On April 13, 2021 Arcellx, a privately held clinical-stage biopharmaceutical company, reported that it raised $115 million in a Series C financing to advance its pipeline of adaptive and controllable cell therapies (Press release, Arcellx, APR 13, 2021, View Source [SID1234577962]). The proceeds will support the company’s development of CART-ddBCMA, a BCMA-specific CAR-modified T-cell therapy currently in Phase 1 and anticipated to begin a pivotal trial in 2022. In addition, the funding will support initiation of clinical trials evaluating ACLX-001 and ACLX-002, cell therapies derived from Arcellx’s uniquely controllable ARC-SparX platform, in multiple myeloma (MM) and acute myelogenous leukemia (AML), respectively.

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This financing follows FDA clearance of Arcellx’s IND for ACLX-001, the first ARC-SparX program to enter clinical trials, and Arcellx’s initial release of clinical results at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting. In the ASH (Free ASH Whitepaper) release, the CART-ddBCMA data showed all six multiple myeloma patients responded per IMWG criteria, with four of those patients achieving stringent complete response. The therapy was also well-tolerated, and CAR-T related toxicities resolved rapidly.

Participants in the Series C financing include both existing and new investors to Arcellx. The financing was co-led by Samsara BioCapital and CAM Capital, joined by new investors Adage, Asymmetry, CaaS Capital, Cambrian Bio, Sixty Degree, Soleus Capital, Surveyor Capital (a Citadel company), Suvretta, and Terra Magnum Capital Partners, and existing investors NEA, Novo Holdings, SR One, Takeda Ventures, LG Tech, and Clough Capital.

"With support from this high caliber syndicate, Arcellx is poised to elevate the field of cell therapy by advancing our treatments for a range of cancers," said Rami Elghandour, Chairman and Chief Executive Officer of Arcellx. "Our platform of both single infusion and controllable CAR-Ts based on our novel synthetic binding domain is built to address the limitations of cell therapy with the opportunity to improve efficacy, reduce toxicity, and shorten the time to intervention while expanding into new indications. This financing positions us to advance to a registrational study in multiple myeloma and to initiate a Phase 1 study in AML in 2022 as well as progress our solid tumor targets toward the clinic. It’s also a reflection of our incredibly talented and diverse team that is powering Arcellx forward. We appreciate the support of our new and existing investors as we advance our novel therapies to the benefit of cancer patients most in need."

"Based on the early clinical data, we believe that CART-ddBCMA represents a potential best-in class therapy for multiple myeloma and with the support of this financing will be positioned to move into pivotal trials next year. We’re also excited about the opportunity for CART-ddBCMA to move into earlier lines of treatment for multiple myeloma based on the safety profile in this early data set. In addition, the ARC-SparX platform will be the first adaptive and controllable CAR-T system to enter the clinic and provides a unique approach to building next generation cell therapies. We look forward to partnering with the Arcellx team to help bring these important therapies to patients," said Mike Dybbs, Ph.D., Partner, Samsara BioCapital.

On April 13, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported updated preclinical data from its lead SAFEbody program, ADG126, are being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (Press release, Adagene, APR 13, 2021, View Source [SID1234577961]).

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"There is a critical unmet need for new anti-CTLA-4 therapies, and we are encouraged by the data generated to date, which demonstrate ADG126 has the potential to overcome the severe immune-mediated adverse reactions associated with the class," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "By leveraging our SAFEbody platform technology, designed to precisely and very efficiently mask the antibody binding interface and activate specifically within the tumor microenvironment, our preclinical data continues to highlight the opportunity to effectively deliver treatment; ADG126 has demonstrated superior systemic safety profile at efficacious dose levels with a significantly enlarged therapeutic index (TI). Our ongoing global Phase 1 trial is expected to provide clinical validation for our SAFEbody platform and our SAFEbody product candidate, ADG126. We have successfully finished DLT evaluation of 3 patients at 0.1 mg/kg of ADG126 and remain on track to report topline safety and efficacy data in the second half of 2021."

A copy of the poster presentation, entitled "A Novel Anti-CTLA-4 Checkpoint Inhibitor Prodrug to Address On-target Off-tumor Toxicity for Cancer Immunotherapy," is available on the AACR (Free AACR Whitepaper) website and is also available for download via our website (View Source).

