On November 2, 2020 Trained Therapeutix Discovery, Inc. ("TTxD"), an immunotherapy biotech company founded by Jean Boulle Therapeutics, reported that the results of a preclinical Study ("the Study") published in Cell showing how nanobiologic immunotherapy promotes trained immunity and elicits a durable anti-tumor response either as a monotherapy or in combination with other checkpoint inhibitor drugs (Press release, Trained Therapeutix Discovery, NOV 2, 2020, View Source [SID1234569659]).

TTxD’s scientific founders Willem Mulder, Zahi Fayad, Jordi Ochando, Leo Joosten and Mihai Netea were all co-authors of the Study which involved scientists from 23 research institutions around the world. The Study shows for the first time how trained immunity can be therapeutically exploited to help fight cancers.

In the Study, the researchers developed a library of nanobiologics (nanomaterials bioengineered from molecules that exist naturally within the body) designed specifically to induce trained immunity in bone marrow cells. Through extensive screening, involving in vitro training assays and in vivo mouse biodistribution experiments, the Study identified a bone marrow-avid nanobiologic lead candidate, named MTP10-HDL.

MTP10-HDL was shown to have potent anti-tumor capabilities in a B16F10 mouse melanoma model. These capabilities resulted from changes to the way in which the bone marrow produced infection fighting cells (myelopoiesis) that were induced by trained immunity. The Study also showed MTP10-HDL’s favorable biodistribution and safety profile in non-human primates. This technology has been exclusively licensed to Trained Therapeutix Discovery, Inc.

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TTxD applies advanced bioengineering methods to develop nanobiologic therapeutics that regulate the innate immune system with materials that are inherently well tolerated by the body. This pioneering approach has potential applications in the treatment of cancer, respiratory infections, autoimmune disorders, and organ transplant rejection.

Commenting on the paper, Willem Mulder, PhD scientific founder of TTxD said:
"This Study is further evidence of the huge potential that trained immunity has to fight a wide range of serious conditions. The identification of a nanobiologic material that can induce a durable anti-tumor response has the potential to open up a new horizon in cancer therapy."

Leighton Durham, Director of Jean Boulle Medtech and Co-CEO of TTxD, said:
"This study, although early stage, provides further support for TTxD’s approach and shows the potential power of trained immunity. The TTxD team is focused on further developing its revolutionary nanobiologic technologies and saving lives across a spectrum of illnesses."

Further information is available from the Eindhoven University of Technology.
Full paper: B. Priem et al., "Trained immunity-promoting nanobiologic therapy suppresses tumor growth and potentiates checkpoint inhibition", CELL, (2020).

On November 2, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported that it has achieved the remaining $5 million milestone associated with interim enrollment under its Collaboration and License Agreement (the "Milestone") with Sanofi for its development of miR-21 programs (Press release, Regulus, NOV 2, 2020, View Source [SID1234569658]). The Milestone was triggered upon achievement of an enrollment metric by Sanofi in its Phase 2 clinical study evaluating RG-012 for the treatment of patients with Alport Syndrome. The proceeds from this Milestone will be used to pay down the Company’s term loan with Oxford LLC. The payment to Oxford will reduce the remaining principal due under the term loan to approximately $4.7 million and enable the Company to receive an extension of interest-only payments through 2021, an extension of seven months from the previous terms.

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"We are very pleased with the commitment of our partner, Sanofi, to this important program," stated Jay Hagan, CEO of Regulus. "This is an important step in advancing a potential treatment for patients with Alport Syndrome, a rare genetic condition affecting the kidneys with no approved therapies."

Previously, the Company announced completion of the Phase 1b renal biopsy study, where patients with Alport Syndrome were dosed every other week for one year. Results from that study demonstrated kidney tissue concentrations that would be predictive of therapeutic benefit based on animal disease models as well as engagement of the target, miR-21. Over the course of the one year open-label study, promising trends in disease markers were observed and RG-012 was generally well tolerated with no serious adverse events. RG-012 has received orphan designation in both the U.S. and Europe.

Under the terms of the Collaboration and License Agreement, the Company is also eligible to receive an additional $25.0 million upon the successful achievement of a development milestone anticipated in 2023 related to the ongoing Phase 2 HERA study.

