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Aclaris Therapeutics Announces $80 Million Private Placement

On Nov. 18, 2024 Aclaris Therapeutics, Inc. (NASDAQ: ACRS) (the "Company" or "Aclaris"), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that it has entered into a securities purchase agreement with a group of accredited investors for the private placement of 35,555,555 shares of common stock at a purchase price of $2.25 per share, for gross proceeds of approximately $80.0 million (Press release, Aclaris Therapeutics, NOV 18, 2024, View Source [SID1234648571]). The private placement is expected to close on or about November 19, 2024, subject to the satisfaction of customary closing conditions.

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The private placement was led by Vivo Capital, with participation by new and existing investors including Forge Life Science Partners, Rock Springs Capital, RA Capital Management, Adage Capital Partners LP, Decheng Capital, Logos Capital and Samsara BioCapital.

Net proceeds from the private placement are expected to fund the research and development of its pipeline and for general corporate purposes.

The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"). Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Concurrently with the execution of the securities purchase agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock sold in the private placement. 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 the 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 such jurisdiction.

Leerink Partners and Cantor acted as placement agents in connection with the private placement.

Aclaris Therapeutics Announces Exclusive, Global License Agreement with Biosion, Inc., adding Potential Best-in-Class Biologics Assets to Pipeline

On November 18, 2024 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that it has entered into an exclusive license agreement with Biosion, Inc. (Biosion) for worldwide rights (excluding Greater China) to BSI-045B, a potential best-in-class, clinical-stage, novel anti-TSLP monoclonal antibody, and BSI-502, a potential best-in-class, pre-clinical stage, novel bispecific antibody that is directed against both TSLP and IL4R (Press release, Aclaris Therapeutics, NOV 18, 2024, View Source [SID1234648570]).

"This transformative transaction, which marks the completion of our strategic review process, accelerates our evolution into becoming a leading immunology company with both small and large molecule drugs," said Dr. Neal Walker, Interim CEO and Chair of the Board of Directors of Aclaris. "Despite recent advances with anti-TSLP and anti-IL4R therapies, there remains substantial unmet need for more effective and convenient treatment options. BSI-045B’s compelling Phase 2a proof-of-concept data in atopic dermatitis, together with BSI-502’s dual-targeting approach, complement our existing ITK inhibitor portfolio, resulting in a pipeline of differentiated assets that targets multiple high-value indications. In addition, the proceeds from the private placement financing announced this morning bolsters our balance sheet and provides us with enhanced financial flexibility to support our strategic growth while maintaining our cash runway into 2028."

In a completed Phase 2a, single-arm, proof-of-concept trial in the United States in 22 patients with moderate to severe atopic dermatitis, BSI-045B was observed to have a pharmacodynamic, safety and efficacy profile that could position it as a potential best-in-class therapy. BSI-045B is also being advanced in multiple Phase 2 studies in China by Biosion’s regional partner, Chia Tai Tianqing Pharmaceutical Group, Co., Ltd. (CTTQ), targeting both severe asthma and chronic rhinosinusitis with nasal polyps, accelerating the potential to show proof-of-concept across additional indications.

"This strategic transaction brings together Biosion’s and Aclaris’ innovative programs with Aclaris’ development capabilities in immunology," said James Loerop, Chief Business Officer of Aclaris. "With our expanded portfolio, we have created a diversified pipeline of strategic opportunities across various immunologic and respiratory indications."

Biosion is a global biotechnology company that has built a pipeline of innovative biologics through its internally derived proprietary technologies. "Our proprietary antibody discovery platforms have enabled us to rapidly identify and optimize novel antibodies with exceptional potency and selectivity," said Mingjiu Chen, Ph.D., Founder and CEO of Biosion. "BSI-045B and BSI-502 demonstrate the power of our discovery capabilities in generating potential first and best-in-class therapeutics."

