On September 8, 2021 Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted induced pluripotent stem cells (iPSC) derived natural killer (NK) and Macrophage cellular immunotherapies, reported that company management will present and be available for one-on-one meetings at the Wells Fargo 2021 Virtual Healthcare Conference, September 9 -10, 2021, and the H.C. Wainwright 23rd Annual Global Investment Conference, September 13 – 15, 2021 (Press release, Shoreline Biosciences, SEP 8, 2021, View Source [SID1234587445]).

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Details on the presentations can be found below.

Wells Fargo 2021 Virtual Healthcare Conference
September 9, 2021 at 12:40 PM ET

H.C. Wainwright 23rd Annual Global Investment Conference
Presentation Date: Corporate presentation will be available on-demand to conference
registrants starting at 7:00 AM ET on September 13, 2021

On September 8, 2021 Sanofi reported that it has entered into a definitive merger agreement with Kadmon Holdings, Inc. (NASDAQ: KDMN) a biopharmaceutical company that discovers, develops, and markets transformative therapies for disease areas of significant unmet medical needs (Press release, Sanofi, SEP 8, 2021, View Source [SID1234587374]). The acquisition supports Sanofi’s strategy to continue to grow its General Medicines core assets and will immediately add Rezurock(belumosudil) to its transplant portfolio. Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.

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Shareholders of Kadmon common stock will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis). The Sanofi and Kadmon Boards of Directors unanimously approved the transaction.

"We are transforming and simplifying our General Medicines business and have shifted our focus on differentiated core assets in key markets," said Olivier Charmeil, Executive Vice President General Medicines. "We are thrilled to add Kadmon’s Rezurock to our well-established transplant portfolio. Our existing scale, expertise, and relationships in transplant create an ideal platform to achieve the full potential of Rezurock, which will address the significant unmet medical needs of patients with chronic graft-versus-host disease around the world."

"We are excited that Sanofi has acknowledged the value of Rezurock and the deep potential of our pipeline," said Harlan Waksal, M.D., President and Chief Executive Officer, Kadmon. "By leveraging Sanofi’s global resources and long-standing expertise in developing and commercializing innovative medicines, Rezurock is now well positioned for global accessibility, faster. I want to thank the entire Kadmon team, including management and the Board of Directors, and the Sanofi organization, for their ongoing commitment to patients and their caregivers."

Sanofi’s transplant business mainly consists of Thymoglobulin (anti-thymocyte globulin), a polyclonal, anti-human thymocyte antibody preparation that acts as a broad immunosuppressive and immunomodulating agent and Mozobil (plerixafor), a hematopoietic stem cell mobilizer. Both products are among General Medicines core assets and are currently registered and marketed in more than 65 countries.

In July 2021, the FDA approved Rezurock for the treatment of adult and pediatric patients 12 years and older with cGVHD after the failure of at least two prior lines of systemic therapy. Rezurock was launched in August in the United States. It is the first and only approved small molecule therapy that inhibits the Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and fibrotic processes. Sanofi will work closely with regulatory authorities across different geographies to ensure that patients suffering from cGVHD can benefit from belumosudil treatment as early as possible. Kadmon is also developing Rezurock for the treatment of diffuse cutaneous systemic sclerosis, with an open-label Phase 2 clinical trial currently ongoing.

Kadmon’s pipeline includes drug candidates for immune and fibrotic diseases as well as immuno-oncology therapies.

The transaction is expected to be modestly dilutive to Sanofi’s EPS in 2022.

Transaction Terms

Under the terms of the merger agreement, holders of Kadmon’s common stock will receive $9.50 per share in an all-cash transaction, reflecting a total equity value of Kadmon of approximately $1.9 billion. The offer price represents a premium of 79% over the closing price on September 7, 2021 and a premium of approximately 113% over the 60 trading days volume weighted average price.

The consummation of the transaction is subject to customary closing conditions, including the approval of holders of a majority of the outstanding shares of Kadmon voting stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the merger, a wholly owned subsidiary of Sanofi will merge with Kadmon and the outstanding Kadmon shares will receive $9.50 per share in cash. Sanofi plans to fund the transaction with available cash resources. Subject to the satisfaction or waiver of customary closing conditions, Sanofi expects to complete the acquisition in the fourth quarter of 2021.

Weil, Gotshal & Manges LLP is acting as legal counsel to Sanofi. Cantor Fitzgerald & Co. and Moelis & Company LLC are acting as exclusive financial advisors to Kadmon in the transaction, while DLA Piper LLP (US) is acting as legal counsel.

On September 8, 2021 Scandion Oncology A/S, the Cancer Drug Resistance Company, reported it will provide novel information on its lead candidate drug SCO-101 and a focused clinical strategy with a clear path to registration at today’s Capital Markets Day (Press release, Scandion Oncology, SEP 8, 2021, View Source,c3411474 [SID1234587392]). The company will also communicate about its pipeline, future business opportunities and give an update from part 1 of the CORIST Phase II study.

