On August 14, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported the ESMO (Free ESMO Whitepaper) Congress decided to move C4T’s previously accepted preliminary monotherapy Phase 1 abstract for CFT1946, a novel BiDAC degrader in mutant BRAF V600 solid tumors, to an oral presentation (Press release, C4 Therapeutics, AUG 14, 2024, View Source [SID1234645892]). This oral presentation session at the ESMO (Free ESMO Whitepaper) Congress 2024 is scheduled for Friday, September 13, 2024, at 4:00 pm to 5:30 pm CEST. Additionally, C4T announced it will host an investor webcast on Friday, September 13, 2024.

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Updated Details for ESMO (Free ESMO Whitepaper) Congress 2024 Presentation
Title: Preliminary Results from a Phase 1 Study of CFT1946, a Novel BiDAC Degrader in Mutant BRAF V600 Solid Tumors
Presentation Date and Time: Friday, September 13, 2024, 4:00 – 5:30 pm CEST
Final Publication Number: 612O
Presenter: Maria Vieito, M.D., Msc (Barcelona, Spain)

C4T Webcast for Analysts and Investors
C4T will host an investor webcast on Friday, September 13, 2024 to discuss the CFT1946 monotherapy data from ongoing CFT1946 Phase 1 trial in BRAF V600 solid tumors. The time of the webcast and access information will be shared closer to the webcast event.

On August 14, 2024 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that allowance for the Company’s "proenzyme composition" patent was received from the Canadian Intellectual Property Office (CIPO) (Press release, Propanc, AUG 14, 2024, View Source [SID1234645927]). The patent broadly captures both high dose and high ratio claims for future clinical doses of the company’s lead asset, PRP. This is the second Canadian patent either allowed or granted in this important North American jurisdiction. Currently, the Company’s intellectual property portfolio consists of 93 patents filed in major jurisdictions relating to the use of PRP against solid tumors.

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The proenzymes composition patent is an important part of the IP portfolio covering possible future clinical dosage ranges for PRP, as the Company advances to a Phase 1, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors. The patent has been granted in major jurisdictions such as Europe, Japan and South East Asia, and is currently under examination in the United States. PRP is targeting the global metastatic cancer treatment market, projected to be worth US$111.2 Billion by 2027, according to current analysis by Emergen Research.

"We continue to grow our intellectual property portfolio in key global jurisdictions," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "Our lead asset, PRP, is a novel method to prevent and treat metastatic cancer from solid tumors, but without the severe, or even serious side effects normally associated with standard therapies. The proenzymes composition patent will cover future PRP clinical doses as a welcome addition to the treatment process, such as when resistant tumors could be pretreated by PRP, as a chemo-sensitizing agent. This practical application of our patent portfolio provides a strong indication of our commercial embodiment for future licensing partners, which we believe can potentially revolutionize the way we treat metastatic cancer from solid tumors. Today, metastatic cancer remains the main cause of patient death for sufferers. We look forward to updating our shareholders as we progress."

About PRP:

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (FDA) for treatment of pancreatic cancer.

To view the Company’s "Mechanism of Action" video on the Company’s lead asset, PRP, please click on the following link: View Source

On August 14, 2024 RemeGen Co. Ltd. (688331.SH/09995.HK) reported that 484 subjects have been enrolled in 74 sites across China in the "randomized, open-label, parallel, controlled and multicenter phase 3 clinical study of Disitamab Vedotin for injection plus Toripalimab vs Gemcitabine plus cisplatin/carboplatin for HER2-expressing locally advanced or metastatic urothelial carcinoma" led by Professor Jun Guo from Beijing Cancer Hospital and Professor Aiping Zhou from Cancer Hospital Chinese Academy of Medical Sciences (Press release, RemeGen, AUG 14, 2024, View Source;cid=115&id=2261 [SID1234656127]).

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This study was initiated in June, 2022 and aimed at comparing the efficacy and safety between Disitamab Vedotin plus Toripalimab and Gemcitabine plus cisplatin/carboplatin in treating HER2-expressing (HER2 IHC 1+, 2+ or 3+) locally advanced or metastatic urothelial carcinoma. HER2-expressing locally advanced or metastatic urothelial carcinoma patients who did not receive systemic treatment (including chemotherapy, targeted therapy and immunotherapy) before were enrolled in this study.

