On June 13, 2022 Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, reported it has purchased the remaining shares of Guardant Health AMEA, Inc., held by SoftBank and its affiliates, giving the company full control over operations throughout the Asia, Middle East and Africa region (Press release, Guardant Health, JUN 13, 2022, View Source [SID1234615939]).

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More than half of the world’s estimated new cancer cases come from Asia, Middle East and Africa (AMEA).1 This acquisition will allow Guardant Health to directly address the growing cancer burden in the region by accelerating the adoption of the company’s blood tests and services used by healthcare providers to detect and manage cancer across all stages of the disease.

Guardant Health AMEA operations support 41 countries across the region. Near term, the company will prioritize bringing blood-based testing to healthcare providers and to patients with advanced cancer in Japan, where, in March 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted regulatory approval of Guardant360 CDx, a liquid biopsy test for tumor mutation profiling in patients with advanced solid tumors.

"By acquiring the remaining shares of Guardant Health AMEA, we can focus on creating a unified and centralized global organization that delivers on our promise to help conquer cancer and improve patient outcomes," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "We believe our blood-based tests can play a significant role in helping address the growing incidence of cancer in the region, and we look forward to continuing to support patients facing cancer diagnoses as we expand our operations in these markets."

In May 2018, Guardant Health and SoftBank Vision Fund established the Guardant Health AMEA joint venture to expand commercialization of Guardant Health’s industry-leading liquid biopsy technology across the region. Under the terms of the parties’ joint venture agreement, Guardant Health paid approximately $177.8 million to acquire the Guardant Health AMEA equity interest held by SoftBank and its affiliates.

On June 13, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company has entered a drug discovery collaboration with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson ("Janssen") (Press release, Evotec, JUN 13, 2022, View Source [SID1234615954]). Evotec’s innovative TargetAlloMod platforms will be evaluated to discover first-in-class novel mode of action therapeutic candidates. The agreement was facilitated by Johnson & Johnson Innovation.

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Under the agreement, Evotec and Janssen will jointly conduct screens on the identified targets and collaborate with hit identification and lead optimisation of the most promising chemical assets, leveraging Evotec’s end-to-end integrated drug discovery and development platform.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are very proud to enter into this collaboration to explore unique approaches to high potential cell surface drug targets with novel therapeutic modalities and to deliver and make innovative therapeutic options available to patients."

Besides research funding, Evotec is entitled to success-based research and commercial milestones up to approximately € 210 m per project as well as tiered royalties on products resulting from this collaboration.

About TargetAlloMod
Scientists at Evotec have discovered that for certain extracellular receptors, small molecules can bind allosterically and induce a natural proteolytic cleavage process to shed the ectodomain. This results in the disruption of cell signalling and the shed ectodomain can, in many cases, further act as a sink for the native ligand of the targeted receptor. The TargetAlloMod platform comprises a suite of proprietary assay principles and computational tools to assess and screen extracellular receptor targets for shedding and the induction of shedding by small molecule allosteric modulators. This platform has broad applicability across many therapeutic areas.

On June 13, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the last patient has been randomized in the Phase 3 clinical trial of trilaciclib for patients with metastatic colorectal cancer (mCRC) receiving chemotherapy (PRESERVE 1) (Press release, G1 Therapeutics, JUN 13, 2022, View Source [SID1234615921]). Enrollment is complete at 326 randomized patients; the trial was over-enrolled by approximately 10 percent to compensate for potential loss to follow up at trial sites in Ukraine.

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Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes. It is approved by the U.S. Food and Drug Administration in another indication.

"FOLFOXIRI is an important chemotherapeutic backbone for people diagnosed with CRC because it is highly efficacious and has shown a survival advantage compared to other chemotherapeutic options; however, it is also the most myelotoxic regimen, so patients may have dose delays and reductions or receive less effective chemotherapeutic regimens – both of which could impact patient outcome and survival," said Raj Malik, M.D., G1’s Chief Medical Officer. "Trilaciclib may be an important addition to this regimen due to its unique ability to preferentially protect the bone marrow from chemotherapy-induced toxicities, and its potential to preserve immune system function and improve survival. Both endpoints are being assessed in PRESERVE 1. We are happy to have completed enrollment, and look forward to presenting initial data, including the primary endpoint of the trial, in the first quarter of 2023. This is a registrational trial; if the data from the primary endpoint are positive, we would work closely with the FDA to expedite our filing for regulatory approval in this indication."

