On April 2, 2025 Lomond Therapeutics Holdings, Inc. ("Lomond Therapeutics"), a clinical-stage biotechnology company dedicated to discovering and developing potentially best-in-class and first-in-class medicines for the treatment of hematological malignancies, reported the addition of two new investors, Yosemite Management and QIA Investments, coincident with a second and third closing, respectively, and the raising of an additional $20 million private placement financing (Press release, Lomond Therapeutics, APR 2, 2025, View Source [SID1234651770]).

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"We are delighted to expand the funding syndicate with the addition of these top tier investors," said Iain Dukes M.A. D.Phil., co-founder and chief executive officer at Lomond Therapeutics."

This transaction provides the additional resources necessary to advance our potentially best-in-class or first-in-class programs, lomonitinib, lonitoclax and our menin inhibitor, through clinical development. Lomonitinib is currently being evaluated in a Phase 1b clinical trial in patients with mutated FLT3 relapsed refractory AML – an area of important unmet need. Lomond enrolls CLL and selected lymphoma patients in a Phase 1b clinical trial to evaluate lonitoclax, a potentially first in class oral targeted selective B-cell lymphoma-2 ("BCL-2-2") inhibitor.

The offering was exempt from registration under Section 4(a)(2) of the United States Securities Act of 1933, as amended, and Rule 506 of Regulation D promulgated by the U.S. Securities and Exchange Commission ("SEC") thereunder. The Common Stock in the offering was sold to "accredited investors," as defined in Regulation D, and was conducted on a "reasonable best efforts" basis.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Raymond James and Wedbush & Co. acted as the placement agents.

On April 2, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that the completion of Clinical Study Report (CSR) for Phase 1/Dose Expansion Trial of Silmitasertib (CX-4945) in the Treatment of Basal Cell Carcinoma(BCC), with positive data outcomes (Press release, Senhwa Biosciences, APR 2, 2025, View Source [SID1234651768]). The study included patients who had relapsed after standard therapies and had no other treatment options. Among them, three patients experienced over 30% tumor reduction (PR), and two patients had a progression-free survival (PFS) exceeding 21 months. CX-4945 significantly prolonged survival in advanced cancer patients, marking a major milestone for both the patients and Senhwa.

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Compared to current first- and second-line therapies, CX-4945 demonstrated superior tolerability and disease control potential. Therefore, Senhwa will actively pursue licensing possibilities while carefully evaluating CX-4945’s potential as a monotherapy or in combination with the second-line immunotherapy Libtayo. The company aims to explore further indications and potential as a first-line treatment, offering better options for patients.

Clinical Trial Overview

The trial enrolled 25 patients with locally advanced BCC (laBCC, 20 patients) and metastatic BCC (mBCC, 5 patients). The primary objective was to determine the recommended Phase 2 dose (RP2D) and optimal dosing regimen for CX-4945.

Among 22 patients eligible for efficacy analysis:

Three laBCC patients achieved partial response (PR).
Ten patients had stable disease (SD), including 2 mBCC and 8 laBCC patients.
Disease control rates:
mBCC patients: 80% (4 patients with complete/partial response or stable disease).
laBCC patients: 65% (11 patients with complete/partial response or stable disease).
Further data analysis showed that:

Median progression-free survival (PFS):
laBCC: 9.2 months
mBCC: 3.7 months
Median duration of disease control (DDC):
laBCC: 10.3 months
mBCC: 7.5 months
CX-4945 exhibited promising anti-tumor efficacy and disease stabilization potential in this indication. Additionally, CX-4945 has a lower study drug discontinuation rate of 24% due to AEs, compared to first-line treatments including Vismodegib and Sonidegib, suggesting superior tolerability.

Future Prospects

This trial is particularly noteworthy as it evaluated CX-4945 monotherapy in patients who had already failed first-line HHIs. Notably, 27.3% (6 patients) had also failed second-line PD-1 inhibitors such as Libtayo or Keytruda.

Among the enrolled patients, two advanced-stage patients achieved a progression-free survival (PFS) of over 21 months, lasting 653 days and 667 days, respectively. Notably, the primary lesion of the former patient was almost undetectable by visual inspection.

