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Checkmate Pharmaceuticals Announces CEO Transition

On October 27, 2021 Checkmate Pharmaceuticals, Inc. (Nasdaq: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that Alan Fuhrman has been appointed as interim President and CEO (Press release, Checkmate Pharmaceuticals, OCT 27, 2021, View Source [SID1234592077]). Mr. Fuhrman succeeds Barry Labinger, who has transitioned from his roles as President and CEO and Director.

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"We believe that vidutolimod has significant potential as a novel investigational therapeutic for melanoma and other difficult to treat tumor types. Our strategic priority is to rapidly advance our vidutolimod clinical program toward meaningful clinical data, and I am excited to lead the Company at this important time," said Alan Fuhrman interim President and CEO.

"On behalf of the entire Board, I want to thank Barry for his contributions to Checkmate, and we wish him much success with his future endeavors," said Mike Powell, Chairman of the Board of Directors.

The Board has initiated a candidate search to identify a permanent CEO.

Monteris Medical Announces Positive Coverage Policy Decision for MR-guided Laser Interstitial Thermal Therapy

On October 27, 2021 Monteris Medical, the leader in MR-guided laser interstitial thermal therapy (LITT or laser ablation), reported that Cigna, a global health services company and one of the largest commercial payors in the United States, has released a national coverage policy supporting the use of LITT for people with brain tumors and drug-resistant epilepsy (Press release, Monteris Medical, OCT 27, 2021, View Source [SID1234592020]).

The medical coverage policy by Cigna considers LITT medically necessary in the treatment of drug-resistant epilepsy and symptomatic brain tumors and radiation necrosis when medical necessity is met, and the patient is not suitable for open brain surgery.

"Many patients with brain tumors face situations in which traditional, open surgery is neither possible, nor the preferred approach. This policy decision by Cigna offers appropriate patients greater access to a targeted, minimally invasive technology that can positively impact their care and improve their quality of life," said Dr. Peter Fecci, director of the Brain Tumor Immunotherapy Program and the Center for Brain and Spine Metastasis at Duke University School of Medicine in Durham, N.C.

A growing body of peer-reviewed clinical evidence continues to show medical advantages of minimally invasive, MR-guided laser ablation technology due to decreased morbidity, faster recovery time, shorter hospital and intensive care stay, and an ability to access lesions not amenable to open surgery. Laser ablation also represents an alternative to surgery for patients with significant comorbidities.

"Cigna and other national payors have progressively widened access to care for the patients we serve. This policy announcement is the latest in a continuum of advancements for LITT, establishing its position in the care pathway for patients and their families afflicted by brain tumors and epilepsy," said Martin J. Emerson, president and chief executive officer of Monteris Medical.

The Cigna coverage policy follows recently issued position statements on the use of LITT for epilepsy and brain tumors, respectively, by the major neurosurgical societies, inclusion of LITT in guidelines issued by the National Comprehensive Cancer Network, and Category Level 1 CPT codes approved by the American Medical Association with an effective date of January, 2022.

Biofrontera AG approves modification of the US-IPO of Biofrontera Inc.

On October 27, 2021 Biofrontera AG reported that its US-subsidiary Biofrontera Inc. intends to raise capital by means of an initial public offering and a stock exchange listing in the United States ("IPO") (Press release, Biofrontera, OCT 27, 2021, View Source [SID1234592075]). On October 1, 2021, Biofrontera AG announced that within the scope of the IPO, up to 3,450,000 shares of Biofrontera Inc. are to be placed with US-investors with a price range of USD 5.00 to USD 7.00 per share and that no existing shares of Biofrontera Inc. held by Biofrontera AG will be offered.

Based on consultation with the underwriters, Biofrontera Inc. now intends to modify these terms and conditions: Up to 3,565,000 units ("Units") consisting of one new Biofrontera Inc. share and one warrant entitling the holder to one additional new Biofrontera Inc. share shall be offered in the IPO. The price range for the Units offered in the IPO is USD 5.00 to USD 7.00 per Unit. The price of a Unit is allocated between the share and the warrant. Each warrant has an exercise price equal to the initial public offering price and expires five years from the date of issuance.

The Management Board has resolved, with the consent of the Supervisory Board, that it is in favor of the above adjustments to the terms and conditions of the IPO being made by Biofrontera Inc.

A registration statement relating to the securities to be offered in the IPO has been filed with the U.S. Securities and Exchange Commission (SEC) but has not yet become effective. These securities may not be sold nor may offers to buy these securities be accepted prior to the time the registration statement becomes effective. This offering is being made only by means of a prospectus which has been filed with the SEC as part of a registration statement once it is effective.

This public disclosure of inside information according to article 17 MAR shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

DiaCarta’s ColoScape™ Assay Detects Precancerous Colorectal Cancer Lesions and Colorectal Cancer Mutations with High Sensitivity

On October 27, 2021 DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy, reported the publication of a study in PLOS ONE that demonstrates that DiaCarta’s ColoScape Xenonucleic Acid (XNA)-mediated quantitative real-time polymerase chain reactions (qPCR) clamping assay detects mutant cell-free DNA (cfDNA) from precancerous colorectal cancer (CRC) lesions and colorectal cancer (Press release, DiaCarta, OCT 27, 2021, View Source [SID1234592074]).

The paper entitled, "A novel xenonucleic acid-mediated molecular clamping technology for early colorectal cancer screening," evaluated the performance of XNA-mediated qPCR clamping technology for the simultaneous and qualitative detection of somatic mutations in CRC patients.1 Nineteen mutations in a panel of genes associated with early events in CRC pathogenesis are targeted in the ColoScape assay.

