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Alligator Bioscience publishes prospectus in connection with forthcoming rights issue

On November 9, 2021 Alligator Bioscience AB (publ) ("Alligator" or the "Company") reported that it has prepared a prospectus (the "Prospectus") relating to the rights issue of shares of approximately SEK 257 million (the "Rights Issue"), which was resolved by the Board of Directors on 7 October 2021 and approved by the Extraordinary General Meeting held on 8 November 2021 (Press release, Alligator Bioscience, NOV 9, 2021, https://alligatorbioscience.se/en/alligator-bioscience-publishes-prospectus-in-connection-with-forthcoming-rights-issue/ [SID1234594882]). The Prospectus has today been approved and registered by the Swedish Financial Supervisory Authority.

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Summary of the Rights Issue

One (1) existing share in the Company entitles to three (3) subscription rights. Two (2) subscription rights entitle to subscription of one (1) new share, i.e., a subscription ratio of 3:2.
The subscription price is SEK 2 per new share, which, assuming the Rights Issue is fully subscribed, results in the Company receiving issue proceeds of approximately SEK 257 million before deduction of transaction costs.
The Company has received subscription commitments from all members of the Company’s board and management with shareholdings in the Company, and a selection of the Company’s larger existing shareholders, including the AP4, Roxette Photo NV and Omentum S.A., amounting to approximately SEK 44 million, corresponding to approximately 17 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments of approximately SEK 214 million, which secures the Rights Issue up to 100 percent. In addition, Öhman Fonder have expressed their intention to subscribe for their pro rata share in the Rights Issue.
For complete information on the Rights Issue, please see the published Prospectus.

Prospectus

The Prospectus has been prepared in connection with the forthcoming Rights Issue and has today, on 9 November 2021, been approved and registered by the Swedish Financial Supervisory Authority. The Prospectus, containing complete terms and conditions, is available on the Company’s, Aktieinvest FK AB’s and Redeye AB’s respective websites (www.alligatorbioscience.com, View Source and View Source). The Prospectus will also be available on the Swedish Financial Supervisory Authority’s website (www.fi.se). Subscription forms will be available on the Company’s, Aktieinvest FK AB’s, and Redeye AB’s respective websites.

Timetable for the Rights Issue

9 November 2021

First day of trading excl. preferential rights

9 November 2021

Publication of prospectus

10 November 2021

Record date

12 November – 23 November 2021

Trading in subscription rights

12 November – 26 November 2021

Subscription period

12 November 2021 – Until the Rights Issue is registered at the Swedish Companies Registration Office

Trading in paid subscription shares (Sw. "BTA")

1 December 2021

Estimated publication of outcome in the Rights Issue

Advisers

DNB Markets, a part of DNB Bank ASA, Sweden Branch and Redeye AB act as Joint Global Coordinators in connection with the Rights Issue. Setterwalls Advokatbyrå AB acts as legal adviser to Alligator and Baker & McKenzie Advokatbyrå KB acts as legal adviser to the Joint Global Coordinators in connection with the Rights Issue. Aktieinvest FK AB acts as the issuing agent in the Rights Issue.

Translational Data From the DeCidE1 Clinical Study in Patients with Advanced, Recurrent Ovarian Cancer to be Presented at SITC Annual Meeting

On November 9, 2021 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and blood cancers while preserving patients’ quality of life, reported that translational data from the Phase 2 clinical study in patients with advanced, recurrent ovarian cancer will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, IMV, NOV 9, 2021, View Source [SID1234594881]).

"Treatment with MVP-S elicited an immune response involving both survivin-specific T and B cells, which further extends our understanding of the MVP-S mechanism of action," said Jeremy Graff, Ph.D., Chief Scientific Officer at IMV Inc. "These results help to bolster further confidence in the therapeutic mechanism of MVP-S based treatment and set the stage for the design of the next Phase 2B study in advanced, recurrent ovarian cancer patients, expected to begin next year."

