On August 8, 2022 Daiichi Sankyo (TSE: 4568) reported that the first patient has been dosed in the global HERTHENA-Lung02 phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with disease progression following treatment with one or more EGFR tyrosine kinase inhibitors (TKIs) including a third-generation EGFR TKI (Press release, Daiichi Sankyo, AUG 8, 2022, View Source [SID1234617811]).

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Patritumab deruxtecan is a specifically designed potential first-in-class HER3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide.1 Approximately 80% to 85% of lung cancer is classified as NSCLC with EGFR mutations occurring in up to 30% of tumors.2,3 While the efficacy and safety of targeted therapy with EGFR TKIs is well-established for the treatment of advanced EGFR-mutated NSCLC, the development of a broad range of resistance mechanisms is likely to lead to disease progression.4,5,6 After failure of one or more EGFR TKIs, platinum-based chemotherapy and subsequent salvage therapies have limited efficacy.7

"We are encouraged by the early results seen with patritumab deruxtecan and have initiated HERTHENA-Lung02 to further evaluate whether this HER3 directed antibody drug conjugate will be more effective than standard chemotherapy in treating patients with previously treated EGFR-mutated metastatic non-small cell lung cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Clinical Development, Oncology R&D, Daiichi Sankyo. "Initiating this phase 3 trial emphasizes our ongoing commitment to accelerate development of patritumab deruxtecan to potentially improve the standard of care for patients with this specific subtype of lung cancer."

About HERTHENA-Lung02

HERTHENA-Lung02 is a global, multicenter, open-label, phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (5.6 mg/kg) versus platinum-based chemotherapy (pemetrexed in combination with cisplatin or carboplatin) in patients with locally advanced or metastatic non-squamous NSCLC with an EGFR-activating mutation (exon 19 deletion or exon 21 L858R mutation) previously treated with an EGFR TKI with disease progression on or after treatment with a third-generation TKI. Patients will be randomized 1:1 to receive patritumab deruxtecan or platinum-based chemotherapy.

The primary endpoint of HERTHENA-Lung02 is progression-free survival (PFS) as assessed by blinded independent central review (BICR). Secondary endpoints include overall survival, investigator-assessed PFS as well as BICR and investigator-assessed objective response rate, clinical benefit rate, disease control rate, duration of response, time to response and safety. HERTHENA-Lung02 will enroll approximately 560 patients at multiple sites across Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide.1 Approximately 80% to 85% of lung cancer is classified as NSCLC with EGFR mutations occurring in up to 30% of tumors.2,3 NSCLC is diagnosed at an advanced stage in more than 50% of patients and often has a poor prognosis with worsening outcomes after each line of subsequent therapy.8,9,10

The introduction of targeted therapies and checkpoint inhibitors in the past decade has improved the treatment landscape for patients with advanced or metastatic NSCLC, and for patients with advanced EGFR-mutated NSCLC, targeted therapy with EGFR TKIs offer higher response rates and PFS compared to chemotherapy.11 However, most patients eventually develop resistance to these therapies and subsequent therapies after EGFR TKI with platinum-based chemotherapy have limited efficacy with PFS of approximately 6.4 months.7,12

HER3 is a member of the EGFR family of receptor tyrosine kinases, which are associated with aberrant cell proliferation and survival.13 It is estimated that about 83% of all NSCLC tumors express the HER3 protein. Overexpression is associated with metastatic progression and decreased relapse-free survival.14

New treatment approaches are needed to overcome resistance and improve survival in EGFR-mutated NSCLC. Currently, there is no HER3 directed medicine approved for the treatment of any cancer.

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is one of three lead DXd ADCs in the oncology pipeline of Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other anticancer therapies. In addition to the HERTHENA-Lung02 trial, patritumab deruxtecan is being evaluated in HERTHENA-Lung01, a pivotal phase 2 trial in patients with EGFR-mutated locally advanced or metastatic NSCLC previously treated with a EGFR TKI and platinum-based chemotherapy; a phase 1 trial in combination with osimertinib in EGFR-mutated locally advanced or metastatic NSCLC; and a phase 1 trial in previously treated patients with unresectable or metastatic NSCLC. A phase 1/2 trial in HER3 expressing metastatic breast cancer also has been recently completed.

