On March 24, 2022 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 oncology and immunology, reported full year 2021 annual results (Press release, Harbour BioMed, MAR 24, 2022, View Source [SID1234610931]). During the reporting period, the Company’s product development continued to make outstanding breakthroughs, unleashing the power of innovative technology platforms and globalization advantages.

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"2021 was a year of strong momentum for Harbour BioMed. The company has been making significant progress with respect to our highly differentiated pipeline products and business operations," said Jingsong Wang, Founder, Chairman and Chief Executive Officer. "Our 10 clinical trials are ongoing while two of them, Batoclimab and Tanfanercept, are in pivotal phase III trials and are progressing towards BLA (Biologics License Application) submission. We’ve seen encouraging data of the global clinical trials of HBM4003 and solid progress of multiple assets through pre-clinical development. The value of our platforms has been further validated with more than 50 leading partners around world.

Moving forward in 2022, we will continue to explore more differentiated novel therapeutics on a global basis, leveraging in-house technology platforms and strong research and development capabilities. I believe that each of our innovative products empowered by our unique platforms has the potential to benefit the patients globally, accelerating our mission to lead a healthy life with breakthrough medicines globally."

Recent Highlights:

Continued advancement across broad pipeline of core assets —

10 clinical trials are ongoing.
2 products, Batoclimab (HBM9161 for patients with myasthenia gravis) and Tanfanercept (HBM9036 for patients with dry eye disease), are in pivotal phase III trials and are progressing towards BLA submission.
Global clinical trials of HBM4003 in both monotherapy and combination therapy are also rapidly advancing at full pace, with encouraging data and promising results to date.
Multiple assets are progressing through pre-clinical development —

6 innovative and differentiated products are nearing clinical stages of development.
HBM7008 was approved for phase I clinical trial in Australia and HBM9378 was approved for phase I clinical trial in China.
HBM1020, HBM1022, HBM1007, and HBM7020 are all advancing towards clinical applications.
Another 7 INDs are approved. This portfolio of innovative and differentiated products entering the clinical stage demonstrates the value of the Company’s technology platforms.
The Company is actively exploring new scientific discoveries in novel therapeutic areas to address unmet medical needs —

Leveraging in-house technology platforms, the Company is incubating NK cell therapy, bispecific NK cell engager and developing innovative antibody drug conjugate (ADC) products.
The Company’s scientific research team strives to scale new heights in science with its strong research and development capabilities —

In the period, 65 patents were filed.
The Company also participated in multiple academic conferences, presenting scientific achievements while highlighting its strong innovation capabilities.
Further advanced its global strategy through multiple collaborations —

Entered into a research collaboration agreement with the Dana-Farber Cancer Institute of the Affiliated Hospital of Harvard Medical School.
Reached a strategic collaboration on artificial intelligence with BioMap, integrating the Company’s AI technology advantages into the Harbour Mice platform.
Further expanded an academic collaboration with the Icahn School of Medicine at Mount Sinai.
Advanced the strategic collaboration with Hualan Bio, and several assets are expected to enter the clinical stage this year.
The value of the Company’s platforms is further validated with more than 50 leading partners around the world.
Driving antibody drug development through innovation

The Company remains committed to the discovery and development of differentiated antibody therapeutics focusing on oncology and immunology. Powered by Harbour BioMed’s unique technology platforms, it has developed a differentiated portfolio and innovation engine for sustained long-term expansion and growth of its self-developed pipeline.

Harbour BioMed is at the forefront of developing next generation immuno-oncology therapeutics, including innovative immune cell engager bispecific antibodies, unique Treg depletion mechanism, and novel immune escape pathway. Cancer treatment market unfolds vast opportunities, and the Company seeks to develop oncology therapeutics that address situations where 70%-80% of patients do not respond to or are resistant to PD1/PD-L1, in its pursuit of next-generation immuno-oncology therapeutics which tap the potential value of this $100 billion market.

With the R&D advantages of HBM’s unique and highly efficient antibody discovery platforms under one organizational umbrella, the Company developed a number of first-in-class clinical and preclinical products. Among them, the bispecific antibody HBM7008 (B7H4/4-1BB) and the monoclonal antibody HBM1020 (B7H7) which represents the next generation of immune checkpoint inhibitors with significant differentiated advantages. In addition, the monoclonal antibody HBM1022 targets the Treg cell protein CCR8. CCR8 is recognized globally as a challenging target but one which is garnering increased attention in immuno-oncology. The Company’s use of mRNA immunization technology combined with its proprietary antibody platforms allow for a suite of solutions of G protein-coupled receptor (GPCR) antibody discovery. These noted products were all developed by the Company and indicative of the encouraging progress HBM has made in overcoming the challenges faced across the competitive landscape. The Company looks forward to continuing this success with promising clinical results as these and other programs move forward in their development lifecycles.

