On February 13, 2024 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that management will present at the 2024 BIO CEO & Investor Conference being held on February 26-27, 2024, in New York, NY (Press release, Sapience Therapeutics, FEB 13, 2024, View Source;investor-conference-302060120.html [SID1234640053]).

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Sapience CEO and President, Dr. Barry Kappel, will present a company overview on Monday, February 26, 2024, at 4:00 pm ET. Company management will also participate in one-on-one meetings with investors during the conference.

More information can be found on the BIO CEO & Investor Conference website.

On February 13, 2024 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ("SHPH" or the "Company"), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), along with its wholly-owned subsidiary, Shuttle Diagnostics, Inc., a Maryland corporation ("Diagnostics"), reported its intent to commence a Rights Offering where it plans to raise up to $4.5 million through the distribution of subscription rights and the exercise thereof, which full rights will entitle existing SHPH stockholders to purchase from the Company units (the "Units"), with each Unit consisting of (i) one share of SHPH common stock, (ii) a warrant to purchase one share of SHPH common stock exercisable at a per share purchase price of $2.35 per share, and (iii) a percentage of equity interest in Diagnostics (Press release, Shuttle Pharmaceuticals, FEB 13, 2024, View Source [SID1234640052]). The Units will be sold at a per Unit price equal to 90% of the VWAP of SHPH common stock for the five trading days immediately preceding closing.

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SHPH has separately entered into a securities purchase agreement with SRO LLC, a Nevada limited liability company, pursuant to which SRO LLC agreed to commit to purchasing from the Company $2.25 million of Units from the Company. In addition, in the event the Company fails to raise a full $4.5 million in the Rights Offering, SRO LLC agreed to a backstop commitment pursuant to which it would have the right to purchase any remaining Units not purchased by existing SHPH stockholders in the Rights Offering, up to an additional $2.25 million.

In conjunction with its entry into the Purchase Agreement, on February 7, 2024, the Company entered into a placement agent and advisory services agreement with Boustead Securities, LLC ("BSL"), pursuant to which BSL and BSL’s affiliates will provide the Company with regular and customary financial consulting advice and will act as placement agent, on a best efforts basis, for the Rights Offering.

SHPH intends to file with the Securities and Exchange Commission (the "Commission") a registration statement under the Securities Act of 1933, as amended, in order to effect the Rights Offering, which Rights Offering will be made to holders of SHPH common stock, and other security holders having the right to participate, as of a yet-to-be-determined record date. SHPH currently plans to fix a record date following its filing of a registration statement on Form S-1 registering the Rights Offering and after it completes the requisite review process by the Commission’s staff. At such time, SHPH stockholders as of the record date will be notified of their right to participate in the Rights Offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy nor will there be any sale of any securities referred to in this press release in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. The Rights Offering, when commenced, will be made only by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

On February 13, 2024 Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, reported that it has entered into agreements with VBI Vaccines, Inc. ("VBI", NASDAQ: VBIV), ensuring expansion and control of future clinical and commercial supplies of BRII-179, a late-stage clinical asset in Brii Bio’s HBV functional cure portfolio (Press release, VBI Vaccines, FEB 13, 2024, View Source [SID1234640051]).

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Under these agreements, Brii Bio will issue a $2.5 million promissory note to VBI initially. This will eliminate royalty and milestone payments for PreHevbri. Upon meeting specific conditions, the note will increase to $10 million, securing all of VBI’s intellectual properties (IP) for BRII-179, with associated payments also eliminated. In addition, subject to certain approvals, Brii Bio and VBI will work together to transfer the manufacturing technologies of BRII-179 to a site designated by Brii Bio. Upon completion of essential activities relating to such technology transfer, subject to certain potential adjustments, Brii Bio will issue up to an additional $8 million promissory note to VBI. After satisfaction of certain conditions, Brii Bio will also take control of VBI’s Rehovot-based manufacturing facilities for BRII-179 and PreHevbrio/PreHevbri for $10 million cash on or after June 30, 2024, when Brii Bio and VBI plan to enter into supply agreement under which Brii Bio will become VBI’s commercial supplier for PreHevbrio and PreHevbri.

Separately, subject to achievement of certain conditions by VBI, Brii Bio will secure an exclusive license to develop and commercialize VBI-1901, VBI’s glioblastoma (GBM) immunotherapeutic candidate, in the Asia Pacific (APAC) region excluding Japan and issue a $5 million promissory note to VBI. VBI-1901 has received fast-track and orphan drug designations from the U.S. Food and Drug Administration (FDA) and a Phase 2b study is ongoing.

