On December 21, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported the presentation of preclinical data from its theranostic in development, VMT-alpha -NET, at the 2021 International Chemical Congress of Pacific Basin Societies (Pacifichem 2021 Congress), taking place virtually, December 16-21, 2021 (Press release, Viewpoint Molecular Targeting, DEC 21, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-presents-preclinical-data-from-vmt-net-theranostic-in-development-for-the-treatment-and-diagnosis-of-neuroendocrine-tumors-at-the-pacifichem-2021-congress/ [SID1234597538]).

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The abstract titled, "Chemical structure modifications to chelator and linker compositions for improved pharmacokinetics of 203/212Pb peptide-based radiopharmaceuticals," was presented

In the Advancements in the Chemistry of Targeted Alpha Therapy (#180) symposium session by Michael K. Schultz, PhD, Chief Science Officer of Viewpoint.

"Emerging evidence suggests that alpha-particle therapy has the potential to significantly improve tumor response. The preclinical data from VMT-alpha -NET demonstrated to-date provides strong evidence that our VMT- -NET image-guided approach can meet the need for an effective therapy with a promising toxicity profile. We are pleased with the progress of VMT-alpha -NET and are committed to advancing the development of this important theranostic forward," commented Dr. Schultz.

The preclinical study was designed to explore chemical modifications to the chelator and chelator-peptide linker of SSTN analogs to optimize for 203Pb/212Pb image-guided alpha-particle radionuclide therapy for SST2R expressing tumors. PEG linkers of varying length were explored to improve tumor cell binding/internalization, in vivo tumor targeting, and renal clearance. In vitro and in vivo performance properties (e.g., radiolabeling, renal clearance) were compared to DOTATOC (203Pb/212Pb).

VMT-a-NET was identified with significantly improved performance. [203Pb]VMT-alpha-NET significantly improved: (1) SST2R IC50 binding affinity (>2-fold); (2) cellular uptake and internalization (a factor of 20); (3) tumor accumulation/retention; and (4) renal clearance compared to [203Pb]DOTATOC. With these improvements, the tumor:kidney ratio (%ID/ gram) improved more than 8-fold (24 h post injection) in AR42J tumor bearing mice compared to [203Pb]DOTATOC. [212Pb]VMT-alpha-NET therapy was effective and well-tolerated in mice (renal injury biomarkers NGAL’ CREA), achieving a 70% complete response rate in tumor bearing mice.

Based on the preclinical data seen to-date, Viewpoint believes that VMT- -NET is well-positioned to apply the new transformative power of alpha-particle treatment to NET tumors and other cancers that express the SST2R biomarker.

The Company recently commenced an investigator-initiated Phase 1 imaging study of VMT-alpha -NET for imaging somatostatin receptor subtype 2 (SSTR2)-positive neuroendocrine tumors, being conducted at the University of Iowa Hospitals and Clinics. The images obtained from the Phase 1 imaging study will inform future therapeutic trials of [212Pb]VMT-alpha-NET alpha-particle therapy for this tumor type. In parallel to this investigator-initiated imaging trial, the Company plans to move forward with a Phase 1/2a therapy study of VMT- -NET for the treatment of neuroendocrine tumors.

About the Pacifichem 2021 Congress

The 2021 International Chemical Congress of Pacific Basin Societies will take place virtually, December 16-21, 2021. Pacifichem 2021 will be the eighth in the series of successful cosponsored scientific conferences of Pacific Basin Chemical Societies. Founded in 1984, these conferences have been held in Honolulu, Hawaii about every five years.

About Neuroendocrine Tumors

Neuroendocrine tumors are rare forms of cancers that occur most commonly in the pancreas or other areas of the gut such as the stomach, small intestine, rectum, colon, or appendix. A neuroendocrine tumor may grow slowly or aggressively and spread to other parts of the body. Diagnosis and treatment of neuroendocrine tumors depend on the type of tumor, its location, whether it produces excess hormones, how aggressive it is and whether it has spread to other parts of the body. Some approaches may include surgery, radiation, and chemotherapy.