The rapid advancement of HBM’s clinical pipeline has continued into 2022, with multiple milestones reported in the first quarter. In February, the fully human monoclonal antibody HBM9378 (or SKB378) generated from the Company’s H2L2 platform was approved for an investigational new drug ("IND") clinical trial application for the treatment of moderate to severe asthma; in the same month, HBM7008 (B7H4/4-1BB), the world’s first-in-class product from the HBICE bispecific antibody platform, was officially approved by the Independent Review Board (IRB) in Australia and could potentially provide improved efficacy with better safety as compared to traditional monoclonal antibody therapies. The Company expects 4-6 products to enter the clinical stage this year and to rapidly push forward innovative products with blockbuster potential, laying a solid foundation for building a global competitive advantage.

HBM’s cutting-edge fully human antibody platforms enable unique innovation and differentiation

HBM’s antibody discovery platforms are the engine of its portfolio innovation: HBICE – a fully human bispecific antibody platform for immune cell engagers, a fully human heavy-chain-only antibody HCAb platform for monoclonal antibodies, and a fully human heavy and light chain antibody H2L2 platform with global patent protection. These robust technology platforms drive the Company to continuously advance antibody drug development while move towards more novel and challenging targets to address unmet medical needs, providing the momentum for sustained therapeutics innovation worldwide.

It is worth noting that, in the field of bispecific antibodies development, the Company’s fully human HBICE bispecific platform for immune cell engagers, the highly differentiated bispecific antibody technology platform globally, is built upon the fully human HCAb based formats for immune cell engagers, which is also a patented achievement independently developed by the Company. The HBICE platform focuses on immune cell engagers, which can flexibly generate multiple molecular structures adapting to different biological mechanisms of action and effectively solving the problem of heavy and light chain mismatch in antibody engineering. The technology platform connects tumor cells with immune cells, activates immune cells, and kills tumor cells specifically, which can improve the effectiveness of treatment and reduce the risk of cytokine storm, avoiding the toxicity risk of systemic activation. Thus, safety is significantly improved, which is conducive to creating more innovative, differentiated, and safe products.

HBM is actively strengthening globalization presence to empowering its long-term development goals

As innovation and development across the biopharmaceutical industry continues to become more global, the Company is thriving on its three global innovation research centers and four major clinical sites, which reflects the Company’s global ambition and continued investment into its R&D capabilities. By integrating R&D centers established in the US, the Netherlands and China, the Company is capable to consolidate leading global scientific and technological innovation resources. By maximizing regional innovation success, resource utilization is improved and translational clinical research results are advanced, accelerating bringing about differentiated innovative therapeutics, facilitating cooperation within the industry for the benefit of patients. At the same time, following the strategy of international research and development, HBM set up with four clinical sites in China, the US, Australia, and Europe to speed up the global development of its self-developed products.

Importantly, innovative solutions shape the global biopharmaceutical industry. The Company is jointly developing the next generation of innovative therapeutics through its proprietary technology platforms and global innovation network; an approach that has been validated by over 50 industry and academia partners with more than 10 products having entered the clinical stage. External collaborations include those with Eli Lilly, AbbVie, Pfizer, BeiGene, Innovent, Dana-Farber Hospital of Harvard Medical School, and Icahn School of Medicine of Mount Sinai Medical System in New York. Our global footprint enables the value proposition the Company’s antibody technology platforms, which can be continuously tapped into and increasing the commercial income generating potential of its R&D capabilities.

In addition, the Company previously announced that it will initiate exploration of NK cell and ADC therapeutics. The Company hopes to leverage its novel technology across these frontier therapeutic areas, expand the application of its technology platforms, and lead next drug development programs to address areas of significant unmet clinical needs.

Accelerating clinical development to unlock potential value

As of now, the Company has independently developed more than ten highly differentiated products, two of which are in pivotal clinical phase III trials and are moving towards Biologics License Application (BLA) submission – namely Batoclimab (HBM9161), which has obtained the national Breakthrough Therapeutics Designation for myasthenia gravis, and Tanfanercept (HBM9036), the first globally innovative biological drug for dry eye disease in China.