Twenty-two women with advanced, recurrent ovarian cancer were enrolled in the DeCidE1 study. Translational analyses showed that:

A higher baseline CD3+CD8+ T cell infiltration in tumor tissue was evident in patients with clinical benefit (defined as >10% on-treatment tumor regression)
Likewise, B cell pathway genes were significantly upregulated in patients with clinical benefit
MVP-S treatment induced increased T and B cell infiltration into tumor on-treatment when compared to the pre-treatment tumor biopsy sample taken from a patient with defined clinical response by RECISTv1.1.
Upregulation of genes or pathways related to immune-suppression (e.g. WNT pathway) or immune evasion/exclusion (CD276, Arg2) were significantly associated with lack of anti-tumor activity, suggesting a potential mechanism for treatment failure.
These findings suggest that immunogenic tumors are more susceptible to MVP-S treatment, in line with its mechanism of action. Collectively, these results provide insight for possible predictors of response to treatment with MVP-S. These translational data will inform the design of next IMV-sponsored clinical trial in patients with advanced, recurrent ovarian cancer, expected to be initiated in 2022. The study will evaluate MVP-S with intermittent low dose cyclophosphamide (CPA).

The poster will be presented on November 12, 2021, by Oliver Dorigo, M.D., Ph.D., Director and Associate Professor, Division Gynecologic Oncology, Department of Obstetrics and Gynecology at the Stanford University, CA.

PosterTitle: Identification of potential response predictors to maveropepimut-S (DPX-Survivac), a novel T cell activating immunotherapy, in patients with advanced recurrent ovarian cancer
Poster Number: 353
Dr. Dorigo will be present in person at lunch time (12:40–2:10 p.m. EST) and during the poster reception (7–8:30 p.m. EST)
An e-poster presentation will be available under the Scientific Publications & Posters section on IMV’s website.

Scholar Rock Reports Third Quarter 2021 Financial Results and Highlights Business Progress

On November 9, 2021 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the third quarter ended September 30, 2021, and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Scholar Rock, NOV 9, 2021, View Source [SID1234594880]).

"The DRAGON trial addresses two key questions; first, can the selectivity of SRK-181 for TGFβ1 increase the therapeutic window for inhibition of this signaling pathway thereby enabling higher doses safely, and second, does SRK-181 exhibit anti-tumor activity effective in overcoming resistance to checkpoint inhibitors in solid tumors. We are pleased with the results of Part A, as will be provided this week at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, and we look forward to exploring the efficacy dimension of our therapeutic hypothesis in Part B," said Nagesh Mahanthappa, Ph.D., Interim CEO of Scholar Rock. "Building on the momentum from the first half of this year, we are also excited about the progress with apitegromab and are on track to initiate by year-end the Phase 3 pivotal trial evaluating its efficacy in patients with non-ambulatory Type 2 and Type 3 spinal muscular atrophy (SMA)."

Company Updates and Upcoming Milestones

Apitegromab is a selective inhibitor of myostatin activation being developed as the potential first muscle-directed therapy for the treatment of spinal muscular atrophy (SMA).

Additional Exploratory Responder Analyses and Pharmacologic Data from the TOPAZ Phase 2 Trial were Presented at Various Medical Congresses. In September 2021, two posters were presented at the World Muscle Society Virtual Congress, including a late-breaker poster featuring an exploratory analysis evaluating time to achieving various thresholds of improvement in Hammersmith Functional Motor Scale Expanded (HFMSE) scores, which are consistent with the observed dose response in clinical efficacy. In October 2021, a poster presented at the 25th World Congress of Neurology (WCN) described the positive correlation between the magnitude of target engagement and motor function improvements following apitegromab treatment. At the 50th Child Neurology Society Annual Meeting, additional exploratory responder analyses on Hammersmith scale scores were presented, including time to achieve different thresholds of improvement in HFMSE scores.
Phase 3 Trial Evaluating Apitegromab in Patients with Non-Ambulatory Type 2 and 3 Patients Remains on Track to Initiate by Year-End 2021. Scholar Rock is preparing to announce the design of the Phase 3 pivotal study later this month. The company is on track to initiate by the end of 2021 the randomized, double-blind, placebo-controlled Phase 3 trial evaluating apitegromab as add-on therapy for patients on either nusinersen or risdiplam with non-ambulatory Type 2 and Type 3 SMA. This patient population comprises an estimated two-thirds of the overall prevalence of SMA, and the greatest improvements in motor function (as measured by HFMSE) observed in the TOPAZ Phase 2 trial were in patients with non-ambulatory Type 2 and Type 3 SMA receiving apitegromab as add-on therapy to background nusinersen.
SRK-181 is a selective inhibitor of latent TGFβ1 activation being developed with the aim of overcoming primary resistance to and increasing the number of patients who may benefit from checkpoint inhibitor therapy.

