On December 14, 2021 Ichnos Sciences Inc., a global biotechnology company developing innovative biologics in oncology and autoimmune diseases, and Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, reported that they have entered into an exclusive licensing agreement for the IL-1RAP antagonist ISB 880 (Press release, Ichnos Sciences, DEC 14, 2021, View Source [SID1234597053]). Under the agreement, Almirall is granted global rights to develop and commercialize this monoclonal antibody for autoimmune diseases. Ichnos will retain rights for antibodies acting on the
IL-1RAP pathway for oncology indications.

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Within the terms of the agreement, Almirall will assume full cost and responsibility for the global development and commercialization of the compound for all autoimmune disease indications. Ichnos will receive an upfront payment of €20.8 million as well as additional development and commercial milestone payments and tiered royalties based upon future global sales.

ISB 880 is a first-in-class fully human, high affinity monoclonal antibody that targets human IL-1RAP. Blockade of IL-1RAP simultaneously abrogates multiple disease drivers among the IL-1 family of proinflammatory cytokine receptors, including IL-1R, IL-33R, and IL-36R, differentiating ISB 880 from single cytokine blockade therapies. These cytokines have been implicated in numerous autoimmune conditions, opening opportunities for ISB 880 to be positioned across broad disease indications. IND-enabling work has been conducted and filings with regulatory authorities are under development.

"This is an exciting step forward for Ichnos as we enhance our focus on oncology and accelerate the pipeline of multispecific antibodies based on our proprietary, BEAT platform," said Cyril Konto, M.D., President and CEO of Ichnos. "ISB 880 anti-IL-1RAP antagonist illustrates Ichnos’ core capabilities in biologics discovery and manufacturing, as well as its strategy to advance a pipeline with potential first- or best-in-class assets. Almirall’s excellent team is well positioned to take ISB 880 through testing and development with the goal of delivering this potential new treatment to patients."

"Given its novel mechanism of action, we believe that ISB 880 has great potential to treat underserved patients across a range of autoimmune dermatological diseases," said Karl Ziegelbauer, Ph.D., CSO of Almirall. "We look forward to beginning to work on ISB 880 and based on the significant data generated by Ichnos we plan to initiate the first-in-human study in the first half of 2022."

On December 14, 2021 Targovax ASA’s (the "Company") stock exchange reported that published on 30 November 2021 regarding the commencement of the subscription period in the rights issue of 101,744,186 new shares in the Company (the "Offer Shares") at a subscription price of NOK 1.72 per offer share (the "Rights Issue") (Press release, Targovax, DEC 14, 2021, View Source [SID1234597052]).

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The subscription period for the Rights Issue will expire today, on 14 December 2021, at 16:30 hours (CET). Correctly completed subscription forms must be received by the managers in the Rights Issue, Carnegie AS and DNB Markets, a part of DNB Bank ASA, (the "Managers"), or, in the case of online subscriptions, be registered, within this deadline. Subscription rights that are not used to subscribe for Offer Shares within this deadline will have no value and will lapse without compensation to the holder.

On December 14, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported new analyses on the ongoing studies of HMPL-523 presented at the 63rd American Society for Hematology’s (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, held virtually and in person at the Georgia World Congress Center in Atlanta, Georgia (Press release, Hutchison China MediTech, DEC 14, 2021, View Source [SID1234597051]).

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Further details of the presentations are as follows:

Title: Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Patients with Primary Immune Thrombocytopenia: A Randomized, Double-Blind and Placebo-Controlled Phase Ib Study
Presenter: Renchi Yang, MD, Hematology Hospital of the Chinese Academy of Medical Sciences
Session: 311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Treatment of Immune Thrombocytopenia
Abstract No.: 149895
Date & Time: Saturday, December 11, 2021 9:30am – 11am ET
Location: Georgia World Congress Center, C101 Auditorium and virtually

As of data cutoff date of September 30, 2021, a total of 34 patients were randomized to receive HMPL-523 and 11 patients to placebo. Among 16 patients who were randomized to receive the recommended phase II ("RP2D") dose of 300mg once daily, 11 patients (68.8%) experienced response as defined by at least one incident of platelet count being ≥ 50×109/L in the initial 8-week double blinded phase of the study, compared to one out of 11 patients (9.1%) randomized to receive placebo. During the subsequent 16-week open-label phase of the study, one additional patient initially randomized to receive the RP2D experienced a response. Four patients randomized to placebo crossed over to receive treatment at RP2D after the initial 8-week double blinded phase of the study; all four of these patients experienced response. In total, 16 out of 20 patients (80%) experienced response during both phases of the study. Durable response, defined as platelet count being ≥ 50×109/L in at least 4 out of 6 last scheduled visits, were reported in 8 out of 20 patients (40%) who received RP2D in both phases of the study.

Safety data were presented for all 41 patients who received treatment at all doses, regardless of whether they were initially randomized to receive active treatment or crossed over during the open-label extension phase of the study. The median duration of treatment was 142 days (range: 23-170). No patients discontinued treatment due to treatment-related adverse events ("TRAE"), and no cases of treatment-related serious adverse events ("SAE") were reported. There were 30 patients (73%) who experienced TRAEs, including 3 (7.3%) who experienced grade 3 or above TRAEs, one of whom received the RP2D. No TRAEs of grade 3 or above occurred in more than one patient.

