On August 22, 2024 Hanmi Pharmaceutical reported the company has signed a technology transfer agreement with domestic research and development company Novomedison for the BTK inhibitor ‘Poseltinib’ (Press release, Hanmi, AUG 22, 2024, View Source [SID1234649253]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On the 14th, Hanmi Pharmaceutical announced in its ‘Semi-Annual Report’ that it had transferred Poseltinib to Novomedison on June 3rd through major contracts and research and development activities.

The technology transfer target region is the entire world. The total contract amount and the amount received were not disclosed under the agreement of both companies.

Novomedison is the new name of Genome Opinion, which signed a joint development agreement with Hanmi Pharmaceutical for Poseltinib in October 2021.

After signing the joint development agreement, Hanmi Pharmaceutical and Novomedison have signed a technology transfer agreement.

After signing the joint development agreement, Novomedison has been conducting an investigator-led clinical trial with a three-drug combination therapy using Poseltinib.

Poseltinib is a drug that Hanmi Pharmaceutical has been developing since 2010 for the indication of diffuse large B-cell lymphoma. It was exported to Eli Lilly in 2015, but the rights were returned in 2019 as its efficacy was not proven in phase 2 for patients with rheumatoid arthritis.

Since then, Hanmi Pharmaceutical has been conducting phase 2 domestic trials for follow-up development.

On August 22, 2024 Geron Corporation (Nasdaq: GERN), a commercial stage biopharmaceutical company, reported that it has granted non-statutory stock options to purchase an aggregate of 261,000 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company (Press release, Geron, AUG 22, 2024, View Source [SID1234646057]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The stock options were granted on August 21, 2024, at an exercise price of $4.54 per share, which is equal to the closing price of Geron common stock on the date of grant. The stock options have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. All of the stock options were granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018, and provides for the granting of stock options to new employees.

On August 22, 2024 HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company reported its participation in the 2024 Annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), taking place September 13-17 in Barcelona, Spain (Press release, HiFiBiO Therapeutics, AUG 22, 2024, View Source [SID1234646058]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The company will present compelling Phase 1 trial data on two novel monoclonal antibodies: the first-in-class TNFR2 agonist HFB200301 (NCT05238883) and the best-in-class BTLA antagonist HFB200603 (NCT05789069). These programs have shown promise both as monotherapy and in combination with anti-PD-1, demonstrating the capability to elicit a robust anti-cancer immune response, even in IO refractory tumors.

Harnessing its innovative Drug Intelligence Science (DIS) platform, HiFiBiO is at the forefront of advancing these therapies by specifically selecting tumor types, optimizing dosing regimens, and identifying predictive biomarkers to increase the probability of clinical success. The insights gained from these Phase 1 trials will play a critical role in guiding Phase 2 dosing strategies and patient selection criteria.

HiFiBiO’s novel immunotherapies and comprehensive translational strategy demonstrate the company’s deep commitment to innovative research and developing impactful therapies to address unmet medical needs. HiFiBiO is now applying this strategy to inflammation and immunology, with plans to submit an IND application for a novel BTLA agonist by the end of September.

Details on the poster presentations are as follows:

Title: Model-informed dose optimization of HFB200301, a TNFR2 agonist monoclonal antibody (mAb), in monotherapy and in combination with the anti-PD-1 mAb tislelizumab (TIS), in patients (pts) with advanced solid tumors.
Presentation Number: 1011P
Session Date: Saturday, 14 September 2024
Speaker: Desamparados Roda Perez, MD, PhD, Hospital Clínico Universitario de Valencia

Title: Phase I dose escalation study of HFB200603, a best-in-class BTLA antagonist monoclonal antibody (mAb), in monotherapy and in combination with the anti-PD-1 mAb Tislelizumab (TIS) in adult patients (pts) with advanced solid tumors.
Presentation Number: 1006P
Session Date: Saturday, 14 September 2024
Speaker: María de Miguel, MD, PhD, MBA, START Madrid – CIOCC HM Sanchinarro

The initial data from these abstracts will be available on the ESMO (Free ESMO Whitepaper) website starting on September 9 at 0:05 CEST. Additionally, the posters will be accessible on the HiFiBiO Therapeutics website following the live presentation.

On August 22, 2024 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, reported that a late-breaking abstract presenting the primary analysis of the IGNYTE clinical trial has been selected for oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 being held September 13-17, 2024, in Barcelona (Press release, Replimune, AUG 22, 2024, View Source [SID1234646060]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation Details:

Title: Primary efficacy, safety, and survival data from the registration-intended cohort of patients with anti-PD-1-failed melanoma from the IGNYTE clinical trial with RP1 combined with nivolumab
Presentation Session Title: Mini Oral Session – Melanoma and other skin tumours
Presentation Number: LBA46
Date and Time: Sunday, September 15, 2024 at 3:45 – 3:50 p.m. CEST
Speakers: Caroline Robert, MD, PhD, Gustave Roussy Cancer Center

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

On August 21, 2024 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported its unaudited financial results for the second quarter of 2024 (Press release, Nykode Therapeutics, AUG 21, 2024, View Source [SID1234646011]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The financial report can be accessed in the Investors section of the company’s website: View Source The company will host a webcast presentation at 4 p.m. CET / 10 a.m. ET.

A live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website and on the following link: View Source;tp_key=dff7ea87a1