"We are grateful to our VBI colleagues at the Rehovot site who despite significant challenges continued to provide uninterrupted supplies of BRII-179," said Dr. Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "As Brii transitions to late-stage development of HBV programs, a global manufacturing strategy becomes critically important. We look forward to working together with the biologics manufacturing experts at the Rehovot site and timely integration of our R&D and manufacturing capabilities."

About BRII-179

BRII-179 (VBI-2601) is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. BRII-179 is currently being investigated in two Phase 2 clinical trials in combination with BRII-835 or PEG-IFNα as part of a potential functional cure regimen for the treatment of chronic HBV infection.

Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018, providing Brii Bio with commercial rights to BRII-179 in the licensed territories of China, Hong Kong, Macau, and Taiwan. The exclusive license for BRII-179 has been extended to worldwide markets since July 2023. In November 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the "NMPA") granted BRII-179 Breakthrough Therapy Designation.

About PreHevbri

PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio (US/Canada), PreHevbri (EU/EEA/UK), and Sci-B-Vac (Israel).

About VBI-1901

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.

On February 13, 2024 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 a corporate update and provided financial results for the fiscal first quarter ended December 31, 2023 (Press release, ESSA, FEB 13, 2024, View Source [SID1234640050]).

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"As we enter 2024, we are focused on advancing the investigation of masofaniten in combination with second-generation antiandrogen agents, with the goal of improving clinical outcomes for patients battling prostate cancer," said David Parkinson, MD, President and CEO of ESSA. "We are extremely pleased with the data reported to date from the Phase 1 dose escalation study evaluating masofaniten combined with enzalutamide in patients with mCRPC naïve to second generation anti-androgens where we continue to observe compelling, deep and durable reductions in prostate-specific antigen ("PSA"), along with an encouraging 16.6 month median time to PSA progression. We look forward to reporting updated Phase 1 dose escalation data during 2024. In addition, we continue to advance enrollment in both Phase 1 arms evaluating masofaniten in combination with apalutamide or abiraterone acetate, respectively, and look forward to reporting preliminary data during the second half of 2024."

"On the financial front, we are bolstered by our strong cash position that we expect will provide sufficient runway to fund our planned operations through several data readouts and beyond 2025. We are excited to execute on our key 2024 objectives which we believe will meaningfully advance the investigation of masofaniten and look forward to providing updates on our progress throughout the year," concluded Dr. Parkinson.

First Quarter Fiscal 2024 and Recent Highlights

Masofaniten Combination Studies

Reported Phase 1 dose escalation data at multiple medical meetings from the four cohorts of its ongoing Phase 1/2 study evaluating masofaniten in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens but may have been treated with chemotherapy in the metastatic castration-sensitive setting. These data were presented at the 2024 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium, the 2023 Prostate Cancer Foundation Scientific Retreat and at the European Society for Medical Oncology 2023 Congress. As of the most recent data presentation, the results demonstrated that the combination continues to be well tolerated at the dose levels tested through up to 25 cycles of dosing in some patients. Deep and durable reductions in PSA were observed across evaluable patients for efficacy in all dosing cohorts (n=16). Across all dosing cohorts, 88% of patients achieved PSA50, 81% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 63% of patients achieved PSA <0.2ng/mL. While the data for time to PSA progression are still maturing with a current median follow up of 11.1 months, the median time to PSA progression is 16.6 months. ESSA expects to report updated data from the Phase 1 dose escalation study during the second half of 2024.
Enrollment is underway in the Phase 2 portion of the Phase 1/2 study evaluating the combination of masofaniten and enzalutamide compared to enzalutamide monotherapy in patients with mCRPC naïve to second-generation antiandrogens but who may have been treated with chemotherapy in the metastatic castration-sensitive setting. The Phase 2 portion of the study is an open-label randomized study comparing 160 mg once-daily of single agent enzalutamide to the combination of masofaniten with enzalutamide, and is expected to enroll approximately 120 patients. The recommended Phase 2 combination dose was identified as masofaniten 600 mg twice-daily combined with enzalutamide 160 mg once daily. The study is currently enrolling at approximately 25 sites in the USA, Canada and Australia. Expansion to European sites is in progress. ESSA plans to provide guidance for timing of the public disclosure of initial data once the Phase 2 portion has been underway for several months.
Initiated two additional masofaniten combination arms as part of the ongoing Phase 1 masofaniten study. One arm will evaluate masofaniten in combination with abiraterone acetate and prednisone in patients with either metastatic castration-sensitive prostate cancer or mCRPC while the second arm will evaluate masofaniten in combination with apalutamide in patients with non-metastatic castration-resistant prostate cancer after 12 weeks of masofaniten single agent. ESSA expects to report preliminary data from these Phase 1 arms during the second half of 2024.
An investigator-sponsored neoadjuvant study was also initiated evaluating neoadjuvant use of the combination of masofaniten and darolutamide compared to darolutamide monotherapy in high-risk patients undergoing prostatectomy.
Masofaniten Monotherapy Study

