On September 9, 2021 AbbVie and Genmab reported that The Lancet published the results of the dose escalation part of the Phase I/II EPCORE NHL-1 first-in-human (FIH) dose escalation and cohort expansion clinical trial evaluating safety and preliminary efficacy of the investigational therapy epcoritamab (DuoBody-CD3xCD20) in patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma (B-NHL) (Press release, AbbVie, SEP 9, 2021, View Source [SID1234587459]). The full manuscript is available on The Lancet’s website. Epcoritamab is being co-developed by Genmab and AbbVie.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FIH trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-NHL, including diffuse large B-cell Lymphoma (DLBCL) and follicular lymphoma (FL), to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). In the dose escalation phase, patients received subcutaneous epcoritamab (doses ranged from 0.0128-60mg) for 28 days. The safety, antitumor activity, and immune biomarkers associated with epcoritamab treatment were assessed.1

No dose-limiting toxicities were observed during the dose escalation, and 48mg was identified as the RP2D. Common adverse events (AEs) were pyrexia (69 percent), primarily associated with cytokine release syndrome (CRS) (59 percent, all grade 1-2), and injection site reactions (47 percent, all grade 1). One case of tumor lysis syndrome (TLS) was observed (1 percent, grade 3). No grade 3 or above CRS events or discontinuations due to treatment-related AEs or death were observed.1

Preliminary efficacy results reported in the trial were 88 percent overall response rate (ORR) and 38 percent complete response (CR) in patients with relapsed/refractory DLBCL who received the RP2D of 48mg of (n=8) epcoritamab. Patients who were treated with 12-60mg of epcoritamab (n=22) achieved a 68 percent ORR and 45 percent CR. Additionally, patients with relapsed/refractory FL treated with 0.76-48mg of epcoritamab (n=10) achieved a 90 percent ORR and a 50 percent CR.1

"The publication of these data in The Lancet, coupled with the presentation of the results at multiple medical congresses, demonstrate the importance of these early results and underscore the significant interest in the potential of next generation antibody therapeutic options for patients diagnosed with hematologic malignancies, whose current treatments may not be providing benefit," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Together with our partner, AbbVie, we are committed to evaluating the safety and efficacy of epcoritamab in patients diagnosed with B-cell Lymphomas and other hematologic malignancies."

"These initial trial results are encouraging, and their publication in The Lancet speaks to the strong interest from the clinical community in this important area of study," said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. "We look forward to further study of epcoritamab in B-cell Lymphomas and other hematologic malignancies, and our continued pursuit of potential new treatment options for patients."

Results from this trial were also recently presented during an oral session at the 16th Annual International Conference on Malignant Lymphoma (ICML), held virtually June 18-22. The abstract is available for download via the 16-ICML Virtual Platform. Additionally, results were presented as a poster at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held virtually, June 4-8, and during the European Hematology Association (EHA) (Free EHA Whitepaper) congress, held virtually, June 9-17. The posters are available for download via the ASCO (Free ASCO Whitepaper) Meeting Library and the EHA (Free EHA Whitepaper) Open Access Library.

About the EPCORE NHL-1 Trial
The dose escalation part of the EPCORE NHL-1 Phase 1/2 clinical trial is evaluating epcoritamab in 68 patients with relapsed, progressive, or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including DLBCL, FL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, mantle cell lymphoma, small lymphocytic lymphoma and marginal zone lymphoma. The trial is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of two parts: a Phase 1 first-in-human (FIH), dose escalation part, and a Phase 2 expansion part. Step-up dosing and standard prophylaxis were used to mitigate severity of cytokine release syndrome (CRS). The purpose of the escalation part is to determine the maximum tolerated dose and the recommended Phase 2 dose (RP2D), as well as evaluate the safety profile of epcoritamab. In the expansion part, additional patients will be treated with epcoritamab with the RP2D to further explore the safety and efficacy of epcoritamab.

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.2 CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.3,4 Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

On September 9, 2021 Acorda Therapeutics, Inc. reported a corporate restructuring to reduce costs and more closely align operating expenses with expected revenue (Press release, Acorda Therapeutics, SEP 9, 2021, View Source [SID1234587460]). The Company also announced changes to its management team.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Corporate Restructuring

As a result of the restructuring, the Company is reducing headcount by 15%. Most of the reduction in personnel will take place immediately, with the balance completed in the first quarter of 2022.

The Company expects to realize annualized cost savings of approximately $20 million from the headcount reductions and the outsourcing of certain operations, beginning in 2022. Acorda estimates that it will incur approximately $3.0 million of pre-tax charges for severance and other costs related to the restructuring, through the first quarter of 2022.

Management Changes

Lauren Sabella, currently Acorda’s Chief Commercial Officer, has been named Chief Operating Officer. She will have responsibility for Quality, Information Technology, Technical Operations, and Business Operations / Strategic Planning. Kerry Clem, Acorda’s Executive Vice President of Sales, Market Access, and Operations, has been named Chief Commercial Officer.

"We have made substantial progress over the past year, growing sales of Inbrija, maintaining Ampyra revenue to a substantial degree, and retiring our short-term debt. We have achieved these outcomes despite the significant impact of the pandemic on our business. When the pandemic subsides, we believe that we will have the opportunity to accelerate Inbrija’s trajectory, as in-person interactions with health care providers and patients return to more normal levels. The headcount reductions and structural changes we have made will enable us to operate more efficiently and further align our expenses with revenue, while continuing to grow Inbrija sales," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We are deeply grateful to the associates who are leaving Acorda for their commitment, hard work, and many contributions."

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.