On November 8, 2021 Boston Scientific Corporation (NYSE: BSX) reported that it will participate in two upcoming investor conferences (Press release, Boston Scientific, NOV 8, 2021, View Source [SID1234594710]).

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On November 15, 2021, Dan Brennan, executive vice president and chief financial officer, and Lauren Tengler, vice president, Investor Relations, will participate in a 30-minute question-and-answer session with the host analyst at the virtual 2021 Stifel Healthcare Conference. The session will begin at approximately 8:00 a.m. EST.

On December 1, 2021, Dave Pierce, executive vice president and president, MedSurg & Endoscopy; Dr. Brian Dunkin, chief medical officer, Endoscopy; and Lauren Tengler will participate in a 45-minute question-and-answer session with the host analyst for the 2021 virtual Evercore ISI HealthCONx Conference. The session will begin at approximately 8:00 a.m. EST.

A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.com. The replay will be available approximately one hour following the completion of each event.

On November 8, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that management will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on Monday, November 15, 2021 at 2:00 p.m. EST (Press release, IGM Biosciences, NOV 8, 2021, View Source [SID1234594726]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On November 8, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported operating results for the third quarter ended September 30, 2021 (Press release, Sesen Bio, NOV 8, 2021, View Source [SID1234594743]). During the quarter, the Company continued to work on its path forward to address chemistry, manufacturing, and controls (CMC) and clinical issues identified by the US Food & Drug Administration (FDA) in its Complete Response Letter (CRL) regarding the Company’s Biologics License Application (BLA) for the Company’s lead program, Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

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"Our team is making progress in advancing our dialogue with the FDA as we work toward potential resolution of the issues raised in the CRL for Vicineum, as demonstrated by our recent CMC Type A Meeting with the agency," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We remain dedicated to saving and improving the lives of patients, and we look forward to continuing to work collaboratively with the FDA in our upcoming Clinical Type A Meeting, expected later this year, to carry our mission into the next stage of the regulatory process and beyond."

Regulatory Update

US:

On August 13, 2021, Sesen Bio announced that it had received a CRL from the FDA regarding its BLA for the Company’s lead program, Vicineum for the treatment of BCG-unresponsive NMIBC. The FDA determined that it could not approve the BLA for Vicineum in its present form and provided recommendations specific to additional clinical/statistical data and analyses, in addition to CMC issues pertaining to a recent pre-approval inspection and product quality.
On October 29, 2021, Sesen Bio participated in a productive CMC Type A Meeting with the FDA (CMC Type A Meeting). The purpose of the meeting was to discuss questions related to CMC raised in the CRL. During the meeting, the Company and the FDA reviewed issues related to CMC to be further discussed during the review of the BLA for Vicineum upon potential resubmission. Key takeaways from the meeting include:
The FDA confirmed that Vicineum manufactured using the proposed commercial process is comparable to Vicineum used in prior clinical trials.
The FDA confirmed that Sesen Bio can utilize Vicineum manufactured during process validation for any potential future clinical trials needed to address issues raised in the CRL, and that these potential trials can proceed while addressing CMC issues.
The Company believes it has a clear understanding of the path forward regarding CMC for resubmission of the BLA.
Sesen Bio is preparing for a separate Type A Meeting to discuss the recommendations specific to additional clinical/statistical data and analyses that the FDA raised in the CRL (Clinical Type A Meeting), which the Company expects to occur later this year. As previously disclosed, the Company anticipates needing to conduct an additional clinical trial with 90-100 patients, and will provide further guidance after the Clinical Type A Meeting.

The Company intends to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union.

