On October 26, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 30th Annual Prostate Cancer Foundation Scientific Retreat, taking place October 26-28, 2023, in Carlsbad, CA (Press release, ESSA, OCT 26, 2023, View Source [SID1234636397]). Masofaniten is a first-in-class N-terminal domain androgen receptor ("AR") inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for the treatment of prostate cancer. The poster presentation is available on the "Publications" section of the Company’s website at www.essapharma.com.

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"This poster, presented today at the Prostate Cancer Foundation Scientific Retreat, contains updated cohort 4 data from the dose escalation portion of our Phase 1/2 study evaluating the combination of masofaniten and enzalutamide in patients with metastatic castration-resistant prostate cancer ("mCRPC")," said David Parkinson, MD, President and CEO of ESSA. "While the data for patients in cohort four are still maturing, these updated data continue to demonstrate that the combination is well tolerated and leads to deep and durable reductions in prostate-specific antigen ("PSA"), including in cohort 4, which reflects the dosing regimen that is being evaluated in the Phase 2 dose expansion. We look forward to providing future updates."

Poster presentation details:

Title: Phase 1/2 Trial of Oral EPI-7386 (masofaniten) in Combination with Enzalutamide (Enz) Compared with Enz Alone in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC): Current Phase 1 (P1) results
Presenting Author: Andrew Laccetti, MD, MS, Memorial Sloan Kettering Cancer Center
Date and time: Thursday, October 26, 2023; 7:30-10:30 p.m. PT

Data summary: This Phase 1/2 multicenter, open-label clinical trial is enrolling patients with mCRPC who have received androgen deprivation therapy and who are naïve to second-generation antiandrogens but may have been treated previously with one line of prior chemotherapy in the metastatic hormone-sensitive prostate cancer setting. The data presented today are from the first four cohorts of patients in the Phase 1 dose escalation portion of the study. Masofaniten has no effect on enzalutamide exposure, thus allowing the use of full dose per label (160mg) of enzalutamide in combination. Enzalutamide reduces masofaniten exposure but twice daily dosing of masofaniten appears to mitigate the reduction and maintains clinically relevant drug exposures.

In patients evaluable for safety (n=18), masofaniten combined with enzalutamide, continues to be well-tolerated at the doses tested through 21 cycles of dosing in some patients. Most frequent adverse events were Grade 1 and 2, related to either AR inhibition or gastrointestinal tract irritation. In Cohort 4, one patient experienced a Grade 3 rash, which was observed immediately following administration of masofaniten combined with enzalutamide and deemed probably related.

In the patients evaluable for efficacy (n=16), rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg). In the first three cohorts, 90% of patients (9 of 10) achieved PSA50 and PSA90, 80% of patients (8 of 10) achieved PSA90 in less than 90 days, and 70% of patients (7 of 10) achieved PSA <0.2mg/mL. Across all dose cohorts including patients in the recently enrolled cohort four, 88% of patients (14 of 16) achieved PSA50, 81% of patients (13 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 56% of patients (9 of 16) achieved PSA <0.2mg/mL. The randomized Phase 2 dose expansion portion of the study is currently enrolling.

About Masofaniten
Masofaniten (formerly known as EPI-7386) is a first-in-class investigational, highly selective, oral, small molecule inhibitor of the N-terminal domain ("NTD") of the androgen receptor ("AR"). Masofaniten’s unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the NTD, a region of the AR that is not currently targeted by other therapies. Masofaniten is currently being studied in an open-label, randomized Phase 2 clinical trial (NCT05075577) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens. ESSA is also conducting a Phase 1 monotherapy study (NCT04421222) in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to masofaniten worldwide.

On October 26, 2023 Medivir reported Updated data show that the combination fostrox + Lenvima provides improved clinical efficacy compared to Lenvima study data alone in second-line HCC (Press release, Medivir, OCT 26, 2023, View Source;interim-report-january–september-2023-301969891.html [SID1234636395]).

