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EXKIVITY® (mobocertinib) Approved for Previously-Treated Adult Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Exon 20 Insertion Mutations

On September 22, 2021 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by Takeda to be a specialty pharmacy partner for EXKIVITY (mobocertinib), the first oral treatment option for 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, Onco360, SEP 22, 2021, View Source [SID1234590144]).

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"Onco360 is excited to become a specialty pharmacy provider for EXKIVITY patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "As a provider of this important treatment option for patients, Onco360 is committed to supporting the highly specialized needs of locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutations and their physicians across the United States."

According to the National Cancer Institute‘s (NCI) Surveillance, Epidemiology, and End Results (SEER) Program, approximately 235,760 patients will be diagnosed with lung cancer in 2021 with a corresponding 131,880 deaths. Approximately 85% of lung cancer cases are represented by NSCLC. When considering all subtypes of lung cancer as well as stages of the disease, lung cancer patients have a poor five-year overall survival (OS) of 21.7%. Unfortunately, 56% of lung cancer patients will have incurable, metastatic disease at the time of initial diagnosis.1 Approximately 0.1 to 4% of all NSCLC patients have EGFR exon 20 insertion mutations.2

EXKIVITY is manufactured by Takeda, a commercial-stage biotechnology company. The FDA’s approval of EXKIVITY is based upon the results of a pooled subset of patients with EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC whose disease had progressed on or after platinum-based chemotherapy who were enrolled in the international, open-label, multicohort Phase I/II AP32788-15-101 (NCT02716116) clinical trial. This data demonstrated that EXKIVITY administration resulted in a 28% overall response rate (ORR) in this patient population.3 For full prescribing information, visit EXKIVITY.com.

Hexagon Bio Raises $61 Million to Advance Novel Small-Molecule Medicines Mined from Microbial Genomes

On September 22, 2021 Hexagon Bio, a biopharmaceutical company pioneering the discovery of medicines encoded in the global metagenome, reported that it has raised $61 million to fuel the continued development of its platform to design and develop new therapeutics mined from microbial genomes (Press release, Hexagon Bio, SEP 22, 2021, View Source [SID1234590143]). Nextech Invest led the financing, with participation from new investors SoftBank Vision Fund 2* and Casdin Capital, as well as existing investors The Column Group, 8VC, and Two Sigma Ventures.

"Microbial genomes are an incredibly rich source of diverse, potent and drug-like compounds that, as a result of millions of years of evolution, provide elegant solutions to human therapeutic targets that have eluded traditional screening approaches. To date, the discovery of these small molecules has been limited to a tiny fraction of the earth’s microbes and hampered by a lack of mechanistic understanding of the intended drug targets," said Maureen Hillenmeyer, Ph.D., Hexagon’s co-founder and CEO. "Hexagon exists to overcome these challenges and unearth new medicines to combat human disease. We are excited to embark on the next phase of growth to discover and develop unique and potent therapeutic compounds for a broad spectrum of intractable diseases."

Hexagon’s interdisciplinary platform combines technological advances and proprietary insights across machine learning, genomics, synthetic biology and automation to systematically discover new chemical compounds linked to known protein targets. Hexagon has built a database of microbial genomes that is more than twice the size of all public databases and is adding thousands of additional genomes per month. Hexagon is leveraging this database to rapidly discover structurally diverse small molecules, and, using its proprietary heterologous expression (HEx) technology, produce and optimize the resulting therapeutic candidates. Proceeds from the financing will enable the company to further expand its genomics database and accelerate its drug discovery efforts with an initial focus on high-value anti-infective and oncology targets.

The latest financing brings the total of committed funding for Hexagon to more than $108 million. In conjunction with Nextech Invest’s participation, managing partner Jakob Loven, Ph.D. will join the Hexagon board of directors.

"Hexagon’s differentiated approach to identifying novel chemical matter against challenging targets presents a compelling opportunity," said Dr. Loven. "We look forward to working with Hexagon’s talented team to help realize the company’s ambitious vision of turning nature’s hidden molecules into first-in-class medicines for patients in need."

Legend Biotech to Host R&D Day on October 18, 2021

On September 22, 2021 Legend Biotech Corporation (NASDAQ: LEGN), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that it will host its first Research & Development Day on Monday, October 18, commencing at 10:00 a.m. (Eastern Time), at Andaz 5th Avenue in New York (Press release, Legend Biotech, SEP 22, 2021, View Source [SID1234590142]).

The meeting will feature updates on the company’s advancing pipeline of hematological and oncological indications and expanding cell therapy capabilities, including its B cell maturation antigen (BCMA) clinical development program. Presentations will be delivered by Legend’s senior leadership team:

Ying Huang, PhD, Chief Executive Officer and Chief Financial Officer
Frank Fan, MD, PhD, Chief Scientific Officer
Steve Gavel, Vice President, US & Europe Commercial
Lida Pacaud, MD, Vice President, Clinical Development
A live webcast and presentation will be available to investors and other interested parties on the Legend Biotech website under "Events and Presentations". A recording of the webcast can be viewed as early as 24 hours after the event and will be archived for six months.

To register for the event, please visit this link.

KSQ Therapeutics to Present at the 2021 Cantor Virtual Global Healthcare Conference

On September 22, 2021 KSQ Therapeutics, a biotechnology company developing drugs to treat cancer and autoimmune diseases using its proprietary, integrated discovery platform to systematically screen the whole genome in cancer and immune cells, reported that Qasim Rizvi, Chief Executive Officer of KSQ, will present at the 2021 Cantor Virtual Global Healthcare Conference on Wednesday, September 29, 2021 at 4:40 PM (ET) (Press release, KSQ Therapeutics, SEP 22, 2021, View Source [SID1234590141]). The conference is being held September 27-30, 2021.

CG Oncology and Roche to Collaborate on Clinical Trial of Oncolytic Immunotherapy CG0070 as Part of Novel Combination for Various Solid Tumor Indications

On September 22, 2021 CG Oncology, Inc. reported that it has entered into a clinical trial collaboration agreement to evaluate the combination of CG Oncology’s investigational oncolytic immunotherapy CG0070, with Roche’s atezolizumab, an anti-PD-L1 (programmed death-ligand 1) therapy (Press release, CG Oncology, SEP 22, 2021, View Source [SID1234590140]).

The Phase 1/2 clinical trial will evaluate the safety and efficacy of this novel immunotherapy combination in patients with various advanced solid tumors yet to be disclosed. CG Oncology will sponsor the study and Roche will provide atezolizumab.

CG0070, CG Oncology’s lead immuno-oncology candidate, is in an ongoing Phase 3 monotherapy study and has been administered in over 100 patients to date for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). CG0070 is based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroying various cancer cells, including bladder tumor cells, through their defective retinoblastoma (Rb) pathway.

"We are pleased to enter into this collaboration agreement with Roche," said Arthur Kuan, CEO of CG Oncology. "We are excited to initiate this important clinical trial with our lead oncolytic immunotherapy, CG0070, in combination with atezolizumab to evaluate the potential synergy of these two immunotherapies in cancer."

Additional details of the collaboration were not disclosed.