In December 2021, patritumab deruxtecan was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic or locally advanced EGFR-mutated NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.

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

On August 8, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development and global access to life-changing radiopharmaceuticals, reported that next week, on Thursday, August 18, 2022 at 12:00 PM ET, the Company will be presenting a 45-minute educational webinar entitled "Understanding the PNT2002 Phase 3 SPLASH Trial Control Arm" (Press release, Point Biopharma, AUG 8, 2022, View Source [SID1234617810]).

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Topics to be presented at the webinar include:

Overview of SPLASH trial design (including lead-in phase) and rationale for hormone switches
What is a control arm benchmark, why PROfound1 & IMbassador2502 were selected as SPLASH benchmarks
Review current treatment patterns, including sequencing considerations, in real-world clinical settings for mCRPC patients
The webinar will feature presentations from two Thought Leaders: Dr. Oliver Sartor & Dr. Kim Chi. They will be joined by members of the Company’s executive leadership team including Dr. Neil Fleshner, Chief Medical Officer, and Dr. Sherin Al-Safadi, VP Medical Affairs.

About Dr. Oliver Sartor
Dr. Oliver Sartor is an internationally recognized expert in prostate cancer. His medical practice and research have focused on prostate cancer since 1990 when he finished a medical oncology fellowship at the National Cancer Institute (NCI). He has published over 400 peer-reviewed articles, led or co-led multiple national and international clinical studies, including three radiopharmaceutical phase III studies pivotal for FDA approval in prostate cancer. He has lectured widely, and at last count has given invited lectures in 33 countries. He is currently the Associate Dean for Oncology, Medical Director of the Tulane Cancer Center, and serves as the Laborde Professor for Cancer Research at Tulane Medical School with appointments in both the Medicine and Urology Departments. He is the Medical Oncology Chair of the GU committee of NRG, a national cancer research group. He is also a past member of the National Cancer Institute Board of Scientific Counselors (Clinical Sciences and Epidemiology).

About Dr. Kim Chi
Dr. Kim Chi, MD is the Vice President and Chief Medical Officer of BC Cancer. His research is focused in the area of genitourinary cancers with a special interest in prostate cancer and investigational new drugs. This includes phase I, II and III clinical trials, therapeutic use of antisense oligonucleotides and mechanisms of treatment resistance. Nationally and internationally he has led a number of multi-center Phase I, II and III clinical trials, and has also contributed to clinical trials that established new standard of care for patients with advanced prostate cancer (docetaxel, abiraterone acetate, enzalutamide).

On August 8, 2022 Sesen Bio (Nasdaq: SESN) reported operating results for the second quarter ended June 30, 2022 (Press release, Sesen Bio, AUG 8, 2022, View Source [SID1234617809]). During the quarter, the Company paused clinical development of its lead asset, Vicineum for the treatment of non-muscle invasive bladder cancer (NMIBC), and turned its primary focus to the assessment of potential strategic alternatives with the goal of maximizing shareholder value, which it believes will be complete by the end of 2022 .

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Business Updates

On July 11, 2022, Sesen Bio participated in a Type B Meeting with the US Food and Drug Administration (FDA). During the meeting, the Company and the FDA discussed outstanding items related to the Company’s proposed protocol and statistical analysis plan design elements for an additional Phase 3 clinical trial for Vicineum for the treatment of NMIBC, which the Company had been evaluating for potential resubmission of a Biologics License Application for Vicineum.

On July 15, 2022, the Company executed an asset purchase agreement (the "Roche Asset Purchase Agreement") with Roche for legacy Interleukin-6 (IL-6) antagonist antibody technology owned by Sesen Bio. Pursuant to the Roche Asset Purchase Agreement, Roche purchased all patent rights and know-how related to the monoclonal antibody EBI-031 and all other IL-6 antagonist monoclonal antibody technology owned by Sesen Bio for up to $70 million. This includes a $40 million payment made by Roche to the Company upon execution of the Roche Asset Purchase Agreement, and an additional $30 million payable to Sesen Bio upon Roche’s initiation of a Phase 3 clinical trial with EBI-031 for a defined indication if initiated prior to December 31, 2026.