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Data from the CORIST study have triggered an updated focused clinical strategy. Scandion has documented a unique Mode of Action (MoA) for SCO-101 in the CORIST study, where the company shows a significant potentiation of Irinotecan by combining SCO-101 with FOLFIRI in patients. The combination resulted in a dramatically increased exposure and half-life of SN-38 (the active metabolite of Irinotecan). The molecular mechanism of action driving the increased exposure has been identified. The Company has filed a patent application on this unique mode of action.

Scandion Oncology will become a Phase III company
"Our path forward is built on a unique Mode of Action (MoA) and we have focused our clinical strategy to provide a clear route to registration and return on investments in RAS wild-type metastatic colorectal cancer. The ultimate outcome is to become a Phase III company as early as in 2023. We further see a huge opportunity for building on this platform knowledge, to broaden the clinical opportunities for SCO-101 in combination with Irinotecan and maximize business value," said Bo Rode Hansen, President & CEO.

Refocusing from last line mCRC to 2nd line
This also means, that Scandion will refocus from last line metastatic colorectal cancer (mCRC) to second line of treatment to add significantly more value. To maximize the market potential in second line mCRC, the Company aims to position SCO-101 in combination with VEGF monoclonal antibodies (mAbs) and/ or EGFR monoclonal antibodies (mAbs) which are used as backbone in 1st and 2nd line of treatment of RAS wild-type mCRC.

In preparation for the pivotal study, the company will redesign part 3 of CORIST, which is funded, to include 10 patients as a separate arm that will run in parallel to the 25 patients in CORIST part 2. CORIST part 3 will evaluate safety of combining SCO-101 and FOLFIRI with mAbs (VEGF and/or EGFR), pharmacokinetics and be included in the overall efficacy assessment in CORIST Phase II. The company is further planning to open an Investigational New Drug (IND), to allow for inclusion of patients from US clinical sites.

Focusing our pipeline on value creation and highest probability of success
"We are prioritizing SCO-101 in combination with Irinotecan over other projects in our pipeline, as we see the most value creation potential for this combination. We will therefore cease investing in less documented MoAs including SCO-101 in combination with anti-oestrogens and in indications outside of cancer (antibiotics). The implications are that we de-prioritize two of our preclinical projects: EndoRIST and SOM-001. In terms of pipeline, we will focus on maximum value creation and highest probability of success. We have defined a clear roadmap for our coming years," said Bo Rode Hansen.

The Capital Markets Day will take place between 9am and 11.30am CET today and will be webcasted live and is accessible at: View Source

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on September 8, 2021 at 8:30 CET.

On September 8, 2021 Seagen Inc. (Nasdaq: SGEN) reported data and trials in progress from its diverse and growing portfolio of marketed and investigational therapies will be presented at the virtual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Annual Meeting, to be held from September 16-21 (Press release, Seagen, SEP 8, 2021, View Source [SID1234587410]). Sixteen presentations will demonstrate the breadth of Seagen’s portfolio and development activities, across multiple cancer types – including a mini oral presentation featuring results from the Phase 1/2 innovaTV 205 clinical trial in recurrent or metastatic cervical cancer.

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The innovaTV 205 trial of tisotumab vedotin (TV) is designed to evaluate the safety and efficacy of TV as monotherapy and in combination with chemotherapy and other agents in recurrent or metastatic cervical cancer. Data to be shared will include interim analyses of TV plus carboplatin as a potential first-line therapy, as well as analyses of TV plus pembrolizumab in previously treated patients.

Seagen’s Biologics License Application for TV monotherapy in recurrent or metastatic cervical cancer is currently under Priority Review by the U.S. Food and Drug Administration (FDA) with a target action date of Oct. 10, 2021.

"The data to be shared at ESMO (Free ESMO Whitepaper) 2021 reflect our commitment to developing transformational cancer medicines for patients in areas of significant unmet medical need, including best-in-class antibody-drug conjugates," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Our research to advance antibody-drug conjugates as monotherapies or in combination with other therapies for the treatment of various cancers has the potential to shape future treatment paradigms."

Other research presentations include subset analyses of EV-301, a phase 3 trial of enfortumab vedotin (EV) versus chemotherapy for previously treated advanced urothelial carcinoma, and the first data from a weekly-dosing trial of ladiratuzumab vedotin (LV), an investigational anti-LIV-1 antibody-drug conjugate, in pre-treated metastatic triple-negative breast cancer.

