On June 7, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported the launch of the Twist MRD Rapid 500 Panel1, a custom solution that can be added to a standard next generation sequencing (NGS) workflow, offering fully customizable and highly cost effective panels to detect minimal residual disease (MRD) in as few as five days (Press release, Twist Bioscience, JUN 7, 2022, View Source [SID1234615719]).

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Twist’s customers develop MRD tests that can be used in a variety of ways for patients with cancer. MRD testing is a non-invasive method for tracking and predicting cancer progression over time, using simple blood draws to track low levels of circulating tumor DNA (ctDNA) in the blood. MRD testing can be used during cancer treatment to determine if there are tumor cells remaining and to assess whether a treatment plan needs to be adjusted. This testing can also be used after a patient achieves remission to monitor for recurrence of cancer cells.

"When it comes to monitoring minimal residual disease, which can inform treatment options for patients with cancer, there is no time to waste. With the Twist MRD Rapid 500 Panel, we are able to rapidly create custom panels for our research customers, including panels specific to each sample’s unique genetic variance of cancer in as few as five days," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "MRD is becoming the gold standard for monitoring cancer and informing personalized treatments for patients. Through this panel, we facilitate the research and development of our customers in developing new MRD solutions that clinicians can use to benefit their patients."

The Twist MRD Rapid 500 Panel can be incorporated into a standard NGS workflow and applies hybrid capture technology to sequence specific regions that may provide customized disease insights to researchers. This technology provides broader coverage than PCR or amplicon sequencing methods, potentially improving sequencing sensitivity and expands utility.

To develop the custom panels, Twist receives targets of interest that have been identified by the customer through sequencing specific tumor cells. Twist then designs the probe sequence in a single day, manufactures and ships the panel in five business days, drastically reducing the waiting period typical of custom products and enabling quick response times. The Twist MRD Rapid 500 Panel leverages Twist’s existing protocols for target enrichment, allowing it to be performed simultaneously with established Twist whole exome NGS workflows.

About Twist MRD Rapid 500 Panel

The Twist MRD Rapid 500 Panel is the latest product in Twist’s expanding portfolio of research use only sequencing products dedicated to improving the performance and accessibility of research tools for advancing R&D in oncology solutions. Paired with Twist’s cfDNA pan cancer reference standards, UMI adapter system, and leading Exome 2.0 product line, the Twist MRD Rapid 500 Panels bridge the gap between costly comprehensive sample screening and small fixed content tests.

On June 7, 2022 ChromaDex Corp. (NASDAQ:CDXC) reported that its Chief Executive Officer, Rob Fried, and Chief Financial Officer, Kevin Farr, will be presenting at Oppenheimer’s 22nd Annual Consumer Growth and E-Commerce Conference (Press release, ChromaDex, JUN 7, 2022, View Source [SID1234615739]).

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The ChromaDex management team is scheduled to present virtually on Wednesday, June 15th at 3:45 p.m. Eastern Time (12:45 p.m. Pacific Time).

ChromaDex management will also attend virtual one-on-one meetings with institutional investors throughout the day.

Webcast link: ChromaDex Investor Presentation – Oppenheimer Consumer Conference

On June 7, 2022 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company pioneering the development of monoclonal antibodies targeting treatment of various cancers and viral infections, reported the completion of the Third cohort in dosing patients for its Phase I trial for Brain Cancer (Press release, Nascent Biotech, JUN 7, 2022, View Source [SID1234615703]). After reviewing the data gathered from the first three cohorts, this milestone will allow the trial to advance to the fourth and possibly final cohort.

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Patient enrollment will continue for Phase I. Anyone interested may review trial requirements at www.clinicaltrials.gov, then search Pritumumab.

"Having completed the first three cohorts, we are excited to move to our fourth and possibly final cohort in the Phase I trial. The third cohort took longer than expected but the data received is very useful moving forward," noted Nascent CEO, Sean Carrick, further stating that, as the fourth cohort is underway, Nascent will also be performing PK studies to help determine if a fifth cohort is needed.

PTB is a natural human antibody that works by binding to Cell surface Vimentin (also referred to as ectodomain vimentin, or EDV), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy unlike chemotherapy targets only cancer cells without damaging healthy cells.

On June 7, 2022 Daiichi Sankyo (TSE: 4568) and Sarah Cannon Research Institute (Sarah Cannon) reported that initial results from the first-in-human phase 1 study of DS-6000, a CDH6 directed DXd antibody drug conjugate (ADC), suggest early clinical activity in patients with advanced ovarian cancer or renal cell carcinoma with disease progression following standard of care treatment (Press release, Daiichi Sankyo, JUN 7, 2022, View Source [SID1234615720]). The data were presented today in an oral session (Abstract #3002) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO22) Annual Meeting.