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July – September

Financial summary for the quarter

Net turnover amounted to SEK 0.8 (1.1) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -23.4 (-13.9) million. Basic and diluted earnings per share amounted to SEK -0.42 (-0.27) and SEK -0.42 (-0.27) respectively.
Cash flow from operating activities amounted to SEK -21.0 (-19.7) million.
Cash and cash equivalents at the end of the period amounted to SEK 61.1 (142.2) million.
Significant events during the quarter

In August, Medivir’s Scientific Advisory Council was formed, consisting of five world-leading experts in liver cancer.
In August, the 15th patient was included in the phase 2a study with fostrox in combination with Lenvima. Interim data from an investigator evaluation showed promising tumor control and good tolerability.
In September, Medivir reported promising interim data from an independent evaluation of the phase 1b dose-escalation arm of fostrox in combination with Lenvima, where, among others, one patient achieved a complete tumor response and two patients a partial tumor response, out of a total of six patients.
In September, Medivir, together with leading cancer experts, arranged a webinar on the treatment landscape and the unique treatment challenges in primary liver cancer (HCC).
In September, data on the additive efficacy of fostrox in combination with Lenvima or Nexavar in non-clinical tumor models were presented at the ILCA Annual Meeting.
In September, Medivir’s partner Tango Therapeutics received IND approval from the FDA to start a phase 1/2 clinical trial with TNG348. TNG348 is a USP-1 inhibitor developed by Tango Therapeutics from the preclinical USP1 program that was in-licensed from Medivir in 2020.
January – September

Financial summary for the period

Net turnover amounted to SEK 3.2 (2.1) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -68.5 (-66.9) million. Basic and diluted earnings per share amounted to SEK -1.23 (-1.27) and SEK -1.23 (-1.27) respectively.
Cash flow from operating activities amounted to SEK -55.1 (-77.1) million.
Cash and cash equivalents at the end of the period amounted to SEK 61.1 (142.2) million.
Events after the end of the period

In October, data from the fostrox + Lenvima combination was presented, showing continued promising tumor control in HCC from an investigator evaluation. All patients in the phase 2a study had dosed at least two treatment cycles at this timepoint.
In October, the Board of Directors announced that Anette Lindqvist is leaving her position as Board Member of Medivir AB due to personal reasons.
In October the nomination committee was appointed ahead of the AGM in May 2024. The Nomination Committee consists of Karl Tobieson, appointed by Linc AB, Richard Torgerson, appointed by Nordea Investment Funds, Anders Hallberg, appointed by HealthInvest Partners and Uli Hacksell, Chairman of the Board, Medivir AB.
This Q3 report and subsequent webcast presents in-depth interim data from the 18 patients in the phase 1b/2a study who have had minimum 12 weeks follow-up. These data continue to demonstrate clear patient benefit for the fostrox + Lenvima combination.
Conference call for investors, analysts and the media

The Interim Report January – September 2023 will be presented by Medivir’s CEO, Jens Lindberg.

Time: Friday, October 27, 2023, at 14.00 (CET).

To access the webcast and find information about the teleconference, please klick HERE!

The conference call will also be streamed via a link on the website: www.medivir.com/investors/calendar.

The presentation will be available on Medivir’s website after completion of the conference.

On October 26, 2023 Biosyngen reported that its TIL therapy BST02 for liver cancer was granted an approval for clinical trial by the US FDA. BST02, a breakthrough product in the field of cell and gene therapy, represents the world’s first TIL therapy designed for the treatment of all types of liver cancer to progress into the clinical stage (Press release, BioSyngen, OCT 26, 2023, View Source [SID1234636394]).

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TIL therapy involves the isolation of natural infiltrating lymphocytes from tumor tissue, followed by in vitro amplification in a controlled laboratory environment to enhance their functionality. These optimized lymphocytes are subsequently re-infused into the patient. TIL therapy offers several notable advantages, including the presence of multiple TCR clones, enhanced tumor homing capabilities, and reduced targeted toxicity. As a result, TIL therapy brings significant promise and benefit in the treatment of solid tumors.

