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ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Second Quarter Ended March 31, 2022

On May 10, 2022 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 financial results for the fiscal second quarter ended March 31, 2022 (Press release, ESSA, MAY 10, 2022, View Source [SID1234614152]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"During this past quarter, we continued to dose patients in our Phase 1 monotherapy study of EPI-7386, a first-in-class N-terminal domain ("NTD") androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer ("mCRPC") whose tumors have progressed on current standard-of-care therapies," stated David Parkinson, M.D., President and CEO of ESSA. "We expect to present a clinical update on the monotherapy trial in the first half of 2022. In addition, several clinical collaborations are underway investigating the potential clinical benefit of EPI-7386 in combination with approved second-generation antiandrogens, including the Company-sponsored Phase 1/2 study of EPI-7386 in combination with enzalutamide in mCRPC patients who have not yet been treated with second-generation antiandrogen therapies."

Clinical and Corporate Highlights

EPI-7386 Monotherapy

The Company is currently dosing patients in the Phase 1a dose escalation study evaluating EPI-7386 as a monotherapy in patients with mCRPC. Patients are being dosed at 1,000 mg QD, 800 mg/day administered as 400 mg twice daily (BID) and 1200 mg/day administered as 600 mg BID.

The Company expects to provide a clinical update on the Phase 1a dose escalation study in the first half of 2022.

The Phase 1b study is expected to commence in the second half of 2022 and will confirm a recommended Phase 2 dose ("RP2D").
EPI-7386 Clinical Collaborations

In January 2022, the Company dosed the first patient in the Company-sponsored Phase 1/2 study of EPI-7386 in combination with Astellas Pharma Inc.’s and Pfizer Inc.’s enzalutamide in patients with mCRPC who have not been treated with second-generation antiandrogen therapies.

Janssen Research and Development LLC has initiated a Phase 1/2 trial of EPI-7386 in combination with apalutamide or abiraterone acetate plus prednisone in earlier line mCRPC patients.

The Bayer-led Phase 1/2 trial will evaluate EPI-7386 in combination with darolutamide in earlier line mCRPC patients.
Preclinical

On April 10, 2022 at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the Company presented preclinical data for its first generation of androgen receptor (AR) ANITen bAsed Chimera (ANITAC) (NTD) degraders showing orally bioavailable ANITAC degraders can eliminate full length, mutant and splice variant forms of AR that are expressed in castration-resistant prostate cancer (CRPC) patients, and that ANITAC degraders inhibit AR-dependent transcription and reduce viability of AR-dependent prostate cancer cells.
Summary Financial Results

Net Loss. ESSA recorded a net loss of $10.9 million ($0.25 loss per common share based on 44,030,480 weighted average common shares outstanding) for the quarter ended March 31, 2022, compared to a net loss of $13.0 million ($0.36 loss per common share based on 36,484,041 weighted average common shares outstanding) for the quarter ended March 31, 2021. For the quarter ended March 31, 2022, this included non-cash share-based payments of $1.9 million compared to $2.7 million for the comparable period in 2021, recognized for stock options granted and vesting.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended March 31, 2022 were $7.6 million compared to $7.3 million for the quarter ended March 31, 2021 and included non-cash costs related to share-based payments ($1.1 million for the quarter ended March 31, 2022 compared to $791,969 for the quarter ended March 31, 2021). The increase in R&D expenditures for the first fiscal quarter ended March 31, 2022 was primarily related to clinical data analysis associated with the Phase 1a clinical study, as well as increased expenses related to intellectual property and salaries, as well as the non-cash share-based expenses.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended March 31, 2022 were $3.8 million compared to $4.6 million for the quarter ended March 31, 2021 and included non-cash costs related to share-based payments of $741,494 for the quarter ended March 31, 2022 compared to $1.9 million for the comparable period in 2021. The increased expenditure is the result of increased professional fees related to higher salaries and benefits, as well as the non-cash share-based payments.
Liquidity and Outstanding Share Capital
At March 31, 2022, the Company had available cash reserves and short-term investments of $181.0 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period. The Company’s cash position is expected to be sufficient to fund current and planned operations through 2024.

As of March 31, 2022, the Company had 44,059,700 common shares issued and outstanding.

