Taipei, Taiwan, 13th September 2023 / Sciad Newswire / BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885), a clinical-stage biotechnology company focusing on developing regenerative peptides for ophthalmology and degenerative joint diseases, announced today that 22,500 shares have been issued at a premium of NT$65 (~US$2.03), raising a total of NT$1.4625 billion (~US$45.8 million). The rights issue was fully paid on 31st August 2023, four days early compared to the scheduled date of 4th September. 

The fund will be used to accelerate the development of several assets within BRIM’s pipeline, including the ongoing phase 3 trial of lead asset BRM421 for dry eye disease (DED) in the US and the enrollment of the phase 2 trial of BRM424 for neurotrophic keratitis (NK). BRIM will also progress the development of BRM521 for osteoarthritis, as well as assessing other applications of its innovative Pigment Epithelium-Derived Factor (PEDF) derived Short Peptide (PDSP) platform.  

Under the leadership of Mr. Andrew Lin, the Chairman of BRIM, who is also the Chairman of TaiRx Inc. and Nuwa Healthcare and the managing partner of Affinity Capital, BRIM completed the NT$1.4625 billion fundraising four days earlier than expected, thanks to the trust and support of both existing and new shareholders.  

Mr. Lin commented, “I would like to express special thanks to both our original shareholders and new investors for their belief in BRIM. The early completion of this rights issue is a great endorsement from our investors that they are confident in BRIM’s future. It also indicates that BRIM’s operation and current development are recognized by the market to have great potential.” 

As well as closing early, the rights issue was over-subscribed, with the demand exceeding NT$3 billion, more than twice the planned fundraising target. Because the share subscription by original shareholders and employees in this round exceeded 70%, Mr. Lin apologized to disappointed investors for the limited availability.  

After this round, BRIM’s largest shareholder is Affinity Health Fund One, L.P. with 10.37% of shares. Affinity Health Fund Two, L.P. also acquired positions with 2.66% of shares. Both funds are managed by Affinity Capital, Inc. which controls 13.03% of the company’s shares. 

BRIM’s regenerative peptides, developed from its proprietary PDSP platform, have neurotrophic effects and can activate stem cells. This unique mechanism of action promotes the proliferation and differentiation of the limbal stem cells around the damaged cornea to repair corneal wounds. The PDSP platform can be applied across multiple therapy areas and indications, including the stimulation of mesenchymal stem cells (MSCs) to regenerate cartilage and help treat osteoarthritis.  

BRIM’s Chief Executive Officer, Dr. Wen Chyi Shyu, commented, “We are on track to achieve our product development milestones for the year. This additional funding will help to speed up the development of our current clinical trials and enable us to expand and diversify our pipeline. We are cautiously optimistic that, subject to the outcomes of the phase 3 trial, BRM421 could become the first-line and first-in-class treatment for DED and help to improve the daily lives of people impacted by this debilitating eye disease in the near future.”

ENDS

For further information, please contact:

BRIM Biotechnology, Inc.  
Yi-Chun Maria Chen, PhD 
E: BD@brimbiotech.com  
T: 886 2 2659 8586 

Sciad Communications, Media Relations 
Maria Patey / Sophie Protheroe
E: BrimBiotech@sciad.com
T: +44 (0)20 3405 7892 

Notes for Editors


About BRIM Biotechnology, Inc. 
 

BRIM Biotechnology, Inc. was established in July 2013 to accelerate the development and transformation of early research technology platforms to clinical drug candidates. BRIM applies efficient translational science to develop new treatments that help combat and cure disease. The company’s virtual business model combined with its proprietary PDSP technology platform bridges the gap between research and clinical development faster, de-risks the process, and accelerates the progression of early-stage candidates in indications with high unmet medical needs. BRIM has three lead products in the pipeline: BRM421, BRM424, and BRM521, all of which are developed from its PDSP technology platform. Lead asset BRM421 for Dry Eye Disease initiated Phase 3 clinical trials in 2022 and is expected to produce topline results at the end of 2023. BRM424 for neurotrophic keratitis will also enter a Phase 2 trial in the US this year. For more information, please visit www.brimbiotech.com.  

Further information about Dry Eye Disease 

DED is a complicated disease with multiple causes. According to Global Data, the global DED market was worth approximately USD 3.9 billion in 2018. This is predicted to reach over USD 11 billion in 2028 with a CAGR of 10.6% [1]. Due to the widespread use of electronic screens, prolonged wearing of contact lenses, and the increasing frequency of myopia laser surgery, the global dry eye population has risen rapidly in recent years, especially amongst younger age groups. In addition, research suggests that COVID-19 patients have a higher risk of developing DED [2]

References 

  1. https://www.globaldata.com/store/report/dry-eye-syndrome-global-drug-forecast-and-market-analysis-to-2028/ 
  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841281/ 

Taiwan is looking to emulate Switzerland and become a prominent player in life sciences despite its relatively small size.