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Patients with advanced ovarian cancer or renal cell carcinoma may have disease progression after initial treatments and there is a need for new therapeutic approaches for recurrent disease, as five-year survival rates in the U.S. are low at 30% and 15%, respectively.1,2,3,4 The CDH6 protein is significantly overexpressed in ovarian cancer and renal cell carcinoma and has been identified as a promising therapeutic target.5,6

Preliminary safety and efficacy results of DS-6000 were reported from the dose escalation part of the phase 1 trial in 30 heavily pretreated patients, including 21 patients with advanced ovarian cancer, one of which was missing a primary diagnosis of ovarian cancer, and nine patients with renal cell carcinoma.

The safety and tolerability of DS-6000 was evaluated at increasing dose levels from 1.6 mg/kg to 9.6 mg/kg with two dose-limiting toxicities observed at the 9.6 mg/kg dose (grade 3 febrile neutropenia and grade 4 thrombocytopenia). The most common treatment-related emergent adverse events (TEAEs) (≥ 10% of patients) reported were nausea (60.0%), fatigue (56.7%), vomiting (30.0%), neutrophil count decrease (23.3%), decreased appetite (20.0%), and diarrhea (13.3%). Grade ≥ 3 TEAEs occurred in seven patients (23.3%), the most common of which were neutrophil count decrease (16.7%), anemia (6.7%) and febrile neutropenia (6.7%). One patient experienced grade 2 pneumonitis at the 9.6 mg/kg dose that led to treatment discontinuation.

Preliminary efficacy results in 20 evaluable patients included six partial responses (PRs) in patients with ovarian cancer (n=5) and renal cell carcinoma (n=1). Four PRs were confirmed and two are awaiting confirmation. Stable disease was reported in 12 patients with platinum-resistant ovarian cancer. Eight CA-125 responses were observed in 17 evaluable patients with ovarian cancer, based on the Gynecologic Cancer Intergroup (GCIG) criteria.

"These initial results from the first-in-human trial of DS-6000 suggest early signals of safety and efficacy in patients with advanced renal cell or ovarian cancer with disease progression following multiple standard treatments," said Erika Hamilton, MD, Director, Breast Cancer and Gynecologic Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, Nashville, Tennessee. "Based on these data, enrollment is underway in the dose expansion phase of the trial to further evaluate safety and efficacy of DS-6000 in patients with platinum-resistant ovarian cancer or clear cell renal cell carcinoma."

All patients enrolled in the study (n=30) had received a median of three prior lines of systemic therapies (range, 1-12), including four (range, 1-12) for patients with ovarian cancer and two (range, 1-6) for patients with renal cell carcinoma. Seventeen of the 20 patients with ovarian cancer had platinum-resistant disease. As of the data cut-off on February 25, 2022, 17 patients (56.7%) were still being treated with DS-6000 including 12 patients with ovarian cancer and five patients with renal cell carcinoma.

"Despite recent additions to the treatment landscapes for recurrent ovarian and renal cell cancer, continued innovation is needed to improve outcomes for these patients. We have combined our DXd ADC technology with a promising therapeutic target, CDH6, with the aim to develop a new class of therapy for patients with cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "We are encouraged by these preliminary data, which suggest that DS-6000 may have the potential to serve as a new type of targeted therapy option for patients with advanced renal cell or ovarian tumors, including platinum-resistant ovarian cancer, and further evaluation is ongoing in the dose expansion part of the trial."

About the Phase 1 Study

The two-part, multicenter, open-label, first-in-human phase 1 trial is evaluating the safety and efficacy of DS-6000 in adult patients with advanced ovarian cancer and renal cell carcinoma resistant or refractory to standard of care therapy. Patients with ovarian cancer need to be previously treated with platinum-based chemotherapy and a taxane.

The first part of the study (dose escalation) is assessing the safety and tolerability of increasing doses of DS-6000 to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE). The second part of the study (dose expansion) will further evaluate the safety and efficacy of DS-6000 at the RDE of 8.0 mg/kg in patients with advanced ovarian cancer and in patients with advanced renal cell carcinoma.