Platinum-based chemotherapy is the current standard of care (SOC) for locally advanced or metastatic urothelial carcinoma but has less favorable long-term efficacy. Urothelial carcinoma is the second indication of Disitamab Vedotin approved in China at the end of 2021 for the treatment of locally advanced or metastatic urothelial carcinoma patients with HER2 IHC 2+ or 3+, who received platinum-containing chemotherapy before. According to the clinical data for the initial BLA submission, the objective response rate (ORR) based on assessment by the Independent Review Committee reached 50.5%, the median progression-free survival (PFS) was 5.9 months and the median overall survival (OS) was 14.2 months, demonstrating significant efficacy and clinical benefit. Another exploratory study of Disitamab Vedotin combined with PD-1 inhibitor also had remarkable results which have been reported by ASCO (Free ASCO Whitepaper) for several times. The phase 3 study based on the above clinical data will be helpful for the transition of Disitamab Vedotin from later-line treatment to first-line treatment, bringing better survival benefits for more patients.

On August 14, 2024 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the second quarter ended June 30, 2024 and other recent business developments (Press release, Celcuity, AUG 14, 2024, View Source [SID1234645893]).

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"We made significant strides advancing the clinical development of gedatolisib this quarter. Overall enrollment in VIKTORIA-1 remains robust and on-track relative to our previous projections," said Brian Sullivan, CEO and co-founder of Celcuity. "We also initiated efforts to launch VIKTORIA-2, a Phase 3 study to evaluate gedatolisib as a first-line treatment option for patients with HR+, HER2- advanced breast cancer."

"In our VIKTORIA-1 study, while overall enrollment is on track, the proportion of patients who have PIK3CA wild-type tumors, versus those with PIK3CA mutations, has recently shifted lower than our original estimates. As a result, we expect to reach the enrollment target for the PIK3CA wild-type cohort in the fourth quarter, rather than the third quarter, as we originally forecasted. In light of this, we expect topline data for the PIK3CA WT cohort to shift to sometime between late Q4 2024 and Q1 2025."

Second Quarter 2024 Business Highlights and Other Recent Developments

● The VIKTORIA-1 Phase 3 trial expects to provide topline data for the PIK3CA wild-type cohort in late Q4 2024 or Q1 2025 and for the PIK3CA mutant cohort in the first half of 2025.

○ VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant with and without palbociclib in adults with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor.
○ Enrollment of the PIK3CA wild-type cohort is more than 80% complete and expected to reach the enrollment target during Q4 2024. The PIK3CA wild-type cohort represents approximately 60% of the total patients enrolled to date in VIKTORIA-1.

● In May, the Company announced its plan to initiate VIKTORIA-2, a Phase 3 study to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant plus a CDK4/6 inhibitor, either ribociclib or palbociclib, in comparison to fulvestrant plus a CDK4/6 inhibitor as a first-line treatment for patients with HR+/HER2- advanced breast cancer.

○ A safety run-in study to evaluate the safety of gedatolisib combined with ribociclib and fulvestrant will precede initiation of the Phase 3 portion of the study.
○ The Phase 3 portion of the study is expected to enroll approximately 638 patients at up to 200 sites across North America, Europe, Latin America, and Asia.
○ First patient enrollment is expected in the second quarter of 2025.

● During the quarter, the Company secured a combined total of $129 million in gross proceeds from equity and debt financings, which extended the cash runway for current clinical development program activities through 2026.

● The Phase 1b/2 trial, evaluating gedatolisib in combination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), remains on track to report preliminary data in the first half of 2025.

○ Enrollment is ongoing and the trial is expected to enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor signaling inhibitor.

● Three manuscripts reporting clinical and nonclinical results for gedatolisib were published recently.

○ In April, The Lancet Oncology published results from the dose expansion groups of its Phase 1b study evaluating gedatolisib in combination with palbociclib and endocrine therapy in HR+/HER2- advanced breast cancer. The published manuscript is available online and on the publications section of Celcuity’s website.
○ In June, npj Breast Cancer published results of nonclinical studies showing gedatolisib’s superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. The article is available online and on the publications section of Celcuity’s website.
○ In August, Molecular Oncology published results of nonclinical studies in prostate cancer models showing gedatolisib’s superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors. The article is available online and will soon be available on the publications section of Celcuity’s website.

Second Quarter 2024 Financial Results

Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2024, compared to the second quarter ended June 30, 2023.

Total operating expenses were $24.3 million for the second quarter of 2024, compared to $15.1 million for the second quarter of 2023.

Research and development (R&D) expenses were $22.5 million for the second quarter of 2024, compared to $13.8 million for the prior-year period. Of the approximately $8.7 million increase in R&D expenses, $6.6 million primarily related to activities supporting the VIKTORIA-1 Phase 3 trial and the initiation of the CELC-G-201 Phase 1b/2 clinical trial, and $2.1 million was related to increased employee and consulting expenses.

