On September 8, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported that it has entered into a Master Services Agreement (the "MSA") with Flora Growth (NASDAQ: FLGC) (Flora) to deploy the Company’s CertainT platform as part of Flora’s global cannabis product validation and authentication platform for consumers, distributors, and government regulators (Press release, Applied DNA Sciences, SEP 8, 2021, View Source [SID1234587450]). Concurrently, the Company received a Statement of Work (SOW) under the MSA from Flora to implement its CertainT platform and supply related equipment and services for three locations (1 in Florida; 2 in the Republic of Colombia), where the Company’s molecular tags will be applied to quantities of Flora’s cannabis flower and derivatives, as well as select products in their portfolio. Financial terms of the SOW were not disclosed.

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The MSA is the result of the Company’s strategic alliance, referral, and technology integration agreement with TruTrace Technologies, Inc. (CSE: TTT; OTCQB: TTTSF) (TruTrace) under which TruTrace’s blockchain-based StrainSecure platform was integrated with CertainT to deliver a complete, end-to-end supply chain security solution to cannabis companies. Flora will employ the integrated CertainT-StrainSecure solution to support its product validation and authentication platform to be utilized to deliver on Flora’s previously announced commercial agreements to export cannabis products internationally to open markets like Australia.

Flora, a manufacturer and wholesaler of cannabis and cannabis derivative products and operator of one of the largest outdoor cannabis cultivation facilities, is differentiated by its use of natural ingredients and value-chain sustainability. Flora’s cannabis derivative products are used in premium cosmetics, hemp textiles, and food and beverage applications.

"Business imperatives centered on branding and supply chain mastery will be the defining characteristics of cannabis companies positioning to compete globally. To that end, CertainT’s value proposition delivers brand and product differentiation, IP protection, and supply chain security from inception to consumption that, we believe, will further catalyze interest and adoption of our platform," stated Dr. James A. Hayward, president and CEO of Applied DNA. "CertainT offers customers like Flora unmatched levels of transparency, traceability, and trust across their supply chains that are further improved through our integration with TruTrace. We are very pleased to undertake our first international commercial cannabis venture alongside Flora and, given its growing and diverse portfolio of cannabis and cannabis derivative products, we believe we are in the early stages of a mutually beneficial commercial relationship with Flora."

Robert Galarza, CEO of TruTrace, stated, "The first fruits of our partnership with Applied DNA have been realized and at a time when the cannabis industry’s globalization has accelerated the need for solutions to verify supply chains in defense of a brand’s intellectual property and brand equity. Companies like Flora, who recognize and address this need, will hold a competitive advantage in the market and offer compelling value to end-customers. The integration of our platform with CertainT is designed specifically to meet that need."

About the CertainT Platform

The CertainT platform has three technology pillars (Tag, Test, Track), which allows raw materials and products to be tagged with a unique molecular identifier. This identifier can then be tested for its presence as it travels throughout a global supply chain. All the data points associated to tagging and testing are tracked by uploading to a secure cloud database. The CertainT platform can be used across industries such as textiles, cannabis, military, leather, fertilizer, pharmaceuticals, personal care.

On September 8, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that members of its executive management team will participate in a virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Monday, Sept. 13 at 3:30 p.m. ET (Press release, LabCorp, SEP 8, 2021, View Source [SID1234587398]).

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A live webcast of the presentation will be available via the Investor Relations section of the company’s website at www.Labcorp.com and archived for replay.

On September 8, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the quarter ended June 30, 2021, and provided an update on clinical and corporate progress (Press release, Affimed, SEP 8, 2021, View Source [SID1234587417]).

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"We are pleased with the continued progress in our development of AFM13, AFM24 and AFM28," said Adi Hoess, CEO of Affimed. "By the end of this year, we expect to report additional data from AFM13-104, progress our parallel development strategy for AFM24 and disclose the details of our AFM28 program. We expect our broad development pipeline will generate an ongoing stream of data over the next several quarters," he concluded.