The approval of the BST02 (TIL therapy) is another significant achievement for Biosyngen, as it marks the fourth first-in-class product in the company’s pipeline that secured IND. This milestone has been made possible through the utilization of Biosyngen’s distinct and effective global integrated R&D translational system. Over the course of the past nine months, Biosyngen has obtained IND approval in both China and the United States for four innovative products. This accomplishment solidifies the company’s position as an emerging biotech with in-house R&D capabilities, specializing in CAR-T, TCR-T, and TIL therapies in the field of T cell therapy.

The utilization of tumor-specific T cells, such as CAR-T, TCR-T, and TIL therapies, signifies a significant advancement in the treatment of solid tumors. While these therapies share a common development trajectory, they also diverge in terms of technological approaches; development and manufacturing process also may vary.

Currently, Biosyngen has established comprehensive technology platforms and database, including IDENTIFIER, which serve as a robust foundation for the discovery and recognition of antigens, antibodies, and TCR, as well as the design of various specialized therapeutic products. Through diligent, consistent and sustainable efforts, Biosyngen is able to address unmet clinical demands and advance development of innovative immunotherapy drugs that hold significant value, ultimately benefiting patients worldwide.

About BST02

Primary liver cancer, which includes hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), is a prevalent malignant tumor of the digestive system globally. Recent data from GLOBOCAN 2020 reveals that liver cancer has become the seventh most common malignant tumor, with an estimated 906,000 new cases annually. Furthermore, it ranks as the second leading cause of cancer-related deaths, with approximately 830,000 fatalities each year. In China, primary liver cancer is the fourth most prevalent malignant tumor and the second most lethal form of cancer. Despite China’s population accounting for 18.6% of the global population, the country experiences a disproportionately high burden of liver cancer, with 410,000 new cases and 391,000 deaths annually. These figures represent 45.3% and 47.1% of the global incidence and mortality rates, respectively. Consequently, liver cancer poses a significant threat to the well-being of Chinese population.

BST02 is a novel adoptive immune cell therapy that involves the expansion of tumor infiltrating lymphocytes derived from the patient’s own cells. This therapy is specifically designed for the treatment of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma.

The fundamental principle involves the collection and enrichment of lymphocytes that possess specific recognition of antigens found in tumor cells from the patient’s own tumor tissue. These lymphocytes are then induced to undergo rapid proliferation in vitro through the use of cytokines, the stemness of these lymphocytes is also maintained. This process aims to maximize the expansion of T cells that possess anti-tumor functionality. Subsequently, these T cells are reintroduced into the patient, with the capability to effectively eliminate tumors. However, the application of traditional TIL drugs is subject to certain limitations. For instance, the production of these drugs must be conducted in close proximity to the clinical center, and their clinical use necessitates high doses of interleukin-2, which may pose certain safety risks.

BST02 overcame the limitations mentioned above – through cryopreservation, it addresses the constraints of distance and it eliminates the need for high levels of interleukin-2. Preliminary findings from exploratory clinical trials have demonstrated evidence of its safety and efficacy.

On October 26, 2023 HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for the third quarter and provided business updates (Press release, HanAll Biopharma, OCT 26, 2023, View Source [SID1234636393]).

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HanAll ended the quarter with a revenue of 33 billion Korean won (KRW), an 11 percent increase year-on-year, mainly driven by two-digit growth from key pharmaceutical products. The net profit recorded was 300 million KRW, with an operation income of 100 million KRW.