In an interview at BIO International Convention 2023 in Boston, Yi-Chun Maria Chen, Vice President of Business Development at BRIM Biotechnology, told APM Health Europe about the shared growth ambitions of both BRIM and Taiwan, saying there are aspirations for biotech to be a “second industry” after semi-conductors, where Taiwan is a leader.

Read the full interview here.

Taipei, Taiwan, 9th May, 2023, BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885), a clinical-stage biotechnology company focusing on developing regenerative peptides for ophthalmology and degenerative joint diseases, announced today that the Board of Directors has approved a seasoned equity offering that will issue 20 to 22.5 million shares of new stocks priced at 60-80 New Taiwan Dollars (~USD 2-2.67) per share. A total of NTD 1.2 to 1.8 billion (~USD 40-60 million) will be raised to accelerate the development of several assets within its pipeline including the current phase 3 trial of lead asset BRM421 for dry eye disease (DED) in the US and speed up the enrollment of the phase 2 trial of BRM424 for neurotrophic keratitis (NK). BRIM will also progress the development of BRM521 for osteoarthritis while also assessing new projects.  

BRIM’s Chairman Andrew Lin, who is also the Chairman of TaiRx Inc. and Nuwa Healthcare and the Managing Partner of Affinity Capital, will be in charge of this round of fundraising. Based on his successful track record and his wealth of connections with seasoned investors, Chairman Lin is expecting a smooth closing in September, especially since BRIM has attracted many inquiries from potential investors after he took the helm of BRIM’s Board of Directors. BRIM’s largest shareholder currently is Affinity Limited Partnership Fund One with 12.78% of shares. As Affinity Capital was the lead investor for the last round, it is expected to maintain its leading position after this round. 

The regenerative peptides developed from BRIM′s proprietary Pigment Epithelial-Derived Factor (PEDF) Derived Short Peptide (PDSP) platform have neurotrophic effects and can activate stem cells. This unique mechanism of action promotes the proliferation and differentiation of the limbal stem cells around the damaged cornea to repair the cornea wound. This action has the potential to be applied across multiple therapy areas and indications including the stimulation of mesenchymal stem cells (MSCs) to regenerate cartilage and help treat osteoarthritis.  

BRIM′s CEO, Dr. Wen Chyi Shyu commented, “We are on track to achieve the product development milestones established for the year. This additional funding will help speed up the development of our current clinical trials and enable us to expand and diversify our pipeline. We are cautiously optimistic that subject to the outcomes of the phase 3 trial, BRM421 could become the first-line treatment for DED and help to improve the daily lives of people impacted by this debilitating eye disease in the near future.” 

BRM424 for NK shows potential for rapid development and regulatory progression 

The FDA granted orphan disease designation for BRM424 treating NK in December 2022 and if successful, this treatment could see seven years of market exclusivity after approval. 

According to Research and Market′s report, the global market of neurotrophic keratitis was about USD 191 million in 2022 and potentially will increase to USD 439 million in 2027 with a CAGR of around 18.1%1. In addition, according to Precedence Research, the global market of osteoarthritis was around USD 8.21 billion in 2022 and will potentially be USD 18.36 billion in 2032 with a CAGR of 8.38%.2  

 

For more information, please contact: 

BRIM Biotechnology, Inc.
Mei-hui Kuo / Henry Hsu
[t] 886 2 2659 8586 #109
[e] Henry.Hsu@brimbiotech.com

Sciad Communications  
Maria Patey / Sophie Protheroe
[t] 020 3405 7892  
[e] Brimbiotech@sciad.com

About BRIM Biotechnology, Inc.  

BRIM Biotechnology, Inc. was established in July 2013 to accelerate the development and transformation of early research technology platforms to clinical drug candidates.  

BRIM applies efficient translational science to develop new treatments that help combat and cure disease. The company’s virtual business model combined with its proprietary PDSP technology platform bridges the gap between research and clinical development faster, de-risks the process, and accelerates the progression of early-stage candidates in indications with high unmet medical needs. BRIM has three lead products in the pipeline: BRM421, BRM424, and BRM521, all of which are developed from its PDSP technology platform. Lead asset BRM421 for Dry Eye Disease initiated Phase 3 clinical trials in 2022 and is expected to produce topline results at the end of 2023. BRM424 for neurotrophic keratitis will also enter a Phase 2 trial in the US this year. For more information, please visit www.brimbiotech.com.  

