On September 30, 2024 Alphamab Oncology (stock code: 9966 HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Alphamab"), a wholly-owned subsidiary of Alphamab Oncology ("the Company"), entered into a licensing agreement (the "Licensing Agreement") on anti-HER2 bispecific antibody-drug conjugate (ADC) JSKN003 with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK) (Press release, Alphamab, SEP 30, 2024, View Source [SID1234653663]).

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According to the terms of the Licensing Agreement, JMT-Bio will obtain the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. JMT-Bio shall bear at its own costs and expenses for the clinical development activities under the Licensing Agreement. Alphamab retains the sole right to supply JSKN003 for any purpose within or outside the Territory.

According to the Licensing Agreement, the Company is entitled to receive upfront payment and milestone payments of up to RMB 3.08 billion in total, including an upfront payment of RMB 400 million, a development milestone payment of RMB 300 million related to enrollment of the first patient for multiple registration trials, and regulatory milestone payments based on regulatory approval progress and commercial milestone payments. In addition, the Company is also entitled to receive a double-digit percentage of royalties on net product sales of JSKN003.

JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. Multiple clinical data presented at several international academic conferences demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors.

About JSKN003

JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. Multiple clinical studies of JSKN003 are currently being conducted in Australia and China, and we are also actively making the progress in its pivotal clinical trial in advanced HER2 low-expression breast cancer in China.

On September 30, 2024 Celaid Therapeutics reported that it has been awarded up to approx. 2.7 billion yen ($19M USD) in non-dilutive grant funding as "Strengthening Program for Pharmaceutical Startup Ecosystem" program by the Japanese Agency for Medical Research and Development (AMED) (Press release, Celaid Therapeutics, SEP 30, 2024, View Source [SID1234649809]). The grant will be used to support the development of Celaid’s lead program "CLD-001", an ex vivo expanded Hematopoietic Stem Cell (HSC) Therapy for pediatric non-malignant diseases.

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"The Japanese government has announced that it will provide funding support for pharmaceutical startups over the next five years through 300 billion yen ($2.1 Billion USD) grant as Strengthening Program for Pharmaceutical Startup Ecosystem program. Being selected for this program is a vote of

Through this grant program, Celaid will reinforce non-clinical and clinical development of CLD-001 in the US. and accelerate development to deliver CLD-001 to patients suffering from pediatric nonmalignant diseases worldwide as soon as possible.

About CLD-001, an ex vivo expanded Hematopoietic Stem Cell (HSC) Therapy
CLD-001 is being developed as a hematopoietic stem cell therapy product for severe pediatric nonmalignant disease. Rare blood diseases such as aplastic anemia, primary immunodeficiency, inherited metabolic disorder, and sickle cell disease, which start in childhood and are associated with various physical and neurological complications, have a very poor prognosis. Currently, the only curative therapy is allogeneic hematopoietic stem cell transplantation (HSCT). On the other hand, there are still significant unmet needs for allogeneic HSCT due to donor problems such as bone marrow donor shortage and HLA type mismatch, as well as side effects such as transplant-related mortality and graft-versus-host disease (GvHD). CLD-001 is a hematopoietic stem cell product that solves the donor problem, side effects, and disadvantages described above

In addition to solving the donor problem by using frozen cord blood stored in a cord blood bank as the cell source, CLD-001 also solves the bottleneck of low HSC counts in cord blood with our proprietary HSC expansion technology, enabling us to provide HSCs with the best HLA type for the patient. CLD-001, the HLA best-match and bone marrow-constructible HSCs, is expected to significantly improve overall survival after HSC therapy.

On September 30, 2024 Valerio Therapeutics reported its half-year 2024 results (Press release, Valerio Therapeutics, SEP 30, 2024, https://valeriotx.com/wp-content/uploads/2024/09/EN_-HY-financial-report-consolidated-Update-Crowe-HAF-v09262024-Formatted-signed.pdf [SID1234647056]).

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On September 30, 2024, Gritstone bio, Inc. (the "Company") reported interim data from the Phase 2 portion of its randomized, open-label Phase 2/3 study evaluating its personalized cancer vaccine, GRANITE (GRTC901/GRT-R902), in combination with immune checkpoint blockade for patients with front-line metastatic microsatellite stable colorectal cancer ("MSS-CRC") (Press release, Gritstone Bio, SEP 30, 2024, View Source [SID1234646976]).

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Key Findings from Interim Phase 2 Data in MSS-CRC

Data cut as of August 19, 2024

104 patients were randomized 1:1 in the study: 69 patients (39 GRANITE arm, 30 control arm) are included in the treated analysis below. Demographics and clinical characteristics were balanced between arms (stage, sidedness, presence of liver metastases), with the vast majority (80%) of patients having liver metastases in the treated analysis. Thirty-five patients did not advance to study treatment after oxaliplatin, most commonly due to withdrawing consent (n=15), disease progression (n=8), and other reasons (n=12) (12 in GRANITE arm; 23 in control arm).

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Interim data demonstrated an emerging progression-free survival ("PFS") benefit to all GRANITE recipients (study not statistically powered for PFS)

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21% relative risk reduction of progression or death with GRANITE vs. standard of care ("SOC") control in all treated population (HR=0.79 [95% CI, 0.42-1.s])

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33% (13/39) GRANITE and 23% (7/30) of control patients remain on study and free of progression

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Last circulating tumor DNA ("ctDNA") assessment is below the assay limit of quantitation in 12/13 GRANITE and 4/7 control patients

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Clinical benefit was most notable in patients with low disease burden (defined as patients with ctDNA equal to or below the trial population median value at study entry)

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38% relative risk reduction of progression or death with GRANITE vs. SOC control with low ctDNA subgroup (HR=0.62 [95% CI, 0.23-1.70])

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Low baseline ctDNA is a likely prognostic and predictive factor

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Immune data were consistent with clinical activity

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Functional neoantigen-specific T cells were observed in all 16/16 GRANITE patients tested by ELISPOT

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Association of PFS and peak ex vivo ELISPOT responses was apparent, suggesting that ex vivo ELISPOT may be a surrogate for PFS

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GRANITE demonstrated a favorable safety and tolerability profile

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No patients discontinued study treatment due to an adverse event ("AE")

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Common AEs were the mild systemic and local effects associated with any potent vaccine, i.e. transient flu-like illness

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One treatment-related serious AE (fatigue) occurred in the GRANITE arm (patient continued GRANITE treatment without recurrence upon recovery)

The Company plans to review the PFS data with the U.S. Food and Drug Administration in the coming months and agree on next steps to advance GRANITE, including a potential Phase 2 or 3 trial using ctDNA levels as eligibility criteria.

On September 30, 2024 Cartherics Pty Ltd ("Cartherics" or "Company"), a biotechnology company developing immune cell therapies for the treatment of cancer and other diseases, reported that it has successfully raised well over its target AU$15M in an oversubscribed financing round (Press release, Cartherics, SEP 30, 2024, View Source [SID1234646960]).

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This funding will support the clinical trial for CTH-401, the Company’s lead cell therapy for ovarian cancer, and expand its pipeline to include other diseases.

Cartherics’ Chief Executive Officer, Prof. Alan Trounson AO commented: "The successful capital raising, in times of scant investment support in biotechnology, is welcome and further supports confidence in the company for the delivery of effective therapies in ovarian cancer and other difficult diseases."

CTH-401 is the only natural killer (NK) cell product currently under development that incorporates a chimeric antigen receptor (CAR) that targets the adenocarcinoma specific antigen, TAG-72 – a well-validated tumour marker, widely expressed in a range of solid tumours, including ovarian, gastric, colorectal, prostate and pancreatic cancers.

Cartherics has demonstrated that CTH-401 is very effective in killing ovarian cancer cells in both tissue culture and animal models, with initiation of the first clinical trial planned for next year.

Cartherics’ Chairman, Bob Moses said: "We are eager to start the CTH-401 clinical trial, building on promising preclinical results. This milestone reflects our commitment to innovative ovarian cancer treatments and our investors’ confidence in our vision to improve patient outcomes and drive growth."