Expanded Leadership Team

Concurrent with the Biosion transaction, Aclaris has made two key additions to its leadership team:

Hugh Davis, Ph.D., joins as President and Chief Operating Officer, bringing over 35 years of experience in biologics development, clinical pharmacology, and business development from leadership roles at Biosion, Frontage, GSK, and Johnson & Johnson.
Steven Knapp, PharmD, joins as Executive Vice President, Head of Regulatory & Quality, with over 35 years of regulatory and quality experience from senior positions at Biosion, Antares, Valeant, and BMS.
"Having led key functions in the development of multiple approved biologics, I’m particularly excited about the potential of BSI-045B and BSI-502," said Hugh Davis, Ph.D. "I am thrilled to join the world class scientific leadership team at Aclaris. Together with their existing compelling portfolio, Aclaris is now well positioned to advance innovative small and large molecule programs through clinical development in the quest to deliver exceptional therapies for patients worldwide."

About BSI-045B

BSI-045B is a humanized anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody that specifically binds to human TSLP, blocking its interaction with the receptor complex and disrupting signal transduction. This mechanism prevents immune cells targeted by TSLP from releasing proinflammatory cytokines. BSI-045B is currently in clinical development, and its safety and efficacy have not been evaluated by regulatory authorities.

About BSI-502

BSI-502 is a humanized anti-TSLP and anti-interleukin 4 receptor (IL4R) bispecific antibody that blocks both the upstream TSLP receptor signal transduction and downstream IL4R activation thereby inhibiting this central proinflammatory pathway. BSI-502 is currently in pre-clinical development, and its safety and efficacy have not been evaluated by regulatory authorities.

Conference Call and Webcast

Management will conduct a conference call at 8:30 AM ET today to discuss the Biosion transaction and a corporate update. To access the live webcast of the call and the accompanying slide presentation, please visit the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

Advisors

Leerink Partners and Cantor acted as financial advisors to Aclaris in connection with the license transaction.

Cooley LLP acted as corporate counsel and DLA Piper LLP (US) acted as IP counsel to Aclaris.

Morgan, Lewis & Bockius acted as counsel to Biosion.

Cancer Targeted Technology Receives Fast Track $2.4M Grant to Develop an Innovative PSMA-Targeted Small Molecule Drug Conjugate for Prostate Cancer

On November 18, 2024 Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology firm focusing on cancer diagnostics and therapeutics, reported that the National Cancer Institute awarded the Phase I portion ($400K) of the fast track Phase I/II ($2.4M) Small Business Innovation Research (SBIR) grant to develop a new drug to treat metastatic prostate cancer (Press release, Cancer Targeted Technology, NOV 18, 2024, View Source [SID1234648491]). The grant focuses on a promising new prodrug, CTT2274, that targets Prostate-Specific Membrane Antigen (PSMA) on prostate cancer and is designed to release a toxic drug, MMAE, within the cell that takes up the prodrug. PSMA is over-expressed on prostate cancer and expression increases as the cancer metastasizes and becomes castrate resistant. CTT’s unique phosphoramidate-based agents, bind irreversibly to PSMA and unlike other agents targeting PSMA, this distinctive mode of binding enhances uptake and internalization by tumor cells, leading to increased accumulation of the therapeutic payload and improved efficacy.

Studies to date using CTT2274 treatment of mice bearing human prostate tumors have shown remission of tumor growth and an overall increase in survival. In addition, because of the prodrug release within the tumor cells, safety of the drug, at doses that are effective at inhibiting or reversing tumor growth, is excellent. In the Phase I portion of the grant, to be completed in Q2 2025, CTT will conduct additional non-clinical efficacy studies and manufacturing optimization. In Phase II of the grant, to be completed in Q2, 2026, CTT will conduct additional manufacturing and safety assessments necessary to advance CTT2274 to an Investigational New Drug (IND) application. These IND studies will support the initial clinical trial in metastatic prostate cancer planned for 2026.

"CTT2274 has a unique structure and linker that maximizes tumor uptake and allows for release of the chemotherapeutic drug only within the tumor cell thus minimizing potential side effects from the chemotherapy. No other prodrug like this is being developed for prostate cancer and CTT2274 holds great promise as a future treatment for men suffering from prostate cancer." stated Dr. Beatrice Langton-Webster, CEO of CTT and Principal Investigator on the grant. Visit CTT’s website at View Source to learn more about CTT2274.

Toragen, Inc. Provides Update on Data from Ongoing Phase 1 Clinical Trial of TGN-S11 as Monotherapy and in Combination with Keytruda® (pembrolizumab) in Patients with Stage 4 Human Papillomavirus-Associated Cancers

On November 18, 2024 Toragen Inc., a San Diego-based clinical-stage biotechnology company focused on developing uniquely selective drugs targeting cancers caused by viruses, reported positive safety data from its ongoing Phase 1 trial of TGN-S11, its small molecule drug candidate, in patients with HPV-associated cancers (Press release, Toragen, NOV 18, 2024, View Source [SID1234648490]).