Further information about Dry Eye Disease 
DED is a complicated disease with multiple causes. According to Global Data, the global DED market was worth approximately USD 3.9 billion in 2018. This is predicted to reach over USD 11 billion in 2028 with a CAGR of 10.6%3. Due to the widespread use of electronic screens, prolonged wearing of contact lenses, and the increasing frequency of myopia laser surgery, the global dry eye population has risen rapidly in recent years, especially amongst younger age groups. In addition, research suggests that COVID-19 patients have a higher risk of developing DED4

References 

  1. https://www.researchandmarkets.com/reports/5650830/global-neurotrophic-keratitis-market-2022-2027 
  1. https://www.precedenceresearch.com/osteoarthritis-therapeutics-market 
  1. https://www.globaldata.com/store/report/dry-eye-syndrome-global-drug-forecast-and-market-analysis-to-2028/ 
  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841281/ 

Taipei, Taiwan, 18th April 2023, BRIM Biotechnology, Inc. (“BRIM”, TPEx 6885) announced that BRM421 for the treatment of dry eye disease, licensed out to Grand Pharmaceutical Group Limited (Grand Pharmaceutical) for the China region, has been approved by the China National Medical Products Administration (NMPA) to conduct Phase 2 clinical trials. The trial is a single-arm, open-label clinical study that aims to recruit no more than 40 patients with moderate to severe dry eye disease and to evaluate the efficacy and safety of BRM421 in treating these patients.

The ophthalmology market in China is expanding, with a compound annual growth rate (CAGR) of 9.3% from USD 1.8 billion in 2015 to USD 2.6 billion in 2019. It is estimated to accelerate at a CAGR of 18.6% from 2019 to 2025 and reach a market size of USD 7.2 billion by 2025. The market size of dry eye disease in China has grown from USD 272 million in 2015 to USD 430 million in 2019, with a CAGR of 12.2%. It is estimated to grow at a CAGR of 28.4% from 2019 to 2030 and potentially reach USD 6.7 billion by 2030 [1].

BRM421 is a new peptide drug for treating dry eye disease developed from BRIM’s pigment epithelial-derived factor (PEDF) peptide platform (PDSP). It has a novel mechanism of action that can promote the proliferation of limbal stem cells and achieve corneal regeneration and repair. Data from completed Phase 2 clinical trials showed that BRM421 has a significant effect on symptoms after one week of treatment and is well tolerated with a good safety profile, giving it a significant advantage in the market competition. BRIM hopes to launch the drug in China as soon as possible through its collaboration with Grand Pharmaceutical and provide an affordable and effective treatment option for dry eye disease patients.

After licensing the commercial development rights in China, Hong Kong, and Macau to Grand Pharmaceutical in 2019, BRIM has been continuously developing BRM421. A multicenter, double-blind, randomized, vehicle-controlled Phase 3 clinical trial is ongoing in the United States. The US trial aims to recruit over 700 patients with moderate to severe dry eye disease, with topline results expected in Q4 2023, subject to enrollment status.

For more information, please contact:

BRIM Biotechnology, Inc.
Mei-hui Kuo / Henry Hsu
[t] 886 2 2659 8586 #109
[e] Henry.Hsu@brimbiotech.com

Sciad Communications 
Maria Patey / Sophie Protheroe
[t] 020 3405 7892  
[e] Brimbiotech@sciad.com

About BRIM Biotechnology, Inc.  

BRIM Biotechnology, Inc. was established in July 2013 to accelerate the development and transformation of early research technology platforms to clinical drug candidates. BRIM applies efficient translational science to develop new treatments that help combat and cure disease. The company’s virtual business model combined with its proprietary PDSP platform, bridges the gap between research and clinical development faster, de-risks the process, and accelerates the progression of early-stage candidates in indications with high unmet medical needs. BRIM has three lead products in the pipeline: BRM421, BRM424, and BRM521, all of which are developed from its PDSP technology platform. Lead asset BRM421 for Dry Eye Disease initiated Phase 3 clinical trials in 2022 and is expected to produce topline results at the end of 2023. BRM424 for neurotrophic keratitis will also enter a Phase 2 trial in the US this year. For more information, please visit the company’s website: https://www.brimbiotech.com/.

Disclaimer:

This press release and related information contain predictive statements, which are judgments and predictions based on existing risks and possible uncertainties, including market factors and other reasons beyond Brim Biotech’s control. These predictive statements are based on current predictions and evaluations and the company is not obligated to update them unless required by law.