General and administrative (G&A) expenses were $1.8 million for the second quarter of 2024, compared to $1.3 million for the prior-year period. Employee and consulting related expenses accounted for $0.3 million of the increase. Professional fees and other administrative expenses accounted for the remaining increase of approximately $0.2 million.

Net loss for the second quarter of 2024 was $23.7 million, or $0.62 loss per share, compared to a net loss of $14.6 million, or $0.66 loss per share, for the second quarter of 2023. Non-GAAP adjusted net loss for the second quarter of 2024 was $22.2 million, or $0.58 loss per share, compared to non-GAAP adjusted net loss of $11.1 million, or $0.51 loss per share, for the second quarter of 2023. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the second quarter of 2024 was $18.1 million, compared to $9.7 million for the second quarter of 2023.

At June 30, 2024, Celcuity reported cash, cash equivalents and short-term investments of $283.1 million.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the second quarter 2024 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 or 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=c55c86e8c3. A replay of the webcast will be available on the Celcuity website following the live event.

On August 14, 2024 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, Pyxis Oncology, AUG 14, 2024, View Source [SID1234645928]). The Company ended the second quarter of 2024 with $157.2 million in cash, cash equivalents, restricted cash and short-term investments, which is expected to provide cash runway into the second half of 2026 and enable the Company to fund the next phase of PYX-201 clinical development, which the Company plans to announce in the fall of 2024.

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"I’m thrilled with our team’s continued operational and clinical execution prowess that keeps us on track to deliver preliminary data from our ongoing Phase 1 trial of PYX-201, a first-in-concept tumor stroma targeting antibody-drug conjugate (ADC) against the stromal Extradomain-B Fibronectin (EDB+FN) target, this fall," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology.

Dr. Sullivan added, "To date, we have dosed 72 subjects in the PYX-201 dose escalation study with a continued focus on head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), ovarian cancer, soft tissue sarcoma, and pancreatic ductal adenocarcinoma cancer (PDAC) based on an assessment of factors including immunohistochemistry target expression, stromal volume, unmet medical need, and clinical investigator judgment. PYX-201 safety data observed to date continues to support go-forward monotherapy and potential combination clinical development strategies, both of which we believe could have the potential to provide additional treatment options to patients with difficult-to treat-cancers."

Recent Clinical Program Updates

PYX-201

PYX-201, an ADC that uniquely targets EDB+FN within the tumor stroma, is the Company’s lead clinical program being evaluated in an ongoing Phase 1 trial in multiple types of solid tumors.

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To date, 72 subjects have been dosed with PYX-201 in this Phase 1 trial. Dose escalation and safety monitoring remain ongoing for the trial.

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The Company expects to announce preliminary data from the Phase 1 trial of PYX-201, including efficacy, safety, pharmacokinetics (PK), and provide an update on future development plans in the fall of 2024.

PYX-106

PYX-106, a fully human Siglec-15-targeting antibody designed to block suppression of T-cell proliferation and function, is being evaluated in ongoing Phase 1 clinical studies in multiple types of solid tumors.

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Dose escalation of PYX-106 and safety monitoring is ongoing with 33 subjects dosed to date in the Phase 1 trial.

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The Company expects to report preliminary data from the Phase 1 trial of PYX-106, including PK/pharmacodynamic results, by year-end 2024.

Second Quarter 2024 Financial Results

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As of June 30, 2024, Pyxis Oncology had cash and cash equivalents, including restricted cash and short-term investments of $157.2 million. The Company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its operations into the second half of 2026, including the Company’s current projections for PYX-201’s next phase of clinical development.

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Research and development expenses were $13.9 million for the quarter ended June 30, 2024, compared to $11.4 million for the quarter ended June 30, 2023. The period-over-period increase was primarily due to increased clinical trial-related expenses, including manufacturing of drug product and drug substance for our ongoing Phase 1 clinical trials of PYX-201 and PYX-106.

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General and administrative expenses were $6.1 million for the quarter ended June 30, 2024, compared to $6.7 million for the quarter ended June 30, 2023. The period-over-period decline was primarily due to lower professional and consultant fees.

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Net loss was $17.3 million, or ($0.29) per common share, for the quarter ended June 30, 2024, compared to $15.9 million, or ($0.41) per common share, for the quarter ended June 30, 2023. Net losses for the quarters ended June 30, 2024 and 2023 included $2.9 million and $3.7 million, respectively, related to non-cash stock-based compensation expense.

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As of August 14, 2024, the outstanding number of shares of common stock of Pyxis Oncology was 58,942,243.