On March 17, 2022 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the filing of a Phase 1 clinical trial for HLX301, a Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody (BsAb), in Patients with advanced tumours has been approved by the National Medical Products Administration (NMPA) (Press release, Shanghai Henlius Biotech, MAR 17, 2022, View Source [SID1234610986]). At present, no bispecific antibody targeting PD-1/PD-L1 and TIGIT has been approved for marketing globally. In February 2022, the first patient was dosed in Australia in Phase 1 clinical trial of HLX301, ahead of the same class of BsAb targeting PD-L1×TIGIT, making HLX301 potentially the first-in-class anti-PD-L1×TIGIT BsAb.

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TIGIT (T cell immunoreceptor with immunoglobulin and ITIM domains) is an inhibitory receptor, mainly expressed on natural killer (NK) cells and activated CD8+ T cells, CD4+ T cells, and T regulatory cells. As an inhibitory receptor, TIGIT can inhibit innate and adaptive responses in various mechanisms of action and act as a "brake" like PD-1/PD-L1 does to stop T cells from attacking tumours. Pre-clinical studies reported that HLX301 can simultaneously block both PD-1/PDL1 and TIGIT/PVR pathways, restore TCR signaling, inhibit tumour growth, and has good tolerance and safety, paving the way for further clinical development to against a variety of advanced tumours, including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, etc.

Underpinned by the patient-centric strategy, Henlius has built an innovative product pipeline with many emerging targets, including PD-1/L1, LAG-3, TIGIT, BRAF, etc., and has been pushing its early R&D research capabilities further while also upgrading the technology platform. The company is currently taking effort to explore different forms of antibody conjugates based on our own core antibody technologies and by using of novel conjugating technologies. Looking forward, Henlius is actively accelerating its evolution to an innovative Biopharma and improving efficiency through innovations. It will preserve its momentum for innovation by further strengthening the in-licensing and collaboration on external innovative assets and bringing more high-quality and affordable therapies to patients worldwide.

On March 17, 2022 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, reported the publication of a peer-reviewed article entitled "AXL targeting restores PD-1 blockade sensitivity of STK11/LKB1 mutant NSCLC through expansion of TCF1+ CD8+ T cells" in the journal Cell Reports Medicine (Press release, BerGenBio, MAR 17, 2022, View Source [SID1234610215]).

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The article reports on research that identifies AXL as a critical targetable driver of immune suppression in STK11/LKB1 mutated non-small cell lung cancer (NSCLC). Mutations in STK11/LKB1 in NSCLC occur in approximately 20% of patients and are associated with poor outcomes and limited response to immune checkpoint blockade, commonly utilized treatments for lung cancer.

This article and its accompanying material are accessible here:

View Source(22)00060-X

The research was led by Professor Rolf A. Brekken, in the Hamon Center for Therapeutic Oncology Research at theUT Southwestern Medical Center. The group introduced a STK11/LKB1 mutation into a preclinical murine model of lung adenocarcinoma, resulting in immune checkpoint blockade refractory tumors. The group posits that the lack of response occurred because the STK11/LKB1 mutated tumors lacked a specific population of immune cells (TCF1-expressing CD8+ immune T cells). This immune cell population was also reduced in human NSCLC tumors carrying STK11/LKB1 mutations.

Systemic inhibition of AXL by the BerGenBio molecule bemcentinib led to increased type I interferon secretion from AXL-expressing dendritic cells, resulting in expansion of the TCF1+ T cell population and restored therapeutic response to immune checkpoint blockade treatment. These results were observed in both an immunocompetent mouse model and in mice bearing human STK11/LKB1 mutant NSCLC tumors along with a humanized immune system. The paper also summarizes clinical data in NSCLC patients with identified STK11/LKB1 mutations receiving bemcentinib and immune checkpoint blockage (pembrolizumab), who demonstrated objective clinical response to combination therapy.

In November 2021 BerGenBio announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for bemcentinib in combination with an anti-PD-(L)1 agent as a treatment for patients with STK11/LKB1 altered advanced/metastatic NSCLC patients without actionable mutations.

Martin Olin, Chief Executive Officer of BerGenBio, commented: "We are pleased to receive this strong preclinical validation of the potential role of bemcentinib to treat STK11/LKB1 mutated NSCLC patients. Data suggests that this significant patient population is underserved by current immune checkpoint blockade therapies, and we hope that the combination with bemcentinib can restore the immune response in these patients. The identification of a new druggable biomarker segment such as the STK11/LKB1 mutations may offer significant hope for improved patient outcomes in combination with the current standard of care therapies. We look forward to initiating a clinical trial this year to advance bemcentinib into development for this patient population."