References:

[1] http://pdf.dfcfw.com/pdf/H2_AN202104061481625025_15.pdf

Taipei, Taiwan, 6th April 2023, BRIM Biotechnology, Inc(“BRIM,” TPEx 6885), a clinical-stage biotechnology company advancing novel regenerative peptide therapies, submitted IND today for BRM424, which received ODD status from the FDA last November. If no comment from the FDA is received within 30 days, BRIM will initiate the BRM424 phase 2 study in the first half of 2023.

Neurotrophic keratitis (NK) is a rare degenerative disabling disease, caused primarily by damage to the trigeminal nerve, which leads to abnormal or loss of corneal sensation. With reduced corneal sensitivity, sufferers have insufficient tear production or blink frequency to respond effectively to outside stimulation or pressure. The cornea will experience persistent and repeated damage, leading to cornea thinning, melting, ulceration, and perforation. Infection is also common, and without treatment, the condition may lead to blindness.

Current treatment plans depend on the severity of the disease. After resolving any infection, artificial tears and/or anti-inflammation eye drops are commonly applied, whereas, for more severe cases, an operation will be needed. While there is only one prescription drug approved for NK in the US and EU, Research and Markets report shows that the market size for the disease is USD 191 million in 2022 and is predicted to be around USD 439 million by 2027 with ~18.1% CAGR [1].

BRIM’s CEO, Dr. Wen Chyi Shyu, explained: “BRM424 for NK and BRM421 for Dry Eye Disease share the same active pharmaceutical ingredient developed from BRIM’s PEDF-derived short peptide (PDSP) platform. This regenerative peptide has neurotrophic properties, and its mechanism of action is based on its ability to stimulate limbal stem cell regeneration. Therefore, it can rapidly repair the damaged cornea, and potentially be used to treat patients with severe corneal damage.” BRIM will take advantage of BRM424’s ODD status and enjoy the benefits of development cost reduction. For BRM424’s phase 2 trials, BRIM will open more clinical trial sites to speed up patient enrollment. The sooner the trial can be completed, the sooner NK patients may have an additional option for effective and affordable treatment.

For more information, please contact:

BRIM Biotechnology, Inc. 
Mei-hui Kuo / Henry Hsu
[t] 886 2 2659 8586 #109
[e] Henry.Hsu@brimbiotech.com

Sciad Communications 
Maria Patey / Sophie Protheroe
T: 020 3405 7892 
E: BrimBiotech@sciad

About BRIM Biotechnology, Inc.  

BRIM Biotechnology, Inc. was established in July 2013 to accelerate the development and transformation of early research technology platforms to clinical drug candidates. BRIM applies efficient translational science to develop new treatments that help combat and cure disease. The company’s virtual business model combined with its proprietary PDSP technology platform, bridges the gap between research and clinical development faster, de-risks the process, and accelerates the progression of early-stage candidates in indications with high unmet medical needs. BRIM has three lead products in the pipeline: BRM421, BRM424, and BRM521, all of which are developed from its PDSP technology platform. Lead asset BRM421 for Dry Eye Disease initiated Phase 3 clinical trials in 2022 and is expected to produce topline results at the end of 2023. BRM424 for neurotrophic keratitis will also enter a Phase 2 trial in the US in 2023. For more information, please visit www.brimbiotech.com

References and further readings

[1] https://www.researchandmarkets.com/reports/5650830/global-neurotrophic-keratitis-market-2022-2027

Taipei, Taiwan, 2nd March 2023 / BRIM Biotechnology Inc. (“BRIM,” TPEx 6885), a clinical-stage biotechnology company advancing novel regenerative therapies to help combat and cure ophthalmology and degenerative joint diseases, announced today that the first patient has been enrolled in its Phase 3 clinical trial of BRM421 for the treatment of Dry Eye Disease (DED). 

“DED affects millions of people worldwide, and there are insufficient treatment options to address the needs of people living with this disease. Due to its unique mechanism of action, BRM421 has the potential to become the first DED treatment to offer rapid and total relief,” said Dr. Wen Chyi Shyu, CEO of BRIM. “In just seven years, BRIM has licensed a technology platform from academia, and through our translational science expertise, we have accelerated development to reach the first patient enrollment in our Phase 3 study. Such rapid progress reflects the unique advantage of our PEDF-derived Short Peptide (PDSP) technology platform and validates our commitment to developing transformational treatments.” 

The Phase 3, multicenter, double-blind, randomized, vehicle-controlled trial is being conducted in the US and plans to enroll more than 700 patients with moderate to severe DED. The topline results are expected to be revealed at the end of 2023.  

