On September 15, 2021 T–Cure Bioscience, Inc., a privately held company focused on developing autologous T cell receptor therapy (TCR–T) products for the treatment of solid tumors, reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate a Phase I clinical study evaluating a TCR–based product candidate for the treatment of tumors expressing Kita–Kyushu
lung cancer antigen 1 (KK–LC–1), such as gastric, cervical, lung, breast cancers and other KK–LC–1 positive epithelial cancers (NCT05035407) (Press release, T-Cure Bioscience, SEP 15, 2021, View Source [SID1234590212]). T–Cure acquired the KK–LC–1 TCR therapy under an exclusive, worldwide license with the National Cancer Institute (NCI) in 2020. This Phase I Clinical Study will be conducted and sponsored by the NCI, part of the National Institutes of Health, where Dr. Scott Norberg and Dr. James Gulley will be the main PIs for this investigator–
initiated trial. The trial will be done under a Cooperative Research and Development Agreement (CRADA) that T–Cure has in place with the NCI.

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Last year, T–Cure entered into an exclusive, worldwide license with the NCI for intellectual property related to autologous TCR–T treatment of tumors expressing KK–LC–1, such as gastric, lung, triple negative breast and cervical cancers.

KK–LC–1 is a cancer germline (CG) antigen that has restricted expression in healthy tissues and frequent expression in epithelial cancers including lung cancer, gastric cancer, triple negative breast cancer, cervical cancer and others. Adoptive T–cell therapy is one potentially powerful treatment for cancer that genetically modifies natural T cells to make them tumor–specific and to improve their ability to destroy tumor cells. TCR–T cell therapy targeting CG antigens has been shown to induce objective responses without autoimmunity or off–target toxicity in patients with melanoma, synovial cell sarcoma and cervical carcinoma.

"TCR–T cell therapy is a promising new treatment modality that has demonstrated clinical activity in a subset of solid tumors." stated Scott Norberg, D.O., Assistant Research Physician, Genitourinary Malignancies Branch, of NCI and Principal Investigator of the study. "Our hope is that KK–LC–1 TCR–T cell therapy can be effective against common epithelial cancers, which account for 80–90% of all human malignancies."

"We are excited that NCI has obtained the regulatory approval from FDA to initiate a first–in–human trial against a very important target in multiple solid tumors." stated Gang Zeng, Ph.D., Chief Executive Officer of T–Cure Bioscience. "Dr. Norberg and Dr. Gulley have extensive experiences in developing novel adoptive T–cell therapies for cancer and they will be invaluable as we advance this program."

Of note, the TCR was isolated from the tumor–infiltrating lymphocytes of a patient who had a complete response to an immunotherapy without any toxicities. As a result, it may hold great promise for engineering patients’ immune cells to effectively target and destroy cancer cells without harming healthy tissue.

On September 15, 2021 Celularity Inc. (Nasdaq: CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, reported the appointment of Andrew L. Pecora, M.D., F.A.C.P., C.P.E., as President effective today (Press release, Celularity, SEP 15, 2021, View Source [SID1234591817]). Reporting to Robert J. Hariri, M.D., Ph.D., Chairperson and Chief Executive Officer, Dr. Pecora will provide senior leadership to advance Celularity’s clinical pipeline toward U.S. Food and Drug Administration (FDA) approval, including responsibility for preclinical and clinical development and regulatory affairs.

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"It is with great pleasure that we announce Andrew’s appointment as Celularity’s President," said Dr. Hariri. "Building on our recent Nasdaq listing, Andrew’s proven track record as an executive leader in biotechnology and healthcare innovation, delivery and reimbursement will help take Celularity to the next level as we advance our clinical pipeline of next-generation placental-derived cellular therapeutic candidates. Andrew and I trained together at the Weill Cornell Medical Center and have worked in cellular medicines on parallel paths for over 30 years," Dr. Hariri continued.

