On September 9, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, announced today that it has priced an offering of $500.0 million aggregate principal amount of 0.550% Senior Notes due 2023 at an issue price of 99.964% of the principal amount, $800.0 million aggregate principal amount of 0.850% Senior Notes due 2024 at an issue price of 99.938% of the principal amount, $500.0 million aggregate principal amount of 1.900% Senior Notes due 2028 at an issue price of 99.928% of the principal amount and $500.0 million aggregate principal amount of 2.250% Senior Notes due 2031 at an issue price of 99.697% of the principal amount (Press release, PerkinElmer, SEP 9, 2021, View Source [SID1234587457]).

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The issuance of the notes is expected to close on September 10, 2021, subject to the satisfaction of customary closing conditions. The notes will pay interest on a semi-annual basis.

PerkinElmer plans to use the net proceeds of the offering to pay a portion of the cash consideration payable for its planned acquisition of BioLegend, Inc.

The joint book-running managers for the offering are Goldman Sachs & Co. LLC, BofA Securities, Inc., J.P. Morgan Securities LLC and Wells Fargo Securities, LLC.

The offering is being made pursuant to an effective registration statement on Form S-3 (including a prospectus) filed with the U.S. Securities and Exchange Commission ("SEC"). Prospective investors should read the prospectus forming a part of that registration statement and the prospectus supplement related to the offering and the other documents that PerkinElmer has filed with the SEC for more complete information about the company and this offering. These documents are available at no charge by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the prospectus supplement and the accompanying prospectus relating to the offering can be obtained by calling one of the joint book-running managers at the following: Goldman Sachs & Co. LLC at 1-866-471-2526 or by emailing [email protected], BofA Securities, Inc. toll-free at 1-800-294-1322, J.P. Morgan Securities LLC collect at 1-212-834-4533 or Wells Fargo Securities, LLC toll-free at 1-800-645-3751.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes, nor shall there be any offer, solicitation or sale of the notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On September 9, 2021 Obsidian Therapeutics, Inc., a biotechnology company pioneering engineered cell and gene therapies, reported it has closed a $115 million Series B financing with a premier syndicate of life science investors led by The Column Group Crossover Fund (TCGX) (Press release, Obsidian Therapeutics, SEP 9, 2021, View Source [SID1234587456]). Additional new investors participating in the financing include RA Capital Management, Surveyor Capital (a Citadel company), Cowen Healthcare Investments, Deep Track Capital, Logos Capital, Pivotal BioVenture Partners, Samsara BioCapital, and Soleus Capital. Existing investors Atlas Venture, Vertex Ventures HC, Amgen Ventures, and Bristol Myers Squibb participated in the financing. Also participating in the round is Vertex Pharmaceuticals, with whom Obsidian recently executed a collaboration to discover novel therapies that regulate gene editing.

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Proceeds from the financing will be used to drive Obsidian’s lead tumor infiltrating lymphocyte (TIL) program, cytoTIL15, into the clinic and to first clinical data for the treatment of metastatic melanoma. In addition, the Company plans to rapidly expand cytoTIL15 into multiple other solid tumor types and to advance its commercial manufacturing build.

"We are pleased to have the support and partnership from this syndicate of premier investors," said Paul Wotton, Chief Executive Officer of Obsidian. "With this funding, we will continue to advance our transformative cytoTIL15 program into clinical studies to treat patients suffering from solid tumors and to further expand our pipeline of engineered TIL therapies."

Cariad Chester, Partner, TCGX, will join the Company’s Board of Directors. "Obsidian’s cytoTIL15 therapy has the potential to be paradigm-shifting for patients with solid tumors. By engineering TILs with membrane-bound IL15, cytoTIL15 have the potential to drive improved efficacy as well as eliminate the need for toxic and costly concomitant IL2 therapy," said Chester. "We are thrilled to support the Obsidian team as they pave the way for cytoTIL15 and the next generation of ‘TIL 2.0’ therapies."

About cytoTIL15

cytoTIL15 is Obsidian’s lead cytoTIL program, currently in preclinical development for the treatment of metastatic melanoma and other solid tumors. cytoTIL15 is a novel engineered tumor infiltrating lymphocyte therapy engineered with regulated membrane-bound IL15 that does not require patients to receive concomitant IL2 therapy, a toxic and costly requirement for conventional TILs. The Company expects to submit an IND for cytoTIL15 in mid-2022.