Dr. Malik continued, "I’d like to thank the patients enrolled in the trial, the clinical investigators, our CRO partners, and the G1 and Simcere teams who worked tirelessly and under extraordinarily challenging conditions to advance the trial to this stage."

PRESERVE 1 is a global multi-center, randomized placebo-controlled, line extension pivotal Phase 3 trial of trilaciclib in 326 patients with metastatic CRC receiving first line trilaciclib or placebo administered prior to FOLFOXIRI (a combination of fluorouracil (5-FU), folinic acid, oxaliplatin and irinotecan) and bevacizumab. The regimen is given for two consecutive days of every 14-day cycle. Patients are receiving trilaciclib or placebo administered prior to their chemotherapy for a maximum of 12 cycles of induction followed by maintenance therapy. Treatment is administered until disease progression.

The primary endpoint is myeloprotection as measured by duration of severe neutropenia (DSN) and the occurrence of severe neutropenia (SN) during induction. Key secondary endpoints include the effects of trilaciclib on chemotherapy-induced fatigue compared with placebo and the effect of trilaciclib on progression free survival (PFS) and overall survival (OS) compared with placebo.

About Colorectal Cancer

Colorectal cancer is the third most common cancer in men and women, excluding certain skin cancers. Globally, it is the second leading cause of cancer death, with more than 1.8 million people newly diagnosed with colorectal cancer each year. In the United States, there are approximately 150,000 new cases of colorectal cancer diagnosed each year. Chemotherapy is the standard of care for colorectal cancer, and the majority of patients in the United States, Europe and Japan receive chemotherapy – commonly 5-FU-based regimens – as part of their treatment regimen.

On June 13, 2022 Daiichi Sankyo (TSE: 4568) reported that the first patient was dosed in the global TROPION-Breast02 phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus investigator’s choice of chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) not eligible to receive PD-1/PD-L1 inhibitor therapy (Press release, Daiichi Sankyo, JUN 13, 2022, View Source [SID1234615940]).

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Datopotamab deruxtecan is a specifically designed TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Approximately 10 to 15% of breast cancers are considered triple negative, the most aggressive subtype of breast cancer.1,2,3 Compared to patients with other breast cancer subtypes, the prognosis for patients with metastatic TNBC is generally worse, with five-year survival rates estimated at 12% and median overall survival generally less than two years.3,4 TNBC is defined by tumors that test negative for estrogen and progesterone hormone receptors (HRs) as well as human epidermal growth factor 2 receptor (HER2), as determined by an IHC test and/or an ISH test; HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.3,5

"Patients with metastatic triple negative breast cancer who are not able to receive PD-1/PD-L1 inhibitor treatment often experience recurrence following chemotherapy, so additional options in the first-line treatment setting are needed," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "The TROPION-Breast02 trial will build on the preliminary efficacy and safety profile seen in the relapsed or refractory triple negative breast cancer arm of the TROPION-PanTumor01 trial to evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients in the first line setting."

"Initial results of datopotamab deruxtecan in patients with pretreated metastatic triple negative breast cancer, a group with a significant unmet need, have been encouraging," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "We are building on these early results by moving forward with the TROPION-Breast02 trial, the second pivotal trial of datopotamab deruxtecan in breast cancer, to determine if this antibody drug conjugate may potentially be used earlier in the treatment of metastatic triple negative breast cancer."

About TROPION-Breast02
TROPION-Breast02 is a global, randomized, open-label, two-arm, multicenter study assessing the efficacy and safety of datopotamab deruxtecan (6 mg/kg) compared with investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC. TNBC is defined as HR negative, meaning tumors test negative for estrogen and progesterone hormone receptors, and HER2 negative, determined by an IHC test and/or an ISH test.3,5 HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.5 Patients must not be candidates for PD-1/PD-L1 inhibitor therapy and must be eligible for one of the investigator’s choice of chemotherapy options.

The dual primary endpoints of TROPION-Breast02 are progression-free survival (PFS) assessed by blinded independent central review and overall survival. Secondary endpoints include PFS assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 will randomize approximately 600 patients with TNBC at sites in Asia, Africa, Europe and North America. For more information visit ClinicalTrials.gov.

