On January 18, 2022 Cosette Pharmaceuticals, Inc., a New Jersey-based specialty pharmaceutical company, reported that it has closed a transaction to acquire the US sales and distribution rights to eight branded commercial products from leading Japanese pharmaceutical company, Daiichi Sankyo Company, Ltd (4568:JP) and affiliates (Press release, Cosette Pharmaceuticals, 18 18, 2022, https://www.businesswire.com/news/home/20220118005370/en/%C2%A0Cosette-Pharmaceuticals-Acquires-Rights-to-Eight-Branded-Products-from-Daiichi-Sankyo [SID1234605656]). The transaction adds eight prescription products focused on cardiovascular indications to Cosette’s current portfolio of over forty-five commercial products:

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BENICAR (olmesartan medoxomil)
BENICAR HCT (olmesartan medoxomil/hydrochlorothiazide)
WELCHOL (colesevelam HCL) tablets
WELCHOL (colesevelam HCL) Oral Suspension
AZOR (amlodipine/olmesartan medoxomil)
TRIBENZOR (olmesartan medoxomil/amlodipine/hydrochlorothiazide)
EFFIENT (prasugrel)
EVOXAC (cevimeline HCL)
"This transformative acquisition represents a significant expansion and diversification of Cosette’s portfolio and business," said Apurva Saraf, Cosette’s President and CEO. "We look forward to build on this transaction and successfully acquire and integrate important product portfolios in the future, and to continue to make these critical medications available for patients and prescribers."

"As part of our 2030 vision of becoming a global top 10 leader in oncology, we are shifting our structure to focus on our oncology portfolio in the U.S., while ensuring these legacy medicines continue to be available to the patients who rely on them," said Ken Keller, President & CEO, Daiichi Sankyo, Inc. "We are proud and thankful of the effort by our teams at Daiichi Sankyo for their dedication to patients and their providers and look forward to a smooth transition with Cosette."

The agreement outlines a 30-month transition period during which Daiichi Sankyo and Cosette Pharmaceuticals will transfer responsibilities for the manufacture, supply and commercialization of these products, including quality assurance, pharmacovigilance and regulatory matters.

According to IQVIA, U.S. annual sales for the acquired products for the 12 months ended November 2021 were approximately $123 million. No financial details will be disclosed.

Products:

Please see Package Insert (PI) for full prescribing information including complete safety information:

BENICAR (olmesartan medoxomil) See full prescribing information including boxed warning regarding fetal toxicity
BENICAR HCT (olmesartan medoxomil/hydrochlorothiazide) See full prescribing information including boxed warning regarding fetal toxicity
WELCHOL (colesevelam HCI) Tablets See full prescribing information
WELCHOL (colesevelam HCI) Oral Suspension See full prescribing information
AZOR (amlodipine/olmesartan medoxomil) See full prescribing information including boxed warning regarding fetal toxicity
TRIBENZOR (olmesartan medoxomil/amlodipine/hydrochlorothiazide) See full prescribing Information including boxed warning regarding fetal toxicity
EFFIENT (prasugrel) See full prescribing Information, including boxed warning regarding bleeding risk, and medication guide.
EVOXAC (cevimeline HCI) See full prescribing Information
Advisors

Morgan Lewis & Bockius LLP served as legal counsel and BofA Securities served as exclusive financial advisor to Cosette Pharmaceuticals. Goldman Sachs & Co. LLC served as exclusive financial advisor to Daiichi Sankyo.

On January 18, 2022 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, reported the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-101, which is being developed in combination with standard chemotherapy, trastuzumab and pembrolizumab in patients in first-line locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (Press release, Celularity, JAN 18, 2022, View Source [SID1234605527]). CYNK-101 is an investigational genetically modified NK cell therapy designed to synergize with approved antibody therapeutics through enhanced antibody-dependent cellular cytotoxicity (ADCC).

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Robert Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity, said, "We are extremely excited to receive this fast track designation and the support from the FDA for our investigational genetically modified NK cell therapy in the first-line setting of G/GEJ cancers. CYNK-101 is built on the foundation of our unique placental-derived source material, which as compared to other cell sources, has naturally enhanced proliferative potential (or "stemness"), that has been shown to be a determinant of persistence and efficacy potential. Using novel genetic engineering, we have enhanced the ability of CYNK-101 cells to synergize with approved antibodies and provide a novel and potentially non-cross resistant therapy to improve the lives of patients with G/GEJ cancers as well as a broad range of other indications."