In addition, as of March 31, 2022 there were 3,234,750 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 314,750 warrants at a weighted average exercise price of $49.69. There were 6,795,736 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.33 per common share.

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with mCRPC whose tumors have progressed on current standard-of-care therapies. The Phase 1 clinical trial of EPI-7386 began in calendar Q3 of 2020 following FDA allowance of ESSA’s Investigational New Drug application and Health Canada acceptance. EPI-7386 is also being studied in earlier line mCRPC patients in Phase 1/2 trials in combination with enzalutamide, apalutamide and abiraterone acetate with prednisone. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to EPI-7386 worldwide.

Corbus Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Corporate Update

On May 10, 2022 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), an immunology company, reported financial results for the first quarter of 2022 (Press release, Corbus Pharmaceuticals, MAY 10, 2022, View Source [SID1234614150]).

Key Corporate and Program Updates:

Anti-integrin monoclonal antibodies (mAb) program targeting the inhibition of TGFβ is progressing on schedule.
CRB-601, an anti-αvβ8 mAb, is being developed as a potential treatment for solid tumors. Corbus presented the first preclinical data for CRB-601 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022. The poster can be viewed at: www.corbuspharma.com/AACRposter.
The most recent data from CRB-601 will be presented on May 11, 2022 at the New York Academy of Sciences Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper). This new data demonstrates effects of CRB-601 in additional syngeneic animal models with increasing levels of resistance to check point inhibitors.
Across models explored to date, CRB-601 demonstrates an enhancement of anti-tumor activity when combined with anti PD-1 therapy compared to either single agent alone. This enhancement of efficacy is associated with tumor infiltration of proliferating CD4+ and CD8+ T cells in addition to NK cells and M1 macrophages.
Collectively, this data supports the hypothesis that blockade of local TGFb production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, potentially enhancing the benefit of PD-1 blockade.
IND-enabling activities for CRB-601 are ongoing and the program is on-schedule for an IND submission in the first half of 2023.

A lead candidate, CRB-913, has been selected for the CB1 inverse agonist program. In animal models of diet-induced obesity, CRB-913 induced weight loss and impacted multiple metabolic parameters, both as monotherapy and in combination with semaglutide and tirzepatide. Corbus is seeking partnerships to advance CRB-913 into clinical studies.

The National Institutes of Health sponsored Phase 2 study of lenabasum in systemic lupus erythematosus has completed its last patient visit and the clinical database has been locked. The Company is awaiting topline results. Corbus is pursuing potential partnerships to fund further development of lenabasum.

A detailed update on the Corbus pipeline can be found in the most recent Corporate Presentation available at: ir.corbuspharma.com/presentations
"We are executing our plan to transform Corbus into a company with a novel and diversified immuno-oncology pipeline. We’re excited about the first data to come out of our integrin program and for the opportunity to present it at scientific conferences. We look forward to entering the clinic in 2023," commented Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "We are actively engaging in business development activities with the goal of expanding our immuno-oncology pipeline while monetizing our ECS assets through new partnerships."

Financial Results for First Quarter Ended March 31, 2022:

The Company reported a net loss of approximately $9.4 million, or a net loss per diluted share of $0.08, for the three months ended March 31, 2022, compared to a net loss of approximately $16 million, or a net loss per diluted share of $0.14, for the same period in 2021.

Operating expenses decreased by $7.5 million to approximately $8.5 million for the three months ended March 31, 2022, compared to $16 million in the comparable period in the prior year. The decrease was primarily attributable to decreased clinical trial and drug manufacturing costs, and an overall reduction in compensation expense.

As of March 31, 2022, the company has $86.8 million of cash and investments on hand which is expected to fund operations into the first quarter of 2024, based on the current planned expenditures.

OncoHost Raises $35 Million Series C Funding Round to Launch Blood Test That May Rewrite the Standard of Care for Precision Oncology

On May 10, 2022 OncoHost, a global leader in next-generation precision oncology for improved personalized cancer therapy, reported the completion of a $35 million Series C funding round (Press release, OncoHost, MAY 10, 2022, View Source [SID1234614149]). The funding will go towards expanding OncoHost’s ongoing multicenter PROPHETIC trial which utilizes PROphet, the company’s machine learning-based host response profiling platform, and supporting the imminent U.S. commercial launch of the precision oncology diagnostic solution.