About Triple Negative Breast Cancer
Approximately 10 to 15% of breast cancers are considered triple negative, the most aggressive subtype of breast cancer.1,2,3 Compared to patients with other breast cancer subtypes, the prognosis for patients with metastatic TNBC is generally worse, with five-year survival rates estimated at 12% and median overall survival generally less than two years.3,4 TNBC is defined by tumors that test negative for estrogen and progesterone hormone receptors (HRs) as well as human epidermal growth factor 2 receptor (HER2), as determined by an IHC test and/or an ISH test; HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.3,5

About TROP2
TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein overexpressed in several types of solid tumors, including breast cancer.6 TROP2 expression has been detected in a wide range of breast cancer subtypes, including approximately 80% of patients with TNBC.7,8,9 High TROP2 expression is an unfavorable prognostic factor for overall survival in all types of breast cancer.7

About Datopotamab Deruxtecan (Dato-DXd)
Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of three leading ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG13 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.

A comprehensive development program called TROPION is underway globally with trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple solid tumors, including TNBC, HR positive/HER2 negative breast cancer, non-small cell lung cancer, small cell lung cancer, urothelial, gastric and esophageal cancer. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.

About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of datopotamab deruxtecan.

On June 13, 2022 Asher Biotherapeutics, Inc. (Asher Bio), a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported the appointment of Andrea Pirzkall, M.D., as its first Chief Medical Officer (Press release, Asher Biotherapeutics, JUN 13, 2022, View Source [SID1234615941]). Dr. Pirzkall has a multi-disciplinary clinical background and a proven track record in developing cancer therapies from research to commercialization.

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"We are delighted to welcome Andrea to the Asher Bio team at this pivotal time as we transition to a clinical-stage company. Her broad background spans early and late-stage development and includes both small molecule and biologic agents. She has expertise in immunotherapies for cancer and is a successful leader of growing clinical teams. Andrea is an ideal fit to our team as we continue to advance our pipeline," said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. "Her expertise and hands-on style will be valuable assets as we implement clinical strategies to deliver our selective and differentiated immunotherapies for patients with cancer and other diseases."

"I am very excited to join Asher Bio’s highly experienced senior management team and to build and lead the clinical development organization to deliver on the company’s promising pipeline of cis-targeted therapeutics," said Dr. Pirzkall. "I am particularly intrigued by the potential of Asher Bio’s cis-targeting platform approach to overcome limitations and broaden the potential of existing immunotherapy by selectively targeting immune cell subsets, and thereby aiming to improve outcomes for patients. That includes Asher Bio’s lead cis-targeted IL-2 immunotherapy, AB248, which is approaching an IND filing and the start of a Phase 1 clinical trial. AB248 has been designed to selectively activate IL-2 signaling in CD8+ effector T cells, while avoiding systemic toxicities and limiting counterproductive pleotropic signaling that results from IL-2 binding to non-targeted cells. I look forward to working with the team to transition this compound into the clinic."

Most recently, Dr. Pirzkall served as Chief Medical Officer at Replimune Group, Inc., where she was responsible for building, developing, and leading clinical development of the company’s pipeline of next-generation oncolytic immunotherapies. Prior to that, Dr. Pirzkall served as Executive Director of Clinical Development at BeiGene, Ltd., where she led and supported the development, startup and execution of several pivotal studies in lung cancer and head and neck cancers, which successfully led to approvals of tislelizumab (anti-PD1) in China and ongoing filings in other jurisdictions. She also served as the global clinical development lead on the BeiGene, Inc./Celgene Corporation joint development committee. Earlier in her career, Dr. Pirzkall spent 10 years at Genentech, Inc., where she held roles of increasing responsibility, including Principal Medical Director and Clinical Development Team Leader. In this role, she worked with cross-functional teams on therapeutics including Avastin, Tarceva, Perjeta, Cotellic and Tecentriq supporting these novel biologic agents through early to late stages of development in oncology as well as through exploratory and combination studies.

Prior to moving to industry, Dr. Pirzkall trained in radiation oncology and completed her dissertation at the University of Heidelberg and the German Cancer Research Center. She completed a fellowship in Medical Physics/Radiation Oncology at the University San Francisco (UCSF) and held academic positions as Associate Adjunct Professor of Radiation Oncology, Radiology, and Neurosurgery at UCSF. Dr. Pirzkall holds a Doctor of Medicine from Friedrich-Schiller University Jena, Germany.