On March 17, 2023 Likang reported that according to the latest data released at the Clinical Trials Implied Approval section on the website of China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), Likang Life Sciences (hereinafter referred to as "Likang") has received implied approval for the clinical trial of its personalized neoantigen-targeted vaccine for advanced solid tumors, LK101 Injection (Press release, Likang Life Sciences, MAR 17, 2023, View Source [SID1234629002]). This is the first personalized neoantigen vaccine & mRNA editing product approved by the NMPA to enter clinical stage.

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 December 22, 2022, Likang submitted an IND application for LK101 Injection to NMPA, and received application shortly after. LK101 Injection, the first in-house developed cancer vaccine candidates by Likang, is a personalized neoantigen-targeted cancer vaccine and also a dendritic cell (DC)-based mRNA vaccine that combines advantages of both mRNA technology and DC by transducing mRNA encoding personalized tumor antigen targets based on dozens of patient-specific tumor mutations information into dendritic cells.

The mRNA editing technology is a highly convenient method that can encode multiple antigens at once while maintaining rapid, efficient expression, making it suitable for the development of personalized cancer treatments. DCs, which are highly specialized and strong antigen-presenting cells in human immune system, have been utilized in the development of tumor vaccines. DC vaccines have demonstrated high safety and good tolerance, effectively activating tumor-specific T cells and establishing immunological memory, resulting in long-term anti-cancer effects. The combination of mRNA vaccine and DC vaccine provides a potential breakthrough in the field of personalized neoantigen treatment, offering an effective and safe approach for patients to fight against cancer.

In 2018, Likang collaborated with the Chinese PLA General Hospital to conduct an investigator-initiated clinical trial (IIT) of LK101 injection for postoperative liver cancer patients. The data showed that LK101 have good safety and tolerance, no grade I or higher drug-related adverse reactions reported. Activation of anti-tumor neoantigen immune response detected in all patients, showing significant advantages in terms of postoperative recurrence rate and survival rate.

On March 17, 2023 Hackensack Meridian Health reported that it is investing $14 million dollars at JFK University Medical Center to expand access to state-of-the-art oncology services (Press release, Hackensack Meridian Health, MAR 17, 2023, View Source [SID1234629001]).

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!

"Hackensack Meridian Health is committed to using every available resource to fight cancer and ensure that our patients, clinical staff, and frontline teams have access to best-in-class, award-winning care in their own backyard," said Robert C. Garrett, FACHE, chief executive officer, Hackensack Meridian Health.

"Our investment in JFK University Medical Center will strengthen patient access to specialized oncology services and meet their future healthcare needs," said Todd Way, president, central market, Hackensack Meridian Health.

The new state-of-the-art oncology facility at JFK University Medical Center will be located in a separate building across the street from the main hospital at 80 James Street. The four-story cancer facility will be designed to enhance the patient experience, along with having access to nationally recognized specialists as well as the latest technologies.

"JFK’s oncology expansion will allow patients in our community to receive comprehensive oncology services within a seamless continuum of care, close to home. Patients will not have to travel out of state or the local community to receive access to the latest clinical trials and advanced treatments," said Amie Thornton, president, chief hospital executive, JFK University Medical Center.

"This new expansion will double the size of the existing infusion capabilities currently offered to our patients," said Joseph Landolfi, D.O., CPE, chief medical officer, JFK University Medical Center.

In addition, JFK University Medical Center’s main campus (65 James St), will offer intensity-modulated radiation therapy (IMRT), Stereotactic Body Radiation Therapy (SBRT), Gamma Knife Radiosurgery and Gynecologic Brachytherapy. The completion of the project is expected in the first quarter of 2024.

On March 17, 2023 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that data from the company’s leading program fostroxacitabine bralpamide (fostrox) and its potential effect on hepatocellular carcinoma (HCC), will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, on April 14-19, in Orlando, USA (Press release, Medivir, MAR 17, 2023, View Source [SID1234628999]).

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 abstract, titled "A triple combination of fostrox (MIV-818) with immune checkpoint and kinase inhibition shows increased anti-tumor efficacy in vivo" will be presented at the conference by Fredrik Öberg, CSO at Medivir. The presentation includes study results describing the potential for enhanced anti-tumor effects when fostrox is combined with both an anti-PD1 antibody and a kinase inhibitor.

– "Inhibition of angiogenesis has the potential to increase the effect of fostrox and the induction of DNA damage and tumor cell death. This can lead to increased tumor antigen presentation and a strengthened immune response, which creates opportunities to combine with both checkpoint inhibitors and tyrosine kinase inhibitors. In line with this, our preclinical results show that fostrox has the potential to amplify anti-tumor activity together with a combination of anti-PD-1 antibodies and kinase inhibitors", says Fredrik Öberg.

– "Although existing combination therapies for HCC can prolong patients’ lives, far from all patients respond to treatment. In order for more patients to have a satisfactory treatment effect, new combination options with several different, additive mechanisms of action will be crucial. Fostrox, with its unique, liver-directed approach, opens up for completely new combinations with three different approaches to effectively treat HCC.", says Pia Baumann, CMO at Medivir.

The abstract and the poster will be available on Medivir’s website after the presentation.

For additional information, please contact
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: [email protected]

About fostrox

Fostroxis a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On March 17, 2023 SkylineDx, an innovative diagnostics company, focused on research & development of molecular diagnostics for oncology and inflammatory diseases, reported the publication of an independent study showing that gene expression profiling (CP-GEP model) can be used to identify primary cutaneous melanoma patients with a high risk for disease recurrence (Press release, SkylineDx, MAR 17, 2023, View Source [SID1234628998]).

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 University of Tuebingen (Germany) study analyzed 543 patients diagnosed with stage I/II primary cutaneous melanoma between 2000 and 2017. It found that when combined with clinicopathologic factors, the CP-GEP model can be used to stratify these patients into high risk and low risk cohorts for disease recurrence. Specifically, the patients determined to have Low Risk have an almost five times favorable 5-year recurrence free survival (RFS) over the CP-GEP High Risk patients in stage I/II melanoma, with 93% of low-risk patients are recurrence-free 5 years after diagnosis [2].

Although the research was focused on patients with a negative sentinel lymph node biopsy (SLNB), a separate analysis on patients with very thin melanomas and unknown SLNB status also demonstrated CP-GEP’s ability to significantly stratify CP-GEP Low Risk from High Risk patients among this group. The publication supports the value of diagnostic information over a long-term period following the initial diagnosis. Outcomes of this study were published earlier this year by the European Journal of Cancer [2].

"We are encouraged by the study’s findings, which support the potential prognostic utility of the Merlin test to inform patient consultation related to disease recurrence," comments Dharminder Chahal, CEO of SkylineDx. "The Merlin test can drive a profound economic benefit by significantly reducing the number of SLNB procedures performed on Low Risk melanoma patients. As we strive to present a complete view of the utility of the Merlin test, this research is an important addition to its clinical dossier."

The CP-GEP model used in the study is an innovative integrated algorithm that combines clinicopathological features with gene expression of the primary melanoma. SkylineDx launched a diagnostic test, Merlin, based on this model in the United States, where it is currently covered by Medicare. It also launched in Europe last year, as a CE-IVD kit. Merlin is used to identify patients (T1-T2 melanoma) at Low Risk for nodal metastasis that may forgo invasive sentinel lymph node biopsy (SLNB) surgery. SLNB surgery is used to determine metastatic spread of the cancer for staging purposes and is negative in approximately 80% of cases [3]. This University of Tuebingen research shows CP-GEP’s potential to replace SLNB in patients that did not undergo the procedure [2].

About the Merlin test

The Merlin test uses the CP-GEP model, a powerful proprietary algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes [3]. The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness, and the patient’s age; and has been analytically and clinically validated. The main focus of the Merlin Study Initiative, developed under the wings of Falcon R&D Program, is to conduct further clinical research and validation studies on the predictive use of the CP-GEP model. More information (including references) may be obtained at www.falconprogram.com. The Merlin test is commercially available and reimbursed by Medicare as a Laboratory Developed Test serviced from SkylineDx’s CAP/CLIA laboratory in San Diego (CA).

On March 17, 2023 Keymed Biosciences Inc. (HKEX: 02162) reported its 2022 annual results (Press release, Keymed Biosciences, MAR 17, 2023, View Source;proactively-develops-global-strategic-collaboration-301775097.html [SID1234628997]). Focused on unmet clinical needs, the Company continued to efficiently develop innovative and differentiated pipelines, proactively carry out global strategic collaboration and accelerate its commercialization progress in 2022.

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!

Development of Innovative and Differentiated Pipelines

Core Product CM310 (IL-4Rα antibody):

Initiated Phase III registrational clinical trial for adults with moderate to severe AD in 2022 Q1; Completed the patient enrollment in 2022 November; The Company plans to complete this trial and submit the NDA for this indication in 2023.
Released Phase II clinical data for the treatment of CRSwNP in end of March 2022: co-primary efficacy endpoints are fully achieved with positive results; Initiated Phase III trial in 2022 H2.
Received Breakthrough therapy designation (BTD) from the CDE for the treatment of moderate to severe AD in June 2022.
Obtained the CDE IND approval for the treatment of AR in July 2022.
Obtained the FDA IND approval for the treatment of AD in August 2022.
Initiated Phase II/III pivotal clinical trial for moderate to severe asthma in March 2023, led by CSPC.
Core Product CM326 (TSLP antibody):

Initiated Phase Ib/IIa clinical trial for patients with moderate to severe AD in 2022 H1; Simultaneously initiated Phase II clinical trial for adults with moderate to severe AD in 2022 H2.
Initiated Phase Ib/IIa clinical trial for patients with CRSwNP in 2022 H2; Completed the patient enrollment in February 2023.
Core Product CMG901 (Claudin 18.2 ADC):

Completed the patients enrollment of Phase Ia dose-escalation clinical trial in subjects with solid tumor by 2022 H1; Initiated Phase Ib dose-expansion clinic trial in 2022 Q2 and patient enrollment for this trial is ongoing.
Received Orphan-drug Designation & Fast Track Designation for the treatment of unresectable or metastatic gastric and gastroesophageal junction cancer from the FDA in April 2022.
Received Breakthrough therapy designation (BTD) for the treatment of Claudin 18.2-positive advanced gastric cancer from the CDE in September 2022.
Presented Phase Ia clinical data in subjects with advanced solid tumor at the 2023 ASCO (Free ASCO Whitepaper) GI in January 2023: The results showed that CMG901 was well-tolerated with a favorable safety profile; Preliminary efficacy results demonstrated that in the 8 Claudin 18.2-positive gastric/GEJ cancer patients receiving CMG901, Objective response rate (ORR) and disease control rate (DCR) were 75.0% and 100%, respectively, with ORR of 100% in the 2.6, 3.0, and 3.4 mg/kg cohorts.
In February 2023, KYM Biosciences Inc. (a non-wholly owned subsidiary owned by Keymed with 70% shares) entered a global exclusive license agreement with AstraZeneca AB, who will be responsible for the research, development, manufacture, and commercialization of CMG901 globally. Under the terms of the agreement, KYM Biosciences will receive an upfront payment of $63m on transaction closing and additional development and sales-related milestone payments of up to $1.1bn as well as tiered royalties up to low double-digits.
Core Product CM313 (CD38 antibody):

Proceeding Phase Ia does-escalation clinical trial for RRMM in 2022; Initiated dose expansion clinical trial in the late stage of 2022 Q1.
Obtained IND approval for the treatment of SLE in China in April 2022; completed the first patient dosing in October 2022; Phase Ib/IIa clinical trial is ongoing.
Core Product CM338 (MASP-2 antibody):

Completed CM338 Phase I clinical trial with healthy volunteers in November 2022.
Initiated CM338 Phase II clinical trial for the treatment of IgAN in March 2023.
Other Assets

CM355 (CD20xCD3):

Completed the first patient dosing in January 2022; Phase I dose-escalation trial is ongoing.
CM336 (BCMAxCD3):

Completed the first patient dosing in September 2022; Phase I dose-escalation trial is ongoing.
CM350 (GPC3xCD3):

Obtained IND approval in China for the treatment of solid tumor in January 2022; Completed the first patient dosing in May 2022; Phase I dose-escalation trial is ongoing.
CM369 (CCR8 antibody):

Obtained IND approval in China for the treatment of advanced solid tumor in August 2022; Completed the first patient dosing in January 2023; Phase I dose-escalation trial is ongoing.
Enlarged Team of Talents & Expanded Manufacturing Capabilities

The Company has built a stable core team and continuously recruit talents to match its growing demand for R&D, clinical trial, manufacture, operation and commercialization. By December 31th 2022, the Company has a total of 613 employees, including over 240 employees in clinical development and operations, and more than 230 employees in production and quality control, with a year-over-year increase of 189%.
In addition to the headquarters in Chengdu, the Company has set offices in Shanghai, Beijing, Wuhan, Guangzhou, Nanjing, Jinan.
The construction of the first phase of commercial-scale facility has been completed by the end of 2022, which will provide 16,000L of manufacturing capacity. The design of all facilities is in compliance with the requirements of cGMP of the NMPA and FDA.
Financial Data & Capital Market Performance

As of December 31, 2022, the Company’s R&D investment amounted RMB 500 million, a year-over-year increase of 42%; Income amounted RMB 100 million, which comes from the out-licensing revenue of CM326 from CSPC; The Company holds a total of RMB 3.17 billion in cash and cash equivalents, time deposits and bank wealth management, which can fully support the Company’s future development.
In March 2022, Keymed Bio (2162.HK) was included as eligible stocks of the Shenzhen-Hong Kong Stock Connect. In Aug 2022, Keymed got listed in FTSE Global Small Cap Index ex US; In Nov 2022, Keymed got listed in MSCI China Small Cap Index.