European Union:

On August 20, 2021, Sesen Bio withdrew its marketing authorization application (MAA) to the European Medicines Agency (EMA) for Vysyneum1 for the treatment of BCG-unresponsive NMIBC. Given that certain components in the EMA’s review are interrelated with elements of the FDA’s decision to issue a CRL for Vicineum, the Company decided to pause its plans to pursue regulatory approval of Vysyneum in the European Union until there is more clarity from the FDA on next steps in the United States.
Other Business Updates

On August 30, 2021, Sesen Bio approved a restructuring plan to reduce operating expenses, to better align its workforce with the needs of its business following receipt of the CRL from the FDA for Vicineum, and to better position the Company to execute on next steps as they are determined. The Company expects the plan to decrease its annual cash costs by approximately $5.7 million.
The Company also implemented a program designed to retain employees as the Company continues to work toward the potential resolution of the issues detailed in the CRL. This retention program applies to all current employees except for the Chief Executive Officer.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and restricted cash were $175.3 million as of September 30, 2021, compared to $55.4 million as of December 31, 2020.
R&D Expenses: Research and development expenses for the third quarter of 2021 were $5.0 million compared to $10.2 million for the same period in 2020. The decrease of $5.2 million was primarily due to lower costs associated with technology transfer and manufacturing ($6.3 million), partially offset by increased license fees related to a milestone payment to the University of Zurich triggered by the completion of the BLA review by the FDA ($0.5 million), regulatory fees triggered by withdrawal of the Company’s MAA to the EMA for Vysyneum ($0.3 million), and regulatory consultant fees ($0.2 million).
G&A Expenses: General and administrative expenses for the third quarter of 2021 were $8.7 million compared to $4.1 million for the same period in 2020. The increase of $4.6 million was due to increases in sales and marketing expense for Vicineum pre-commercial launch planning ($2.4 million), employee-related compensation driven by increased headcount as part of the commercial build ($1.3 million), and professional fees for accounting services ($0.2 million). The majority of these expenses were incurred prior to receipt of the CRL in August 2021. Additionally, an increase in legal fees was driven primarily by legal proceedings and the on-going independent review related to Vicineum ($0.9 million). Such increase was partially offset by certain other decreases in G&A expenses, none of which were individually material ($0.2 million).
Restructuring Charges: Restructuring charges for the third quarter of 2021 were $5.5 million, which were due to one-time costs of approximately $2.7 million associated with the termination of certain contracts, and severance and other employee-related costs of approximately $2.8 million.
Non-Cash Related Expenses:
Intangibles impairment charge for the third quarter of 2021 was $31.7 million. In light of the CRL, the Company performed an interim impairment test for In-Process Research and Development (IPR&D) assets, which resulted in the decrease in fair value of Vicineum’s US rights.
The change in fair value of contingent consideration was a decrease of $114.0 million compared to an increase of $18.4 million for the same period in 2020. This was primarily due to management’s assessment of a lower probability of regulatory success and a refinement of timelines given the CRL.
Income Tax Benefit (Provision): Benefit from income tax was $8.6 million compared to $1.1 million tax expense for the same period in 2020. In connection with the intangibles impairment charge for the third quarter of 2021, the Company wrote-down the associated deferred tax liability by $8.6 million as a benefit.
Net Income (Loss): Net income was $71.7 million, or $0.36 per basic and $0.36 per diluted share, for the third quarter of 2021, compared to net loss of $22.6 million, or $0.19 per basic and diluted share, for the same period in 2020. The change was primarily attributable to favorable changes in non-cash related expenses ($110.4 million, including tax benefit), offset by restructuring charges ($5.5 million) and lower license revenue recognized ($11.2 million).
1 Vysyneum is the proprietary brand name that was conditionally approved by the EMA for oportuzumab monatox in the European Union.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum 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 NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target 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. 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 drugs, 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 November 8, 2021 iOnctura SA, a clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface, reported it has fully enrolled the metastatic uveal melanoma expansion cohort of the DIONE-01 study evaluating iOnctura’s lead compound, the selective PI3Kδ inhibitor IOA-244 (Press release, iOnctura, NOV 8, 2021, View Source [SID1234640243]).