On September 9, 2021 GlaxoSmithKline (GSK) plc reported that it will present new data across the Company’s oncology pipeline and portfolio at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (16-21 September), including new data on JEMPERLI (dostarlimab) and ZEJULA (niraparib), as well as early-stage research in immuno-oncology and oncology cell therapy (Press release, GlaxoSmithKline, SEP 9, 2021, https://www.gsk.com/en-gb/media/press-releases/gsk-to-highlight-continued-progress-in-oncology-pipeline-and-portfolio-with-data-presented-at-esmo/ [SID1234587454]). With 13 presentations at the meeting (12 GSK-sponsored and one GSK-supported), GSK will demonstrate its momentum in advancing dostarlimab and niraparib, and provide new insights into investigational therapies through early-stage research.

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The data being presented at ESMO (Free ESMO Whitepaper) reflect GSK’s commitment to strengthening its oncology pipeline across its focus areas of immuno-oncology, synthetic lethality and oncology cell therapy. GSK has a diverse portfolio and pipeline, including three marketed oncology medicines and 16 assets in clinical development that leverage the science of the immune system, human genetics and advanced technologies to address a variety of tumour types.

Continuing to advance immuno-oncology therapies

Presentations from the phase I GARNET study will address anti-tumour activity by tumour mutational burden in patients with recurrent or advanced endometrial cancer (Abstract #76P) in addition to treatment-related adverse events occurring during the study (Abstract #991P). GSK will also present a real-world analysis of the demographics and survival outcomes in patients from England with advanced or recurrent endometrial cancer following platinum-based doublet therapies (Abstract #812P).

Dostarlimab is the first anti-PD-1 monotherapy approved for endometrial cancer in the European Union (EU) and received a conditional approval in April for the treatment of women with mismatch repair-deficient (dMMR) /microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. The treatment also received accelerated approval in the United States (US) for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, who have progressed on or following prior treatment with a platinum-containing regimen.

Last month, the FDA granted accelerated approval of an additional indication for dostarlimab for the treatment of adult patients with dMMR recurrent or advanced solid tumours, as determined by an FDA-approved test, who have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The new indication for dostarlimab is the fourth approval for GSK oncology in less than 1.5 years, demonstrating GSK’s unyielding commitment to address the unmet needs of cancer patients.

Continued research and development in synthetic lethality

Results from the phase III PRIMA trial will examine quality-adjusted time without symptom or toxicity of niraparib in patients with advanced ovarian cancer (Abstract #738P). Additionally, GSK will present real-world analyses from three studies in patients with advanced ovarian cancer across the UK, France and US.

Niraparib is a once-daily oral monotherapy maintenance treatment approved for women with first-line platinum-responsive advanced ovarian cancer regardless of biomarker status in the US and the EU. The research that will be presented at ESMO (Free ESMO Whitepaper) bolsters the understanding of the use of this poly (ADP-ribose) polymerase (PARP) inhibitor for maintenance treatment in ovarian cancer.

GSK will also present a trial in progress poster on the recently initiated phase III ZEAL-1L study in advanced or metastatic non-small cell lung cancer, expanding the Company’s clinical development programme into other solid tumours to potentially bring niraparib to more patients.

The complete list of GSK sponsored and supported abstracts accepted by ESMO (Free ESMO Whitepaper) for presentation and/or publication from the company’s areas of oncology research is below.

Immuno-oncology

Abstract Name

Presenter

Abstract Number

Analysis of antitumor activity of dostarlimab by tumor mutational burden (TMB) in patients (pts) with endometrial cancer (EC) in the GARNET trial

Oaknin, A

#76P

Demographics and survival outcomes in patients with advanced or recurrent endometrial cancer (EC) following platinum-based doublet (PBD) in the English real-world (RW) setting

Heffernan, K

#812P

Treatment-related adverse events (TRAEs) occurring during dostarlimab therapy in the GARNET study​

Andre, T

#991P

ENGOT-EN6/GOG-3031/NSGO-RUBY Part 2: A phase 3, randomized, double-blind, study of dostarlimab + carboplatin-paclitaxel followed by

dostarlimab + niraparib versus placebo (PBO) + carboplatin-paclitaxel followed by PBO in recurrent or advanced endometrial cancer (EC)

Mirza, MR

#820TiP

Adverse event management during treatment with bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1: treatment guidelines based on experience in clinical trials