The data presented show:

Notable Findings: ADG126 demonstrated an impressive safety margin while maintaining its potent antitumor activity.
Unique Epitope with Broad Species Cross-Reactivity: ADG126 targets a conserved epitope of CTLA-4 with broad species cross-reactivity and is an activatable prodrug for tumor suppression in multiple syngeneic mouse models in single and combination therapies.
Differentiated Mechanism of Action: Although the activated ADG126 is softer in blocking CTLA-4 binding with its ligands than ipilimumab, the activated ADG126 exhibited more potent antibody dependent cellular cytotoxicity (ADCC) in the tumor microenvironment.
Intra-Tumoral Treg Depletion: Treg cells in tumor tissues exhibited higher CTLA-4 expression than in peripheral tissues and were efficiently depleted upon treatment with ADG126 in the immune-competent mouse syngeneic colon tumor model.
Human T-Cell Activation in Vitro: Activated ADG126 potently enhanced T-cell activation, measured by IL-2 secretion, whereas the masked ADG126 did not.
In Vivo Monotherapy Antitumor Activity: ADG126 exhibited potent antitumor activity as a single agent in different immune-competent syngeneic mouse tumor models.
In Vivo Combination Antitumor Activity: ADG126 combined synergistically with other IO agents, such as anti-PD-1 antibody, to inhibit tumor growth in vivo. Combination therapy significantly slowed tumor growth and caused complete regression in 50% of Lewis lung cancer mouse models.
Safety and Tolerability: ADG126 was well tolerated in animals suggesting the potential for high therapeutic index. The highest non-severely toxic dose (HNSTD) was determined to be 200 mg/kg/dose, which is one of the highest reported HNSTD for anti-CTLA-4 antibodies.
About ADG126
ADG126 is a fully human antagonistic mAb targeting a novel epitope of CTLA-4 and has been shown to specifically deplete regulatory T-cells in tumors. ADG126 is Adagene’s lead SAFEbody product candidate. The SAFEbody technology, developed using Adagene’s AI-powered platform, enables binding of an antibody to a specific target only after conditional activation of the antibody in target tissues.

In preclinical studies, ADG126 was well tolerated in cynomolgus monkeys and demonstrated an encouraging antitumor response in multiple immune-competent mouse tumor models in a dose-dependent manner both as a single agent and in combination with anti-PD-1 and other therapies.

Unlike anti-PD-1/PD-L1 check point inhibitors, anti-CTLA-4 is known for its dose-dependent clinical response in single and combination therapies, which is severely limited by the narrow therapeutic window available to current anti-CTLA-4 therapies. The large safety margin shown by ADG126 GLP toxicology studies of up to 200 mg/kg in targeting CTLA-4 will make it possible to dose patients for their optimal clinical benefits in single and combination therapies.

On April 13, 2021 Sanofi (Euronext: SAN and NYSE: SNY) and Kiadis (Euronext Amsterdam and Brussels: KDS) reported that that a total of 95.03% of the Kiadis shares on a Fully Diluted basis have been tendered or irrevocably committed to be delivered to Sanofi at Settlement under the Offer by Sanofi (Press release, Sanofi, APR 13, 2021, View Source [SID1234577958]). Sanofi declares the Offer unconditional (doet gestand) now all Offer Conditions described in the Offer Memorandum have either been satisfied or waived. As a result of the adoption of the Post-Offer Restructuring Resolution at the Kiadis extraordinary meeting of shareholders ("EGM") of 30 March 2021, under the terms and subject to the conditions of the Offer, the Acceptance Threshold is 80% (and not 95%) of Kiadis’ aggregate issued and outstanding ordinary share capital on a Fully Diluted basis, as of the time and date on which the Offer expires.

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Acceptance
During the Acceptance Period, that expired at 17:40 (CET) on 12 April 2021, 39,860,388 Shares were tendered under the Offer, representing approximately 92.9% of the aggregate issued and outstanding ordinary share capital of Kiadis as of today and an aggregate value of approximately
EUR 217,239,114.60 (for an Offer Price of EUR 5.45 (cum dividend) per Share). Together with any Shares directly or indirectly owned by Sanofi, the Offeror or any of their Affiliates, any Shares irrevocably committed to be delivered to Sanofi at settlement of the Offer and any Shares to which the Offeror Group is entitled but which have not yet been delivered (gekocht maar nog niet geleverd), this represents a total of 58,051,156 Shares. This equals approximately 95.03% of the aggregate issued and outstanding ordinary share capital of Kiadis on a Fully Diluted basis.