On March 17, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported the appointment of Joseph Todisco as Chief Executive Officer of the company (Press release, CorMedix, MAR 17, 2022, View Source [SID1234610254]). Mr. Todisco also will join the CorMedix Board of Directors. The company expects Mr. Todisco to join CorMedix on May 16th or such earlier date as he completes his contractual responsibilities to his current employer.

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Myron Kaplan, Chairman of CorMedix’s Board of Directors commented, "We are delighted to welcome Joe to CorMedix as the new Chief Executive Officer. Having built pharmaceutical businesses in the past and led successful commercial organizations globally, Joe brings significant and relevant experience to the company. The Board believes he is the right person to lead CorMedix as we continue to advance DefenCath and aim to build a successful commercial franchise around our lead product. The Board also is grateful for Dr. Matt David’s leadership throughout the interim period and we look forward to continuing to work with him and the executive team."

"CorMedix has a strong late-stage pre-commercial asset in DefenCath with a compelling value proposition for patients in the hemodialysis community," said Mr. Todisco. "I am excited to be taking on this role, and I look forward to working alongside the CorMedix board, management, and employees to continue building the company as we prepare for a potential commercial launch in hemodialysis and explore new opportunities for growth."

"With the recent announcement of our resubmission of the DefenCath NDA to the FDA, the CorMedix team has been active on all fronts as we have worked through manufacturing challenges and continued to build our understanding of the commercial opportunity for DefenCath," said Dr. Matt David, interim CEO and Chief Financial Officer. "I join my colleagues in welcoming Joe to CorMedix as Chief Executive Officer. I look forward to working closely with Joe as we seek to transform CorMedix to a commercial stage entity."

Joe Todisco is an experienced pharmaceutical industry leader with a track record of building businesses globally and providing commercial leadership over the last 20 years. Previously, Mr. Todisco was a senior executive at Amneal Pharmaceuticals, where for the past 11 years he has held various roles, most recently as Executive Vice President, Chief Commercial Officer where he was responsible for Amneal Specialty, a growing branded products business with $380 million in revenue and approximately 200 employees. During his tenure at Amneal, Mr. Todisco held roles overseeing corporate development and international operations, leading commercial teams in several international markets including the UK, Australia and Germany, as well as leading Amneal’s merger integration with Impax Laboratories in 2018.

Mr. Todisco was previously Co-Founder and managing executive of Gemini Laboratories, a specialty pharmaceutical company focused on the sales and marketing for niche branded products in the US Market. Gemini Laboratories was established as an affiliate of Amneal Pharmaceuticals and was subsequently acquired by Amneal in 2018.

Prior to joining Amneal, Mr. Todisco was Vice President, Business Development & Licensing at Ranbaxy, Inc. where he was responsible for developing and executing Ranbaxy’s North American commercial business strategy. Prior to Ranbaxy, he held various roles at Par Pharmaceutical, and in his earlier career held positions at Oppenheimer & Company and Marsh & McLennan Companies. Mr. Todisco obtained his MBA in finance from Fordham Graduate School of Business and his BA in Economics from Georgetown University.

On March 17, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will host a conference call and webcast to discuss its fourth quarter and full year 2021 financial results and provide an operational update on Monday, March 21, 2022, at 5:00 p.m. ET (Press release, ORIC Pharmaceuticals, MAR 17, 2022, View Source [SID1234610270]).

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Webcast and Conference Call

To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID 8637367. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

On March 17, 2022 Nanjing Bioheng Biotech Co., Ltd reported that China National Drug Administration Drug Review Center (CDE) approved first Universal Chemeric Antigen Receptor T (UCAR-T) cell drug (Acceptance No. : CXSL2101509). CTA101 is independently developed by targeting CD19 and CD22, for the indication of adult recurrent or refractory B-cell acute lymphoblastic leukemia ( r / r B-ALL ) (Press release, Bioheng Biotech, MAR 17, 2022, View Source;301505078.html [SID1234610288]).

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"The approval of CTA101 product IND is an important milestone for Bioheng in developing innovative immuno-cell therapies", said Xiaohong He, CEO of Bioheng."It will further accelerate the development and commercialization of "off-the-shelf" allogeneic CAR-T, which potentially offers greater benefits to patients over autologous CAR-T. We look forward to pushing more such disruptive products to clinical and providing more choices to solve the unmet medical needs and treatment accessibility".