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The DIONE-01 study entitled "A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients with Metastatic Cancers" (NCT04328844) consists of two parts, A and B. In Part A, now complete, the objective was to determine the safety, tolerability, and dosage of IOA-244 in cancer patients to determine the predicted biologically effective dose range. Safety, PK and PD data from Part A will be presented as a poster (#405) at ESMO (Free ESMO Whitepaper) IO in Geneva between December 8-11, 2021.

Part B of the DIONE-01 study consists of expansion cohorts of patients with different tumor types, including patients with metastatic uveal melanoma. It will include the assessment of whether IOA-244 can increase the anti-tumor immune response in patients both as monotherapy and in combination with pemetrexed/cisplatin and an immune checkpoint inhibitor. The study will enroll up to 182 patients with uveal melanoma, cutaneous melanoma, NSCLC, mesothelioma, myelofibrosis, and NHL.

Within Part B, up to 26 patients with metastatic uveal melanoma will be recruited to determine the monotherapy activity of IOA-244. Patients with metastatic uveal melanoma currently have no approved treatment options. Positive outcome from this part of the trial is expected to support transition to subsequent registration studies for metastatic uveal melanoma. Interim data is expected in Q2 2022 with final top-line data scheduled for Q4 2022.

"iOnctura is entering a highly exciting phase as it progresses two tumor-stroma-immune interface targeting programs through clinical development. IOA-244 continues to demonstrate an unprecedented clinical profile among PI3Kδ inhibitors," said Catherine Pickering, CEO of iOnctura. "iOnctura is moving rapidly in the use of IOA-244 to treat a range of solid tumor types including metastatic uveal melanoma, an underserved cancer with no currently approved drug treatments and poor patient outcomes. We look forward to releasing early data from our preclinical and clinical evaluations of this exceptional molecule at ESMO (Free ESMO Whitepaper) IO."

Contacts

iOnctura
Catherine Pickering
Chief Executive Officer
T : +41 79 952 72 52
E: [email protected]

Press Relations
Jeremy Nieckowski
LifeSci Advisors
T: +41 79 699 97 27
E: [email protected]
iOnctura SA is clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface. iOnctura’s best-in-class drug development programs combine immune-mediated and direct anti-tumor activity to deliver molecules with superior clinical efficacy and safety in oncology. Its lead program, IOA-244 is the only semi-allosteric PI3Kδ specific, orally dosed, small molecule inhibitor that is being developed in solid and hematologic malignancies to address tumor and stroma induced immune suppression. IOA-244 is currently in a Phase 1 study which will support transition to subsequent registration studies. iOnctura’s second program, IOA-289, is an oral small molecule that inhibits the cross-talk between the tumor and its stroma and is in a Phase 1 study. iOnctura is backed by blue chip investors including M Ventures, Inkef Capital, VI Partners, Schroders Capital, and 3B Future Health Fund. For more information, please visit www.ionctura.com

IOA-244 is a PI3Kδ specific, orally dosed, small molecule inhibitor that overcomes tumor and stroma induced immune suppression. Its unique chemistry, semi allosteric binding mode and mechanism of action contribute to its unprecedented clinical profile. IOA-244 is currently in the cohort expansion phase of the DIONE-01 trial, a two-part, first-in-human dose study evaluating IOA-244 in solid tumors and hematologic malignancies and as a combination partner for conventional and immune-therapies.

Uveal melanoma (UM) is a rare malignancy arising within the uveal tract of the eye. There are approximately 7,000 newly diagnosed cases of uveal melanoma each year (around 2,000 in the United States). Over 50% of patients will progress to metastatic disease. Median overall survival is approximately 1 year for metastatic uveal melanoma and there are no approved therapies.

On November 8, 2021 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported financial results for the third quarter ended September 30, 2021 (Press release, Aduro Biotech, NOV 8, 2021, View Source [SID1234594695]).