Specifically, Batoclimab is a next generation fully human monoclonal antibody that selectively binds to and inhibits the neonatal crystal fragment receptor (FcRn) and has the potential for breakthrough treatment of various autoimmune diseases. Tanfanercept is the most advanced product candidate currently being developed by the Company for the treatment of moderate-to-severe dry eye disease, which has a bright market potential in the emerging dry eye drug market in China. These two products are highly differentiated and have large potential market opportunities.

As people begin to emerge from the global pandemic, good health is even more in focus now. In the increasingly competitive biopharmaceutical market, innovation is no doubt the core commodity. Harbour BioMed has built a broad moat with its innovation engine and differentiated pipeline, leveraging its unique and robust antibody technology platforms, regional global innovation ecosystem, and accelerated clinical operations of its core products.

On March 24, 2022 Novocure (NASDAQ: NVCR) reported that Dr. David Tran, Chief of the Division of Neuro-Oncology at the McKnight Brain Institute at the University of Florida, will present updated results from his investigator-initiated phase 2 pilot 2-THE-TOP clinical trial testing the safety and preliminary efficacy of Tumor Treating Fields (TTFields) together with pembrolizumab and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma (GBM) (Press release, NovoCure, MAR 24, 2022, View Source [SID1234610929]).

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These preliminary results, which are based on a median follow-up time of 16.8 months, compare outcomes for 26 patients in the ongoing 2-THE-TOP trial versus a historical, matched-control group of 26 patients from the TTFields plus temozolomide arm of the phase 3 pivotal EF-14 clinical trial. For patients in the 2-THE-TOP trial, median progression-free survival was 12.1 months, compared with 7.9 months for the matched-control patients in EF-14 (hazard ratio=0.46, p=0.033). Patients in 2-THE-TOP had a median overall survival of 25.2 months, compared with 15.9 months for the matched-control patients in EF-14 (hazard ratio=0.38, p=0.020).

Of the 15 patients in 2-THE-TOP with measurable target lesions, six (40%) achieved partial to complete response and eight (53%) had stable disease.

"These data from 2-THE-TOP are exciting and point to the potential benefit of Tumor Treating Fields together with pembrolizumab and temozolomide," said Uri Weinberg, Novocure’s Chief Science Officer. "TTFields’ ability to activate a downstream immune response, effectively turning a cold tumor hot, is a unique element of TTFields therapy."

Dr. Tran will present his data from 2-THE-TOP at the 6th Quadrennial Meeting of the World Federation of Neuro-oncology Societies (WFNOS 2022) in Seoul, South Korea on March 26, 2022. His oral presentation, which has been selected for a Best Abstract Award, will be delivered during the conference’s Top 10 Session 2 at 10:15 a.m. KST, followed by a live question-and-answer session.

In a preclinical study published in the Journal of Clinical Investigation (JCI) on Feb. 24, 2022, Dr. Tran’s research group reported that TTFields-mediated cell disruption activates the immune system, triggering an anti-tumor cell response that may be effectively used together with existing immunotherapy approaches in the treatment of solid tumors with limited systemic toxicity. These preclinical findings provided the mechanistic rationale for the 2-THE-TOP study.

"We are very encouraged by the data from Dr. Tran’s 2-THE-TOP study, and by the mechanistic insights published by his research group in JCI," said William Doyle, Novocure’s Executive Chairman. "We plan to continue exploring the potential of using Tumor Treating Fields with immunotherapies, which could shift the treatment paradigm for patients with this aggressive disease."

Dr. Tran’s oral presentation at WFNOS 2022 is one of three oral presentations at the conference highlighting research on TTFields.

Dr. Carsten Hagemann of the Department of Neurosurgery at University Hospital Würzburg will present preclinical data on TTFields as a novel chemotherapeutic delivery strategy on March 25, 2022 at 17:30 KST.

Dr. Wenyin Shi, Co-Director of the Brain Tumor Center of the Sidney Kimmel Cancer Center, will present data from the SPARE trial: Scalp sparing radiation with concurrent temozolomide and TT Fields (200 kHz) for patients with newly diagnosed glioblastoma on March 26, 2022 at 18:00 KST.

In addition, 28 posters at WFNOS 2022 will feature research on TTFields.

TTFields is investigational for the treatment of newly diagnosed GBM when used together with pembrolizumab.

