On February 3, 2025 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported that Daniel Faga, president and chief executive officer of Anaptys, will present at the Guggenheim SMID Cap Biotech Conference on Wednesday, Feb. 5, 2025 at 1:00pm ET / 10:00am PT (Press release, AnaptysBio, FEB 3, 2025, View Source [SID1234649992]).

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A live webcast of the presentation will be available on the investor section of the Anaptys website at View Source A replay of the webcast will be available for at least 30 days following the event.

On February 3, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Janssen-Cilag International NV, a Johnson & Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT (amivantamab) in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy (Press release, Halozyme, FEB 3, 2025, View Source [SID1234650008]).

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"We are pleased that the subcutaneous formulation of amivantamab, which was developed with our ENHANZE drug delivery technology, was recommended for approval in Europe," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The data that support the recommendation could represent a very compelling proposition for patients with the approximate five-minute administration time and five-fold reduction in infusion related reactions."

The CHMP positive opinion is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For more information on the study and its findings, please view Johnson & Johnson’s press release issued today.

Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO (Free ASCO Whitepaper) Journal of Clinical Oncology. 2024;42(3):3593-3605.

2 Leighl NB, et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605.

3 ClinicalTrials.gov. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). View Source Accessed January 2025.

On February 3, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported the completion of the acquisition of Biotheus ("Biotheus"), a clinical-stage biotechnology company dedicated to the discovery and development of novel antibodies to address unmet medical needs of patients with oncological or inflammatory diseases (Press release, BioNTech, FEB 3, 2025, View Source [SID1234649993]). The acquisition was announced on November 2024 and builds on the successful collaboration on the late-stage clinical asset BNT327, an investigational bispecific antibody targeting PD-L1 and VEGF-A, and other bispecific antibody candidates.

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The transaction is part of BioNTech’s oncology strategy, aimed at expanding the Company’s capabilities to research, develop and commercialize BNT327 as a pan-tumor technology platform for combination therapies. With this completion of the acquisition, BioNTech obtains full global rights to BNT327 and rights to all other candidates of Biotheus’ pipeline as well as to its in-house antibody generation platform and bispecific antibody drug conjugate capability. Biotheus will operate as a new indirect Chinese subsidiary of BioNTech, adding a local research and development hub and an advanced biologics manufacturing facility to the Company’s network.

The total consideration to acquire 100 percent of the issued share capital by Biotheus amounts to $800 million, predominantly in cash, with a small portion in BioNTech American Depositary Shares, plus additional performance-based payments of up to $150 million if certain milestones are met.

About BNT327
BNT327 is a novel investigational bispecific antibody combining two complementary, validated mechanisms in oncology into one single molecule. BNT327 combines PD-L1 checkpoint inhibition aimed at restoring T cells’ ability to recognize and destroy tumor cells with the neutralization of VEGF-A. The blocking of VEGF-A is aimed at reversing the tumor’s immuno-suppressive effect in its microenvironment and cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), with the intention of preventing the tumor from growing and proliferating. BNT327 may be differentiated via its mechanism of action of targeting PD-L1 on the tumor cells aimed at enriching BNT327 in the tumor microenvironment and promoting localized anti-cancer activity. The co-localized blockade of the PD-(L)1 pathway and the VEGF-A driven formation of an immuno-suppressive microenvironment has been shown to deliver synergistically enhanced anti-tumor immune responses in several solid tumor types.1,2

More than 750 patients have been treated with BNT327 in clinical trials to date. Multiple clinical trials are currently ongoing evaluating BNT327 either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in various solid tumor indications. Multiple global trials are ongoing or planned to start in 2025, including three global clinical trials with registrational potential in first-line small cell lung cancer ("SCLC"), non-small cell lung cancer ("NSCLC") and triple-negative breast cancer ("TNBC"). Additional trials will explore combining BNT327 and BioNTech’s proprietary antibody-drug conjugate candidates ("ADCs"). If successfully developed and approved, BioNTech aims to use this bispecific antibody candidate as a next-generation immuno-oncology ("IO") backbone in combination with other treatment modalities targeting a broad range of cancer indications.

On February 3, 2025 TriSalus Life Sciences Inc. (Nasdaq: TLSI), a biomedical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies and its investigational immunotherapy, reported that it has requested a drawdown of $10 million under its previously announced $50 million credit agreement with OrbiMed, a healthcare investment firm (Press release, TriSalus Life Sciences, FEB 3, 2025, View Source [SID1234650009]).

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Pursuant to the to the Agreement, OrbiMed agreed to provide a term loan facility in an aggregate principal amount of $50 million. The $10 million drawdown became available to TriSalus upon achievement of product revenue-based milestone of $30 million for the trailing 12-months ending on January 31, 2025. With the closing of the $10 million tranche, the company has drawn a total of $35 million under the credit agreement with OrbiMed.

On February 3, 2025 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported that CEO Dr. Adi Mor and other members of its senior management team will deliver a corporate presentation and participate in one-on-one investor meetings at the virtual Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025 (Press release, Chemomab, FEB 3, 2025, View Source [SID1234649994]). The Oppenheimer Conference presentation will be webcast live and will be available on the investor relations section of the Chemomab website for 90 days.

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Oppenheimer 35th Annual Healthcare Life Sciences Conference

Date: February 11, 2025
Time: 8:00 am ET
Venue: Virtual
Format: Webcast presentation
Webcast Link: View Source
Information: [email protected]