"The third quarter marked a significant milestone. Our second anti-FcRn asset, HL161ANS (IMVT-1402), demonstrated a favorable safety and efficacy profile from the initial phase 1 Single Ascending Dose (SAD) and 300 mg subcutaneous MAD study, indicating it may be a potentially best-in-class anti-FcRn antibody for the treatment of IgG-mediated autoimmune diseases. We have also successfully initiated a Phase 1 clinical study for HL192 (ATH-399A) in collaboration with our partners to evaluate its potential as a treatment for Parkinson’s disease," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

"In the fourth quarter, we anticipate the Phase 2 initial results for batoclimab in Grave’s disease as well as additional MAD study results for HL161ANS 600 mg. We also plan to finalize the next Phase 3 study design for tanfanercept in dry eye disease before the end of 2023. We stay dedicated to our mission to humbly serve our patients by continuing to evolve ourselves into a global innovative biopharmaceutical company," he added.

THIRD QUARTER 2023 BUSINESS UPDATE

Pipeline Development Highlights

A comprehensive update of HanAll’s pipeline development below includes an overview of research along with lists of compounds, targeted indications, and developmental phase.

AUTOIMMUNE DISEASES PROGRAMS

Batoclimab (HL161BKN)

A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies.

Harbour BioMed, a licensed partner in China, announced the official acceptance of the Biologics License Application (BLA) of batoclimab for the treatment of generalized myasthenia gravis (gMG) in June 2023. This application was based on a positive topline result from the Phase 3 clinical trial in March 2023.
Immunovant, another licensed partner in United States and Europe, is actively engaged in the development of a FcRn inhibitor in four autoimmune indications: Grave’s disease (GD), Chronic inflammatory demyelinating polyneuropathy (CIDP), gMG and Thyroid eye disease (TED). Anticipated milestones include the initial Phase 2 results for GD in the fourth quarter of 2023 and the initial data from Phase 2b clinical trials for CIDP in the first half of 2024. The top-line results from the gMG Phase 3 study are expected in the second half of 2024, with top-line data from the Phase 3 clinical study at TED expected in the first half of 2025.
HanAll and Immunovant initiated a Phase 3 clinical study of batoclimab in gMG in Japan while preparing to initiate a Phase 3 study in TED.
HL161ANS

Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG is designed to deliver maximum lgG reductions while minimizing interference with albumin recycling.

Immunovant announced favorable initial HL161ANS (Immunovant project designation: IMVT-1402) Phase 1 SAD and 300 mg MAD results in September 2023. In the MAD portion of the study, HL161ANS achieved a 63% lgG reduction from the baseline after four weekly doses of 300 mg subcutaneous administration. No decrease in serum albumin below baseline and no increase in LDL-cholesterol level above baseline were observed. Overall, HL161ANS demonstrated a consistent reduction in lgG level with potency similar to or greater than that of batoclimab, without significant reduction from baseline of serum albumin levels and without significant increase in LDL-cholesterol levels observed at any timepoint measured (all p’s > 0.05). Additional data from the MAD 600 mg cohort is expected in the fourth quarter of 2023.
OPHTHALMIC DISEASE PROGRAM

Tanfanercept (HL036)

A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF alpha, a key mediator of ocular inflammation

HanAll Biopharma and Daewoong Pharmaceutical conducted an in-depth medical advisory board meeting to discuss the completed Phase 3 VELOS-3 study data and the planned Phase 3 VELOS-4 study design of tanfanercept ophthalmic solution for the treatment of DED. HanAll and Daewoong intend to discuss the VELOS-4 study design and development plan with the FDA within the second half of 2023, with plans to begin the next study in the year of 2024.
The completed Phase 3 VELOS-3 study demonstrated a highly statistically significant improvement in the secondary efficacy endpoint of the unanesthesized Schirmer test, evaluating the change in tear volume from baseline in subjects treated with tanfanercept compared to vehicle assessed at week 8 (p=0.002). Additionally, the proportion of subjects whose Schirmer test improved from baseline by at least 10 mm, as assessed at week 8, was statistically significant (p=0.011) in the tanfanercept arm (13%) relative to the vehicle arm (4%). It is notable that per the FDA’s 2020 Draft Guidance on Dry Eye Drug Development, measurement of a statistically significant difference between the percentage of patients achieving at least a 10 mm increase in Schirmer test is an acceptable primary efficacy endpoint option. Another DED approval pathway option which the FDA has published would include demonstrating both an objective prespecified sign of dry eye but additionally requires at least one subjective prespecified symptom of dry eye. This second pathway often involves a greater degree of complexity, requiring additional studies to be conducted.
NEUROLOGY PROGRAM