Given the significant potential of CX-4945 as a monotherapy, Senhwa is now actively pursuing regional licensing to accelerate commercialization through strategic partnerships, ultimately benefiting more patients.

On April 2, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its novel B7-H3-targeting ADC (R&D code: 7MW3711) has been approved by the NMPA to enter Phase Ib/II clinical trial in combination with a PD-1 Inhibitor, with or without antitumor therapies, for the treatment of advanced solid tumors (Press release, Mabwell Biotech, APR 2, 2025, View Source [SID1234651767]).

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7MW3711 is developed by Mabwell’s Interchain-Disulfide Drug Conjugate (IDDC) platform and is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. The approved phase Ib/II clinical trial aims to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic profile of 7MW3711 in combination with a PD-1 inhibitor, with or without antitumor therapies, in patients with advanced solid tumors. Previously, 7MW3711 has been approved for clinical studies in advanced solid tumors by the NMPA and the FDA, respectively, and was granted orphan drug designation (ODD) by the FDA for the treatment of small cell lung cancer.

On April 2, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported the Company will present five posters at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois (Press release, Enliven Therapeutics, APR 2, 2025, View Source [SID1234651766]).

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Poster Presentation Details

Abstract 4712 – ELVN-002, a potent, selective HER2 inhibitor with a differentiated binding mode conferring the potential for enhanced efficacy in combination with HER2-targeting antibody-drug conjugates
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Targeted Therapies and Combinations 2
Location: Poster Section 34

Abstract 4361 – Development and application of a mechanistic pharmacokinetic pharmacodynamic (PKPD) model to predict anti-chronic myeloid leukemia (CML) effects of tyrosine kinase inhibitors
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Pharmacokinetics and Pharmacodynamics of Cancer Therapeutics
Location: Poster Section 20

Abstract LB295 – ELV-3111, a type 1 pan-RAF inhibitor, that safely combines with MEK inhibitors for enhanced anti-tumor activity in NRAS and BRAF mutant cancers including the most common mechanisms of BRAF inhibitor clinical resistance
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Location: Poster Section 52

Abstract LB294 – Mechanism of tumor-selective inhibition of dimeric RAF by a Type 1 RAF inhibitor
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Location: Poster Section 52

Abstract 5515 – ELVN-001, a highly selective ATP-competitive ABL1 tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia alone or in combination with asciminib
Date/Time: Tuesday, April 29, 2025, 2:00 p.m. – 5:00 p.m. CDT
Session: Drug Resistance in Molecular Targeted Therapies 3
Location: Poster Section 17

On April 2, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno oncology company, reported it has received clearance from the Cohort Review Committee (CRC) to escalate the dose level in the intravenous (IV) combination arm of its Phase 1 onCARlytics trial (Press release, Imugene, APR 2, 2025, View Source [SID1234651765]).

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With the successful completion of the safety observation period the IV combination arm will progress to a higher dose level.

Known as OASIS, the Phase 1 dose escalation onCARlytics clinical trial is targeting adult patients with advanced or metastatic solid tumours. The trial aims to evaluate the safety and efficacy of two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion of either onCARlytics (a CD19-expressing oncolytic virus) alone, or in combination with CD19 targeting bispecific monoclonal antibody blinatumomab (Blincyto), which is a cancer immunotherapy.

OASIS is being conducted at seven sites in the U.S. including City of Hope, University of Cincinnati, MD Anderson Cancer Center, Emory, Roswell Park, University of Pittsburgh, Northwestern and University of Nebraska, with the potential to open a total of 10 sites to recruit approximately 40-50 patients with advanced solid cancers that have spread.

Imugene’s Managing Director and Chief Executive Officer, Leslie Chong, said:

"CD19 is a very significant target for blood cancers, but solid cancers like breast, lung or gastric do not have a common target on their cell surface, and therefore the aim with onCARlytics is to make available a target for CD19 therapies to treat these solid cancers. As the trial continues to progress and dose escalation is executed, we are eager to learn of the potential impact our treatment is having for patients in need."