Clinical Stage Program Updates
AFM13 (CD30/CD16A)

Affimed is continuing to recruit patients in the REDIRECT study (AFM13-202) after reporting positive results from the preplanned interim futility analysis in March 2021; the trial combined the high- and low-CD30 expressing cohorts into one. Affimed expects to complete enrollment in the study in the first half of 2022. REDIRECT is a phase 2, registration-directed study of AFM13 as monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).
Affimed reported that all three dose escalation cohorts in the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center of AFM13 precomplexed with cord blood-derived natural killer (NK) cells (AFM13-104) are now fully enrolled and patients have completed at least the first cycle of therapy without dose limiting toxicities. Additional patients are being enrolled at the highest dose level to generate additional data on safety and efficacy. The study is evaluating increasing doses of cord-blood derived NK cells precomplexed with AFM13 followed by three weekly infusions of AFM13 monotherapy in patients with recurrent or refractory CD30-positive lymphomas. As presented at AACR (Free AACR Whitepaper) in April 2021, the first four patients showed a 100% objective response rate with two out of four patients having a complete response (50%).
AFM24 (EGFR/CD16A)

For AFM24, an EGFR/CD16A targeted innate cell engager (ICE) for patients with EGFR-expressing solid tumors, Affimed is executing a strategy intended to deliver the highest probability of success. Affimed announced that it has identified pharmacologically active doses in its monotherapy dose escalation study and will initiate its three-pronged development strategy in parallel across a broad set of solid tumor indications. The three studies are expected to generate a continuous flow of data.
In AFM24-101, the monotherapy phase 1/2a clinical trial of AFM24, Affimed increased the size of cohort 5 (320 mg) and cohort 6 (480 mg) to generate additional pharmacokinetic and pharmacodynamic data that is expected to aid the selection of the recommended phase 2 dose. To date, no classic EGFR related side effects have been observed. Affimed expects to determine the recommended phase 2 dose and start the dose expansion phase of the trial in 2021. The indications will be as follows:
Renal cell carcinoma (clear cell), failing standard of care (SoC) including TKIs and PD1 targeted therapy
Non-small cell lung cancer (EGFR-mutant), failing SoC TKIs and PD1 naïve; and,
Colorectal cancer, failing chemotherapy plus EGFR-targeted antibodies
AFM24-102, the phase 1/2a combination study of AFM24 with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in EGFR-expressing solid tumors, is on track to start in the second half of 2021. The combination trial will include the following indications:
Non-small cell lung cancer (EGFR-wildtype), failing chemotherapy and PD1 targeted therapy
Gastric/gastroesophageal junction (GEJ) cancer failing chemotherapy and/or PD1 targeted therapy; and,
A basket of EGFR-expressing tumors comprising pancreatic, hepatocellular and biliary tract cancer failing standard of care therapy for the respective disease
AFM24-103, the phase 1/2a combination study of AFM24 with NKGen Biotech’s autologous NK cell therapy, SNK01, a first-in-human proof of concept trial in EGFR-expressing solid tumors, is on track to start in 2021. The combination trial will include the following indications:
Non-small cell lung cancer (EGFR-wildtype), failing chemotherapy and PD1 targeted therapy
Squamous cell carcinoma of the head and neck, failing chemotherapy and PD1 targeted therapy; and,
Colorectal cancer, failing standard of care therapy
Preclinical Programs
Affimed expects to disclose the target of its preclinical asset, AFM28, and publish initial preclinical data in Q4 2021. The company remains on track to file an IND application for AFM28 in the first half of 2022.
Second Quarter 2021 Financial Highlights
(Figures for the quarters ended June 30, 2021, and 2020 are unaudited.)

