On July 6, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that, based on currently available information, it estimates that both reported and organic revenue1 growth will be approximately 10% for the second quarter ended June 27, 2020 (Press release, Thermo Fisher Scientific, JUL 6, 2020, View Source [SID1234561689]).

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The better-than-expected organic revenue growth was primarily driven by strong global sales of PCR-based tests and other products and services supporting the COVID-19 response, which contributed more than $1.4 billion of revenue in the second quarter and reflects the scale of the company’s role in helping customers battle the pandemic.

Thermo Fisher will release its financial results for the second quarter on Wednesday, July 22, 2020, before the market opens, and will hold a conference call to discuss those results and provide a business update on the same day at 8:30 a.m. ET.

To listen, call (833) 714-0931 within the U.S. or (778) 560-2662 outside the U.S. The conference ID is 1239877. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can be found in that section of our website under "Financial Results." A replay of the call will be available under "Webcasts and Presentations" through Friday, July 31, 2020.

On July 6, 2020 ADC Therapeutics SA (NYSE:ADCT), a clinical-stage oncology-focused biotechnology company leading the development and commercialization of next-generation antibody drug conjugates (ADCs) with highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology, reported that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami, formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma (HL) (Press release, ADC Therapeutics, JUL 6, 2020, View Source [SID1234561688]).

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"The ADC Therapeutics team worked diligently to provide a thorough and prompt response to the FDA following its request for information about our pivotal Phase 2 clinical trial of Cami," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "During the partial clinical hold we continued to treat patients benefiting from Cami, and now look forward to resuming the enrollment of new patients in the trial as soon as possible."

The 100-patient Phase 2, multi-center, open-label, single-arm clinical trial is evaluating the safety and efficacy of Cami in patients with relapsed or refractory HL. Patients with pathologically confirmed relapsed or refractory HL who have failed three prior lines of therapy, including brentuximab vedotin and a checkpoint inhibitor approved for HL such as nivolumab or pembrolizumab, are eligible for enrollment in the clinical trial. The trial is intended to support the submission of a Biologics License Application to the FDA.

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead killing the cell with an immunogenic cell death. The intra-tumoral release of its PBD warhead may also cause bystander killing of neighboring tumor cells. The ADC also depletes CD25-positive regulatory T cells in the tumor environment. All of these properties of Cami may enhance immune-mediated anti-tumor activity. Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL), as well as in a Phase 1a/1b clinical trial in patients with relapsed or refractory HL and non-Hodgkin lymphoma and a Phase 1b clinical trial in solid tumors.

On July 6, 2020 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that it has raised $15m (£12m) in equity investment (Press release, Mission Therapeutics, JUL 6, 2020, View Source [SID1234561675]). The round was led by existing investor Pfizer Ventures, the venture capital arm of Pfizer Inc. ("Pfizer")(NYSE: PFE).

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Mission and Pfizer Inc. have also expanded their relationship by entering into an evaluation and option agreement for DUB target validation.

Fund raising

Pfizer Ventures has been an investor in Mission Therapeutics since 2013. Today it made a further equity investment into the Company, contributing a super pro rata amount. All other existing investors within Mission joined the round on a pro rata basis. No further financial details have been disclosed.

The new capital will support development of Mission’s world-leading DUB platform, as well as growth of its pipeline of DUB inhibitor programmes.

Expansion of Pfizer collaboration

DUBs have attracted significant interest as potential drug targets. Playing an integral role in protein homeostasis, this large family of enzymes is involved in diverse cellular processes and many disease pathologies.

Under the terms of the evaluation and option agreement, Pfizer will access specific DUB inhibitors from Mission’s platform and test these compounds in phenotypic screens to validate promising drug targets. Pfizer will then have the option to negotiate target exclusivity for each of the DUBs of interest.

The agreement does not include any of Mission’s own lead DUB programs, such as USP30.

Commenting on the agreement, Dr. Denis Patrick, Managing Partner of Pfizer Ventures and Member of Mission’s Board of Directors, said:
"Since our initial investment in Mission seven years ago, the company has grown tremendously and the depth of its scientific expertise and capability has grown alongside it. We are proud to expand our relationship with the company and our scientists are looking forward to a successful collaboration in this important area of research."