"The addition of immune-based therapy of blocking PD-1 with a checkpoint inhibitor (pembrolizumab) to the prior standard of care (chemotherapy and traztuzumab) has recently been shown to be of benefit in patients with first-line HER2/neu positive unresectable G/GEJ cancer," added Andrew Pecora, M.D., President of Celularity. While overall response rates in first-line G/GEJ treated with the triple combination of chemotherapy, traztuzumab and pembrolizumab were significantly greater with the addition of pembrolizumab (74.4% vs 51.9%; p=0.000006; Keynote-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer; Janjigian Y et al., Nature 600, 727-730 (2021), complete response rates remained modest, however (11.3%). "Our recently accepted IND enables the assessment to possibly further improve outcomes in G/GEJ treated with triple combination therapy by adding CYNK-101 cells, a potentially non-cross resistant therapy (enhanced ADCC, direct NK cell tumor killing and help of T cell function and memory) after initially cytoreducing the tumor mass and potentially diminishing resistance in the tumor microenvironment with combined chemotherapy, traztuzumab and pembrolizumab "induction" followed by reinduction and maintenance with CYNK-101 cells in combination with traztuzumab and pembrolizumab."

About Fast Track Designation

Fast Track Designation is an FDA process designed to facilitate the development and expedite the review of new drugs that are intended to treat a serious condition and have the potential to address unmet medical needs. The purpose of Fast Track designation is to expedite the process of getting important new drugs to patients. The designation may offer frequent interactions with the FDA review team on the product’s development and the product may be eligible for rolling review and priority review if certain criteria are met.

About Gastric Cancer

Gastric cancer is the fifth most common cancer worldwide(1). Despite recent improvements in treatment quality and options, advanced gastric cancer remains one of the hardest to cure cancers, with a median overall survival (OS) of 10–12 months and a five-year OS of approximately 5–20%. In May 2021, the U.S. FDA granted accelerated approval to pembrolizumab in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2+ G/GEJ cancers (2)

REFERENCES

Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68 (6):394–424. doi:10.3322/caac.21492.
FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer. Access here: View Source Accessed January 17, 2022.
About CYNK-001

Celularity’s lead therapeutic program based on its placental-derived unmodified NK cell type is CYNK-001, an allogeneic unmodified NK cell being developed as a treatment for hematologic malignancies, solid tumors, and infectious diseases. CYNK-001 is a cryopreserved allogeneic off-the-shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells. The safety and efficacy of CYNK-001 have not been established, and CYNK-001 has not been approved for any use by the U.S. Food and Drug Administration or any other analogous regulatory authority.

On January 17, 2022 Midatech Pharma PLC (AIM: MTPH; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, reported that it is pleased to announce the extension of its R&D collaboration with Janssen Pharmaceutica NV (Janssen) originally announced on 21 July 2020 (Press release, Midatech Pharma, JAN 18, 2022, View Source [SID1234605544]).

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On 17 June 2021, the Company announced that, using its Q-Sphera technology, it had successfully encapsulated a proprietary Janssen experimental large molecule medicine and importantly preserved its functional integrity. The Company believes no other commercial or academic organisation has been able to successfully deliver any such experimental medicine over extended periods using methods capable of commercial scaling.

Building on this important discovery, the Company has extended its R&D collaboration with Janssen. Under the extended collaboration the Company will focus on maximizing drug loading and optimizing in vitro duration of release for this undisclosed Janssen experimental molecule using the Company’s Q-Sphera technology.

Dmitry Zamoryakhin, Chief Scientific Officer of Midatech, said:

"We are excited about the potential of our Q-Sphera technology in the delivery of API via long acting injectables. We look forward to our continued collaboration with Janssen and the application of our technology specific to these APIs."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

On January 18, 2022 TC BioPharm reported that Executive Chairman and Founder, Dr. Michael Leek will be participating in Advanced Therapies Week in Miami, Florida January 25-28 (Press release, TC Biopharm, JAN 18, 2022, View Source [SID1234605603]).

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Michael will participate in a session titled, Treating Cancer and Covid – Use of Banked Allogeneic Gamma-Delta T Cells in Oncology and Severe Viral Infection. The presentation will take place on Friday January 28th at 9:50 am ET at the Miami Beach Convention Centre. For more information or to register for the event, please visit; View Source

Dr. Michael Leek has 30 years’ experience in regenerative medicine, during which he progressed 10 different cell-based products from the laboratory into clinic. In 2017, Michael received the ‘Scottish Life-Sciences Entrepreneurial Business Leadership’ award for 2016-2017. Michael is also a Fellow of the Royal Society of Medicine and Honorary Lecturer at the University of Aberdeen, School of Medical Sciences.