About 2-THE-TOP

The 2-THE-TOP trial is an investigator-initiated, phase 2 pilot trial designed to assess the safety and preliminary efficacy of Tumor Treating Fields (TTFields) together with pembrolizumab and temozolomide for the treatment of adult patients with newly diagnosed GBM. Patients enrolled in the trial underwent maximal tumor resection followed by standard chemoradiation. Following the completion of chemoradiation, patients began a course of monthly cycles of adjuvant temozolomide. Treatment with TTFields started at approximately the same time as the first cycle of adjuvant temozolomide. Pembrolizumab was introduced in the second cycle of treatment and subsequent cycles of pembrolizumab were administered every three weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.

About EF-14

The EF-14 trial was a randomized, phase 3 pivotal trial which compared, post radiation, TTFields plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM. Median progression-free survival, the primary endpoint, was 6.7 months for TTFields plus temozolomide versus 4 months for temozolomide alone. Median overall survival was 20.9 months for TTFields plus temozolomide versus 16 months for temozolomide alone.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 22,000 patients have been treated with TTFields therapy.

On March 24, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that Brian M. Culley, the Company’s Chief Executive Officer, will be presenting at the 2022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest (Press release, Lineage Cell Therapeutics, MAR 24, 2022, View Source [SID1234610928]). Mr. Culley will be participating in an "Ophthalmology Panel" hosted by Jason McCarthy, Ph.D., Senior Managing Director, Biotechnology, on March 28th, 2022 at 10am ET / 7am PT . Mr. Culley will also provide a corporate overview which will be available to investors on demand, starting on Monday March 28th, 2022.

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The live panel and on-demand presentation will be available to registered users directly through the M-Vest platform: https://m-vest.com/events/2022-virtual-growth-conference. Registration is required for conference participation. An archived webcast of the corporate presentation will also be available on the Events and Presentations page of the Lineage website. Additional videos are available on the Media page of the Lineage website.

On March 24, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that investigators at the Louis Stokes Cleveland Department of Veterans Affairs Medical Center ("Cleveland VA") have enrolled their first patient in a Department of Defense ("DoD") funded study of its EsoGuard Esophageal DNA Test ("EsoGuard") in at-risk patients with gastroesophageal reflux disease ("GERD") (Press release, Lucid Diagnostics, MAR 24, 2022, View Source [SID1234610927]). Cleveland VA gastroenterologist Katarina B. Greer, M.D., Associate Professor of Medicine at Case Western Reserve University School of Medicine, is serving as the study’s principal investigator. Lucid is providing EsoCheck Esophageal Cell Collection Devices ("EsoCheck") for the study and will perform EsoGuard testing on the samples collected.

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"Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for Barrett’s Esophagus (BE), a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer"

"We are proud to be partnering with Dr. Greer and the Cleveland VA on this important investigator-initiated clinical study," said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. "The study will add important clinical evidence on the impact of EsoGuard in enhancing early detection of esophageal precancer to prevent esophageal cancer deaths by reserving endoscopy for those with a positive EsoGuard test."

"Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for Barrett’s Esophagus (BE), a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer," said Dr. Greer. "We hope to demonstrate that a strategy which incorporates initial office-based non-endoscopic testing of at-risk patients with EsoGuard improve the yield of endoscopy and overall cost-effectiveness."

Traditional, invasive upper gastrointestinal endoscopy (EGD) is performed in less than 10% of at-risk GERD patients recommended for esophageal precancer (BE) screening. Of those who do undergo EGD screening, over 80% have a negative result, exposing the vast majority of these patients to a complex, invasive, costly, and inconvenient procedure requiring anesthesia at a specialized procedure center or hospital. EsoGuard performed on samples collected with EsoCheck, has been shown to be 90% sensitive and specific at detecting esophageal precancer and cancer with the potential to eliminate the majority of these negative EGDs delivering benefits to patients, providers, and the healthcare system.

The study will enroll up to 100 Cleveland VA patients who fulfil the American College of Gastroenterology criteria for esophageal precancer screening. The study compares two screening strategies: (1) EGD screening, the current standard of care; and (2) EsoGuard testing followed by EGD only in those with a positive EsoGuard result. The study will report whether using EsoGuard to triage patients to EGD will increase the overall BE screening rate and decrease the percentage of negative screening EGDs. The study will also estimate cost implications within the VA system between these two strategies.

About EsoGuard and EsoCheck
Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard and EsoCheck are the missing element and constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.

On March 24, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported that it will announce fourth quarter and full year 2021 financial results and provide a business update on Tuesday, March 29, 2022 (Press release, Scynexis, MAR 24, 2022, View Source [SID1234610926]). The company will host a conference call and webcast at 8:30 a.m. Eastern Daylight Time on the same day.

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A recording of the webcast will be posted on the Company’s website, www.scynexis.com, following the event