Dr. Pecora commented, "I am excited to take on this new role at Celularity. I have been very impressed by the early clinical insights and underlying translational science of these novel, placental-derived, off-the-shelf cellular medicines. The potential of Celularity’s clinical pipeline, including its CYNK-101, CyCART-19 and APPL-001 programs, is tremendous. I look forward to providing leadership and strategic vision, working with Bob and his team to realize the potential of these novel allogeneic cell therapies for patients with cancer, infectious disease and degenerative disease."

Dr. Pecora is an award-winning clinician, scientist, and healthcare executive and innovator, with a track record of success leading biotechnology companies to pioneer novel cellular medicines. He is among the world’s foremost experts in blood and bone marrow stem cell transplantation, drug development, and the advancement of novel cell therapies. Dr. Pecora previously served as President of the Physician Enterprise, Chief Innovations Officer, and the Institutional Research Official of Hackensack Meridian Health. There, he oversaw more than 7,500 physicians as well as the business and clinical operations of the John Theurer Cancer Center and clinical and basic research of the Center for Discovery and Innovation. Dr. Pecora also is a Professor of Medicine and Oncology at Georgetown University.

Dr. Pecora is Founder and serves as Chairman of Cota, Inc., a real-world evidence-based data and analytics company focused on leveraging information technology and big data analytics to bridge the gap between precision medicine and population-based health outcomes and to accelerate the development of innovative medicines for patients with difficult to treat diseases.

Prior to Cota, Dr. Pecora served as Co-Founder, Chair and CEO of Progenitor Cell Therapy (PCT), an internationally recognized cellular medicine cGMP manufacturing company. He facilitated the purchase of the Dendreon, Inc., which ultimately led to the FDA approval of PROVENGE (sipuleucel-T), the first FDA approved cell therapy used to treat certain men with advanced prostate cancer. Dr. Pecora eventually led the sale of PCT to Caladrius Biosciences, and co-led multiple public and private capital raises that exceeded USD 500 million.

Earlier in his career, Dr. Pecora was Founder and Chairman of Amorcyte, Inc., a clinical-stage cell therapy company focused on developing novel treatments for cardiovascular disease. At Amorcyte, Dr. Pecora led the capital raise, preclinical and clinical development efforts for AMR-001, a cellular therapy product candidate for vascular injury, through Phase 1 development. This work led to Amorcyte’s sale to Caladrius Biosciences, where Dr. Pecora led the regulatory and clinical development efforts for Amorcyte through Phase 2 development and facilitated a Phase 3 registration trial in Japan.

Dr. Pecora has authored more than 200 peer-reviewed publications and holds over 50 patents, many involving cellular medicines. He has led numerous clinical trials in cancer and other diseases serving as principal investigator. He also has served on national and international steering committees, and contributed to international guidelines for development of cellular medicines, FDA regulatory approval and commercialization standards, including FACT-ISCT International Standards for Hematopoietic Cellular Therapy Production, Processing and Administration. An award-winning healthcare executive, he was recognized in 2019 by Modern Healthcare as one of the top 50 influential clinical healthcare executives.

On September 15, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales. EXPAREL (bupivacaine liposome injectable suspension) net product sales increased 15 percent to $41.4 million for the month of August 2021, compared with $36.1 million for the prior year (Press release, Pacira Pharmaceuticals, SEP 15, 2021, View Source [SID1234587752]). Net product sales of iovera° increased 13 percent to $0.9 million for the month of August 2021, compared with $0.8 million for the prior year. EXPAREL average daily sales for the month of August 2021 were 109 percent of August 2020. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL selling days were 22 in August 2021 and 21 in August 2020.

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"We continue to solidify our leadership position in opioid-sparing pain management with EXPAREL now having treated more than nine million patients since launch with penetration increasing across all target market segments," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "EXPAREL utilization continues to significantly outpace the recovery of the elective surgery market, which is facing additional pandemic-related challenges this summer with regional surges in delta variant cases, staffing shortages, and surgical fatigue from care teams addressing significant procedure backlogs. We expect these variables to subside and the fourth quarter to reflect improving market dynamics."

