On January 8, 2025 Araris Biotech AG ("Araris"), a Swiss oncology biotech company developing next-generation antibody drug conjugates (ADCs), reported they have entered a Research Collaboration and Option to License Agreement ("RCO") under which Araris will use its proprietary linker-conjugation platform, AraLinQTM, to generate novel ADCs using antibodies against undisclosed targets provided by Chugai Pharmaceutical Co., Ltd. ("Chugai") (Press release, Araris Biotech, JAN 8, 2025, View Source [SID1234651283]).

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"We are excited to enter a collaboration with Chugai Pharmaceutical and look forward to working closely with the Chugai team and apply our ADC technology to develop next-generation ADCs with improved efficacy and tolerability," said Dr. Dragan Grabulovski, CEO and co-founder of Araris.

Dr. Philipp Spycher, CSO and co-founder of Araris added: "This second collaboration with a large pharmaceutical company is a testimony of the attractiveness of our highly differentiated ADC platform and its potential to generate innovative ADCs with excellent pharmacokinetic properties and wide therapeutic index, incorporating dual- or triple-warheads into one step on native antibodies, without any requirement of prior antibody engineering."

Under the terms of the RCO Agreement, Chugai will pay an upfront fee, fund all research activities and after exercising the option be solely responsible for the development, manufacturing and global commercialization activities. Upon achievement of certain development, regulatory and commercial milestones by Chugai after exercising the option, Araris will be eligible for potential milestone payments of approximately USD 780 million, plus royalties on net sales of products.

On January 8, 2025 ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, reported that Tim McCarthy, CEO, Dr Tim Franklin, COO, and Dr Sebastien Goudreau, CEO of the R&D subsidiary ImmuPharma Biotech will be attending both the JP Morgan Conference and the Biotech Showcase from 11-16 January 2025, in San Francisco (Press release, ImmuPharma, JAN 8, 2025, View Source [SID1234649505]).

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The JP Morgan conference and Biotech Showcase are annual premier partnering events, designed to provide biotechnology companies with the opportunity to present to and connect with global Biopharma companies and investors.

The advances made by ImmuPharma with the P140 program, particularly in the latter part of 2024, have led to significant interest from leading Biopharmaceutical companies and we are progressing discussions as we move to establish global licensing agreements.

There have been eleven $1bn+ licensing deals for immunology assets across the BioPharma industry from 2023 to late September 2024. The current trend suggests that Immunology and Autoimmune drug assets are becoming very highly sought by the leading BioPharma companies.

Commenting on this announcement, Tim McCarthy, CEO of ImmuPharma said: "Attending and taking meetings at both the JP Morgan conference and the Biotech Showcase offers the opportunity to continue discussions across our whole unique portfolio and specifically with global BioPharma companies that have an interest in autoimmune diseases demonstrated within our P140 technology platform. Our focus remains on track to establish global partnering opportunities across all of our programs."

On January 8, 2025 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage immunology company advancing RNA therapeutics to conquer cancer, reported its participation at the 43rd Annual JP Morgan Healthcare Conference, taking place January 13-16, 2025 (Press release, Myeloid Therapeutics, JAN 8, 2025, View Source [SID1234649521]).

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Daniel Getts, Ph.D., CEO of Myeloid, will present on Wednesday, January 15, 2025, at 8:30 am PT. Company management will also participate in one-on-one meetings with investors during the conference.

On January 8, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the National Medical Products Administration (NMPA) of China approved GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases (Press release, Merck & Co, JAN 8, 2025, View Source [SID1234649506]). The approval makes GARDASIL the first HPV vaccine approved for use in males in China. GARDASIL is now indicated in China to prevent anal cancers caused by HPV Types 16 and 18, genital warts (condyloma acuminata) caused by HPV Types 6 and 11, and the following precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18: grade 1, grade 2, and grade 3 anal intraepithelial neoplasia (AIN).

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"The approval of GARDASIL for use in males 9-26 years old in China is a significant step forward in advancing public health," said Joseph Romanelli, president, Human Health International, Merck. "Since first approval, our HPV vaccines have helped protect over 50 million females in China from certain HPV-related cancers and diseases. With this expanded approval, we look forward to helping protect this new population of Chinese males from certain HPV-related cancers and diseases."

Indications for GARDASIL1

GARDASIL is a vaccine indicated in females 9 through 45 years of age. GARDASIL is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18, and for the prevention of genital warts caused by HPV Types 6 and 11.

GARDASIL is indicated in males 9 through 26 years of age. GARDASIL is indicated for the prevention of anal cancer caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18, and for the prevention of genital warts caused by HPV Types 6 and 11.

GARDASIL does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, and anal cancers as recommended by a health care provider.

GARDASIL has not been demonstrated to provide protection against diseases caused by:

– HPV types not covered by the vaccine

– HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal, and anal cancers caused by HPV Types 6, 11, 16 and 18.