Gulley, J

#1689P

Long-term follow-up of patients (pts) with human papillomavirus (HPV)–associated malignancies treated with bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1

Strauss, J

#957O

Synthetic Lethality

Abstract Name

Presenter

Presentation Details

Impact of residual disease on outcomes in patients with ovarian cancer: A meta-analysis

Chase, D

#761P

Ovarian Cancer Retrospective European (O’CaRE) observational study to assess burden of disease and time to next treatment in real-world clinical practice: results from the United Kingdom (UK)​

McGrane, J

#745P

Quality-Adjusted Time without Symptom or Toxicity​ (Q-TWiST) and Quality-Adjusted Progression-Free Survival (QA-PFS) of First-Line (1L) maintenance niraparib in patients with advanced Ovarian Cancer (OC) – Results from the PRIMA trial

Barretina-Ginesta, P​

#738P

Real-world clinical outcomes of patients with de novo advanced high-grade epithelial ovarian cancer eligible to niraparib maintenance in France

Rodrigues, M

#746P

Survival in patients (pts) with advanced ovarian cancer (AOC) changes with cumulative number of risk factors (RFs), a US real-world (RW) analysis

Chase, D

#742P

First-line (1L) maintenance therapy with niraparib (nira) + pembrolizumab (pembro) vs placebo + pembro in advanced/metastatic non-small cell lung cancer (NSCLC): Phase III ZEAL-1L study​

Ramalingam, S

#1360TiP

Oncology Cell Therapy

Abstract Name

Presenter

Presentation Details

A novel, comprehensive glimpse at NY-ESO-1 expression, mRNA to protein translation, & potential impact on clinical studies

​Blouch, K

#109P

About Dostarlimab

Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.[1] In addition to GARNET, dostarlimab is being investigated in other registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers.

Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: dostarlimab, a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of each of these Products under the Agreement.

Important Information for JEMPERLI in the EU

Indication

JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability‑high (MSI‑H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum‑containing regimen.

Refer to the JEMPERLI Prescribing Information for a full list of adverse events and the complete important safety information in the EU.

About Niraparib

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies.

Important Information for ZEJULA

Indication

ZEJULA is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Refer to the ZEJULA Prescribing Information for a full list of adverse events and the complete important safety information.

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, tumour cell targeting therapies and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.

GSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.

On September 9, 2021 Anticancer Bioscience (ACB), pioneers in synthetic lethal approaches to precision oncology, reported its first granted US patent (11104633), entitled "cancer treatment using compounds that selectively target polyploid cancer cells for disruption", which was issued by the US Patent and Trademark Office (USPTO) on August 31 (Press release, Anticancer Bioscience, SEP 9, 2021, View Source [SID1234587452]).

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The method covered in this patent has been used to identify compounds that selectively kill polyploid cells, key to the discovery of inhibitors of MYC, overexpression of which occurs in over half of tumors, and is correlated with poorly differentiated and aggressive cancer.

Dun Yang PhD, Founder, President, and CEO of ACB, said: "The grant of our first patent in the USA is a key milestone and underlines our innovative approach to identifying first-in-class and best-in-class approaches for the treatment of cancer, using synthetic lethal approaches. It forms part of our growing patent estate with nine additional patents pending, covering both methods and composition of matter."

ACB is applying synthetic lethal approaches to develop targeted cancer therapies. These have the potential to be much safer and more effective than current therapies. ACB has access to world-leading cancer biology expertise and drug discovery platforms that enable the company to identify novel compounds that can target both genetic and epigenetic vulnerabilities of cancer cells. ACB has bespoke chemical compound libraries and has invested in developing one of the world’s largest natural product libraries, providing a rich screening resource for potential cancer therapeutics.

With five drug discovery programs, ACB is progressing rapidly through optimization to candidate selection toward IND enabling studies, with the aim of initiating two clinical trials in the USA in 2022.

On September 9, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held from September 13-15, 2021 (Press release, Anavex Life Sciences, SEP 9, 2021, https://www.anavex.com/anavex-life-sciences-to-present-at-the-h-c-wainwright-23rd-annual-global-investment-conference/ [SID1234587451]).

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A webcast of the on-demand presentation will be available beginning Monday, September 13, 2021, at View Source or on the Company’s website at www.anavex.com. The on-demand presentation will open on September 13 at 7:00 A.M. (ET). A webcast replay will be accessible for 30 days following the event.