"From a competitive standpoint, we have not experienced impact from new market entrants and EXPAREL remains extremely well positioned given its broad efficacy label that spans infiltration, field blocks and brachial plexus nerve block. In addition, a pristine safety profile and proven ability to reliably facilitate surgical migration to outpatient sites of care continue to be hallmarks of EXPAREL adoption across pediatric and adult settings. Looking ahead, we remain confident in our ability to achieve our five-year objectives and deliver topline annual growth in the high teens with operating margins that exceed 50 percent by the end of our planning period," continued Mr. Stack.

The company’s net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise.

To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the third quarter or full year 2021.

On September 15, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that the U.S. Food and Drug Administration (FDA) has approved EXKIVITY (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy (Press release, Takeda, SEP 15, 2021, View Source [SID1234587769]). EXKIVITY, which was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations. This indication is approved under Accelerated Approval based on overall response rate (ORR) and DoR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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"The approval of EXKIVITY introduces a new and effective treatment option for patients with EGFR Exon20 insertion+ NSCLC, fulfilling an urgent need for this difficult-to-treat cancer," said Teresa Bitetti, president, Global Oncology Business Unit, Takeda. "EXKIVITY is the first and only oral therapy specifically designed to target EGFR Exon20 insertions, and we are particularly encouraged by the duration of the responses observed with a median of approximately 1.5 years. This approval milestone reinforces our commitment to meeting the needs of underserved patient populations within the oncology community."

The FDA simultaneously approved Thermo Fisher Scientific’s Oncomine Dx Target Test as an NGS companion diagnostic for EXKIVITY to identify NSCLC patients with EGFR Exon20 insertions. NGS testing is critical for these patients, as it can enable more accurate diagnoses compared to polymerase chain reaction (PCR) testing, which detects less than 50% of EGFR Exon20 insertions.

"EGFR Exon20 insertion+ NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR TKIs," said Pasi A. Jänne, MD, PhD, Dana Farber Cancer Institute. "The approval of EXKIVITY (mobocertinib) marks another important step forward that provides physicians and their patients with a new targeted oral therapy specifically designed for this patient population that has shown clinically meaningful and sustained responses."

"Patients with EGFR Exon20 insertion+ NSCLC have historically faced a unique set of challenges living with a very rare lung cancer that is not only underdiagnosed, but also lacking targeted treatment options that can improve response rates," said Marcia Horn, executive director, Exon 20 Group at ICAN, International Cancer Advocacy Network. "As a patient advocate working with EGFR Exon20 insertion+ NSCLC patients and their families every day for nearly five years, I am thrilled to witness continued progress in the fight against this devastating disease and am grateful for the patients, families, healthcare professionals and scientists across the globe who contributed to the approval of this promising targeted therapy."

The FDA approval is based on results from the platinum-pretreated population in the Phase 1/2 trial of EXKIVITY, which consisted of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the 160 mg dose. Results were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the Phase 1/2 trial and demonstrated a confirmed ORR of 28% per independent review committee (IRC) (35% per investigator) as well as a median DoR of 17.5 months per IRC, a median overall survival (OS) of 24 months and a median progression-free survival (PFS) of 7.3 months per IRC.

The most common adverse reactions (>20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The EXKIVITY Prescribing Information includes a boxed warning for QTc prolongation and Torsades de Pointes, and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

The FDA review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international partners. We look forward to continuing our work with regulatory agencies across the globe to bring mobocertinib to patients.

Delivering Takeda’s Wave 1 Pipeline
Takeda is positioned to deliver near-term growth through global brand expansions and its Wave 1 pipeline, which includes multiple best-in-class/first-in-class new molecular entities (NMEs) with potential for approvals through FY2024. Our Wave 2 pipeline contains approximately 30 NMEs and next-generation platforms that will support Takeda’s sustainable growth through FY25 and beyond.

About EXKIVITY (mobocertinib)
EXKIVITY is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations.

EXKIVITY is approved in the U.S. for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Results from the Phase 1/2 trial of mobocertinib have also been accepted for review by the Center for Drug Evaluation (CDE) in China for locally advanced or metastatic NSCLC patients with EGFR Exon20 insertion mutations who have been previously treated with at least one prior systemic chemotherapy.