The ColoScape XNA-mediated qPCR clamping assay is a novel multi-gene mutation diagnostic assay for the qualitative detection of colorectal cancer-associated gene mutations in liquid biopsy and FFPE tissue samples. ColoScape utilizes XNA technology, innovative synthetic Xenonucleic acid molecular oligomers that hybridize with target wild-type DNA sequences. The XNA oligomers act as molecular clamps to enable the accurate amplification of mutant sequences only, using qPCR.

In this study, a total of 380 clinical samples, including plasma cfDNA and FFPE samples from patients with precancerous and different stages of CRC, were analyzed with the ColoScape assay.1 With liquid biopsy the preliminary assay clinical specificity for CRC was 100% and the clinical sensitivity was 92.2%; for precancerous lesions clinical specificity was 95% and clinical sensitivity was 62.5%.1 With FFPE samples the preliminary assay clinical specificity for CRC was 96% and the clinical sensitivity was 92%, making this assay robust, specific and highly sensitive. Currently, DiaCarta has large clinical trials ongoing in Europe, Asia, and US.

"This study validates the diagnostic application of the ColoScape assay in the early detection of precancerous lesions and colorectal cancer based on the amplification and detection of cfDNA mutants from one tube of blood," said Aiguo (Adam) Zhang, Ph.D., CEO, DiaCarta, Inc. "Our technology has the potential to disrupt the standard method of FFPE or stool samples used for the diagnosis of colorectal cancer. ColoScape’s sensitivity and specificity may yield detection of colorectal cancer before the disease progresses to more acute stages. In addition, our new generation of ColoScape test includes a panel of methylation genes powered by XNA, which generates even higher sensitivity, especially for the precancerous lesions."

Innovent and NeoCura Announce Strategic Collaboration to Study the Combination Therapy of Sintilimab and Neoantigen Vaccine NEO_PLIN2101 for Cancer Treatment in China

On October 27, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and NeoCura Bio-Medical Technology Co., Ltd. ("NeoCura"), a leading AI-enabled RNA precision medicine biotech company committed to building a global top RNA innovative drug platform, reported that they have entered into a strategic collaboration agreement to carry out a clinical study in China on the combination therapy of sintilimab from Innovent and individualized neoantigen vaccine NEO_PLIN2101 from NeoCura (Press release, Innovent Biologics, OCT 27, 2021, View Source [SID1234592071]).

Innovent will collaborate with NeoCura in China to assess the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the combination therapy using sintilimab from Innovent and NEO_PLIN2101 from NeoCura in cancer patients, to advance the clinical development of combination immunotherapy for multiple solid tumors, and prepare to submit the Investigational New Drug (IND) application to the National Medical Products Administration (NMPA) in the near future.

Dr. Liu Yongjun, President of Innovent, stated: "We are impressed by NeoCura’s differentiated R&D pipeline and international research team, and we are pleased to enter into this strategic collaboration to explore the clinical value of sintilimab in combination with neoantigen vaccines for solid tumors. Innovent has a robust pipeline with strong capabilities in immunology and cancer biology. Currently, we have five innovative drugs approved and launched in China and will have more than 10 innovative drugs to be launched in the next 2-3 years. Our fully integrated platform has accumulated strong R&D, clinical development and commercialization capabilities and is ideal for partners at home and abroad. We also hope to further explore the new opportunities in expanding indications and enhancing therapeutic efficacy of sintilimab in combination with novel therapies. We look forward to wider and in-depth collaboration between the two parties in the future. "

Dr. Wang Yi, founder of NeoCura, stated: "At present, neoantigen vaccines are a revolutionary emerging therapeutic approach worldwide. NeoCura has been focusing on the R&D of tumor neoantigen vaccines since its establishment, hoping to overcome the challenges of existing immunotherapy in the treatment of solid tumors through the application of new technologies. The collaboration with Innovent will play a synergistic role of personalized neoantigen vaccines and monoclonal antibody drugs and jointly explore the clinical effect of the combination therapy in the treatment of solid tumors, which is expected to improve the objective response rate of cancer immunotherapy and bring new opportunities for cancer combination regimens."

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of non-squamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of hepatocellular carcinoma
Additionally, Innovent currently has one regulatory submission under review in China for sintilimab, for the first line treatment of esophageal squamous cell carcinoma.

Additionally, four clinical studies of sintilimab have met their primary endpoints:

Phase 3 study in combination with oxaliplatin and capecitabine for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma
Phase 2 study as second-line treatment of esophageal squamous cell carcinoma
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy
Phase 3 study in combination with BYVASDA (bevacizumab biosimilar injection) and chemotherapy (pemetrexed and cisplatin) for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of non-squamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

About NEO_PLIN2101

NEO_PLIN2101 is a personalized neoantigen vaccine developed by NeoCura, which can be custom made according to the unique tumor gene mutation of each patient. Through high-throughput sample sequencing and AI algorithm epitope prediction, high-quality neoantigen fragments that can be efficiently presented by tumor cells and elicit a potent immune response are selected from patient’s tumor sample. The mRNA vaccine encoded corresponding neoantigen is synthesized in vitro, vaccinated into patients to activate tumor-specific T cells to control tumor growth and reduce tumor burden. Compared to conventional approach, NEO_PLIN2101 has stronger specificity and immunogenicity that can induce anti-tumor immune response in cancer patients.