications that are primarily metabolized by CYP3A4, CYP2C19, or CYP2C9 can result in lower exposure to these medications. Substitution for these medications is recommended when possible or evaluate for loss of activity if medication is continued. Concomitant administration of ERLEADA with medications that are substrates of UDP-glucuronosyl transferase (UGT) can result in decreased exposure. Use caution if substrates of UGT must be co-administered with ERLEADA and evaluate for loss of activity.

P-gp, BCRP, or OATP1B1 Substrates — Apalutamide is a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically. Concomitant use of ERLEADA with medications that are substrates of P-gp, BCRP, or OATP1B1 can result in lower exposure of these medications. Use caution if substrates of P-gp, BCRP, or OATP1B1 must be co-administered with ERLEADA and evaluate for loss of activity if medication is continued.

On April 3, 2023 Leica Biosystems reported the US Food and Drug Administration (FDA) 510(k) clearance of the BOND MMR Antibody Panel, providing customers with a high-performing IHC Mismatch Repair (MMR) option when screening colorectal cancer patients for the identification of probable Lynch syndrome (Press release, Leica Biosystems, APR 3, 2023, View Source [SID1234629770]).

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!

"Pathologists can utilize the Leica Biosystems BOND MMR Antibody Panel on the BOND-III for clear, accurate assessment of mismatch repair protein status in only 2.5 hours," said Dr. Robert Monroe, Chief Medical Officer at Leica Biosystems. "With this panel, clinicians can feel increased confidence in their MMR results."

Colorectal cancer (CRC) is the third most diagnosed cancer worldwide. Approximately 3-5% of all cases are thought to be due to Lynch syndrome, a rare inherited cancer susceptibility syndrome that increases the likelihood of developing colorectal cancer.[1]

Current cancer treatment guidelines support the importance of screening for MMR status with all newly diagnosed CRCs as a preliminary screening method for Lynch syndrome. IHC is one of the suggested methods of testing, used increasingly in clinical practice.

"Leica Biosystems is proud to help our customers continue the fight against cancer through the fast, accurate results of the BOND MMR Antibody Panel, which provides the clinicians an important piece of the diagnostic puzzle in aiding the detection of Lynch syndrome," said Gustavo Perez-Fernandez, President of Leica Biosystems. "Our test enables targeted treatment for patients, supporting our mission of Advancing Cancer Diagnostics, Improving Lives."

Leica Biosystems has more than 20 years of experience developing and manufacturing IHC stains at its Newcastle, UK facility. With the 2006 acquisition of Novocastra, the company expanded its menu of antibodies and continues to innovate to offer laboratories clinically relevant antibodies for the most demanding workload. The BOND MMR Antibody Panel with 510(k) clearance is the company’s latest offering.

On April 3, 2023 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it earned a $30 million milestone payment from GSK (LSE/NYSE: GSK) following the start of GSK’s Phase 2b trial of GSK4532990, formerly called ARO-HSD, an investigational RNA interference (RNAi) therapeutic for the treatment of patients with non-alcoholic steatohepatitis (NASH) (Press release, Arrowhead Pharmaceuticals, APR 3, 2023, View Source [SID1234629769]).

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!

GSK4532990 is being developed under the November 2021 exclusive license agreement between Arrowhead and GSK. GSK received an exclusive license to develop and commercialize GSK4532990 in all territories except Greater China, which was retained by Arrowhead. GSK is wholly responsible for further clinical development and commercialization, outside of Greater China.

GSK4532990 targets HSD17B13, a member of the hydroxysteroid dehydrogenase family involved in the metabolism of hormones, fatty acids, and bile acids. Published human genetic data indicate that a loss of function mutation in HSD17B13 provides strong protection against alcoholic hepatitis, cirrhosis, and NASH, with approximately 30-50% risk reduction compared to non-carriers.1

The double-blind, placebo-controlled Phase 2b HORIZON trial (NCT05583344) will evaluate the efficacy and safety of GSK4532990 in adults with pre-cirrhotic NASH. It will enroll up to 246 participants.