For more information about EXKIVITY, visit www.EXKIVITY.com. For the Prescribing Information, including the Boxed Warning, please visit View Source

About EGFR Exon20 Insertion+ NSCLC
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 2.2 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.1,2 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ NSCLC make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.3-7 This disease carries a worse prognosis than other EGFR mutations, as EGFR TKIs – which do not specifically target EGFR Exon20 insertions – and chemotherapy provide limited benefit for these patients.

Takeda is committed to continuing research and development to meet the needs of the lung cancer community through the discovery and delivery of transformative medicines.

EXKIVITY IMPORTANT SAFETY INFORMATION
QTc Interval Prolongation and Torsades de Pointes: EXKIVITY can cause life-threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation. Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with EXKIVITY, which may further prolong the QTc. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of QTc prolongation.

Interstitial Lung Disease (ILD)/Pneumonitis: Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold EXKIVITY in patients with suspected ILD/pneumonitis and permanently discontinue EXKIVITY if ILD/pneumonitis is confirmed.
Cardiac Toxicity: Monitor cardiac function, including left ventricular ejection fraction, at baseline and during treatment. Withhold, resume at reduced dose or permanently discontinue based on severity.
Diarrhea: Diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment. Monitor electrolytes and advise patients to start an antidiarrheal agent at first episode of diarrhea and to increase fluid and electrolyte intake. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective non-hormonal contraception.

Takeda’s Commitment to Oncology
Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

On September 15, 2021 Herantis Pharma Plc ("Herantis" or the "Company") reported the result of the offering of new shares (the "Placing Shares") in a private placement to institutional and other qualified investors (the "Placing") (Press release, Herantis Pharma, SEP 15, 2021, View Source,c3416074 [SID1234587799]). The Company announced the launch of the Placing by way of a company release published on 15 September 2021. Herantis raises gross proceeds of EUR 4.04 million in the Placing.

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In the Placing, the Company expects to issue a total of 1,346,500 Placing Shares in a directed share issue. The Placing Shares represent approximately 13.8 per cent. of the issued shares in Herantis prior to the Placing and approximately 12.1 per cent. of the issued shares in Herantis following the Placing. The total number of issued shares in the Company after the Placing will be 11,103,568.

The subscription price of the Placing Shares is EUR 3.00 per Placing Share, corresponding to a discount of 6.5 per cent to the closing price on First North Growth Market Finland immediately before the commencement of the Placing on 15 September 2021. The subscription price shall be recorded in the invested unrestricted equity reserve.

The Placing was carried out based on offers received in an accelerated book building and based on the authorisation given to the board of directors by the Company’s extraordinary general meeting of 2 December 2020.

As previously announced, Acme Investments SPF Sarl, a company controlled by Timo Syrjälä, and Nanoform Finland Plc participated in the Placing among several other investors.

The Placing Shares (ISIN code FI4000087861) will be registered with the trade register maintained by the Finnish Patent and Registration Office on or about 16 September 2021. The Placing Shares are expected to be ready for delivery to the investors against payment through Euroclear Finland Oy or, as applicable, through Euroclear Sweden AB on or about 20 September 2021.

Herantis intends to make applications for the admission into trading of the Placing Shares on Nasdaq First North Growth Market Finland and on Nasdaq First North Growth Market Sweden. Trading in the Placing Shares is expected to commence on Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden on or about 20 September 2021, subject to the respective listing applications being approved.

The CEO of Herantis, Craig Cook comments: "We are pleased with the support amongst existing as well as respected new shareholders in Herantis. The funds will clearly enable us to continue the important development activities of our novel disease-modifying CNS drugs rhCDNF and xCDNF (HER-096). These assets are the epitome of our ground-breaking science and have the potential to slow, stop or even reverse the progression of neurodegenerative diseases with high impact for patients and society. Herantis is well positioned to capitalize on this momentum and create value for our growing list of world class shareholders."

Swedbank AB (publ) is acting as the global coordinator and bookrunner of the Placing in association with Kepler Cheuvreux. Krogerus Attorneys Ltd is acting as the legal counsel to the Company as to Finnish law and Borenius Attorneys Ltd is acting as the legal counsel to the global coordinator and bookrunner of the Placing as to Finnish law.