The primary objective of the dose escalation part of the study is to assess the safety and tolerability of increasing doses of DS-6000 to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in patients with advanced ovarian tumors or renal cell carcinoma. The primary objective of the second part of the study (dose expansion) is to further evaluate the safety and efficacy of DS-6000 at the RDE in two cohorts including patients with advanced renal cell carcinoma in Cohort 1 and patients with advanced ovarian cancer in Cohort 2. The study will evaluate safety endpoints including dose-limiting toxicities and adverse events and efficacy endpoints including objective response rate, duration of response, disease control rate, clinical benefit rate, time to response and progression-free survival. Pharmacokinetic and exploratory biomarker endpoints also will be assessed.

A total of approximately 102 patients are expected to be enrolled in this study at multiple sites in the U.S. For more information, please visit Clinicaltrials.gov.

About CDH6

CDH6 (human cadherin-6) is a cadherin family protein overexpressed in several cancers, particularly ovarian tumors and renal cell carcinoma.5 Overexpression of CDH6 is associated with tumor growth and proliferation and is correlated with poor prognosis in patients with renal cell carcinoma.5 No CDH6 directed cancer therapies are currently approved for treatment of any cancer.

About Ovarian Cancer and Renal Cell Carcinoma

Approximately 314,000 women were diagnosed with ovarian cancer worldwide in 2020 and more than 207,000 died from the disease.7 The five-year survival rate for patients in the U.S. with advanced ovarian cancer is 30%.3 More than 70% of patients diagnosed with stage III or IV ovarian cancer will have a recurrence of their disease within the first five years following standard treatment with platinum chemotherapy-based regimens.8 For patients who develop resistance to platinum-based chemotherapy, treatment options are especially limited.8

Renal cell carcinoma accounts for approximately 90% of all kidney cancer.9 Approximately 431,000 people were diagnosed with kidney cancer worldwide in 2020 and more than 179,000 people died from the disease.7 The five-year survival rate for patients in the U.S. with advanced renal cell carcinoma is 15%.4 Patients with advanced or metastatic renal cell cancer may progress after first-line treatment with immune checkpoint inhibitor-based regimens and have limited treatment options as disease progression continues.10

The introduction of targeted treatments and immunotherapies in recent years has increased options and improved survival outcomes for some patients with ovarian cancer or renal cell carcinoma, but new therapeutic approaches and options are needed for tumors that progress on available medicines.10,11

About DS-6000

DS-6000 is an investigational potential first-in-class CDH6 directed ADC and one of five ADCs in clinical development in the oncology pipeline of Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, DS-6000 is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Daiichi Sankyo is developing DS-6000 through a strategic collaboration with Sarah Cannon Research Institute with study operational oversight and delivery provided through Sarah Cannon’s early phase oncology clinical research organization, Sarah Cannon Development Innovations in Nashville, TN.

DS-6000 is an investigational medicine that has not been approved for any indication in any country. Safety and efficacy have not been established.

On June 7, 2022 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, reported that it has entered into a committed equity purchase agreement (the "Agreement") with Lincoln Park Capital Fund, LLC ("LPC"), for the issuance and sale, from time to time, of up to $40 million of its American Depositary Shares (the "ADSs"), each of which represents one ordinary share, DKK 1 nominal value, of the Company (the "Ordinary Shares") (Press release, Evaxion Biotech, JUN 7, 2022, View Source [SID1234615741]).

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Under the terms of the Agreement, Evaxion has the right, at its sole discretion, but not the obligation, to sell to LPC up to $40 million of its ADSs over the 36-month term of the Agreement, subject to certain conditions.

Lars Wegner, CEO of Evaxion, said: "We are pleased to conclude this Agreement with Lincoln Park Capital, securing access to $40 million from a widely respected investor in the biotech industry and further strengthening Evaxion’s financial position during a period of market uncertainty. This equity facility will contribute to the progression of our exciting portfolio of assets, including personalized cancer medicines, developed in programs EVX-01 and EVX-02, both of which are currently in Phase 2 clinical development, according to plan. This gives us momentum to reach our value-creating, upcoming clinical milestones. Importantly, it also maintains Evaxion’s flexibility in deciding if and when to exercise the option to sell, so we can continue to choose the optimum development path for the Company."

Evaxion had cash and cash equivalents of $31.4 million at the end of the first quarter of 2022 and expects its cash position, without proceeds from the Agreement, to be sufficient to fund operating expenses and capital expenditure requirements through at least the next 12 months.

There are no upper limits to the price LPC may pay to purchase the ADSs, and the purchase price will be based on the prevailing market prices of the ADSs at the time of each sale to LPC. Evaxion controls the timing and amount of any future sales of its ADSs to LPC. The Company may terminate the Agreement at any time, in its sole discretion, without any additional cost or penalty. In consideration for entering into the Agreement, LPC received 428,572 Ordinary Shares represented by ADSs from the Company.