Settlement
With reference to the Offer Memorandum, Shareholders who accepted the Offer shall receive the Offer Price for each Tendered Share tendered during the Acceptance Period and transferred (geleverd) for acceptance pursuant to the Offer, under the terms and conditions of the Offer and subject to its restrictions.

Settlement of the Shares and payment of the Offer Price will take place on 16 April 2021. Following Settlement, the Offeror will (directly or indirectly) hold 58,051,156 Shares, representing approximately 95.03% of the aggregate issued and outstanding ordinary share capital of Kiadis on a Fully Diluted basis.

Upon Settlement the changes to the composition of the Supervisory Board and Management Board of Kiadis, as approved by the EGM on 30 March 2021, will become effective.

Post-Closing Acceptance Period
The Offeror hereby announces that Shareholders who have not tendered their Shares during the Acceptance Period will have the opportunity to tender their Shares under the same terms and conditions applicable to the Offer, during the Post-Closing Acceptance Period which will start at 09:00 (CET) on 14 April 2021 and end at 17:40 (CET) on 28 April 2021 (the "Post-Closing Acceptance Period").

The Offeror will publicly announce the results of the Post-Closing Acceptance Period and the total number and total percentage of Shares held by it in accordance with Section 17, paragraph 4 of the Decree ultimately on the third Business Day following the last day of the Post-Closing Acceptance Period.

The Offeror shall continue to accept for payment all Shares validly tendered (or defectively tendered provided that such defect has been waived by the Offeror) during the Post-Closing Acceptance Period and shall pay for such Shares as soon as reasonably possible and in any case no later than on the fifth Business Day following the last day of the Post-Closing Acceptance Period.

During the Post-Closing Acceptance Period, Shareholders have no right to withdraw Shares from the Offer, regardless of whether their Shares have been validly tendered (or defectively tendered, provided that such defect has been waived by the Offeror) during the Offer Period or the Post-Closing Acceptance Period.

Delisting
The Offeror and Kiadis shall seek to procure the delisting of the Shares on Euronext Amsterdam and Euronext Brussels as soon as possible under Applicable Rules. Delisting may further adversely affect the liquidity and market value of any Shares not tendered.

Further implications of the Offer being declared unconditional
Remaining Shareholders who do not wish to tender their Shares in the Post-Closing Acceptance Period should carefully review the sections of the Offer Memorandum that further explain the intentions of the Offeror, such as (but not limited to) Section 6.11 (Consequences of the Offer for non-tendering Shareholders), which describes certain implications to which such Shareholders may become subject with their continued shareholding in Kiadis.

The Offeror intends to initiate the Buy-Out in an expeditious manner. Reference is made to section 6.11(c) (Buy-Out) of the Offer Memorandum.

Announcements
Any announcement contemplated by the Offer Memorandum will be issued by press release. Any press release issued by the Offeror will be made available on the website of the Offeror (www.sanofi.com). Any press release issued by Kiadis will be made available on the website (www.kiadis.com).

Subject to any applicable requirements of the applicable rules and without limiting the manner in which the Offeror may choose to make any public announcement, the Offeror will have no obligation to communicate any public announcement other than as described above.

Offer Memorandum, Position Statement and further information
This announcement contains selected, condensed information regarding the Offer and does not replace the Offer Memorandum and/or the Position Statement. The information in this announcement is not complete and additional information is contained in the Offer Memorandum and the Position Statement.

Digital copies of the Offer Memorandum are available on the website of the Offeror (www.sanofi.com) and digital copies of the Position Statement are available on the website of Kiadis (www.kiadis.com). Such websites do not constitute part of, and are not incorporated by reference into, the Offer Memorandum. Copies of the Offer Memorandum and the Position Statement are on request also available free of charge at the offices of Kiadis and the Settlement Agent at the addresses below

On April 13, 2021 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company reported that IMV’s executive management team will be participating in the 2021 Bloom Burton & Co. Healthcare Investor Virtual Conference which will be held April 20 and April 21, 2021 (Press release, IMV, APR 13, 2021, View Source [SID1234577956]).