HL192 (ATH-399A)

A pipeline candidate originated from NurrOn Pharmaceuticals that targets Nurr1, a master regulator in dopaminergic neuron development and maintenance, is being developed to treat neurodegenerative diseases, including Parkinson’s disease (PD).

HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals initiated a Phase 1 clinical trial of HL192, which is being developed for the treatment of PD. This Phase 1 Study evaluates the safety, tolerability, and pharmacokinetics of both single and multiple doses of orally administered HL192 in healthy subjects. The initial results from the Phase 1 clinical trial of HL192 are expected in the second half of 2024.
ONCOLOGY PROGRAMS

HL187/ HL186

HL187 is a monoclonal antibody that targets TIGIT (T cell immunoreceptors with Ig and ITIM domains {Immunoreceptor tyrosine-based inhibitory motif domains}). HL186 is a monoclonal antibody that targets TIM-3 (T cell Ig and mucin domain-3). These antibodies are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments.

HanAll is currently progressing with the pre-clinical study of HL187 (anti-TIGIT), while assessing the potential of HL186 (anti-TIM-3) under the strategic portfolio review.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)

Key Highlights

(KRW in billion)

Q3 2023

Q3 2022

% change

Sales

33

29.6

+11 %

Gross Profit

17.5

16.5

+6 %

Selling, marketing and administrative expenses

12.9

11.7

+11 %

Research and development expenses

4.6

4.2

+8 %

Operating income

0.1

0.6

-85 %

Net Income

0.3

0.7

-30 %

Sales recorded 33 billion KRW for the three-month period ending on September 30, 2023, an 11 percent increase from the three months ended September 30, 2022. The increase was primarily due to strong pharmaceutical sales, including ‘Normix’, ‘Eligard’, and ‘BioTop’.

Research and development expenses were 4.6 billion KRW for the three-month period ending on September 30, 2023, up by 6 percent compared to the same period in 2022.

Net income was 300 million KRW for the three-month period ending on September 30, 2023, compared to 700 million KRW for the three months ended September 30, 2022.

On October 26, 2023 Codagenix Inc., a clinical-stage synthetic biology company with a rational virus design platform for viral vaccines and immuno-oncology therapeutics, reported the presentation of preclinical data for CodaLytic, a codon-modified virus being developed for breast cancer immunovirotherapy, at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting being held virtually and in-person November 1-5, 2023 in San Diego, California (Press release, Codagenix, OCT 26, 2023, View Source [SID1234636392]).

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"These results demonstrate that CodaLytic treatment induced tumor immune infiltration driving anti-tumor efficacy in multiple, diverse preclinical models, and underscore the potential utility of this candidate as a valuable component of novel therapeutic regimens," said Johanna Kaufmann, Ph.D., Executive Vice President of Oncology and Immunology at Codagenix. "CodaLytic is the first codon-modified virus developed by Codagenix to treat cancer, and we look forward to building upon these promising results and deepening our understanding of how this virotherapeutic candidate can support anti-tumor immunity in breast cancer patients."

Presentation Details
Title: Immunovirotherapy with the codon-modified influenza virus CodaLytic modulates the quality of the tumor immune infiltrate in support of anti-tumor immunity
Abstract Number: 1100
Date and Time: Saturday, November 4, 2023: 11:55–1:25 p.m. PDT and 7-8:30 p.m. PDT
Presenting Authors: Johanna Kaufmann, Ph.D. and Katarina Blagovic, Ph.D.