Leveraging advanced proteomic analysis and AI-based host response science, OncoHost’s PROphet platform is a personalized, real-time, dynamic ‘disease navigator’ that provides early identification of an individual’s responsiveness to cancer therapy, analysis of treatment resistance mechanisms, and potential available strategies to overcome this resistance. Clinical trial results have shown PROphet to have remarkably high accuracy in assessing non-small cell lung cancer (NSCLC) patient response at three months, six months and one year. Through one blood test pre-treatment, the company’s multi-patented platform also provides clinicians with potential combination strategies to overcome treatment resistance.

The funding round, which was upsized and oversubscribed, was led by ALIVE Israel HealthTech VC, a pioneer mid-to-late stage healthtech fund. Additional investors included leading Israeli financial firm Leumi Partners, Israel’s largest pension fund Menora Mivtachim, OurCrowd and other existing investors. ALIVE’s co-founder and general managing partner, Prof. Ari Shamiss, was recently named a new member of OncoHost’s board.

"OncoHost provides significant value to both cancer patients and their clinicians and it is an honor to have led this transformational funding round," said Prof. Ari Shamiss, "With promising and significant clinical results, OncoHost’s unique approach can create a brighter and better future for the world of precision oncology, maximizing the likelihood of selecting the correct therapy combinations and dramatically improving therapeutic results for cancer patients. We are confident that Oncohost is set to become a pivotal proteomics market leader in personalized oncology treatment."

"This is OncoHost’s third and most significant investment round to date, demonstrating the company’s maturity, credibility and scalability," said Dr. Ofer Sharon, CEO of OncoHost. "We are honored to be supported by leading local and global investment funds that understand and support our vision to shift the landscape of oncology to a truly personalized approach and want to be part of our journey in revolutionizing cancer care."

OncoHost continues to open additional clinical trial sites around the world and will be expanding its research to further cancer indications. PROphet is set to commercial launch in the U.S. in the third quarter of 2022.

Nature Medicine Publishes Results from an Investigator-Initiated Trial of CARsgen’s CT041 Claudin18.2 CAR T Cells in Gastrointestinal Cancers

On May 10, 2022 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that the phase I trial interim results of an investigator-initiated trial of CT041 have been published in Nature Medicine (View Source), which is one of the top international medical journals in the Nature Portfolio (2-year Impact Factor of 53.44) (Press release, Carsgen Therapeutics, MAY 10, 2022, View Source [SID1234614148]).

The publication, titled "Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase I trial interim results" presented results from a multi-center, open-label Phase I clinical trial conducted in China to explore the safety, efficacy, and cellular pharmacokinetics of CT041 in patients with advanced CLDN18.2-positive gastrointestinal cancers. The interim trial results showed that among 37 patients with advanced gastrointestinal cancers, CT041 was well tolerated with a manageable safety profile including no dose-limiting toxicity in 28 days post infusion, no grade ≥3 cytokine release syndrome, no neurotoxicity, and no treatment-related death. The objective response rate (ORR) and disease control rate (DCR) in patients with gastrointestinal cancers were 48.6% and 73.0%, respectively. In patients with gastric cancer or gastroesophageal junction cancer (GC/GEJ), the ORR and DCR reached 57.1% and 75.0%, respectively.

As of the date of this announcement, CT041 is the world’s first and only CAR T-cell candidate for the treatment of solid tumors entering a confirmatory Phase II clinical trial.

The corresponding author for the article, Professor Lin Shen of Beijing Cancer Hospital, said, "CAR T-cell therapy has successfully treated a variety of hematologic malignancies, while few breakthroughs have been made in solid tumors. CT041 is the first-in-class CAR T-cell product candidate against Claudin18.2. In this clinical trial, CT041 showed promising efficacy and manageable safety for patients with gastrointestinal cancers, particularly gastric cancer, who have failed prior lines of conventional therapies. As the largest clinical trial for solid tumors to date, the CAR T-cell therapy showed unprecedented efficacy against solid tumors. The publication of the interim trial results in Nature Medicine enables us to better share the results with our peers and advance CAR T-cell therapy in solid tumors. It also demonstrates the potential for more innovative, China-developed medicines to reach and benefit patients in global markets."