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IMV’s presentation details include:

Date: Tuesday, April 20, 2021
Time: 4:00 p.m. ET
There will be a live webcast of IMV’s presentation accessible in the ‘Events, Webcasts & Presentations’ page of IMV’s website. The webcast will then be archived following the live presentation and a copy of the presentation will be available www.imv-inc.com.

On April 13, 2021 Cofactor Genomics, the company bridging the precision medicine gap, reported commencement of the first multicenter clinical trial of its OncoPrismTM diagnostic assay, using the company’s patented approach to generating multidimensional immune biomarkers (Press release, Cofactor Genomics, APR 13, 2021, View Source [SID1234577954]). Fifteen hospitals and healthcare networks, including Mayo Clinic, MultiCare Institute for Research and Innovation, and Revive Research Institute, are currently enrolling in the PREDAPT (Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies) Trial to evaluate use of the OncoPrism test in patients with recurrent and metastatic squamous cell carcinoma of the head and neck (RM-HNSCC) to effectively predict a patient’s response to immunotherapy. The company expects additional sites to join the trial before the end of 2021.

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While the trial will initially recruit RM-HNSCC patients, the protocol is approved for recruitment of patients with 10 additional indications where independent market research has identified an unmet clinical need in predicting tumor response to immunotherapy. Specimens collected in the study will be analyzed at Cofactor’s CAP/CLIA accredited laboratory.

"Opening recruitment for the PREDAPT study is a significant milestone for Cofactor. It represents not only the world’s first Predictive Immune Modeling clinical validation study, but the first of many studies we intend to sponsor. These studies will lead to predictive diagnostics that are undeniably needed in the field, for therapies that are in development or those already on the market," stated David Messina, PhD, Cofactor’s Chief Operating Officer. "Physicians do not currently have adequate information to predict tumor response to immune checkpoint inhibitors, resulting in ineffective and inconsistent treatment. This is ultimately a heavy burden on both patients and the healthcare system that supports them; we intend to change that."

The study includes both retrospective and prospective specimen collection, but does not require any additional visits or surgery outside of standard care for enrolled patients. The PREDAPT trial builds on preliminary results recently presented that showed the performance of a multidimensional RNA biomarker built using the company’s Predictive Immune Modeling approach was more effective than the on-label PD-L1 immunohistochemistry (IHC) assay in predicting tumor response to anti-PD-1 therapy in RM-HNSCC.

PREDAPT is uniquely designed to be a decentralized study. To enable that, Cofactor has contracted Curebase as the CRO partner, who enables highly virtual clinical trials by offering a full-service CRO and eClinical Platform, complete with eConsent, electronic data capture, and remote monitoring capabilities. This enables individual investigators, who may be passionate about science and improving patient outcomes, the ability to participate in the clinical trial even if their hospital is unable to participate as a traditional clinical site. It has also enabled Cofactor to establish two major recruitment streams to ensure maximum diversity and streamlined recruitment, traditional clinical sites and direct-to-patient recruitment.

"The PREDAPT study is exactly what we had in mind when we built the Curebase platform. Using software-powered, decentralized research methods, we are proving with Cofactor that any patient can be part of a clinical trial no matter where they live," noted Tom Lemberg, CEO at Curebase.

Despite the thousands of new clinical trials that are started every year and the significant advances made in launching innovative therapies such as immunotherapies, physicians are still prescribing the wrong therapy to more than 80 percent of patients.1 The gap in matching these innovative therapies to the patients that will benefit (and avoiding those who will not respond or may have adverse reactions) is a major problem in healthcare.

"Technologies that are capable of playing matchmaker and bridging this gap are key," said Jarret Glasscock, PhD, Cofactor’s Chief Executive Officer. "The field of Predictive Immune Modeling is building this next generation of predictive diagnostics that are showing an enhanced ability to accurately predict patient response prior to treatment. We expect these technologies to not only improve patient treatment paths, but to also provide cost savings to the entire healthcare system."

Sites interested in joining this high impact study may contact [email protected] or express their interest here.