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"During the third quarter of 2021, we focused on execution and advancement of our lead clinical programs, atrasentan and BION-1301 for IgA nephropathy, a serious progressive disease for which there are no approved therapies. We are advancing enrollment in the ALIGN and AFFINITY studies of atrasentan, and the data we recently presented at ASN from the ongoing phase 1/2 study of BION-1301 in patients with IgAN shows consistent mechanistic biomarker responses and clinically meaningful reductions in proteinuria within three months of initiating treatment, demonstrating its potential as a novel disease-modifying therapy," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "We’re enthusiastic about the potential of precision medicine to provide new treatments for kidney disease, and we look forward to continuing to advance our other pipeline programs, including initiating a phase 1 study of CHK-336 next year and making progress on our research and discovery programs."

Atrasentan

Atrasentan is a potent and selective endothelin A (ETA) receptor antagonist that has the potential to provide benefit in multiple chronic kidney diseases by reducing proteinuria and having direct anti-inflammatory and anti-fibrotic effects to preserve kidney function. The phase 3 ALIGN trial of atrasentan is currently enrolling patients with IgAN, and the phase 2 AFFINITY basket trial of atrasentan is currently enrolling patients with proteinuric glomerular diseases.

Enrollment of the phase 3 ALIGN trial of atrasentan continues to progress with the activation of new trial sites and expansion into additional countries. Chinook expects to report topline data from the six-month interim proteinuria endpoint analysis in 2023 to support an application for accelerated approval under Subpart H in the U.S.

Chinook continues to enroll all four cohorts of the phase 2 AFFINITY basket trial, including patients with lower proteinuria IgAN (between 0.5 and 1.0 g/day), focal segmental glomerulosclerosis (FSGS), Alport syndrome and diabetic kidney disease in combination with SGLT2 inhibitors. Chinook expects to present data from the IgAN patient cohort of this study in the first half of 2022, with data from one or more additional cohorts expected in the second half of 2022.

Several abstracts on atrasentan were delivered as poster presentations at ASN Kidney Week 2021, including:

Data demonstrating endothelin pathway activation in the kidneys of patients with IgAN has a strong association with clinical progression. Atrasentan was also shown to inhibit endothelin-1 mediated transcriptional networks, including cell proliferation, inflammation and fibrosis in human mesangial cells. This translational research was conducted in collaboration with the laboratory of Matthias Kretzler, M.D., Professor of Nephrology and Professor of Computational Medicine & Bioinformatics at University of Michigan Medical School, and supports the therapeutic potential of ETA receptor blockade with atrasentan in patients with IgAN at high risk of progression.
Analysis of three separate single-dose, randomized phase 1 studies of atrasentan demonstrated consistent and predictable safety, tolerability and pharmacokinetic profiles in healthy Chinese, Japanese and North American adults of non-Asian descent. The consistent profile of atrasentan across these ethnicities and geographic regions, supports the inclusion of patients with IgAN in Asia, where there is an increased prevalence and potentially accelerated disease progression, in the ongoing global phase 3 ALIGN study.
BION-1301

BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 1/2 development for patients with IgAN. BION-1301’s potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1) has been demonstrated preclinically as well as clinically in both healthy volunteers and patients with IgAN.
Chinook completed enrollment of Cohort 1 of Part 3 of the ongoing phase 1/2 study of BION-1301 and presented additional patient data and follow-up from this cohort at ASN Kidney Week 2021, indicating BION-1301 was well-tolerated and caused durable reductions in Gd-IgA1, IgA, IgM, and to a lesser extent, IgG levels in patients with IgAN. BION-1301 demonstrated a greater than 50% geometric mean reduction in 24-hour urine protein creatinine ratio (UPCR) after three (n=6) to six (n=4) months of treatment, with further reductions in two patients through one year of treatment.
Chinook recently initiated enrollment of Cohort 2 of Part 3 of the ongoing phase 1/2 study of BION-1301. Patients in Cohort 2 will receive a subcutaneous dose of 600 mg of BION-1301 every two weeks for up to 52 weeks.
Chinook expects to present additional data from the ongoing phase 1/2 trial of BION-1301 in patients with IgAN and provide an update on planned later-stage clinical trials of BION-1301 in the first half of 2022.
CHK-336