GARDASIL is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL may not result in protection in all vaccine recipients.

Select Safety Information for GARDASIL

GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion. Safety and effectiveness of GARDASIL have not been established in pregnant women. The most common (≥1.0%) adverse reactions were headache, fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising. The duration of immunity of GARDASIL has not been established.

Dosage and Administration

GARDASIL should be administered intramuscularly in the deltoid or anterolateral area of the thigh.

For GARDASIL, a complete vaccination regimen for individuals 9 through 26 years of age consists of 3 doses at the following schedule: 0, 2 months, 6 months.

On January 8, 2025 Annals of Oncology (IF: 56.7), a top oncology journal globally, reported remarkable long-term follow-up results of a phase 1b/2 clinical trial on Disitamab Vedotin (DV) (developed by Remegen Co., Ltd) combined with Toripalimab in treating locally advanced or metastatic urothelial carcinoma (la/mUC) (NCT04264936, study ID: RC48-C014) (Press release, RemeGen, JAN 8, 2025, View Source [SID1234649522]). This trial was supervised by Professor Jun Guo and Professor Xi’nan Sheng’s teams from Peking University Cancer Hospital.

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It is the first time that long-term follow-up data has been released for a HER2-targeted antibody-drug conjugate (ADC) and PD-1 inhibitor combination therapy in treating la/mUC, marking it a significant milestone. The nearly-three-year follow-up data revealed an objective response rate (ORR) of 73.2% and median overall survival (OS) of 33.1 months, superior to data published from any other prospective clinical studies on ADC plus PD-1 combination therapies for la/mUC.

New Treatment Options for Patients with La/mUC

UC is the sixth most common cancer worldwide. GLOBOCAN 2022 estimated the year 2021 saw 614,298 new cases and 220,596 deaths of UC. In recent years, the prognosis for patients with la/mUC has significantly improved with new drugs and combination therapies approved, among which ADCs demonstrated outstanding potential.

As a HER2-targeted ADC, DV has been approved in China for patients with HER2-overexpressing (defined as immunohistochemistry [IHC] test results of 2+ or 3+) la/mUC previously treated with platinum-containing chemotherapy. The approval is based on the pooled results of two studies (NCT03507166 and NCT03809013, study IDs: RC48-C005 and RC48-C009) where the ORR registered 50.5% and the median duration of response (DOR) registered 7.3 months.

Multiple clinical studies on la/mUCin recent years have confirmed the synergistic antitumor effects of ADC combined with immunotherapy. NCT04264936 offered stronger evidence as its long-term follow-up results published in the Annals of Oncology demonstrated the high response rate, significant survival benefits, and manageable safety profile of the DV and Toripalimab combination therapy.

DV Combined with Toripalimab: High Response Rate and Prolonged Survival

NCT04264936 is an open-label, multicenter, investigator-initiated phase 1b/2 clinical trial investigating the safety and efficacy of DV in combination with Toripalimab for the treatment of patients with HER2-expressing la/mUC. The dose-escalation study (phase 1b) assessed two dose levels of DV (1.5 and 2.0 mg/kg) combined with Toripalimab (3.0 mg/kg) to determine the recommended phase 2 dose which was then evaluated in the dose-expansion stage (phase 2).

From August 2020 to December 2021, 41 patients were enrolled with a median age of 66 years. 53.7% of the participants were male, 70.7% had an ECOG performance status score of 1, 17 (41.5%) had lung metastasis, and 10 (24.4%) had liver metastasis.

As of March 1, 2024, among all participants, the ORR was 73.2% with 4 (9.8%) achieving complete response and 26 (63.4%) achieving partial response, the DCR was 90.2%, the median progression-free survival (PFS) was 9.3 months, the median DOR was 8.6 months, the median OS was 33.1 months and the 36-month OS rate was 49.2%.

Subgroup analysis revealed ORR benefits across all subgroups regardless of the number of prior lines of systemic treatments, HER2 expression (IHC 1+/2+/3+), and PD-L1 expression status. The ORRs for chemotherapy-naïve patients and those who progressed on platinum-based chemotherapy were 76.0% (19/25) and 68.8% (11/16), respectively. The ORRs for patients with HER2 IHC 3+, 2+, 1+, or 0 were 80.0%, 84.2%, 64.3%, and 33.3%, respectively. Compared with the three HER2 IHC 0 participants (one of whom achieved partial response), those with HER2 expression (IHC 1+/2+/3+) had a higher ORR (76.3% vs 33.3%) and longer PFS (median PFS: 9.3 vs 1.7 months).

In summary, the DV and Toripalimab combination therapy has preliminarily demonstrated promising efficacy and manageable safety profile among patients with la/mUC, wherein those with HER2 expression (IHC 1+/2+/3+) achieved high response rates and long-term survival benefits. These findings support the further exploration and validation of the benefits of DV combined with PD-1 inhibitors in treating la/mUC.