With its unique mechanism of action, BRM421 Phase 2 data demonstrates its potential to be a first-in-class regenerative peptide that repairs corneal damage and potentially relieves DED patients’ symptoms in just two weeks. The Phase 3 clinical trial will evaluate BRM421’s efficacy and safety for treating DED patients. Patients will be treated with BRM421 or vehicle control eye drops for two weeks, with evaluation on Day 8 and Day 15. The co-primary endpoints for signs and symptoms are the total corneal fluorescein staining score on Day 15 and the visual analog score (VAS) of burning and stinging on Day 8.

  

For more information, please contact: 

BRIM Biotechnology, Inc.  
Mei-hui Kuo / Henry Hsu
[t] 886 2 2659 8586 #109
[e] Henry.Hsu@brimbiotech.com  

Sciad Communications  
Maria Patey / Sophie Protheroe 
[t] 020 3405 7892  
[e] BrimBiotech@sciad.com  

  

About BRIM Biotechnology, Inc.  

BRIM Biotechnology, Inc. was established in July 2013 to accelerate the development and transformation of early research technology platforms to clinical drug candidates. BRIM applies efficient translational science to develop new treatments that help combat and cure disease. The company’s virtual business model combined with its proprietary PDSP technology platform, bridges the gap between research and clinical development faster, de-risks the process, and accelerates the progression of early-stage candidates in indications with high unmet medical needs. BRIM has three lead products in the pipeline: BRM421, BRM424, and BRM521, all of which are developed from its PDSP technology platform. Lead asset BRM421 for Dry Eye Disease initiated Phase 3 clinical trials in 2022 and is expected to produce topline results at the end of 2023. BRM424 for neurotrophic keratitis will also enter a Phase 2 trial in the US in 2023. For more information, please visit www.brimbiotech.com.  

Further information about Dry Eye Disease 

DED is a complicated disease with multiple causes. According to Global Data, the global DED market was worth approximately USD 3.9 billion in 2018. This is predicted to reach over USD 11 billion in 2028 with a CAGR of 10.6% [1]. Due to the widespread use of electronic screens, prolonged wearing of contact lenses, and the increasing frequency of myopia laser surgery, the global dry eye population has risen rapidly in recent years, especially amongst younger age groups. In addition, research suggests that COVID-19 patients have a higher risk of developing DED [2]

References 

  1. https://www.globaldata.com/store/report/dry-eye-syndrome-global-drug-forecast-and-market-analysis-to-2028/ 
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841281/ 

There is currently no cure for Dry Eye Disease. Existing treatments are often not enough to control discomfort for moderate to severe patients unless there is a way to further speed up the healing process.

Through its multi-modal mechanism of action, BRIM’s novel regenerative peptide therapy, BRM421, has the potential to break the vicious cycle of corneal damage in Dry Eye Disease, offering patients rapid and total relief.

A recent article in the Feb/March edition of Eye News Magazine shared the news that BRM421 has advanced to Phase 3 clinical trials. Enrolment is currently underway for more than 700 patients with moderate to severe DED. The multi-centre, double-blind, randomised, placebo-controlled trial in the US, is expected to be completed in Q4 2023.

Read the full article using the link below to discover more.

This article was published in the Dry Eye Supplement of Eye News magazine in Feb/Mar 2023.

Dry Eye Supplement: https://bit.ly/3R6cyFj

Eye News Magazine: https://bit.ly/3Y50xSL

BRIM’s new Board of Directors elects Andrew Lin as the new Chairman of the Board and appoints Dr. Wen-Chyi Shyu as the new CEO

Taipei, Taiwan, February 20th, 2023 / BRIM Biotechnology, Inc. (BRIM, TPEx 6885), a clinical-stage company developing novel regenerative therapies to help combat and cure ophthalmology and degenerative joint diseases, is pleased to announce that Andrew Lin was elected as the new Chairman of the Board on 8th February, 2023, and that the new board has appointed Dr. Wen-Chyi Shyu as the company’s new Chief Executive Officer (CEO) from 1st March, 2023. The new leadership team will guide BRIM through what is set to be a transformational year for the company.

BRIM held an investor conference today to announce the news, as well as to provide an update on the progress of BRM421, the company’s lead asset which has recently entered a US Phase 3 study for dry eye disease (DED), and BRM424, an orphan disease designation (ODD) asset that will enter a US Phase 2 study for neurotrophic keratitis later this year.

BRIM successfully listed on the Taipei Exchange in June last year, and recently completed series E funding, raising $18 million to accelerate the development of its lead asset, BRM421 for DED. Since its establishment in 2013, BRIM has successfully developed a diverse pipeline of novel drug products, all underpinned by the company’s proprietary stem cell regenerative peptide technology (PDSP).