These results supported the initiation of a Phase III registration study of HMPL-523 in adult patients with immune thrombocytopenia ("ITP"), ESLIM-01. The first patient in this study received their first dose on October 27, 2021. Additional details may be found at clinicaltrials.gov, using identifier NCT05029635.

Title: Preliminary Results from a Phase I Study of HMPL-523, a Selective, Oral Syk Inhibitor, in Patients with Relapsed or Refractory Lymphoma
Presenter: Paolo Strati, MD, The University of Texas MD Anderson Cancer Center
Session: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemio­logical: Poster II
Abstract No.: 2432
Date & Time: Sunday, December 12, 2021 6:00pm – 8:00pm ET
Location: Georgia World Congress Center, Hall B5 and virtually

As of data cutoff date of August 25, 2021, 21 patients received a median of two cycles of treatment (range: 1-19). Among 16 response-evaluable patients, 4 responses were seen in patients in the 400-800 mg cohorts totaling 10 patients. Nine patients experienced disease progression, three in the 400-800mg cohorts and six in the 100-200mg cohorts.

Among 21 enrolled patients, 17 (81.0%) patients experienced TRAEs, including 7 (33.3%) who experienced grade 3 or above TRAEs. Specific to TRAE at grade 3 or above, neutropenia, which occurred in 2 patients, was the only TRAEs of grade 3 or above to have occurred in more than one patient. SAEs were reported in 6 patients (28.6%). Adverse events leading to discontinuation were reported in 2 (9.5%) patients. 7 patients withdrew from the study for reasons other than progressive disease.

These results support progressing HMPL-523 into the ongoing dose expansion phase of the study to evaluate its safety and efficacy in multiple subtypes of B-cell and T-cell lymphoma at the R2PD of 700 mg.

About HMPL-523
HMPL-523 is a novel, investigational, selective small molecule inhibitor for oral administration targeting spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders.

HUTCHMED currently retains all rights to HMPL-523 worldwide. The ESLIM-01 Phase III trial is underway to evaluate the efficacy and safety of HMPL-523 in treating adult patients with primary ITP, an autoimmune disorder that can lead to increased risk of bleeding. Additional details may be found at clinicaltrials.gov, using identifier NCT05029635. HMPL-523 is also being studied in indolent non-Hodgkin’s lymphoma and multiple subtypes of B-cell malignancies in China (NCT02857998), the U.S. and Europe (NCT03779113). A trial to study HMPL-523 in patients with warm autoimmune hemolytic anemia (wAIHA), another autoimmune disorder, is also planned.

On December 13, 2021 PharmAbcine, a clinical-stage biotech company focusing on the development of fully human antibody therapeutics, reported that its next-generation bispecific antibody discovery project has been selected for a research grant by Korea Drug Development Fund (KDDF) (Press release, PharmAbcine, DEC 13, 2021, View Source;bmode=view&idx=9120925&t=board [SID1234649184]). KDDF is a South Korean government-initiated program that aims to promote the global competitiveness of local biotech companies.

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The Company will use the grant to develop a bispecific antibody that targets both PD-L1, an immune checkpoint molecule present on tumor cells, and SIRPα, an inhibitory receptor on macrophages that binds to CD47 and inhibits phagocytic action of macrophages.

The market for bispecific antibodies looks promising. According to Roots Analysis, a market research firm, the global bispecific antibody market is expected to rise to U$9 b with a CAGR (Compound Annual Growth Rate) of 34% by 2030.

Bispecific antibodies targeting PD-L1 and SIRPα/CD47 appear more exciting given the strong interests of late among global pharmaceutical companies. Notably, in August 2021, a global pharmaceutical company announced that it paid about U$2.2b to acquire an immune-oncology drug development company that possesses an anti-SIRPα antibody asset.

"Bispecific antibody development has always been one of PharmAbcine’s specialties since its foundation," said Dr. Joo Hyoung Lee, head of Antibody Engineering department. "We expect this research funding will provide a tremendous momentum in our drug development efforts which will ultimately benefit patients with unmet medical needs."

On December 13, 2021 Zetagen Therapeutics, Inc., a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported it has received a two year, $2 million USD grant from the National Cancer Institute of the National Institutes of Health (NIH) (Press release, Zetagen Therapeutics, DEC 13, 2021, View Source [SID1234643706]). The grant will be used for the Phase 2 clinical and commercial development of its ZetaMet (Zeta-BC-003) technology. ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone..

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"This support from the NCI marks a key milestone and will facilitate the continued development of ZetaMet (Zeta-BC-003) for the use in treating metastasis in bone," said Bryan S. Margulies, PhD,chief scientific officer of Zetagen Therapeutics. "Preclinical trials have successfully demonstrated ZetaMet (Zeta-BC-003)’s ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration. If these results hold true in the next phase of study, ZetaMet (Zeta-BC-003) could offer an entirely new treatment for patients living with certain late-stage cancers where present therapies do not offer desired results."

ZetaMet (Zeta-BC-003) works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts".

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called "lytic lesions." Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.[1]

"We know there are hundreds of thousands of patients living with late-stage cancers which involve painful, debilitating metastatic bone lesions," said Joe C. Loy, CEO of Zetagen Therapeutics. "This recognition from the NCI further reinforces our commitment to developing breakthrough therapies that will make a tangible difference in quality of life as they battle these devastating diseases."

Earlier this year, ZetaMet (Zeta-BC-003) received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The first human clinical trial using ZetaMet (Zeta-BC-003) in Stage 4 breast cancer patients is being targeted for early 2022.