As of June 30, 2021, cash and cash equivalents totaled €222.7 million compared to €146.9 million on December 31, 2020. Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the second half of 2023.
Net cash used in operating activities for the quarter ended June 30, 2021 was €17.3 million compared to €15.0 million for the quarter ended June 30, 2020.
Total revenue for the quarter ended June 30, 2021, was €9.7 million compared with €2.9 million for the quarter ended June 30, 2020. Revenue predominately relates to the Genentech and Roivant collaborations.
Research and development expenses for the quarter ended June 30, 2021 amounted to €21.8 million compared to €11.7 million for the quarter ended June 30, 2020. The increase is largely due to increased costs for AFM24, including costs associated with the ongoing phase 1/2a clinical trial and manufacturing costs for clinical trial material required for the ongoing study and planned future studies, as well as an increase in costs associated with early-stage development/discovery activities. In addition, there was an increase associated with research and development that is non-project specific, including share-based payment expense, intellectual property-related expenses and facility costs.
General and administrative expenses increased 108.7% from €2.6 million in the quarter ended June 30, 2020, to €5.4 million in the quarter ended June 30, 2021. The increase relates largely to higher personnel expenses due to an increase in headcount, higher premiums for our Directors and Officers liability insurance and higher legal and consulting expenses.
Net finance costs for the quarter ended June 30, 2021 increased by 63% from €1.0 million in the quarter ended June 30, 2020, to €1.6 million. This increase is largely due to foreign exchange losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the quarter.
Net loss for the quarter ended June 30, 2021 was €18.8 million, or €0.16 per common share compared with a net loss of €12.2 million, or €0.16 per common share, for the quarter ended June 30, 2020.
The weighted number of common shares outstanding for the quarter ended June 30, 2021 was 119.6 million.
Additional information regarding these results will be included in the notes to the consolidated financial statements as of June 30, 2021, of Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed will host a conference call and webcast today, September 8, 2021, at 8:30 a.m. EDT to discuss second quarter 2021 financial results and recent corporate developments. The conference call will be available via phone and webcast. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 6156773 approximately 15 minutes prior to the call.
A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be accessible at the same link for 30 days following the call.

On September 8, 2021 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported the Phase Ib results of the dual Bcl-2/Bcl-xL inhibitor, APG-1252 (pelcitoclax), in combination with osimertinib in patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) resistant non-small cell lung cancer (NSCLC), during a Mini Oral Session at the 2021 World Conference on Lung Cancer (WCLC) (Press release, Ascentage Pharma, SEP 8, 2021, View Source;mini-oral—ascentage-pharma-announces-latest-data-of-its-investigational-bcl-2bcl-xl-inhibitor-pelcitoclax-apg-1252-combined-with-osimertinib-in-patients-with-egfr-tki-resistant-non-small-cell-lung-cancer-301371959.html [SID1234587436]). The data was presented by Prof. Li Zhang, the principal investigator of the study from Sun-Yat Sen University Cancer Center.

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Organized by the International Association for the Study of Lung Cancer (IASLC), the World Conference on Lung Cancer (WCLC) is the world’s largest multidisciplinary oncology event dedicated to lung cancer and other thoracic cancers, with a focus on the most cutting-edge research and clinical advances in the field. Results presented by Ascentage Pharma at this year’s WCLC are from a single-arm, multicenter Phase Ib dose-escalation and dose-expansion study designed to evaluate the pharmacokinetics (PK), safety and preliminary efficacy of pelcitoclax in combination with osimertinib in patients with advanced EGFR-mutant NSCLC.

Being developed by Ascentage Pharma, pelcitoclax is a novel small-molecule drug candidate that restores apoptosis by selectively inhibiting Bcl-2 and Bcl-xL proteins simultaneously. In preclinical studies, pelcitoclax in combination osimertinib has demonstrated synergistic anti-tumor effects in animal models of EGFR-mutant NSCLC that were sensitive or resistant to osimertinib. Therefore, pelcitoclax in combination with osimertinib has the potential of offering a new treatment option.

Highlights of the data presented during a Mini Oral Session at this year’s WCLC:

Phase 1b Study of Pelcitoclax (APG-1252) in Combination With Osimertinib in Patients With EGFR TKI-Resistant NSCLC

Abstract: MA02.06

Track: Novel Therapeutics and Targeted Therapies

Time: 10:05 – 10:10, September 8, 2021, Mountain Time / 00:05 – 00:10, September 9, 2021, Beijing Time

This single-arm, multicenter Phase Ib study of pelcitoclax in combination with osimertinib in patients with advanced EGFR-mutant NSCLC, comprised a dose-escalation phase and a dose-expansion phase. Pelcitoclax was administered at 160 mg or 240 mg by IV infusion once a week, and osimertinib was administered orally at 80 mg daily (QD). The dose-escalation primarily evaluated the safety and tolerability of the combination regimen in patients progressed on prior EGFR TKI treatments, and determined the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of pelcitoclax. The dose-expansion comprised two arms: 1) Patients with third-generation EGFR TKI-resistant NSCLC; 2) Patients with osimertinib-naïve NSCLC. Each arm planned to enroll 20 patients.