As a result of the Roche Asset Purchase Agreement, the Company’s previous license agreement with Roche dated June 10, 2016 (the "Roche License Agreement") was terminated. Prior to the termination of the Roche License Agreement, the Company had received $50 million in upfront and milestone payments from Roche.

On July 18, 2022, Sesen Bio announced that it had made the strategic decision to voluntarily pause further development of Vicineum in the US. The decision was based on a thorough reassessment of Vicineum following recent discussions with the FDA, which included feedback that had implications on the size, timeline, and costs of the required additional Phase 3 clinical trial for the treatment of NMIBC. The Company continues to believe that Vicineum has benefits for patients and healthcare providers that can be maximized through a company with a larger infrastructure, and as such, intends to seek a partner that can execute further development to realize the full potential of Vicineum.

As a result of this decision, the Company has turned its primary focus to the careful assessment of strategic alternatives with the goal of maximizing shareholder value. As previously disclosed, the Company is actively working with an investment bank in the assessment process, and believes it will be complete by the end of 2022.

On July 20, 2022, Sesen Bio announced the approval of a restructuring plan to reduce operating expenses and to better align its workforce with the needs of its business following the decision to pause further development of Vicineum in the US. Execution of the restructuring plan is expected to be substantially complete by the end of the fourth quarter of 2022.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $161.2 million as of June 30, 2022, compared to $151.1 million as of June 30, 2021.
R&D Expenses: Research and development expenses for the second quarter of 2022 were $29.9 million compared to $7.2 million for the same period in 2021. The increase of $22.7 million was primarily due to the expense of prepaid balances related to consumables and manufacturing reservations, as the balances were evaluated and deemed to have no future value ($25.2 million). This increase was partially offset by lower costs associated with manufacturing ($2.5 million).
G&A Expenses: General and administrative expenses for the second quarter of 2022 were $15.6 million compared to $6.8 million for the same period in 2021. The increase of $8.8 million was primarily due to an increase in legal expense ($10.3 million). This increase was driven by the preliminary settlement of the securities and derivative litigation, net of expected insurance recovery ($8.6 million), related legal fees ($0.9 million), legal fees related to the internal review ($0.3 million), and other legal expenses ($0.5 million). This increase was partially offset by a decrease in marketing and commercial expenses, which were incurred in the second quarter of 2021 in preparation for potential commercial launch of Vicineum but were discontinued as a result of the Complete Response Letter from the FDA received in August 2021 ($1.5 million).
Non-Cash Related Expenses:
Intangibles impairment charge for the second quarter of 2022 was $27.8 million. In light of assumption changes in market share for Vicineum and the Company’s strategic decision to voluntarily pause further development of Vicineum in the US, the Company performed an interim impairment test for In-Process Research and Development (IPR&D) assets and goodwill. This resulted in the full impairment of IPR&D assets ($14.7 million) and goodwill ($13.1 million).
The change in the fair value of contingent consideration was a decrease of $37.3 million for the second quarter of 2022, compared to an increase of $13.6 million for the same period in 2021. This decrease was due to a change in projected net sales for Vicineum subject to contingent consideration liability, which was based upon projected net sales in the Greater China region in the second quarter of 2022 compared to projected net sales worldwide in the second quarter of 2021.
Income Tax Benefit: Benefit from income tax was $3.9 million for the second quarter of 2022. In connection with the intangibles impairment charge for the second quarter of 2022, the Company wrote-down the associated deferred tax liability by $4.0 million as a benefit. This was partially offset by $0.1 million in income tax paid to foreign jurisdictions pursuant to the Company’s license agreement with Qilu Pharmaceutical. There was no tax benefit or provision in the second
quarter of 2021.
Net Loss: Net loss was $32.0 million, or $0.16 per basic and per diluted share, for the second quarter of 2022, compared to net loss of $25.4 million, or $0.15 per basic and diluted share, for the same period in 2021. The change was primarily attributable to increases in R&D and G&A expenses ($31.5 million), primarily driven by the reduction of prepaid balances related to consumables and manufacturing reservations and the preliminary settlements of the securities and derivative litigation. Additionally, license and related revenue recognized decreased ($2.2 million). This was partially offset by favorable changes in non-cash related expenses of $27.0 million (including tax benefit).
About Vicineum

