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]).

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"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.

On November 18, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has dosed its first patient in the third cohort in the ongoing Phase 1 clinical trial of its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer (Press release, Anixa Biosciences, NOV 18, 2024, View Source [SID1234648465]). The study is being conducted through a research partnership with Moffitt Cancer Center ("Moffitt").

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No dose limiting toxicity was observed in the initial three-patient cohort or in the second three-patient cohort, in which patients received a CAR-T cell dose triple that of the first cohort. After the required one-month waiting period to assess the occurrence of dose limiting toxicity and review of all safety data, the trial has now dosed its first patient in the third cohort at a tenfold increase over the initial dose.

Anixa’s FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. The first-in-human trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed on at least two prior therapies. The study is designed to evaluate safety and identify the maximum tolerated dose, while monitoring efficacy.

Dr. Robert Wenham, principal investigator of the study and Chair of the Department of Gynecologic Oncology at Moffitt, stated, "With no dose-limiting safety issues observed in the first and second patient cohorts, we have advanced to the next cohort to evaluate a 10x higher dose compared with the starting dose. As the trial continues, our aim is to demonstrate the tolerability of our CAR-T but we are optimistic and hopeful about seeing efficacy in this solid tumor—a challenging area for traditional CAR-T therapies, which have shown efficacy mainly in hematologic tumors and lymphomas. We are very encouraged how the trial has progressed and our observation in one patient from the first cohort who had relative stability and even some mild improvement for well over a year after her infusion. This is highly unusual for a platinum resistant multiply treated ovarian cancer. A tumor biopsy showed necrosis and T cell infiltration. Based on these findings, we recently submitted an amendment to the trial protocol to allow patients who may benefit from an additional dose. Generally, we expect higher cell doses to increase efficacy, although we also anticipate a second dose may further improve response rates and durability. We are proud of the progress to date and look forward to treating additional patients in the third cohort."

On November 18, 2024 VelaVigo Cayman Limited (VelaVigo), a biotech company focusing on discovery and development of multi-specific antibodies and antibody-drug conjugates (ADC), reported it has entered into an agreement with Avenzo Therapeutics, Inc. (Avenzo) granting Avenzo an exclusive option to an exclusive license to develop, manufacture and commercialize a potential first-in-class Nectin4/TROP2 bispecific ADC globally (excluding Greater China) (Press release, Avenzo Therapeutics, NOV 18, 2024, View Source [SID1234648481]). VelaVigo will maintain rights for Greater China and plans to collaborate with Avenzo in global development.

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"The partnership with Avenzo is a validation of VelaVigo’s strong antibody and ADC discovery engine for First-in-Class/Best-in-Class (FIC/BIC) molecules. I’m proud of our team’s achievement in bringing multiple molecules to IND-enabling stage within 3 years and look forward to continued advancement of our pipeline", said Jing Li, founder, Chairman and CEO of VelaVigo. "Partnership is an integral part of VelaVigo’s strategy to bring our novel pipeline to patients in need and maximize value for our investors. We look forward to advancing the development of our Nectin4/TROP2 ADC program globally with Avenzo’s strong expertise", commented Tong Zhang, co-founder, CBO and CFO of VelaVigo.

Since its inception in 2021, VelaVigo has built an extensive pipeline of over ten FIC/BIC multi-specific antibodies and ADC molecules for oncology and autoimmune diseases. It has also set up VelaVigo Bio, Inc. in the US to drive clinical development and partnership globally.

Under the terms of the agreement, VelaVigo will receive an upfront fee and potential near-term milestones upon option exercise by Avenzo of up to $50 million. In addition, VelaVigo is eligible to receive future potential development, regulatory, and commercial milestone payments of up to approximately $750 million in total, as well as tiered royalties on sales in Avenzo’s territory.

An Investigational New Drug application is planned for submission to the U.S. Food and Drug Administration (FDA) and Chinese National Medical Products Administration (NMPA) in 2025.

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.

On November 18, 2024 AstraZeneca reported that Tagrisso (osimertinib) has been recommended for approval in the European Union (EU) for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT) (Press release, AstraZeneca, NOV 18, 2024, View Source [SID1234648466]).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the LAURA Phase III trial, which were published in The New England Journal of Medicine.

Results showed Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio [HR] 0.16; 95% confidence interval [CI] 0.10-0.24; p<0.001) as assessed by blinded independent central review. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo.

Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.

Each year in Europe, there are more than 450,000 people diagnosed with lung cancer.1 Among those with NSCLC, the most common form of lung cancer, about 10-15% of patients in Europe have tumours with an EGFR mutation.2,3 Additionally, nearly one in five people with NSCLC has an unresectable tumour.4

Manuel Cobo, MD, Specialist Physician of the Medical Oncology Service at the Carlos Haya University Hospital, Malaga, Spain, and investigator for the trial, said: "The LAURA results build on the established efficacy of osimertinib and support the approval of the first targeted therapy for patients with unresectable, EGFR-mutated lung cancer. Today’s positive recommendation marks an important step towards offering patients in Europe a targeted treatment option that can extend the time before their disease progresses by more than three years."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Today’s news reinforces Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer, meeting the critical unmet need for an effective targeted treatment option in the unresectable setting. Tagrisso has now demonstrated its benefit across all stages of EGFR-mutated lung cancer, representing a pivotal step in transforming care for patients who are urgently in need of innovative therapies that can help extend their lives."

The safety and tolerability of Tagrisso in the LAURA trial was consistent with its established profile and no new safety concerns were identified.

Tagrisso following CRT was recently approved for the treatment of adult patients with unresectable, Stage III EGFRm NSCLC in the US. Regulatory applications are also currently under review in China, Japan and several other countries based on the LAURA trial.

Tagrisso is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan. Approved indications include 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC. Tagrisso is also approved in combination with chemotherapy in the US, China and several other countries for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

Notes

Lung cancer
Each year, an estimated 2.4 million people are diagnosed with lung cancer globally.5 Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.5 Lung cancer is broadly split into NSCLC and small cell lung cancer.3 The majority of all NSCLC patients are diagnosed with advanced disease.6

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.7-9 Patients with EGFRm NSCLC are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which blocks the cell-signalling pathways that drive the growth of tumour cells.10

LAURA
LAURA is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial in patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed following definitive platinum-based CRT. Patients were treated with Tagrisso 80mg once-daily oral tablets until disease progression, unacceptable toxicity or other discontinuation criteria were met. Upon progression, patients in the placebo arm were offered treatment with Tagrisso.

The trial enrolled 216 patients in more than 145 centres across more than 15 countries, including in the US, Europe, South America and Asia. The primary endpoint is PFS. The trial is ongoing and will continue to assess the secondary endpoint of OS.

Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of Tagrisso as standard of care in EGFRm NSCLC. Tagrisso improved patient outcomes in early-stage disease in the ADAURA Phase III trial, Stage III, unresectable disease in the LAURA Phase III trial, late-stage disease in the FLAURA Phase III trial, and with chemotherapy in the FLAURA2 Phase III trial.

As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the neoadjuvant setting in the NeoADAURA Phase III trial and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.
The Company is also researching ways to address tumour mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, and the SAFFRON Phase III trial, which test Tagrisso plus savolitinib as well as other potential new medicines.

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