Andrew Lin elected as the new Chairman of the Board

BRIM’s new Chairman, Andrew Lin, is an internationally renowned entrepreneur with a wealth of experience in finance, technology, and biotechnology companies. He is the Chairman of TaiRx, Inc., a Taiwanese drug developer focusing on oncology treatments, and serves as an Independent Board Director for Fubon Insurance. His previous positions include Chairman of Lotus Pharmaceutical, the largest generic drug company listed on the Taiwan Stock Exchange, and Chief Executive Officer of Hasumi Biotechnology International, a global leader in cancer vaccines and immunotherapy. Mr. Lin founded Affinity Capital Fund One, along with Sophia Cheng, the current Chief Investment Officer of Cathay Financial Holdings.

Mr. Lin commented, “I am honored to take on the role as the Chairman of the Board of Directors at BRIM, a company that has already fast-tracked to become a clinical-stage company in less than 10 years, delivering promising clinical data for BRM421. I look forward to working closely with the team and driving forward the strategy to deliver innovation and continued business success.”

Dr. Wen-Chyi Shyu appointed as the new CEO

Dr. Shyu will return to Taiwan to lead BRIM through a significant period of international expansion in her role as the new CEO. With extensive corporate management experience at a global scale, she brings a fresh international perspective and a strong pharmaceutical network that will be invaluable to BRIM as the company enters a new period of growth.

Dr. Shyu has served on the scientific advisory board of BRIM since its inception and has more than 30 years of experience in life sciences, bringing a unique combination of technical and commercial knowledge. She has served in a range of global leadership roles for some of the world’s top pharmaceutical companies, including Bristol Myers Squibb and Takeda Pharmaceutical Company. Her capabilities span the entire drug discovery process, from research and development to pre-clinical and clinical drug metabolism, pharmacokinetics, drug development, and life cycle management. She was responsible for over 15 market approvals of new drugs and over 100 IND applications.

Dr. Haishan Jang, the former Chairman and CEO of BRIM, commented, “Dr. Shyu has the international experience and expertise to lead BRIM as it continues to advance late-stage development of our first regenerative peptide therapy for DED, which we are confident will be available for people living with this debilitating chronic condition, in the next 5 years. The new appointments are part of a rigorous and strategic process to bolster BRIM’s growth strategy as the company prepares to expand internationally while continuing to achieve sustainable growth.”

Dr. Shyu commented, “Regenerative peptides are an innovative and exciting class of therapies with the potential to deliver disease-modifying treatments that can transform patients’ lives. BRIM has already been highly successful in developing its lead drug candidates and I look forward to working with our dedicated and experienced leadership team to fulfil our mission to bring sustainable and affordable healthcare innovation to the world.”

BRIM strengthens its Board and leadership team with several new appointments

Dr. Jang will continue to support the growth of the company in her new role as Chief Global Strategist (CGS), with a focus on accelerating BRIM’s overseas development and international expansion. Dr. Frank W. Lee will continue in the role of Chief Scientific Officer (CSO), leading the company’s RD projects forward and scouting new pipeline leads. The former COO of BRIM, Ms. Mei-Hui Kuo will return to BRIM as COO once again. With over 30 years of operation experience, her expertise will be crucial to helping BRIM navigate a smooth transition into its new phase of growth.

In addition to new Chairman Andrew Lin, BRIM’s new Board members include Haishan Jang, Audrey Tseng, Affinity Capital Fund One, Isaiah Capital LLC., and CIDC Consultants INC. The Independent Directors are Johnsee Lee, Howard Guo and James S. J. Cheng. The new Directors and Independent Directors have a term of office of three years.

With expertise across both translational science and business, the new leadership team will guide BRIM through a significant new period of growth and development as it continues to expedite its rapidly expanding pipeline.

ENDS

For more information, please contact:

BRIM Biotechnology, Inc.

Yi-Chun Maria Chen, PhD
[t] 886 2 2659 8586 #110
[e] yichun.chen@brimbiotech.com

Sciad Communications Ltd
Maria Patey / Sophie Protheroe
[t] 020 3405 7892
[e] BrimBiotech@sciad.com

Notes to Editors

About BRIM Biotechnology, Inc.

BRIM Biotechnology, Inc. was established in July 2013 to accelerate the development and transformation of early research technology platforms to clinical drug candidates.