Vicineum, a locally administered fusion protein, is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in non-muscle invasive bladder cancer (NMIBC) cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio has completed the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. On July 18, 2022, Sesen Bio announced that it had made the strategic decision to voluntarily pause further development of Vicineum in the US. The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs, following recent discussions with the FDA. The Company continues to believe that Vicineum has benefits for patients and healthcare providers that can be maximized through a company with a larger infrastructure, and as such intends to seek a partner for further development of Vicineum while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology therapies, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On August 8, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of novel peptide therapeutics to address difficult-to-treat cancers, reported that the company will conduct a sub-study of its ongoing Phase 1-2 clinical trial of ST101 in recurrent and newly diagnosed GBM patients (Press release, Sapience Therapeutics, AUG 8, 2022, View Source [SID1234617808]). The sub-study will be conducted by Sapience in collaboration with principal investigators at Columbia University and Northwestern University. Partial funding for the sub-study was awarded to Fabio Iwamoto, Principal Investigator at Columbia University, through a research grant from the Ben and Catherine Ivy Foundation.

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The study is a multi-site, open-label surgical sub-study of the Phase 1-2 protocol ST101 to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in 18 patients with recurrent (n=6) and newly diagnosed GBM (n=12). The primary objectives of the study will be to evaluate the safety and tolerability of ST101 as monotherapy in recurrent GBM patients post resection and in newly diagnosed GBM patients in combination with radiation ± temozolomide post resection. The secondary objectives of the study will be to determine the penetration of ST101 in the brain and its correlation with plasma levels. In both study arms, patients will be resected following two to four doses of ST101 and will continue on ST101 following surgery.

"We are thrilled to continue to evaluate the therapeutic potential of ST101, which has demonstrated very promising clinical data in the ongoing Phase 1-2 study with confirmed partial responses in multiple tumor types, including GBM. In the surgical sub-study, we aim to demonstrate further evidence of ST101’s ability to penetrate the brain and inhibit transcription of C/EBPβ, which is a master regulator of GBM tumors," said Fabio Iwamoto, Principal Investigator at Columbia University. "Our team at Columbia remains very excited about our work with Sapience and we look forward to continuing to deliver clinical benefit to cancer patients with ST101."

ST101 is a first-in-class peptide antagonist of C/EBPβ with a dual mechanism of action. ST101 antagonism of C/EBPβ promotes (1) a more favorable immune tumor microenvironment by inhibiting formation of immunosuppressive myeloid-derived suppressor cells (MDSCs) and (2) cytotoxic activity in tumor cells by disrupting C/EBPβ-driven oncogenic activity. In its ongoing Phase 1-2 study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM, a durable RECIST 1.1-confirmed partial response in a patient with cutaneous melanoma and long-lasting stable disease in several additional patients.

Alice Bexon, Sapience’s Chief Medical Officer, commented, "We remain very pleased with ST101’s clinical profile and we look forward to evaluating ST101 in the surgical sub-study announced today. The data generated from this study, if positive, will provide early safety and efficacy signs that would allow us to advance ST101 into a first-line therapeutic option for GBM, which would be transformative for this patient population."

About ST101 and the Phase 1-2 Study
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 dose expansion. In the ongoing Phase 2 dose expansion, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, castration-resistant prostate cancer and locally advanced or metastatic hormone-receptor positive breast cancer. In the ongoing dose escalation part of the study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients.

ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

On August 8, 2022 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported that it will host an investor conference call on Wednesday, August 10, 2022 at 1:30 p.m. Pacific Time to discuss its financial and operating results for the second quarter 2022 as well as provide a corporate update (Press release, Adamis Pharmaceuticals, AUG 8, 2022, View Source [SID1234617807]). The company’s press release concerning its second quarter 2022 financial results is expected to be available after 1 p.m. Pacific Time on August 10, 2022, and on its website.

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David J. Marguglio, President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during the year, and certain goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

A live audio webcast of the conference call will also be available via this link, with a replay available shortly after the live event.