Data to be presented at ESMO (Free ESMO Whitepaper) 2021 for Seagen medicines and investigational agents:

Presentation #

Abstract Title

Lead
Author

Presentation
Type

Tisotumab Vedotin

723MO

Tisotumab Vedotin (TV) + Carboplatin (Carbo) in First-line (1L) or + Pembrolizumab (Pembro) in Previously Treated (2L/3L) Recurrent or Metastatic Cervical Cancer (r/mCC): Interim Results of ENGOT-Cx8/GOG-3024/innovaTV 205 Study

I. Vergote

Mini Oral Session – Gynaelogical Cancers, Sunday, September 19, 5:30-5:35 PM CEST

930TiP

innovaTV 207: New Dosing Cohort in the Open Label Phase 2 Study of Tisotumab Vedotin in Solid Tumors

D. Hong

On Demand E-Poster

PADCEV (enfortumab vedotin)

698P

Analysis of hard-to-treat subgroups from EV-301, a phase 3 trial of enfortumab vedotin (EV) vs chemotherapy for previously treated advanced urothelial carcinoma

J. Rosenberg

On Demand E-Poster

705P

Systematic literature review (SLR) and network meta-analysis (NMA) of first-line (1L) therapies for locally advanced/metastatic urothelial carcinoma (la/mUC)

L. Bloudek

On Demand E-Poster

704P

Treatment Patterns Among Patients with Advanced Urothelial Carcinoma (aUC) in the US

A. Morgans

On Demand E-Poster

TUKYSA (tucatinib)

331TiP

HER2CLIMB-04: Phase 2 Trial of Tucatinib + Trastuzumab Deruxtecan in Patients With HER2+ Locally Advanced or Metastatic Breast Cancer With and Without Brain Metastases (Trial in Progress)

L. Carey

On Demand E-Poster

1434TiP

MOUNTAINEER-02: Phase 2/3 study of tucatinib, trastuzumab, ramucirumab, and paclitaxel in previously treated HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC): Trial in Progress

D. Catenacci

On Demand E-Poster

557TiP

SGNTUC-019: Phase 2 basket study of tucatinib and trastuzumab in previously treated solid tumors with HER2 alterations (Trial in Progress)

M. Reck

On Demand E-Poster

1437TiP

Phase 1b/2, open label, dose escalation and expansion trial of tucatinib in combination with trastuzumab and oxaliplatin-based chemotherapy in patients with unresectable or metastatic HER2+ gastrointestinal cancers (Trial in Progress)

H. Park

On Demand E-Poster

439P

Characteristics and treatment patterns among patients with HER2-amplified advanced/metastatic colorectal cancer (mCRC): a clinical-genomic database study

J. Strickler

On Demand E-Poster

Ladiratuzumab Vedotin

259P

Weekly ladiratuzumab vedotin monotherapy for metastatic triple negative breast cancer

M. Tsai

On Demand E-Poster

643TiP

Open-Label, Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors (SGNLVA-005, Trial in Progress)

HT. Arkenau

On Demand E-Poster

ADCETRIS (brentuximab vedotin)

1029TiP

Phase 2 Trial of Pembrolizumab (Pembro) and Brentuximab Vedotin (BV) in Patients With Metastatic Solid Malignancies After Progression on Prior Programmed Cell Death Protein (PD)-1 Inhibitors (SGN35-033, Trial in Progress)

C. Lance Cowey

On Demand E-Poster

Early Pipeline

555TiP

A First-in-Human Trial of the Integrin Beta-6-Targeted Antibody–Drug Conjugate, SGN-B6A, in Patients With Advanced Solid Tumors (SGNB6A-001, Trial in Progress)

E. Calvo

On Demand E-Poster

556TiP

A Phase 1 Study of SGN-STNV, a Novel Antibody–Drug Conjugate Targeting Sialyl-Thomsen-nouveau Antigen (STn), in Adults With Advanced Solid Tumors (SGNSTNV-001)

N. Lakhani

On Demand E-Poster

On September 8, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic and medical imaging applications, reported that Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes, will present at the H.C. Wainwright 23rd Annual Global Investment Conference, being held in a virtual format September 13 – 15, 2021 (Press release, NorthStar Medical Radiostopes, SEP 8, 2021, View Source [SID1234587428]). Additionally, Company management will host one-on-one meetings during the conference.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A pre-recorded presentation will be available to registered attendees for on-demand viewing beginning Monday, September 13, 2021, at 7:00 a.m. ET on the conference website.

"NorthStar is expanding its leadership position in the rapidly growing area of therapeutic radioisotopes, used in targeted precision radiopharmaceuticals for the treatment of cancer, respiratory and other diseases," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "In addition, NorthStar continues its successful commercialization of our lead SPECT diagnostic imaging radioisotope, which has informed critical healthcare decisions for hundreds of thousands of patients since launch. Our presentation and meetings will focus on the Company’s robust development portfolio of game-changing therapeutic and diagnostic products, and the ways in which NorthStar is strongly positioned for continued rapid growth and industry leadership. We look forward to sharing our success with the investor community at H.C. Wainwright’s 23rd Annual Global Investment Conference."