This Phase 1 trial is an open-label, non-randomized study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The study is being conducted in two parts: Part 1 is escalating doses of TGN-S11 monotherapy and Part 2 is TGN-S11 in combination with Keytruda, a PD-1 checkpoint inhibitor. The dose escalation part consists of up to five Cohorts of three to six patients on monotherapy with increasing doses of TGN-S11. The Keytruda combination part consists of up to five Levels of three to six patients with increasing doses of TGN-S11 and the standard dose of Keytruda.

In Part 1, 9 patients were treated with TGN-S11 as monotherapy in the first 3 dose cohorts with no safety issues identified. One-third of the patients in this portion of the study showed drug activity with decreases in tumor size and decreases in circulating tumor HPV DNA (ctHPV DNA). In addition, three patients have been treated in Part 2 Level 1 evaluating TGN-S11 in combination with Keytruda with no safety issues. Two of these 3 patients in this portion of the study showed drug activity with decreases in tumor size and decreases in circulating tumor HPV DNA. One of these 3 patients continues to receive combination therapy and has a 93% reduction in ctHPV DNA. The study is ongoing with patients currently being dosed in Part 1 Cohort 4 and Part 2 Level 2.

"We have been very pleased with the positive safety profile for TGN-S11 in patients who completed the first 3 monotherapy dose cohorts of Part 1 and the first level of Part 2 in combination with Keytruda in this ongoing Phase 1 trial," said Dr. Sandra Coufal, Toragen’s CEO. "The drug activity observed in 5 of these 12 subjects is also very encouraging. Based on the current progress, we believe both parts of the study will be completed by the end of 2024."

Foresight Diagnostics to Present New Data on Foresight CLARITY™ Ultra-Sensitive MRD Detection Across Multiple Studies at the 66th American Society of Hematology Annual Meeting

On November 18, 2024 Foresight Diagnostics, a leader in ultrasensitive minimal residual disease (MRD) testing, reported the presentation of multiple studies showcasing Foresight CLARITY MRD at the upcoming 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 7-10 in San Diego, California (Press release, Foresight Diagnostics, NOV 18, 2024, View Source [SID1234648489]).

The presentations span various lymphoma types and treatment settings, demonstrating the broad applicability of the Foresight CLARITY MRD detection technology for monitoring treatment response and predicting patient outcomes. The studies include collaborations with multiple pharmaceutical companies and research institutions, including AstraZeneca, Bristol Myers Squibb (BMS), Daiichi Sankyo (DSI), Stanford University, Washington University, and others.

"These studies add to the growing body of evidence supporting ultra-sensitive MRD testing as a critical tool in lymphoma care and drug development," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "We see in these studies that MRD measurement with Foresight CLARITY consistently enables earlier and more accurate treatment response assessment than conventional imaging-based methods. The ability to monitor disease status in real-time with ultra-sensitive MRD assays like Foresight CLARITY may help accelerate clinical trials and lead to more personalized decision-making for patient care."

Results utilizing Foresight CLARITY MRD technology are featured in six abstracts, including three that are co-authored by Foresight.

Presentation highlights include:

LBCL/DLBCL:

ctDNA-MRD as a surrogate endpoint for 2L CAR T – Analysis of the Phase 3 TRANSFORM trial in second-line treatment for large B-cell lymphoma (LBCL) reinforced the potential of circulating tumor DNA (ctDNA) as an earlier endpoint for response assessment and assessment of clinical trial results. In the TRANSFORM study, patients receiving lisocabtagene maraleucel (liso-cel) had significantly improved event-free survival compared to standard of care. Consistent with this result, patients receiving liso-cel also demonstrated higher rates of MRD clearance, demonstrating CLARITY’s ability to measure differential treatment responses.
MRD Response with novel first-line therapy in high-risk DLBCL – Analysis of a Phase 1b trial CC-220-DLBCL-001 combining golcadomide with R-CHOP in previously untreated aggressive B-cell lymphoma showed promising MRD clearance rates. The data demonstrated that 90% of patients achieved MRD negativity at end of treatment with golcadomide 0.4mg + R-CHOP, with strong responses observed even in high-risk patients. These data further support the ongoing Phase 3 GOLSEEK-1 study investigating this novel combination therapy in high-risk 1L LBCL.
Enhanced risk stratification by MRD vs. traditional methods – New research investigates the predictive value of the International Prognostic Index (IPI), currently the primary pre-treatment risk assessment tool for DLBCL. The study revealed that pre-treatment IPI scores did not significantly correlate with end-of-treatment MRD status, with MRD testing being a superior predictor of progression-free survival.
Follicular Lymphoma:

MRD-based response assessment of novel FL therapies – Two studies demonstrated the value of MRD assessment in follicular lymphoma trials, with new treatment approaches showing early clearance. The CD19xCD3 bispecific antibody AZD0486 achieved 89% MRD negativity in relapsed or refractory FL patients by 12 weeks in complete responders. In the 1L setting, the chemotherapy-free combination of mosunetuzumab and polatuzumab vedotin showed similar early MRD clearance, with 7 of 8 complete responders achieving MRD negativity before cycle 3. These results highlight the potential for MRD as an early indicator of therapeutic response in FL clinical trials.
PTCL:

ctDNA as a prognostic biomarker for T-cell lymphoma – Analysis from the VALENTINE-PTCL01 Phase 2 trial in relapsed/refractory peripheral T-cell lymphoma (PTCL) revealed that patients achieving early, deep ctDNA reduction (>5-fold decrease by Cycle 2 Day 1) experienced significantly longer progression-free survival, establishing ctDNA monitoring as a powerful tool for early response assessment.
Information on abstract presentation time and dates can be found below. To meet with Foresight Diagnostics, visit booth #3423 or contact us at [email protected].

Oral Presentations:

Circulating Tumor DNA (ctDNA) as an Early Outcome Predictor in Patients with Second-Line Large B-Cell Lymphoma After Lisocabtagene Maraleucel Versus Standard of Care Treatment from the Phase 3, Randomized TRANSFORM Study

Presenter: Ash Alizadeh, MD, PhD (Stanford University)
Session 628
Date/Time: Saturday, December 7, 2024, 10:45 a.m.
Sponsor: Bristol Myers Squibb
Co-authored by Foresight Diagnostics
Escalating Doses of AZD0486, a Novel CD19xCD3 T-Cell Engager, Result in High Complete Remissions with Rapid Clearance of Minimal Residual Disease in Patients with Relapsed/Refractory Follicular Lymphoma

Presenter: Jing-Zhou Hou, MD, PhD (UPMC Hillman Cancer Center)
Session 623
Date/Time: Saturday, December 7, 2024, 5 p.m.
Sponsor: AstraZeneca
Golcadomide (GOLCA) Plus R-CHOP Has High Minimal Residual Disease (MRD) Negativity across High-Risk, Untreated Aggressive B-Cell Lymphoma (a-BCL)

Presenter: Jason R. Westin, MD (MD Anderson)
Session 627
Date/Time: Sunday, December 8, 2024, 12:30 p.m.
Sponsor: Bristol Myers Squibb
International prognostic index poorly predicts EOT ctDNA MRD status in DLBCL and has limited impact on its predictive value for outcomes

Presenter: Jordan S. Goldstein, MD, MS (Stanford University)
Session 626
Date/Time: Sunday, December 8, 2024, 5 p.m.
Co-authored by Foresight Diagnostics
Poster Presentations:

Prediction of Clinical Response by Phased Variants in Circulating Tumor DNA (ctDNA) in the VALENTINE-PTCL01 trial of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma

Presenter: Neha Mehta-Shah, MD, MSCI (Washington University)
Abstract #4342, Session 621
Date/Time: Monday, December 9, 2024, 6-8 p.m.
Sponsor: Daiichi Sankyo
Co-authored by Foresight Diagnostics
Mosunetuzumab Plus Polatuzumab Vedotin Induces Early Complete Responses in Previously Untreated High Tumor Burden Follicular Lymphoma

Presenter: David A Russler-Germain, MD, PhD (Washington University)
Abstract #4414, Session 623
Date/Time: Monday, December 9, 2024, 6-8 p.m.