BRIM applies efficient translational science to develop new treatments that help combat and cure disease. The company’s virtual business model combined with its proprietary PDSP technology platform, bridges the gap between research and clinical development faster, de-risks the process, and accelerates the progression of early-stage candidates in indications with high unmet medical needs. BRIM has three lead products in the pipeline: BRM421, BRM424, and BRM521, all of which are developed from its PDSP technology platform. Lead asset BRM421 for Dry Eye Disease is in Phase 3 clinical trials since 2022 and is expected to have topline results at the end of 2023. For more information, please visit www.brimbiotech.com.

Taipei, Taiwan, 8th December 2022 / BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for BRM424 in the treatment of neurotrophic keratitis (NK), a rare degenerative eye disease which causes very severe cornea damage and can lead to loss of sight.

Dr. Haishan Jang, Chairwoman and CEO of BRIM Biotechnology, commented, “Receiving FDA orphan drug designation allows us to proceed confidently with plans to advance the development of BRM424, a novel, first-in-class, potential treatment for NK. Clinically, the treatment of NK is very complicated, and there is a lack of effective and affordable treatment options. This is an important regulatory milestone that enables us to bring this potentially transformative treatment to patients sooner. Additionally, the designation validates our belief in the potential of our stem cell regenerative PEDF-Derived Short Peptide (PDSP), which underpins several products in our pipeline, and has the potential to be effective in multiple therapy areas and indications.” 

Orphan Drug Designation is granted to drugs or biological products for the treatment of rare diseases or conditions that impact fewer than 200,000 people in the United States. Incentives that come with the designation include eligibility for federal grants, research and development tax credits, a waiver of prescription drug user fees, and the potential for a 7-year market exclusivity period upon FDA approval. 

BRM424 uses the same active pharmaceutical ingredient (API) as BRM421, BRIM’s lead candidate for Dry Eye Disease which is about to begin Phase 3 clinical trials. The API is a synthetic peptide comprised of 29 amino acids derived from Pigment Epithelium-Derived Factor (PEDF) with neurotrophic and anti-inflammatory properties. This novel peptide activates limbal stem cells to regenerate and repair the cornea, meaning it can be used to treat various indications involving severe corneal damage.

NK is characterized by reduced corneal sensitivity, epithelium breakdown and impairment of corneal healing. Currently, there are very limited pharmacological treatment options available that involve either artificial tears for the passive relief of discomfort or aggressive surgery using invasive procedures. There is currently only one drug approved by the FDA for the treatment of NK which has a very high price point and requires a strict regimen of multiple daily doses.

BRIM plans to apply for a Phase 2 NK clinical trial of BRM424 in the US, with the intention of providing an affordable and effective new drug for treating NK patients. Using the NK rabbit model, BRM424 has demonstrated preclinical efficacy and safety in compliance with regulatory requirements.

Dr. Jang further commented, “The novel, regenerative effect of BRM424 could provide a new treatment option for patients that actively stimulates repair of corneal damage. Our ongoing studies indicate that the dosing regimen will be significantly less frequent than current treatment options and we estimate that the cost of treatment will be more affordable. Our focus now is to finalize our Phase 2 study protocol and accelerate the development toward commercialization, to bring this novel treatment to patients as early as possible. The ODD status of BRM424 may also help to speed up progress toward marketing approval and launch of BRM421. BRIM plans to harness its proprietary PDSP platform to address other diseases beyond ophthalmology and bring sustainable and affordable healthcare innovation to the world.”

ENDS

For more information, contact:

BRIM Biotechnology, Inc.
Yi-Chun Maria Chen, PhD
T: 886 2 2659 8586 #110
E: yichun.chen@brimbiotech.com

Sciad Communications
Maria Patey / Sophie Protheroe
T: 020 3405 7892
E: BrimBiotech@sciad.com

Notes to Editors:

About BRIM Biotechnology, Inc.

BRIM Biotechnology, Inc. was established in July 2013 to accelerate the development and transformation of early research technology platforms to clinical drug candidates. BRIM applies efficient translational science to develop new treatments that help combat and cure disease. The company’s virtual business model combined with its proprietary PDSP technology platform, bridges the gap between research and clinical development faster, de-risks the process, and accelerates the progression of early-stage candidates in indications with high unmet medical needs. BRIM has three lead products in the pipeline: BRM421BRM424, and BRM521, all of which are developed from its PDSP technology platform. Lead asset BRM421 for Dry Eye Disease is expected to enter Phase 3 clinical trials in 2022. For more information, please visit www.brimbiotech.com.