Update from Part A of the DRAGON Phase 1 Trial and Part B Dose to be Presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting. A poster titled, "First-in-Human Phase 1 Trial of SRK-181: A Latent TGFβ1 inhibitor, Alone or in Combination with Anti-PD-(L)1 Treatment in Patients with Advanced Solid Tumors (DRAGON trial)" will be presented at the SITC (Free SITC Whitepaper) meeting on November 12, 2021. The poster will include initial clinical data from Part A of the DRAGON trial as well as the rationale for the identified Part B dose.

The Company has initiated the Part B dose expansion portion of the trial, which consists of multiple cohorts, each enrolling up to 40 patients with various solid tumors who have demonstrated primary resistance to anti-PD-(L)1 therapy.
U.S. Patent Issued Providing Composition of Matter Product Protection for SRK-181. In September 2021, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,130,803 with an expiry of May 2040, including 313 days of Patent Term Adjustment (PTA). The European counterpart has also been granted.
Third Quarter 2021 Financial Results

For the quarter ended September 30, 2021, net loss was $37.5 million or $1.02 per share compared to a net loss of $23.6 million or $0.79 per share for the quarter ended September 30, 2020.

Revenue was $5.5 million for the quarter ended September 30, 2021, compared to $3.0 million for the quarter ended September 30, 2020 and was related to the Gilead Collaboration Agreement that was executed in December 2018.
Research and development expense was $31.3 million for the quarter ended September 30, 2021, compared to $18.4 million for the quarter ended September 30, 2020. The increase year-over-year primarily reflects manufacturing costs associated with apitegromab, clinical trial costs for SRK-181, and additional personnel and facility-related costs.
General and administrative expense was $11.3 million for the quarter ended September 30, 2021, compared to $8.3 million for the quarter ended September 30, 2020. The increase year-over-year was primarily attributed to additional personnel, professional fees, and facility-related costs.
"As we approach the end of 2021, I am incredibly proud of the execution by the entire Scholar Rock team this year. Not only have we initiated Part B of the DRAGON trial, but we’re also very close to initiating our Phase 3 pivotal trial for apitegromab," said Ted Myles, CFO and Head of Business Operations of Scholar Rock. "We ended the third quarter with approximately $246 million in cash and cash equivalents and are well-funded to continue executing on our development programs while continuing to invest in our robust discovery platform."

Sanofi completes acquisition of Kadmon

On November 9, 2021 Sanofi reported the completion of its acquisition of Kadmon Holdings, Inc. The acquisition further strengthens growth and expansion for the General Medicines portfolio (Press release, Sanofi, NOV 9, 2021, View Source [SID1234594879]).

Shareholders of Kadmon common stock voted to approve the acquisition at a special meeting of stockholders on November 5, 2021 and will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis).

Sanofi completed its acquisition of Kadmon through the merger of a wholly owned subsidiary of Sanofi with and into Kadmon, pursuant to Section 251 of the General Corporation Law of the State of Delaware, with Kadmon continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi.

As of November 9, 2021, Kadmon common stock will cease to be traded on the NASDAQ Global Select Stock Market and will be subsequently deregistered.

Centerview Partners acted as exclusive financial advisor to Sanofi while Weil, Gotshal & Manges LLP acted as legal counsel to Sanofi. Cantor Fitzgerald & Co. and Moelis & Company LLC acted as exclusive financial advisors to Kadmon in the transaction, while DLA Piper LLP (US) acted as legal counsel. H.C. Wainwright & Co., LLC acted as capital markets advisor to Kadmon management.