"This study is made possible by the joint efforts of CARsgen’s research and development team and our investigators, as well as the support and trust from the patients and their families. For CT041, the world’s first solid tumor CAR T-cell product candidate that has entered a confirmatory Phase II clinical trial, we will spare no efforts to advance the clinical trials and benefit patients as soon as possible," added Shen.

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, said, "Congratulations to the research team led by Prof. Shen. We thank the patients participating in the trial for their trust and thank all the researchers for their dedication. Publication of the interim CT041 trial results in Nature Medicine demonstrates the high quality and value of this trial. The development of innovative therapies has always been an arduous journey, particularly for effective CAR T-cell therapies against solid tumors. Despite these challenges, we started to collaborate with our investigators in 2015 for the treatment of hepatocellular carcinoma and glioblastoma. Since then, we have continued to explore innovative technologies and products. I am very glad to see the breakthrough interim results of CT041 in the research led by Prof. Shen. We will continue the joint efforts with our investigators in the global CT041 clinical development."

About CT041

CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first-in-class globally. CT041 targets the treatment of CLDN18.2-positive solid tumors with a primary focus on GC/GEJ and pancreatic cancer (PC).

In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib clinical trial for advanced GC/GEJ and PC, confirmatory Phase II clinical trial for advanced GC/GEJ in China and initiated a Phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in North America. CARsgen also intends to initiate a pivotal Phase 2 clinical trial in North America in 2022.

CARsgen plans to submit an NDA to the NMPA in China in the first half of 2024 and to submit the BLA to the U.S. FDA in 2024.

In 2020 and 2021, CT041 received Orphan Drug designation from the U.S. FDA for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA for the treatment of advanced gastric cancer. In November 2021, CT041 was granted PRIME Eligibility by the EMA for the treatment of advanced gastric cancer. In January 2022, CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. FDA for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors.

As of the date of the announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with IND/CTA approvals from the FDA, the NMPA, and Health Canada.

Bridge Biotherapeutics to Announce Updated Data from its Phase 1 Study of BBT-176 in Advanced Non-Small Cell Lung Cancer in an Oral Presentation at IASLC 2022 World Conference on Lung Cancer

On May 10, 2022 Bridge Biotherapeutics Inc. (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer, fibrosis and inflammation, reported it will deliver an oral presentation highlighting the analysis data from the first-in-patient study of BBT-176[1] at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (IASLC 2022 WCLC) (Press release, Bridge Biotherapeutics, MAY 10, 2022, View Source [SID1234614147]).

At its latest presentation to investors, Bridge Biotherapeutics shared interim Phase 1 study data of BBT-176 in advanced non-small cell lung cancer (NSCLC) showing that the drug candidate was well-tolerated and demonstrated efficacy against EGFR-mutation positive NSCLC, including C797S containing EGFR triple mutations. According to the company’s presentation, BBT-176 has shown anti-tumor efficacy with two partial response cases, one in the 160 mg QD cohort (51 percent tumor shrinkage) and the other in the 320 mg QD cohort (30 percent tumor shrinkage).

Pharmacokinetics data show that BBT-176 exhibits dose-dependent exposure. In addition, safety data have shown that adverse events (AEs) typically associated with EGFR inhibitors have been found but were limited to Grade 1-3 adverse events. The Phase 1 dose escalation study will be continued through an exploratory cohort to determine the maximum tolerable dose (MTD) and recommended Phase 2 dose (RP2D).

Sang-Yoon Lee, M.D., Bridge Biotherapeutics’ chief medical officer, said, "We are encouraged by these interim results from our Phase 1 trial of BBT-176, a fourth-generation EGFR TKI. In addition to continuing the trial, Bridge Biotherapeutics is promoting innovation by exploring the potential clinical value of liquid biopsies for both diagnosis and evaluation of therapeutic responses in NSCLC. We believe this will be another innovative aspect of our clinical development of BBT-176. Bridge Biotherapeutics remains focused on delivering novel treatment options to address the high unmet medical needs of advanced NSCLC patients."

The company’s oral presentation on BBT-176 is expected to be held on August 8, during IASLC 2022 WCLC, in Vienna, Austria.