CHK-336 is an oral small molecule lactate dehydrogenase A (LDHA) inhibitor with liver-targeted tissue distribution that Chinook is developing for the treatment of patients with primary hyperoxaluria, secondary hyperoxaluria due to increased endogenous oxalate production and idiopathic stone formation.
Chinook has completed IND-enabling toxicology studies and is advancing CHK-336 towards IND submission and initiation of a phase 1 clinical trial in healthy volunteers in the first half of 2022.
Research & Discovery

Chinook is focused on the discovery and development of novel precision medicines for rare, severe chronic kidney diseases (CKDs) with defined genetic or molecular drivers of disease initiation and progression, and efficient development paths.

Chinook has multiple preclinical programs across the discovery, target validation, lead identification and lead optimization stages to generate future clinical pipeline candidates.

Chinook is leveraging its ongoing strategic collaboration with Evotec to identify and validate novel targets and enable patient stratification strategies through access to the NURTuRE CKD Patient Biobank, which provides comprehensive PANOMICS characterization of thousands of CKD patients with prospective clinical follow-up and retained bio-samples of urine and blood for exploratory biomarker analysis.
Third Quarter 2021 Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $204.8 million at September 30, 2021, compared to $250.4 million at December 31, 2020.

Revenue – Total revenue increased by less than $0.1 million for the third quarter of 2021 and increased by $0.4 million for the nine months ended September 30, 2021, compared to the same periods in 2020 due to revenue recognized related to research and development services provided under the collaboration agreement with Lilly, which was acquired under the merger with Aduro.

Expenses –

Research and development expenses were $23.6 million for the third quarter of 2021 and $72.1 million for the nine months ended September 30, 2021, compared to $7.6 million and $14.3 million, respectively, for the same periods in 2020. The increase was primarily due to external clinical and manufacturing expenses related to the atrasentan and BION-1301 clinical programs; higher employee-related costs, including salaries, benefits and stock-based compensation expense associated with hiring staff to build out Chinook’s clinical and development capabilities; increased spending for consulting and outside services; costs related to our collaboration with Evotec; and an increase in facilities and other costs.

General and administrative expenses were $6.8 million for the third quarter of 2021 and $24.2 million for the nine months ended September 30, 2021, compared to $2.9 million and $8.0 million, respectively, for the same periods in 2020. The increase was primarily due to higher employee-related costs, including salaries, benefits and stock-based compensation expense associated with the addition of administrative staff to build out Chinook’s public-company infrastructure; higher legal, consulting and outside services costs; and an increase in facilities and other costs.

Expenses due to the change in fair value of contingent consideration and contingent value rights liabilities were $0.2 million for the third quarter of 2021 and $21.6 million for the nine months ended September 30, 2021, compared to nil for the same periods in 2020. These non-cash expenses are due to the quarterly revaluation of assets and liabilities related to the Sairopa transaction and an updated valuation of Chinook’s CVR liability under the Merck collaboration, as a result of the merger with Aduro. In the second quarter of 2021, Merck informed Chinook that it intends to explore the potential benefit of the product candidate MK-5890 in a phase 2 clinical study for a new indication, which may result in potential milestone and royalty payments under the Merck collaboration for the benefit of CVR holders.

Other –

The sale of certain of Chinook’s non-renal assets to Sairopa in the second quarter of 2021 resulted in a $7.2 million gain for the nine months ended September 30, 2021.
Net Loss – Net loss for the third quarter of 2021 was $30.7 million or $0.69 per share and $110.5 million or $2.54 per share for the nine months ended September 30, 2021, compared to net loss of $18.8 million or $4.50 per share and $31.7 million or $7.65 per share, respectively, for the same periods in 2020.

Cash Used in Operations – For the nine months ended September 30, 2021, cash used in operations totaled $80.2 million.