On August 21, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a GSK-sponsored Phase 1/2 clinical trial to evaluate GSK101 (IDE705), a small molecule inhibitor of Pol Theta Helicase, in combination with niraparib, the GSK small molecule inhibitor of poly-(ADP-ribose) polymerase (PARP), for the treatment of patients having tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD) (Press release, Ideaya Biosciences, AUG 21, 2023, View Source [SID1234634603]).

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"There remains an unmet medical need for patients having tumors with homologous recombination mutations, such as BRCA1/2 mutations. Based on Pol Theta’s critical role in microhomology-mediated end joining and BRCA reversions, a central mechanism of resistance to PARP inhibitors, we view the niraparib and GSK101 combination as having potential to improve depth and duration of tumor responses that could potentially impact longer-term outcomes for these cancer patients," said Dr. Ramon Kemp, Vice President, Global Head of Oncology Early Development, GSK.

"We are pleased to have our fourth potential first-in-class program advance into the clinic with GSK101, and we believe GSK is well-positioned to maximize the value of GSK101 by creating a potential best-in-class combination with niraparib to treat solid tumors. We are also targeting the Werner Helicase development candidate nomination later this year with GSK, which represents our fifth potential first-in-class program," said Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences.

GSK101 is a potential first-in-class small molecule inhibitor of the helicase domain of DNA Polymerase Theta (Pol Theta). The Pol Theta enzyme facilitates DNA repair through microhomology-mediated end joining (MMEJ), an enzymatic function that enables reversion of BRCA mutations. Approximately 30% of patients who progress following treatment with PARP inhibitors have tumors with MMEJ signatures at reversion sites, reflecting a significant medical need and potential commercial opportunity for GSK101 in combination with niraparib.

GSK101 was discovered and preclinically evaluated by IDEAYA in collaboration with GSK. In preclinical studies, the GSK101 and niraparib combination resulted in deeper and more durable regressions or efficacious responses relative to either single agent in BRCA mutant models.

GSK is targeting first-in-human studies for GSK101 in the fourth quarter of 2023. GSK is the sponsor of the IND application and plans to develop GSK101 in combination with niraparib in a Phase 1/2 clinical trial for patients with advanced solid tumors who have exhausted standard of care options and who may benefit from a PARP or POLQ inhibitor, pursuant to the clinical protocol. Enrollment may include patients harboring tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD).

GSK will lead clinical development for the Pol Theta program pursuant to its global, exclusive license to develop and commercialize the Pol Theta Helicase Inhibitor DC (GSK Pol Theta License). GSK is responsible for all research and development costs for the program. IDEAYA is eligible to receive a $7 million milestone payment upon acceptance of the IND by the U.S. Food and Drug Administration (FDA), and a potential additional $10 million milestone payment upon initiation of Phase 1 clinical dose expansion. IDEAYA may potentially also receive further aggregate later-stage development and regulatory milestones of up to $465 million.

Upon potential commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones and tiered royalties on global net sales by GSK, its affiliates and their sublicensees ranging from high single digit to sub-teen double-digit percentages, subject to certain customary reductions.

On August 21, 2023 ProMIS Neurosciences Inc. (Nasdaq: PMN) ("ProMIS" or the "Company"), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), reported that it has entered into a securities purchase agreement with certain new and existing accredited investors to issue and sell an aggregate of approximately $20.4 million of (a) common share units, each consisting of one of the Company’s common shares (the "Common Shares") and one warrant to purchase one Common Share (the "Warrants") (the "Common Share Units") and (b) pre-funded units, each consisting of one pre-funded warrant to purchase one Common Share and one Warrant (the "Pre-Funded Units") (Press release, ProMIS Neurosciences, AUG 21, 2023, View Source [SID1234634602]). The Common Share Units were sold at a price of $1.88 per unit and the Pre-Funded Warrants were sold at a price of $1.87 per unit through a private investment in public equity ("PIPE") financing.

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The PIPE included participation from Affinity Asset Advisors, LLC, Ally Bridge Group, Sphera Healthcare and other institutional and individual accredited investors.

ProMIS anticipates the gross proceeds from the PIPE to be approximately $20.4 million, before deducting fees to the placement agents and other offering expenses payable by the Company. The financing is expected to close on August 23, 2023, subject to customary closing conditions.

Proceeds from the PIPE financing are expected to be used to advance the clinical development of PMN310, ProMIS’ lead therapeutic candidate, as well as for working capital and other general corporate expenses.

Certain directors and officers of the Company are subscribing for up to approximately $145,000 of Common Share Units. The issuance of Common Share Units to insiders will be considered a "related party transaction" within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company is relying on exemptions from the formal valuation requirements of MI 61-101 pursuant to section 5.5(a) and the minority shareholder approval requirements of MI 61-101 pursuant to section 5.7(1)(a) in respect of such insider participation as the fair market value of the transaction, insofar as it involves interested parties, does not exceed 25% of the Company’s market capitalization.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended ("Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. ProMIS Neurosciences has agreed to file a registration statement with the SEC registering the resale of the Common Shares and the Common Shares issuable upon the exercise of the Pre-Funded Warrants and Warrants issued in the PIPE financing.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or other jurisdiction.

On August 21, 2023 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML) (Press release, Gilead Sciences, AUG 21, 2023, View Source [SID1234634601]).

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The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes (HR-MDS).

Effective immediately, screening and enrollment of new study participants under the U.S. investigational new drug application (IND 147229) and U.S. Expanded Access Program will be paused. Patients already enrolled in AML clinical studies may continue to receive treatment and be monitored, according to the current study protocol. Global regulatory authorities and clinical trial investigators involved in the studies have been informed of the FDA’s decision. Studies of magrolimab in solid tumors continue without any impact from the FDA action.

Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment in the magrolimab AML studies.