Dr. Anker Lundemose, CEO of Mission Therapeutics added:
"We are pleased to expand our relationship with Pfizer, one of the world’s premier biopharmaceutical companies. We have benefitted from the valuable contributions of Dr. Denis Patrick as a member of our Board of Directors and we look forward to working with the wider Pfizer team."

On July 6, 2020 Ascentage Pharma (6855.HK), a global, clinical-stage biotechnology company developing novel therapies for cancers, chronic hepatitis B (CHB), and senesce diseases, reported a clinical collaboration with MSD to evaluate the combination of APG-115, Ascentage’s MDM2-p53 inhibitor, and KEYTRUDA(pembrolizumab), MSD’s anti-PD-1 therapy, for the treatment of patients with advanced solid tumors (Press release, Ascentage Pharma, JUL 6, 2020, View Source [SID1234561671]).

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Under the agreement, Ascentage will sponsor an open-label, multicenter, phase Ib/II study (NCT03611868) is designed to evaluate the safety and efficacy of APG-115 with KEYTRUDA in multiple cohorts of solid tumors (i,e., NSCLC, melanoma, Urothelial cancer, Liposarcoma, MPNST and ATM mutated/p53 WT tumors resistant or relapsed to PD-1/PD-L1 treatment or without previous PD-1/PD-L1 treatment). The Phase II portion of the study has initiated and is expected to enroll 80 patients at multiple sites in the US. MSD and Ascentage will use a joint development committee to exchange information about the study.

Preclinical studies demonstrated that APG-115 promoted the production of proinflammatory cytokines in T cells, enhanced CD4+ T cell activation, and increased PD-L1 expression on various tumor cells. Enhanced antitumor activity was demonstrated in various tumor models after APG-115 was combined with PD-1 blockade. Results of the phase 1b portion of this trial was recently published at ASCO (Free ASCO Whitepaper)2020 and demonstrated that APG-115 in combination with pembrolizumab is well-tolerated, with encouraging anti-tumor effects in several tumor types.

"We are excited to collaborate with MSD, a pharmaceutical industry leader. APG-115 is a key drug candidate in our development pipeline targeting apoptosis, with great potential in the treatment of advanced solid tumors," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Based on the promising Phase Ib data, we are looking forward to working closely with MSD to further study the combination of APG-115 with KEYTRUDA, potentially offering more effective treatment options to patients with advanced solid tumors."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About APG-115

APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 PPI. APG-115 has strong binding affinity to MDM2 and is designed to activate p53 tumor suppression activity by blocking the MDM2-p53 PPI. Ascentage Pharma has previously commenced three clinical trials of APG-115 in the US, including a Phase I study as single agent, a Phase Ib/II study in combination with pembrolizumab for treatment of metastatic melanoma and other advanced solid tumors, and a Phase I/II study as a single agent or in combination with chemotherapy for treatment of salivary gland cancer. APG-115 is the first MDM2-p53 inhibitor to enter clinical studies in China. A Phase I study as a single agent, and a Phase Ib study as a single agent or in combination with chemotherapy for treatment of AML (acute myeloid leukemia) or MDS (myelodysplastic syndrome) are ongoing in China.

On July 6, 2020 Aichi Cancer Center (*1) and NEC Corporation (NEC; 6701) reported the launch of fundamental research aiming to realize the promise of advanced personalized cancer immunotherapy by improving the performance of NEC’s neoantigen prediction system and developing predictive biomarkers for patient stratification through the fusion of AI and experimental immunology (Press release, NEC, JUL 6, 2020, View Source [SID1234561670]).

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This research aims to identify suitable neoantigen for vaccine use by using the neoantigen prediction system which NEC has been working on and the screening techniques using T cells for neoantigen from Aichi Cancer Center. In addition, this research aims to develop biomarkers for patient stratification using AI based on analytical data on a tumor immune microenvironment and clinical data.

The partners will realize the promise of advanced personalized cancer immunotherapy which boosts the immune system especially in combination with immune checkpoint inhibitors (ICIs).