On February 20, 2023 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that MediciNova’s research collaborator, Justin Lathia, PhD, Scientific Director of the Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center at Cleveland Clinic and Professor, Department of Molecular Medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Professor and Vice Chair in the Department of Cardiovascular & Metabolic Sciences at the Lerner Research Institute, Cleveland Clinic presented new data regarding tumor tissue analysis and clinical outcome from a glioblastoma clinical trial (protocol no. MN-166-GBM-1201; NCT03782415) at the 20th Annual World Congress of SBMT (Society for Brain Mapping and Therapeutics) held on February 16 – 19, 2023, in Los Angeles, CA (Press release, MediciNova, FEB 20, 2023, View Source [SID1234627412]).

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This tumor analysis study was a collaborative effort between MediciNova, Dr. Patrick Wen (Dana- Farber Cancer Institute), and Dr. Lathia (Cleveland Clinic Foundation). MN-166-GBM-1201 is an ongoing Phase 1/2 study targeting recurrent and newly diagnosed glioblastoma being conducted at Dana-Farber Cancer Institute under Principal Investigator: Dr. Wen, Director at Center for Neuro-Oncology Dana-Farber Cancer Institute, Professor of Neurology, Harvard Medical School.

The highlights of Dr. Lathia ‘s presentation are as follows:

Tumor tissues were analyzed to determine potential predictors of treatment response to MN-166 (ibudilast) and temozolomide (TMZ) combination treatment.
Pre-treatment tumor tissues were obtained from the resected tumors at the initial surgery or biopsy of trial participants (Part 1) diagnosed with recurrent glioblastoma.
Immunohistochemistry was performed on resected tumor tissue to evaluate MIF (macrophage migration inhibitory factor), pERK, Ki67, CD3, CD11b, and CD74. A masked researcher calculated the score for each protein per patient.
Study participants were divided into two groups: non-responders (disease progression within five months after receiving MN-166 and TMZ) and responders (no disease progression for five months after receiving MN-166 and TMZ).
Responders had a lower percentage of CD3+ T cells than non-responders (p<0.05). Additionally, CD74 expression was also lower in the responders and this trended towards significance (p=0.06).
CD3 expression was the best predictor for tumor progression for five months in recurrent glioblastoma patients treated with MN-166 and TMZ.
Dr. Lathia commented "Previously we reported that MN-166, as a brain-penetrant MIF-CD74 interaction inhibitor, reduced myeloid-derived suppressor cells (MDSC) generation and reversed their T cell suppressive capacity in vitro. Additionally, MN-166 reduced monocytic-MDSCs and increased CD8+ T cell number and function in the tumor microenvironment in murine model study. These new findings from clinical tumor tissue analysis may be explained by treatment with MN-166 resulting in increased CD3+ infiltration into tumor tissue in the patients who began with low CD3+ due to high MDSCs. This will need to be confirmed in a larger cohort."

Kazuko Matsuda, M.D. Ph. D, M.P.H., Chief Medical Officer, MediciNova, Inc., commented, "GBM is the most common primary malignant brain tumor and has a poor prognosis. It is a highly immunosuppressive tumor and there are limitations to the extent of a safe immune response in the central nervous system. We are excited by the findings presented by Dr. Lathia. Recently, we have completed study enrollment with MN-166-GBM-1201 study and look forward to the upcoming data analysis with more tissue samples."

About Glioblastoma

According to the American Association of Neurological Surgeons, glioblastoma is an aggressive brain cancer that often results in death during the first 15 months after diagnosis. Glioblastoma develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. Glioblastoma is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that glioblastoma represents about 15% of all primary brain tumors and approximately 10,000 cases of glioblastoma are diagnosed each year in the U.S. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with glioblastoma. Median survival is about 11-15 months for adults with more aggressive glioblastoma (IDH-wildtype) who receive standard treatment of surgery, temozolomide, and radiation therapy.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

On February 20, 2023 Biogen Inc. (Nasdaq: BIIB) reported that Christopher A. Viehbacher, President and Chief Executive Officer, will participate in the Cowen 43rd Annual Health Care Conference. The webcast will be live on Monday, March 6, 2023, at 9:50 a.m. ET. To access the live webcast, please visit the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available following the presentation (Press release, Biogen, FEB 20, 2023, View Source [SID1234627410]).