Magrolimab is an investigational agent and has not been approved anywhere globally. Its safety and efficacy have not been established.

About Magrolimab

Magrolimab is a potential first-in-class investigational anti-CD47 immunotherapy. The primary mechanism of action of magrolimab is to block the inhibitory CD47-signal regulatory protein (SIRPα) interaction, enhancing the ability of macrophages and other phagocytes to identify and destroy foreign and malignant cells, with the goal of blocking the "don’t eat me" signal used by cancer cells. Magrolimab is being developed as a potential treatment for AML, myeloid malignancies, lymphoma, myeloma, head and neck cancer, colorectal cancer, lung cancer, and breast cancer. More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.

On August 21, 2023 Soligenix, Inc. (NASDAQ: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended June 30, 2023 (Press release, Soligenix, AUG 21, 2023, View Source [SID1234634599]).

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"During the second quarter we advanced multiple clinical trials, while continuing our collaborative discussions with the U.S. Food and Drug Administration (FDA) regarding the design of a second, confirmatory Phase 3 pivotal study evaluating HyBryte (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL), where we successfully demonstrated statistically significant results in the first Phase 3 clinical trial," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "A HyBryte expanded treatment CTCL trial at the University of Pennsylvania was recently opened for patient enrollment, supported by a $2.6 million Orphan Products Development grant award from the FDA. We are continuing to actively enroll patients in the Phase 2a trial of SGX302 (synthetic hypericin sodium) for the treatment of mild-to-moderate psoriasis after demonstration of a clear biological signal in all five of the initial patients, with the majority recording an improvement in their PASI (psoriasis area and severity index) score. Additionally, we announced positive clinical results from a compatibility study evaluating HyBryte in the treatment of CTCL that confirmed and extended response results from the first Phase 3 study conducted."

Dr. Schaber continued, "During the second quarter of 2023, we completed a public offering with gross proceeds of approximately $8.5 million, which has allowed us to continue to move our rare disease pipeline forward. With approximately $13.2 million in cash at June 30, 2023, we are managing cash burn very carefully in order to achieve our near-term milestones, as we continue to assess all strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On August 10, 2023, the Company announced that patient enrollment had been opened for the HyBryte expanded treatment investigator-initiated CTCL study at the University of Pennsylvania, supported by a $2.6 million Orphan Products Development grant award from the FDA. To view this press release, please click here.
On July 11, 2023, the Company announced the expansion of its Phase 2a trial of SGX302 for the treatment of mild-to-moderate psoriasis after demonstration of biological effect in all five of the initial subjects. To view this press release, please click here.
On May 16, 2023, the Company announced the European Patent Office had granted a patent entitled "Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis". To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2023

Soligenix’s revenues for the quarters ended June 30, 2023 and 2022 were $0.2 million. Revenues primarily relate to third party licensing and the government contracts and grants awarded in support of HyBryte, our therapeutic candidate for early-stage CTCL; SGX943, our therapeutic candidate for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s net loss was $1.6 million, or ($0.22) per share, for the quarter ended June 30, 2023, as compared to $2.4 million, or ($0.83) per share, for the quarter ended June 30, 2022. The decrease in net loss was primarily due to a decrease in operating expenses.

Research and development expenses were $0.8 million as compared to $2.0 million for the quarters ended June 30, 2023 and 2022, respectively. The decrease was primarily due to the decrease in manufacturing and regulatory costs associated with the HyBryte new drug application filing.

General and administrative expenses were $0.9 million and $1.4 million for the quarters ended June 30, 2023 and 2022, respectively. This decrease in general and administrative expenses is primarily attributable to a reduction in legal and consulting expenses associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries.

As of June 30, 2023, the Company’s cash position was approximately $13.2 million.

On August 21, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported that its clinical development partners, AgonOx, Inc. and Providence Cancer Institute of Oregon, have dosed their first patient in an Adoptive Cell Therapy clinical trial (Press release, Phio Pharmaceuticals, AUG 21, 2023, View Source [SID1234634598]).

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This first-in-human trial is investigating the safety and the potential for enhanced therapeutic benefit from the administration of AgonOx’s AGX148 ‘double positive’ (DP) CD8 tumor-infiltrating lymphocytes (TIL) alone and in combination with Phio’s PD-1 silencing PH-762 in patients with melanoma and other advanced solid tumors. More information about this clinical trial is available at clinicaltrials.gov. The clinical trial is one of two studies cleared by the FDA which will utilize Phio’s lead product candidate, PH-762.

The trial is being conducted at Providence Cancer Institute in Portland, Oregon, by Principal Investigator Brendan Curti, M.D., medical oncologist and Robert W. Franz Endowed Chair for Clinical Research at the Earle A. Chiles Research Institute, a division of Providence. "Our institute has been at the leading edge of immunotherapy clinical research including checkpoint immunotherapy, novel co-stimulatory agents and cancer vaccines," said Dr. Curti. "Our vision of the future is to select and engineer immune cells with enhanced abilities to attack tumors. We have a strong record of accomplishment in translating laboratory ideas into clinical practice. The work with Dr. Weinberg is another example of exciting first-in-human translational science from our Institute and its many ongoing collaborations."

"TIL therapies hold the promise of clinical benefit in patients with solid malignancies. This product is different from current TIL therapies as we are selectively expanding the tumor-reactive T cells and potentially increasing their potency by reducing PD-1 suppression," said Andrew Weinberg, Ph.D., Founder and CSO of AgonOx, Inc., and Judith Ann Hartmann Endowed Chair for the Laboratory of Basic Immunology at the Earle A. Chiles Research Institute.

"This is an important collaborative milestone between these organizations in the advancement of treatments for solid tumors," said Robert Bitterman, President and CEO of Phio Pharmaceuticals.