Advanced Therapies Week is a large and immersive expo for companies in the cell and gene therapy sector. It has a focus on knowledge sharing, relationship building and deal making to advance a major pillar of medicine.

On January 18, 2022 Global Coalition for Adaptive Research (GCAR) reported an update on the progress of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447) (Press release, , 18 18, 2022, View Source [SID1234605657]). GBM AGILE is a revolutionary patient-centered, adaptive platform trial for registration that tests multiple therapies for patients with newly-diagnosed and recurrent glioblastoma (GBM) – the deadliest form of brain cancer.

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Key updates

As of January 2022, GBM AGILE has screened over 1000 patients. Enrollment rates are 3 to 4 times greater than traditional GBM studies, with active sites averaging 0.75 to 1 patients/site/month.
With the active enrollment, Biohaven Pharmaceutical Holding Company Ltd.’s (NYSE: BHVN) troriluzole and Vigeo Therapeutics’ VT1021 have been selected to participate in GBM AGILE with anticipated commencement of recruitment in Q1 2022. They will be evaluated in all patient subgroups of the trial which include newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent GBM.
Biohaven’s troriluzole and Vigeo’s VT1021 will be the fourth and fifth arms to join the trial, respectively. GBM AGILE allows multiple drugs from different pharmaceutical companies to be evaluated simultaneously and/or over time against a common standard of care control.
GBM AGILE recently received IND approval in China for the evaluation of Kazia’s paxalisib. Study start up activities in China have commenced with site openings planned for Q2/Q3 2022.
GBM AGILE continues to expand its global access, with plans to open Europe including sites in Austria, France, Germany, Italy, and Switzerland in early 2022. Additional regions globally are being assessed.
GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application (NDA) and biologics license application (BLA) submissions and registrations to the FDA and other health authorities.

Biohaven’s troriluzole is a novel, orally administered small molecule that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. Troriluzole is thought to restore glutamate homeostasis by enhancing glutamate cycling, decreasing presynaptic glutamate release, and augmenting the expression and function of excitatory amino acid transporters (i.e., EAAT2) located on glial cells that play a key role in clearing excess glutamate from the synapse. Troriluzole was selected for inclusion in GBM AGILE, based on compelling evidence showing deregulation of glutamate in glioblastoma. The therapeutic potential of troriluzole in glioblastoma and other oncology indications is supported by several recent clinical and translational research studies conducted with troriluzole and its active moiety.

Dr. Michael Lim, Chair of the Department of Neurosurgery at Stanford University and Dr. Michael Weller, Director Department of Neurology, University Hospital Zurich, Switzerland have been selected to serve as arm Principal Investigators for troriluzole’s evaluation in GBM AGILE.

Vigeo’s VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates the apoptotic and macrophage reprogramming activity of CD36. The result of the dual modulating activity is the induction of apoptosis in tumor and endothelial cells, as well as an increase in both CTL:Treg and M1:M2 macrophage ratio. The biological/therapeutic activity of VT1021 is mediated by the stimulation of thrombospondin-1 (Tsp-1). Through these dual-modulating effects VT1021 reprograms the tumor microenvironment from one that is immune suppressive, or "cold," to immune enhanced (or sensitized), or "hot," that are more susceptible to attack from the immune system. With its novel mechanism of action and clinical data from a Phase 2 expansion study in recurrent GBM patients, VT1021 is undergoing further studies to determine its effect in treating the disease, given that CD36 and CD47 are found to be highly expressed in tumor cells compared to normal brain tissue. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.

VT1021 will be led by arm Principal Investigators, Dr. Howard Colman, Professor, Huntsman Cancer Institute and Department of Neurosurgery, University of Utah, and Dr. Tom Mikkelsen, Medical Director, Henry Ford Precision Medicine Program & Clinical Trials.

The opening of study locations in Europe is anticipated to occur in early 2022 with sites planned in Austria, France, Germany, Italy, and Switzerland. Dr. Michael Weller, Director Department of Neurology, University Hospital Zurich, is serving as regional Principal Investigator of Europe.

"We are excited about the many achievements of GBM AGILE over the last 2.5 years since its launch," said Meredith Buxton, CEO, GCAR. "As an innovative collaboration between academic investigators, patient organizations and industry, GBM AGILE serves as a model for more efficient, cost-effective, and accelerated drug development. While we are encouraged by our accomplishments to date, we know have a lot more work to do to help identify and confirm new drugs for approval to support patients with GBM and their families. We are optimistic that GBM AGILE will provide important information to accelerate the evaluation of new treatments and may identify new and improved options for patients."