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On February 19, 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, reported 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 (Press release, BRIM Biotechnology, FEB 19, 2023, View Source [SID1234627436]). The new leadership team will guide BRIM through what is set to be a transformational year for the company.

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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.

On February 19, 2023 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported an IRS Form 8937 (the "Form 8937") to supplement its previously issued "Frequently Asked Questions" document under the "Investors" section of its website at www.sorrentotherapeutics.com regarding its recent dividend to Sorrento stockholders of shares of common stock of Scilex Holding Company ("Scilex") previously held by Sorrento (Press release, Sorrento Therapeutics, FEB 19, 2023, View Source [SID1234627400]).

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The Form 8937 has been filed with the Internal Revenue Service and Sorrento expects to send copies of the form in the coming days to brokerage firms, banks, dealers and similar organizations to whom a dividend confirmation had previously been distributed by Scilex’s transfer agent, Continental Stock Transfer & Trust Company.

After the close of trading on the Nasdaq Capital Market on January 19, 2023, Sorrento issued a distribution of an aggregate of 76,000,000 shares of Scilex common stock to the record holders of Sorrento common stock. Sorrento issued the distribution on a pro rata basis among its stockholders in accordance with each stockholder’s ownership percentage of Sorrento common stock as of the record date. The distribution ratio was 0.1410127 of a share of Scilex common stock for each one share of Sorrento common stock. Fractional shares issued as part of the stock distribution have been paid in cash in lieu of distributing fractional shares. At the time of the filing of the Form 8937, Sorrento estimated that its current and accumulated earnings and profits would be insufficient to characterize the distribution as a dividend. Therefore, the estimate would provide that the distribution of the Scilex common stock would be characterized as non-dividend return of capital.

Sorrento stockholders are urged to consult their own tax advisor as to the particular tax consequences of the distribution of the Scilex common stock, including potential tax consequences under state, local and non-U.S. tax laws. Sorrento is providing the details on the Form 8937 for informational purposes only and not to be considered or construed as legal or tax advice.

The Form 8937 is available here.

On February 19, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported detailed positive results from its completed pivotal Phase III ZIRCON trial (ClinicalTrials.gov Identifier: NCT03849118)[1] (Press release, Telix Pharmaceuticals, FEB 19, 2023, View Source [SID1234627398]). The study met primary and secondary endpoints, with TLX250-CDx demonstrating the ability to reliably characterise and detect the clear cell phenotype and provide a non-invasive method of diagnosing the presence and spread of ccRCC, delivering on an unmet medical need in this disease setting.

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The results were featured in an oral presentation delivered by Associate Professor Brian Shuch, MD, Director, Kidney Cancer Program, UCLA Institute of Urologic Oncology (Los Angeles, California) and a Principal Investigator in the Phase III ZIRCON study, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (ASCO GU), on Saturday, 18 February 2023. This marks the first time that detailed analyses of the primary endpoints and key secondary endpoints from the ZIRCON study have been presented to the medical community.

A total of 300 patients were dosed with TLX250-CDx resulting in 284 evaluable patients (those patients with central histology reading and evaluable TLX250-CDx PET scan at central review). Each patient received a single dose of TLX250-CDx and a tumour sample from surgical resection (centrally reviewed) was used as the standard of truth comparator.

The study delivered highly consistent results across three readers of an average 86% sensitivity and 87% specificity (see Figure 1), exceeding the pre-determined threshold required to demonstrate the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate and non-invasive method for identifying the presence and spread of ccRCC. Confidence intervals (CIs) exceeded expectations in all three readers showing high accuracy and consistency of interpretation.

The study also met the key secondary endpoint, achieving 85% sensitivity and 89% specificity in detecting ccRCC in tumours ≤4cm ("T1a" classification), currently a significant clinical challenge in the diagnosis of ccRCC. See Figure 2.

Figure 1: Co-primary endpoints (full analysis set)

Sensitivity and specificity thresholds exceeded by all three independent readers[2]

Reader 1

Reader 2

Reader 3

Overall %

(95% CI)

Sensitivity, %

84.13

85.19

87.30

85.5

Lowest bounds, Wilson 95% CI

78.24

79.42

81.80

(79.8; 89.8)

Specificity, %

88.42

88.42

84.21

87

Lowest bounds, Wilson 95% CI

80.45

80.45

75.57 %

(78.8; 92.3)

Positive predictive value, %

93.53

93.60

91.67

93

(88; 96)

Negative predictive value, %

73.68

75.00

76.92

75

(66; 82)

Accuracy, %

85.56

86.27

86.27

86

(81.5; 89.6)

Figure 2: Key secondary endpoints (small lesions, cT1a ≤4cm)

Sensitivity and specificity thresholds were met by all three independent readers (full analysis set)

Reader 1

Reader 2

Reader 3

Overall %

(95% CI)

Sensitivity, %

84.05

86.17

86.17

85.5

Lowest bounds, Wilson 95% CI

75.33

77.76

77.76

(77; 91.2)

Specificity, %

90.74

90.74

87.04

89.5

Lowest bounds, Wilson 95% CI

80.09

80.09

75.58

(78.6; 95.2)

Positive predictive value, %

94.05

94.19

92.05

93.4

(86.1; 97)

Negative predictive value, %

76.56

79.03

78.33

78

(66.2; 86.5)

Accuracy, %

86.5

87.8

86.5

87

(80.6; 91.4)

A clinical case study example was presented, demonstrating the potential for clinical decision making and accurately identifying clear cell renal cancer even in very small renal masses, smaller than 2cm (Figure 3).

Figure 3: ZIRCON clinical case in a 1cm mass[3]

Potential support for clinical decision making

For such cases the high sensitivity and PPV shows that this patient is highly likely to have a ccRCC diagnosis, confirming that they should have this malignant tumour removed. The image could help understand the stage of the disease as well as the location, defining the surgical plan. In such a patient a biopsy would be avoided and they would likely move to surgery with confidence in the diagnosis.

The favourable safety and tolerability profile of TLX250-CDx was also confirmed, with the majority of adverse events (AEs) being post-surgical complications and not study treatment related. No unexpected safety signals were observed and tolerability profile was consistent with experience of girentuximab in previous therapeutic and imaging studies.

A/Prof Brian Shuch, MD, Director, Kidney Cancer Program, UCLA Institute of Urologic Oncology (Los Angeles, California) said, "On behalf of Telix and all of the investigators and clinical sites that contributed towards the successful ZIRCON study, it is a privilege to present at ASCO (Free ASCO Whitepaper) GU. Since the news of positive top line data in November there has been tremendous interest from peers in the medical community and it’s great to be able to dig a little deeper into the clinical impact of these excellent results, including in particular patient sub-sets. The high sensitivity and specificity will allow us to change patient management accurately identifying which patients do or don’t have ccRCC."

Dr Colin Hayward, Chief Medical Officer at Telix said: "We are pleased to share these key Phase III ZIRCON study results with the urologic oncology community for the first time at ASCO (Free ASCO Whitepaper) GU, the leading specialised event for GU cancer care worldwide. The consistency of results and accuracy of the test in both larger and smaller renal masses is especially encouraging. Telix would like to thank Dr Shuch for his personal commitment to this study, as well as all of the patients and clinical teams who participated worldwide."

Telix is also pleased to inform shareholders that the ZIRCON study has been accepted for presentation at the 38th Annual European Association of Urology (EAU) Congress taking place in Milan, Italy, from 10 – 13 March 2023. Professor Peter Mulders, Head of Urology at Radboud University Nijmegen Medical Centre and a Principal Investigator in the ZIRCON study will present further analyses in a "game-changing" oral presentation on 11 March. Further details on this and other Telix presentations at EAU to follow.

Investor Briefing

Telix is hosting an investor briefing with A/Prof Brian Shuch and Dr Colin Hayward, Telix Group Chief Medical Officer tomorrow, Tuesday 21 February at 8.30am AEDT (Monday 20 February at 4.30pm EST).

The briefing provides an opportunity for investors to hear Dr Shuch’s ASCO (Free ASCO Whitepaper) GU presentation and a clinician’s perspective on the clinical utility of this investigational imaging agent. This will be followed by a Q&A session.

Please register at the following link to access the investor briefing:
View Source

Dr Shuch’s presentation can be viewed or downloaded from the Telix corporate website here.