On track to complete the Phase 1b masofaniten monotherapy study evaluating masofaniten in patients with late-line mCRPC, which is currently ongoing. The initial results from the study were reported at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium, which demonstrated that masofaniten monotherapy was well-tolerated, achieved clinically significant exposures, and showed preliminary signals of anti-tumor activity in a subset of patients. ESSA plans to present the complete Phase 1a and 1b monotherapy results in 2024 at a medical conference.
Summary Financial results
(Amounts expressed in U.S. dollars)

Net Loss. ESSA recorded a net loss of $6.0 million for the first quarter ended December 31, 2023 compared to $6.7 million for the first quarter ended December 31, 2022. The decrease in the first quarter was primarily attributed to an increase in investment income over the prior period of $0.5 million.
Research and Development ("R&D") expenditures. R&D expenditures for the first quarter ended December 31, 2023 were $5.4 million compared to $5.3 million for the first quarter ended December 31, 2022, and include non-cash costs related to share-based payments $526,241 for the first quarter ended 2023 compared to $791,192 for the first quarter ended 2022. Reduced expenditure on manufacturing for the period was offset by additional investment in the clinical trial work on masofaniten.
General and Administration ("G&A") expenditures. G&A expenditures for the first quarter ended December 31, 2023 were $2.2 million compared to $2.5 million for the first quarter ended December 31, 2022 and include non-cash costs related to share-based payments of $277,177 for the first quarter ended 2023 compared to $772,419 for the first quarter ended 2022. The overall expenditure is largely comparable to the Company’s additional spend on professional fees to update Company’s documents for its shelf prospectus and ATM program.
Liquidity and Outstanding Share Capital

As of December 31, 2023, the Company had available cash reserves and short-term investments of $142.1 million. The Company’s cash position is expected to be sufficient to fund current and planned operations beyond 2025.
On November 6, 2023, the Company announced that it had entered into an Open Market Sale AgreementSM (the "ATM Sales Agreement") with Jefferies LLC, effective as of November 3, 2023. Under the ATM Sales Agreement, ESSA may, within the period that the ATM Sales Agreement is in effect, sell its common shares from time to time for up to $50.0 million in aggregate sales proceeds. No offers or sales of common shares will be made in Canada, to anyone known by Jefferies LLC to be a resident of Canada or on or through the facilities of any stock exchange or trading markets in Canada.
As of December 31, 2023, the Company had 44,163,647 common shares issued and outstanding.
In addition, as of December 31, 2023, there were 2,920,000 common shares issuable upon the exercise of prefunded warrants at an exercise price of $0.0001.

On February 13, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), reported that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registrational Phase III trial of olverembatinib (HQP1351) in previously treated adult patients with chronic-phase chronic myeloid leukemia (CML-CP) (Press release, Ascentage Pharma, FEB 13, 2024, View Source;cleared-by-fda-302061303.html [SID1234640049]).

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Under protocol HQP1351CG301, titled "A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2)," the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation. The US FDA’s clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted. The trial is scheduled to commence during the first half of 2024.

Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma. As the first and only China-approved third-generation BCR-ABL inhibitor, olverembatinib can effectively target BCR-ABL and a spectrum of BCR-ABL mutants, including the T315I mutation. In November 2021, olverembatinib was approved in China for the treatment of adult patients with TKI-resistant CML-CP or accelerated-phase CML (CML-AP) harboring the T315I mutation. In November 2023, olverembatinib was approved for a new indication in adult patients with CML-CP resistant and/or intolerant of first-and second-generation TKIs. And in early 2024, the drug was included in the latest guidelines from the National Comprehensive Cancer Network (NCCN) for the management of CML.

Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma, remarked that, "FDA’s clearance of POLARIS-2 marks another major milestone for olverembatinib and our company at large, as we conduct a range of global registrational trials of our major assets to combat challenging hematologic malignancies. We are most encouraged that our cutting-edge, patient-centric innovation, which has culminated in a safe and effective treatment in China even in patients with relapsed, refractory, and/or difficult-to-treat cases of CML, will bring meaningful improvement to patients’ lives. Recent inclusion of olverembatinib in the prestigious NCCN CML management guidelines also marks another major milestone for olverembatinib, signalling its widespread acceptance by the oncology community. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will continue to investigate olverembatinib and accelerate our clinical development programs to benefit more patients."

*Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland.