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Keymed Biosciences | The Latest Results from the Phase Ia Clinical Study of CMG901 was presented at the 2023 ASCO GI CANCERS SYMPOSIUM

On January 17, 2023 Keymed Biosciences Inc. (Stock Code: 02162 HK) is pleased to reported that the latest data from the Phase Ia dose-escalation trial of CMG901 (Claudin 18.2 antibody drug conjugate), a novel drug candidate, for advanced solid tumors will be presented as a poster at the 2023 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (2023 ASCO (Free ASCO Whitepaper) GI) (Press release, Keymed Biosciences, JAN 17, 2023, View Source;the-latest-results-from-the-phase-ia-clinical-study-of-cmg901-was-presented-at-the-2023-asco-gi-cancers-symposium-301724117.html [SID1234626307]).

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Poster Title：A Phase 1a dose-escalation, multicenter trial of anti-claudin 18.2 antibody drug conjugate CMG901 in patients with resistant/ refractory solid tumors

Abstract #：352
Poster Bd #：E13
Abstract Presenter：Rui-hua Xu, Department of Medical Oncology, Sun Yat-sen University Cancer Center

This Phase Ia trial (NCT04805307) was designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of CMG901 in patients with advanced solid tumors. During the dose-escalation phase, Claudin 18.2 expression was retrospectively tested by the central lab.

As of August 4, 2022, totally 27 patients (13 gastric/gastroesophageal junction (gastric/GEJ) cancer and 14 pancreatic cancer patients) were enrolled in the Phase Ia clinical study of CMG901. The results showed that CMG901 was well-tolerated with a favorable safety profile. Drug-related grade ≥3 adverse events (AEs) occurred in 3/27 (11.1%) patients. No drug-related grade ≥4 AEs were reported. Patients received CMG901 at dose levels up to 3.4 mg/kg, and maximum tolerated dose (MTD) was not reached. One patient in the 2.2 mg/kg cohort developed a dose-limiting toxicity.

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. Median progression free survival (mPFS) and median overall survival (mOS) were not reached yet.

Efficacy of CMG901 in CLDN18.2-positive Gastric/GEJ Cancer (N=8)

ORR#

75.0% (6/8)

DCR*

100% (8/8)

Median PFS, day

NR&

Median OS, day

NR&

# Proportion with complete response (CR) + partial response (PR)
* Proportion with CR+PR+stable disease
& mPFS and mOS were not reached.

CMG901 showed a favorable safety and tolerability profile in this trial. CMG901 at doses of ≥1.8 mg/kg yielded encouraging anti-tumor activity in patients with Claudin 18.2-positive gastric/GEJ cancer.

ABOUT KYM901

KYM901 is a first-in-human Phase I trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of CMG901 in patients with advanced solid tumors who had failed to respond to standard of care or had no available standard of care regimen. KYM901 comprises modified dose escalation part (Phase Ia) and dose-expansion part (Phase Ib). Patients enrolled in Phase Ia are not required to be positive for Claudin 18.2 expression, whereas Claudin 18.2 positivity tested by the central lab was required for patient entry into the Phase Ib trial.

ABOUT CMG901

CMG901, a novel recombinant humanized monoclonal antibody drug conjugate targeting Claudin 18.2, has been approved for clinical trials in both China and the United States. CMG901 consists of an anti-Claudin 18.2 monoclonal antibody, a protease-degradable linker, and a cytotoxic small molecule monomethyl auristatin E (MMAE). Enrollment of patients with solid tumors in Phase I dose-escalation trial of CMG901 was completed in the first half of 2022. Furthermore, Phase I dose-expansion trial of CMG901 in patients with solid tumors in China is simultaneously initiated since the second quarter of 2022.

CytomX Therapeutics to Present at the B. Riley Securities Virtual Annual Oncology Investor Conference

On January 17, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported that Sean McCarthy, D.Phil., president, chief executive officer, and chairman, will present at the B. Riley Securities Virtual Annual Oncology Investor Conference on Thursday, January 19, 2023 at 2:30 p.m. ET (Press release, CytomX Therapeutics, JAN 17, 2023, View Source [SID1234626306]).

A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. An archived replay will be available for 30 days following the event. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conference.

Theriva Biologics Announces First Patient Dosed in VIRAGE, a Phase 2b Trial of Systemically Administered VCN-01 in Combination with Chemotherapy in Pancreatic Ductal Adenocarcinoma

On January 17, 2023 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported the first patient has been dosed in VIRAGE, the Phase 2b randomized, open-label, placebo-controlled, multicenter clinical trial of systemically administered VCN-01 in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Theriva Biologics, JAN 17, 2023, View Source [SID1234626305]).

"The dosing of the first patient in our Phase 2b PDAC trial represents an important step in our pursuit to address unmet needs for patients with difficult-to-treat cancers," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "The incidence of PDAC continues to rise and while it continues to have one of the lowest survival rates among all cancer types, efforts to improve upon the standard of care treatment have largely stalled. In contrast, we are encouraged by the growing clinical data that underscore VCN-01’s differentiated mechanism of action, as well as the biological activity and synergistic clinical benefit observed in combination with SoC chemotherapy for patients with PDAC and other solid tumors. With regulatory clearance from the FDA and AEMPS, we look forward to the continued progress of this program and more broadly, the advancement of our novel OV platform."

About VIRAGE
VIRAGE is a two-arm Phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. VIRAGE is expected to enroll up to 92 adult participants at up to 25 sites across the US, Spain, and Germany. In both the control and treatment arms, patients will receive gemcitabine/nab-paclitaxel standard of care chemotherapy over 28-day cycles. In the treatment arm only, patients will also receive systemically administered VCN-01 seven-days prior to the first and fourth cycles of gemcitabine/nab-paclitaxel treatment. Primary endpoints for the trial include overall survival and VCN-01 safety/tolerability. Additional endpoints include progression free survival, objective response rate, and measures of biodistribution, VCN-01 replication, and immune response. Since this is an open label trial, progress will be monitored very closely and steps to accelerate the clinical program may be implemented if supported by the emerging data. More information about the trial is available here and through the Spanish Clinical Trials Registry (EudraCT Number: 2022-000897-24).

Actinium Pharmaceuticals, Inc. to Present at the 3rd Annual B. Riley Securities Oncology Conference

On January 17, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported that the Company’s management team will participate in a fireside chat on Thursday, January 19, 2023 at 10:30 AM EST at the 3rd Annual B. Riley Securities Oncology Conference (Press release, Actinium Pharmaceuticals, JAN 17, 2023, View Source [SID1234626304]). The webcast of the presentation will be accessible on the event’s website at View Source and on the investor relations page of Actinium’s website View Source A replay of the presentation will be available on the day of the fireside chat through the same links.

B. Riley Securities 3rd Annual Oncology Conference

B. Riley Securities 3rd Annual Oncology Conference, January 18-19, will feature over 30 SMiD cap healthcare companies focused on the development and commercialization of new medicines and key enabling technologies, cutting across multiple next-generation therapeutic modalities. The conference will feature KOL panel discussions with academic and industry leaders at the forefront of translational and clinical research underway with novel immunotherapy, cell therapy, and targeted oncology approaches, as well as imaging and radiation oncology initiatives, aimed at driving meaningful improvements to current standard of care for cancer patients.

Lantern Pharma Receives Pre-IND Feedback from the FDA, Clearing a Path for Drug Candidate LP-184’s Phase 1 Clinical Trial in Q2 2023

On January 17, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported it has received guidance from the United States Food and Drug Administration (FDA) on Lantern’s clinical development plans for its LP-184 program (Press release, Lantern Pharma, JAN 17, 2023, View Source [SID1234626303]). LP-184 has shown nanomolar potency across a range of cancers including several solid tumors and multiple adult and pediatric central nervous system (CNS) cancers. The FDA feedback clears Lantern’s path for an IND submission and the targeted initiation of a first-in-human clinical trial in Q2 2023.

During Q4 2022, Lantern requested a pre-investigational new drug (pre-IND) meeting with the FDA, requesting agency feedback in connection with its planned LP-184 IND application. The FDA’s responses and guidance have been aligned with the company’s clinical, CMC, and preclinical development plans and solidifies Lantern’s timeline for an IND submission and clinical trial initiation in Q2 2023. The upcoming LP-184 Phase 1 trial is expected to enroll patients with pancreatic cancer, select solid tumors with DNA damage repair deficiency, and malignant gliomas-including glioblastoma (GBM). The FDA previously granted Lantern Orphan Drug Designations (ODD) for LP-184 in both pancreatic cancer and malignant gliomas.

The upcoming LP-184 first-in-human Phase 1 trial is expected to include patients across a range of solid tumor types, including adult brain and central nervous system (CNS) cancers. CNS cancer patients have some of the lowest 5-year cancer survival rates and have had little to no meaningful treatment progress in nearly two decades. LP-184’s anti-tumor synthetic lethality mechanism of action, favorable blood brain permeability, and compelling pre-clinical efficacy for CNS cancers give it the potential to become the next generation standard-of-care agent for CNS cancer patients.

"We expect to have multiple cancer indications and sub-types in this upcoming LP-184 trial that have been identified with the help of our A.I. platform, RADR. The identification and preclinical validation of these indications has been accomplished in timelines that are typically unheard of in oncology drug development. This gives us a unique advantage of generating multiple meaningful and clinically needed programs that we can develop, partner, and monetize for the benefit of our shareholders and for cancer patients," stated Panna Sharma, Lantern’s President and CEO. "Our team has been very focused on aligning multiple workstreams to make for an impactful launch of our LP-184 Phase 1 program later this year across multiple cancer types that have the molecular characteristics for sensitivity to this exciting new drug candidate," continued Sharma.

Lantern’s LP-184 program has benefitted from involvement and collaboration with top academic centers including the Kennedy Krieger Institute at Johns Hopkins, Fox Chase Cancer Center, The Danish Cancer Society Research Center, and the Greehey Children’s Cancer Research Institute at University of Texas Health Science Center, San Antonio. These collaborations have been a key component of further validating and focusing the clinical potential of LP-184 for patient groups with high unmet need.