Further information about Neurotrophic Keratitis1,2

Neurotrophic keratitis (NK) is a rare degenerative and disabling eye disease with an incidence rate of less than five in 10,000. The main pathological cause is trigeminal nerve damage. NK patients have reduced corneal sensation and tear production, which leads to corneal epithelial breakdown, poorly maintained epithelial integrity, and persistent corneal damage. Patients usually start with corneal thinning and ulceration, accompanied by loss of sensation. In severe cases, the cornea begins to dissolve and perforate, affecting vision and potentially leading to blindness. Clinically, the treatment of neurotrophic keratitis is very complicated, and there is a lack of effective treatment options. Treatment usually consists of artificial tears for passive relief of discomfort, or aggressive surgery with invasive procedures.

References

1. Lambiase A, Sacchetti M (2014) Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol 8:571. https://doi.org/10.2147/OPTH.S45921
2. Orphanet: https://www.orpha.net/consor/cgi-bin/OC_Exp.php?lng=EN&Expert=137596 (Last accessed: 22.11)

Taipei, Taiwan, 1st December 2022 / BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885), a clinical-stage biotechnology company advancing novel regenerative therapies to help combat and cure ophthalmology and degenerative joint diseases, announced today that it has raised $20 million in its Series E funding round. This demonstrates the heightened interest and growing demand for new treatments for Dry Eye Disease (DED). News of this latest funding round comes as BRIM prepares to initiate the Phase 3 clinical trial for its lead asset BRM421 for DED in the US.

Since the company’s inception in 2013, BRIM has successfully developed several platform technologies, including the regenerative peptide technology (PDSP) upon which the lead asset BRM421 for the Phase 3 clinical trial is based. Two of the platforms were spun out as a new company, Ascendo Biotechnology, to reshape the future of immunotherapeutics. This series E funding investment will be used to accelerate the development of BRIM’s diverse pipeline of wholly-owned drug candidates as well as to invest in new innovation, leveraging BRIM’s extensive translation research experience.

“We are tackling chronic, life-limiting diseases using our proprietary stem cell regenerative Pigment Epithelium-Derived Factor (PEDF) derived Short Peptide (PDSP) technology platform to not only alleviate symptoms but to address and repair the damage caused by diseases. This funding round is the latest in a series of funding that has been planned strategically to enable the company to achieve its core mission of advancing discoveries into disease-modifying treatments that transform patients’ lives. We are unwavering in our commitment to bringing sustainable and affordable healthcare to the world. The oversubscribed interest from investors is an endorsement of BRIM’s solid foundations built on the strength of our team, our expertise in translational science, and the progress of our development programs to date. We look forward to initiating the Phase 3 clinical trial for BRM421 for Dry Eye Disease at this exciting time of new growth,” said Dr. Haishan Jang, the founder, Chairwoman and CEO of BRIM.  

As of today, BRIM has submitted BRM421’s Phase 3 study protocol to the FDA and is ready to initiate the Phase 3 clinical trial as early as the end of this year. Founded in Taiwan, BRIM has over 70 global IPs for the PDSP platform and quality operation to meet international regulatory standards.

For investment-related inquiries, please contact: ir@brimbiotech.com

For more information, contact:

BRIM Biotechnology, Inc.
Yi-Chun Maria Chen, PhD
T: 886 2 2659 8586 #110
E: BD@brimbiotech.com

Sciad Communications
Maria Patey / Sophie Protheroe
T: 020 3405 7892
E: BrimBiotech@sciad.com

Notes to Editors:

About BRIM Biotechnology, Inc.

BRIM Biotechnology, Inc. was established in July 2013 to accelerate the development and transformation of early research technology platforms to clinical drug candidates.

BRIM applies efficient translational science to develop new treatments that help combat and cure disease. The company’s virtual business model combined with its proprietary PDSP technology platform, bridges the gap between research and clinical development faster, de-risks the process, and accelerates the progression of early-stage candidates in indications with high unmet medical needs. BRIM has three lead products in the pipeline: BRM421BRM424, and BRM521, all of which are developed from its PDSP technology platform. Lead asset BRM421 for Dry Eye Disease is expected to enter Phase 3 clinical trials in 2022. For more information, please visit www.brimbiotech.com.

Further information about Dry Eye Disease

DED is a complicated disease with multiple causes. According to Global Data, the global DED market was worth approximately USD 3.9 billion in 2018. This is predicted to reach over USD 11 billion in 2028 with a CAGR of 10.6%1. Due to the widespread use of electronic screens, prolonged wearing of contact lenses, and the increasing frequency of myopia laser surgery, the global dry eye population has risen rapidly in recent years, especially amongst younger age groups. In addition, research suggests that COVID-19 patients have a higher risk of developing DED2.

References

1. https://www.globaldata.com/store/report/dry-eye-syndrome-global-drug-forecast-and-market-analysis-to-2028/
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841281/