Fate Therapeutics Announces Abstract Highlighting FT538 and FT573 Programs Selected for Presentation at SITC 2021 Annual Meeting Press Conference

On November 9, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Communications Committee selected an abstract featuring preclinical data from the Company’s FT538 and FT573 programs for showcase at the SITC (Free SITC Whitepaper) 2021 Annual Meeting Press Conference (Press release, Fate Therapeutics, NOV 9, 2021, View Source [SID1234594878]). The selected abstract entitled "Off-the-shelf, engineered iPSC-derived NK cells mediate potent cytotoxic activity against primary glioblastoma cells and promote durable long-term survival in vivo" will be presented by Jeffrey S. Miller, M.D., Professor of Medicine, University of Minnesota and Deputy Director, Masonic Cancer Center. The press conference is being held on Wednesday, November 10 from 12:30-2 pm ET.

Dr. Miller’s presentation will describe the anti-tumor activity of the Company’s FT538 clinical product candidate as monotherapy and in combination with an NK cell engager targeting B7-H3, an immune checkpoint transmembrane protein overexpressed on many human cancer cells and commonly associated with poor prognosis. The presentation will also describe the integration of a novel chimeric antigen receptor (CAR) construct targeting B7-H3 into the master induced pluripotent stem cell (iPSC) line of FT538 to create the Company’s preclinical product candidate FT573, a B7-H3-targeted CAR NK cell incorporating multiple anti-tumor modalities.

In a recently published peer-reviewed article in Cell Stem Cell entitled "Harnessing features of adaptive NK cells to generate iPSC-derived NK cells for enhanced immunotherapy", FT538 was shown to share metabolic, transcriptional, and functional features with adaptive NK cells, a rare subset of NK cells with memory-like properties that have a genome-wide epigenetic profile and recall response that parallel cytotoxic effector CD8+ T cells. The published data demonstrate that FT538 exhibits significantly enhanced serial killing and functional persistence compared to peripheral blood NK cells. The superior anti-tumor activity of FT538 was attributable to its novel engineered components, including the knockout of CD38 and the expression of IL-15/IL-15R fusion protein, which were shown to improve metabolic fitness, increase resistance to oxidative stress, and induce a protein expression program that enhanced NK cell activation and effector function. The studies in the Cell Stem Cell publication were conducted as part of a collaboration between scientists at Fate Therapeutics and the laboratory of Dr. Miller, and were led by Frank Cichocki, Ph.D., University of Minnesota.

Investor Event Webcast and Conference Call

The Company will host a live audio webcast on Monday, November 15, 2021 at 4:30 p.m. ET to highlight its emerging pipeline of off-the-shelf, multiplexed-engineered, iPSC-derived NK cell programs for the treatment of solid tumors. In order to participate in the conference call, please dial (877) 303-6235 (domestic) or (631) 291-4837 (international) and refer to conference ID 2793475. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT538
FT538 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components: a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; an IL-15 receptor fusion (IL-15RF) that augments NK cell activity; and the deletion of the CD38 gene (CD38KO), which promotes persistence and function in high oxidative stress environments. FT538 is designed to enhance innate immunity in cancer patients, where endogenous NK cells are typically diminished in both number and function due to prior treatment regimens and tumor suppressive mechanisms. In preclinical studies, FT538 has shown superior NK cell effector function, as compared to peripheral blood NK cells, with the potential to confer significant anti-tumor activity to patients through multiple mechanisms of action. FT538 is being investigated in a multi-dose Phase 1 clinical trial for the treatment of acute myeloid leukemia (AML) and in combination with daratumumab, a CD38-targeted monoclonal antibody therapy, for the treatment of multiple myeloma (NCT04614636). FT538 is also being investigated in a multi-dose Phase 1 clinical trial in combination with one of an array of tumor-targeting monoclonal antibodies for the treatment of advanced solid tumors (NCT05069935).