As of June 24, 2021, 56 patients were enrolled in the study. 33 of them were enrolled in the dose-escalation and dose-expansion arm 1. Those patients had received a median of 4 (range: 1-10) lines of prior treatment, 87.9% had received chemotherapies, 75.8% had been treated with osimertinib, and 63.6% had brain metastasis at the time of enrollment. The 23 patients enrolled in arm 2 had received a median of 0 (range: 0-2) lines of prior treatment, 8.7% had received chemotherapies, 17.4% had been treated with first-generation tyrosine kinase inhibitors (TKIs), and 30.4% had brain metastasis at the time of enrollment.

In dose-escalation, 1 partial response (PR) was observed in the 11 evaluable patients. In arm 1 of the dose-expansion phase, 3 PRs (2 were osimertinib-resistant) and 13 stable diseases (SDs) were observed in the 20 evaluable patients, at an objective response rate (ORR) of 15% and a disease control rate (DCR) of 80%. In arm 2 of the dose-expansion phase, 13 PRs and 8 SDs were observed in the 22 evaluable patients, including 3 patients harboring EGFR Exon 20 insertion, at an ORR of 59.1% and a DCR of 95.5%.

In dose-escalation, one case of dose-limiting toxicity (DLT) of grade 4 thrombocytopenia was observed at 240 mg; while no grade 3 or higher thrombocytopenia was observed at 160 mg, and the increase in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) also occurred at much lower rate than 240 mg. Thus, pelcitoclax 160 mg per week plus osimertinib 80 mg QD was selected as the RP2D. The most common treatment-related adverse events (TRAEs) included transient thrombocytopenia, increased AST, increased ALT, increased amylase, increased blood creatinine, decreased leukocytes, anemia, and rash.

Conclusion: Pelcitoclax in combination with osimertinib was safe and well-tolerated. Preliminary synergistic anti-tumor effects were observed in some patients with osimertinib-resistant NSCLC. In patients who received osimertinib for the first time, pelcitoclax has demonstrated preliminary synergistic anti-tumor effects with osimertinib similar to that of navitoclax.
Prof. Li Zhang, the principal investigator of the study from Sun-Yat Sen University Cancer Center, said: "Although osimertinib is currently the preferred first-line treatment for patients with EGFR-mutant NSCLC, there are still no effective treatments for patients who are resistant to osimertinib. Our data presented at this year’s WCLC has demonstrated synergistic anti-tumor effects of pelcitoclax plus osimertinib in some osimertinib-resistant patients, thus indicating the potential as a new clinical strategy that could address this unmet medical need. In the next step, we will carry out additional analysis of biomarkers in an effort to enrich the patient population responding to this regimen."

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented: "There is currently an enormous unmet medical need in patients with NSCLC, especially in the EGFR TKI-resistant subgroup that is in desperate need of effective treatment options. These results reported at the WCLC this year showed the therapeutic potential of pelcitoclax plus osimertinib in patients with EGFR TKI-resistant NSCLC, therefore provided rationale for the continued clinical investigations. We will press forward with this clinical development program which hopefully will offer a new treatment option to patients in need."

On September 8, 2021 Sandoz, a Novartis division, reported that it has entered into a commercialization agreement with Bio-Thera Solutions, Ltd. for biosimilar bevacizumab (BAT1706) (Press release, Novartis, SEP 8, 2021, View Source [SID1234587400]). Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor (VEGF), a key mediator of angiogenesis in cancer, and is used in combination with other treatments1,2.

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Bio-Thera Solutions, Ltd. will maintain responsibility for development and manufacturing, Sandoz will have the right to commercialize the medicine upon approval in the US, Europe**, Canada and selected other countries. According to the terms of the agreement, Bio-Thera Solutions, Ltd. will receive an upfront and milestone payments and is entitled to receive profit share payments in the partnered territory.

This agreement builds on Sandoz’s leading off-patent oncology portfolio, which comprises four marketed oncology biosimilars and over 50 generic medicines worldwide3,4. We see external collaborations as complementary to our internal programs, with an appropriate strategic balance enabling us to drive patient access by delivering portfolio breadth, balancing risks and costs and positioning us to play a leading role in the future biosimilar market.

Bio-Thera Solutions, Ltd. is a biopharmaceutical company located in Guangzhou, China, and dedicated to research and development into novel therapeutics, as well as biosimilars to treat a range of cancer and autoimmune diseases.