On December 21, 2021 Xspray Pharma AB, a specialty pharmaceutical company, reported that it has signed a Manufacturing and Supply Agreement with NerPharMa S.r.l., a pharmaceutical manufacturing company in Milan, Italy, to manufacture its lead product candidate HyNap-Dasa (Press release, Xspray, DEC 21, 2021, View Source [SID1234649533]). The agreement covers the clinical and world-wide commercial supply of HyNap-Dasa, and includes production of both drug substance and the finished product. HyNap-Dasa is one of three product candidates that Xspray currently has under development. The company’s goal is to launch HyNap-Dasa in the US-market in 2021.
Under the terms of the agreement, Xspray has contracted NerPharMa to manufacture drug substance and the finished product to supply material for clinical programs and for future world-wide commercial sales. Xspray is developing HyNap-Dasa both as a completely interchangeable variant of Sprycel to be registered in the United States by the Abbreviated New Drug Application (ANDA) route or as an improved product by the 505(b)(2) procedure. NerPharMa is a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences S.r.l., Milan, Italy.

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NerPharMa’s GMP manufacturing facility is approved by both the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, and the U.S. Food and Drug Administration (FDA).

"This contract is a significant step in our development of HyNap-Dasa," said Per Andersson, CEO of Xspray Pharma. "We are pleased to have secured access to GMP production of drug substance and finished product for our continued clinical program as well as to GMP quantities of HyNap-Dasa for future commercial activities in an US FDA approved manufacturing facility."

"We are pleased to be working with Xspray Pharma to manufacture and provide finished product for their investigational and commercial needs," said Angelo Colombo, CEO of NerPharMa.

On December 21, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, reported that it will present at the upcoming virtual 40th Annual J.P. Morgan Healthcare Conference (Press release, Biomea Fusion, DEC 21, 2021, View Source [SID1234597523]). Thomas Butler, Chief Executive Officer and Chairman of the Board, is scheduled to present on Wednesday, January 12, 2022, at 12:00pm Pacific Time.

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A live audio webcast of the presentation can be accessed at www.biomeafusion.com and will be available for 30 days following the presentation.

On December 21, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for QINLOCK (ripretinib) in the UK for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib1 (Press release, Deciphera Pharmaceuticals, DEC 21, 2021, View Source [SID1234597524]).

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"The approval of QINLOCK in the UK is an important milestone for patients with advanced GIST who have been waiting for a new treatment option," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "The results from the INVICTUS study underscore the potential for QINLOCK to transform the treatment of advanced GIST and establish a new standard of care in the UK for fourth-line GIST."

The QINLOCK approval was supported by efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001)2. Secondary endpoints include Objective Response Rate (ORR) as determined by independent radiologic review using modified RECIST and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504)2 In addition, QINLOCK demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36)2.

The most frequently observed adverse drug reactions (≥25%) in a pooled safety population (n=392) treated with QINLOCK were fatigue, alopecia, nausea, myalgia, constipation, diarrhea, palmar-plantar erythrodysesthesia syndrome (PPES), weight decreased, and vomiting1,2.

In the INVICTUS study, adverse reactions resulting in permanent discontinuation occurred in 8% of patients, dosage interruptions due to an adverse reaction occurred in 24% of patients and dose reductions due to an adverse reaction occurred in 7% of patients who received QINLOCK2.

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation3,4. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST3,4.

On December 21, 2021 EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported it has completed its acquisition of Intouch Group, a full-service global agency network serving the pharmaceutical industry (Press release, EVERSANA, DEC 21, 2021, View Source [SID1234597525]). The acquisition immediately propels EVERSANA’s position as a $1 billion commercial services leader with more than 40 locations and 5,500 employees worldwide, poised to solve any global pricing, access, reimbursement, promotion, adherence, or product delivery challenge.

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"Today marks a milestone day for not only our employees and clients, but for an industry desperately in need of a better way to bring innovations to market, create long-term value, and improve patient lives," said Jim Lang, CEO of EVERSANA. "With the added power of Intouch and millions more invested in data, analytics and digital transformation, we are reinventing commercial approaches for the benefit of our clients and their patients."

Under terms of the agreement announced in October 2021, Intouch’s industry-leading creative and media services, enterprise solutions and data analytics will join EVERSANA’s fully integrated commercialization services platform. Agencies from both firms will integrate, as EVERSANA ENGAGE joins forces with the Intouch agency network. Faruk Capan, CEO of Intouch Group, now reports to Jim Lang.

"This is so much more than an integration. This is our opportunity to improve every sector of product commercialization," said Capan. "Over the last 20 years we transformed pharmaceutical promotion and digital engagement. Imagine what the next 20 years will bring as we set our sights even higher, unafraid to transform healthcare as we know it."

Financial details will not be disclosed. Houlihan Lokey served as the exclusive financial advisor to Intouch Group.