On November 2, 2020 Seagen Inc. (Nasdaq: SGEN) reported that it will host a virtual R&D day for investors and analysts on Monday, November 16, 2020 beginning at 10:00 a.m. Eastern Time (Press release, Seagen, NOV 2, 2020, View Source [SID1234569657]). The program will include a presentation by members of Seagen leadership on the broad clinical development of the Company’s marketed products, ADCETRIS (brentuximab vedotin), PADCEV (enfortumab vedotin-ejfv) and TUKYSA (tucatinib), and its deep pipeline of innovative therapies for cancer.

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Access to the event will be available at the Company’s website www.seagen.com in the Investors section. A replay will be archived on the Company’s website following the live presentation.

On November 2, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, NOV 2, 2020, View Source [SID1234569655]).

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Stifel Virtual Healthcare Conference
Fireside Chat on Monday, November 16, 2020, at 9:20 a.m. EST
Jefferies Virtual London Healthcare Conference
Fireside Chat on Wednesday, November 18, 2020, at 2:55 p.m. EST
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On November 2, 2020 Sanofi and Kiadis, a clinical-stage biopharmaceutical company developing innovative ‘off the shelf’ natural killer (NK) cell based medicines for the treatment of life-threatening diseases, reported that it entered into a definitive agreement under which Sanofi will make a public offer (subject to satisfaction of certain customary conditions) to acquire the entire share capital of Kiadis for EUR 5.45 per share, representing an aggregate adjusted equity value of €308m1 (Press release, Sanofi, NOV 2, 2020, View Source [SID1234569644]).

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"We believe the Kiadis ‘off the shelf’ K-NK cell technology platform will have broad application against liquid and solid tumors, and create synergies with Sanofi’s emerging immuno-oncology pipeline, providing opportunities for us to pursue potential best-in-disease approaches," said John Reed, M.D., Ph.D., Global Head of Research & Development at Sanofi.

"Kiadis’ vision is to bring novel cell-based medicines to people with life-threatening diseases, and this transaction will help achieve that vision," said Arthur Lahr, Chief Executive Officer of Kiadis. "After the discontinuation of our lead product candidate and subsequent reorganization in 2019, we restarted Kiadis in 2020 as an entirely new company focused solely on the proprietary and differentiated NK-cell platform that we obtained through the acquisition of Cytosen Therapeutics. Sanofi’s offer is a clear testimony to the uniqueness of our NK-cell platform and the rapid success of Kiadis’ transformation. The Kiadis Boards unanimously believe that Sanofi has the resources and financial strength to accelerate development of our NK-cell products, to the benefit of patients. We believe this transaction represents compelling value to shareholders and offers a fair reflection of the potential of our platform and pipeline, given the risk/reward profile typical to biotech and the capital required to execute our business plan. Finally, this transaction will provide excellent career opportunities for our employees, who will be viewed by Sanofi as their internal cell-therapy experts."

Innovative K-NK cell platform

Kiadis’ proprietary platform is based on allogeneic or ‘off-the-shelf’ NK cells from a healthy donor. NK cells seek and identify malignant cancer cells and have broad application across various tumor types. The platform has the potential to make products rapidly and economically available for a broad patient population across a wide range of indications.

Kiadis’ NK cell-based medicines will be developed alone and in combination with Sanofi’s existing platforms.

Complementary strong science to generate first-in-class medicines and strategic fit across core therapeutic areas

Sanofi’s research, development, and commercial expertise will be leveraged to advance Kiadis’ pipeline, which includes NK cell based medicines for the treatment of patients undergoing hematopoietic stem cell transplant, liquid and solid tumors, as well as infectious disease.

In July 2020, Sanofi licensed Kiadis’ pre-clinical K-NK004 program for potential combination for multiple myeloma.

Kiadis’ pipeline of NK cell therapies includes:

K-NK002 is in a Phase 2 clinical study evaluating NK cells to prevent post-transplant relapse in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes. The Phase 2 trial will be conducted in collaboration with premier U.S. transplant centers.

K-NK003 is a Phase 1 study evaluating NK cells for patients with relapsed or refractory AML.

KNK-ID-101 is a program evaluating the properties of K-NK cells and their suitability to fight SARS-CoV-2 and the option to develop K-NK cells as a post-exposure pre-emptive therapy for COVID-19 in high risk patients. Kiadis plans to initiate a phase 1/2a clinical trial evaluating use of K-NK cells to treat COVID-19 patients with government grant funding.

Accelerates the clinical development and broadens patient reach of current Kiadis pipeline

Subject to the completion of the public offer, Sanofi will provide the resources and capabilities necessary to accelerate the development of current Kiadis programs for the treatment of blood tumors, solid cancers, and infectious diseases, maximizing their potential to the benefit of patients.