Moderna to Present at the 20th Annual Needham Virtual Healthcare Conference

On April 9, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that David Meline, Chief Financial Officer, and Lavina Talukdar, Senior Vice President & Head of Investor Relations, will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on April 15th, 2021 at 11:45 a.m. ET.

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A live webcast will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for 30 days following the presentation.

Sanofi acquires Tidal Therapeutics, adding innovative mRNA-based research platform with applications in oncology, immunology, and other disease areas

On April 9, 2021 Sanofi acquired Tidal Therapeutics, a privately owned, pre-clinical stage biotech company with a novel mRNA-based approach for in vivo reprogramming of immune cells (Press release, Sanofi, APR 9, 2021, View Source [SID1234577780]). The new technology platform will expand Sanofi’s research capabilities in both immuno-oncology and inflammatory diseases, while likely having broad applicability to other disease areas as well. Sanofi acquired Tidal Therapeutics for an upfront payment of $160 million and up to $310 million upon achievement of certain milestones.

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"We anticipate that this next generation, off-the-shelf approach has the potential to bring CAR-T cell therapy to a much broader patient population," said Frank Nestle, Global Head of Research and Chief Scientific Officer at Sanofi. "We believe that the underlying mRNA targeting platform will create disruptive therapeutic approaches across a variety of oncology and autoimmune conditions."

Tidal Therapeutics utilizes a novel mRNA-based approach to in vivo reprogramming of immune cells. The technology is based on proprietary nanoparticles that deliver mRNA (messages) to reprogram immune cells inside the body. The technology delivers mRNA cargos selectively to designated types of cells in the body, with initial applications targeting specific types of immune cells. The in vivo approach is designed to provide similar efficacy to current ex vivo (outside the body) approaches where immune cells are genetically modified to enhance their therapeutic properties (such as chimeric antigen receptor [CAR]-expressing T-cells), with the potential for improved safety, outpatient dosing, and repeat dosing. Currently, Tidal Therapeutics has ongoing pre-clinical programs including in vivo re-programming of T cells or other types of immune cells for cancer indications.

"Teaming up with Sanofi gives us the opportunity to further develop our unique platform and rapidly apply it to ultimately help patients across a range of diseases," said Ulrik Nielsen, President and CEO, Tidal Therapeutics.

IntelGenx Announces Intention to Amend Convertible Unsecured Promissory Notes

On April 9, 2021 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQB:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that it is proposing to amend the terms of its 6.0% convertible unsecured promissory notes due June 1, 2021, originally issued by private placement on May 8, 2018 (the "Notes"), to (i) extend the maturity date to October 31, 2024, (ii) change the conversion ratio for conversions at the option of the holders of the Notes from 6,250 fully paid and non-assessable shares of common stock for each U.S.$5,000 aggregate principal amount of the Notes then outstanding to 11,363 fully paid and non-assessable shares of common stock for each U.S.$5,000 aggregate principal amount of the Notes then outstanding, effectively representing a reduction of the conversion price from U.S.$0.80 to U.S.$0.44, and (iii) reduce the trigger price for a conversion at the option of IntelGenx from U.S.$1.40 or greater for 20 consecutive trading days to U.S.$0.88 or greater for 20 consecutive trading days (Press release, IntelGenx, APR 9, 2021, View Source(TSX%2DV%3AIGX),date%20to%20October%2031%2C%202024%2C [SID1234577797]). The proposed amendments are subject to approval of the TSX Venture Exchange and holders holding a majority of the aggregate outstanding principal amount of the Notes.

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An aggregate principal amount of U.S.$1,600,000 of Notes is outstanding as of the date hereof.

Werewolf Therapeutics looks to make a killing in the public markets with a $100M IPO

On April 9, 2021 Werewolf Therapeutics reported that now wants an IPO (Press release, Werewolf Therapeutics, APR 9, 2021, View Source [SID1234577882]).

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The early-stage biotech is working on shape-shifting cytokine drugs, i.e., ones that deliver the promise of cytokines without their nasty side effects. Known as Indukines, Werewolf’s candidates are "switched off" when they’re given to patients and activate only when they arrive in cancer cells.

Cytokines, such as interleukin-2, emerged decades ago as promising cancer treatments. But they evolved as signaling molecules and not as drugs, so it’s no surprise that they’re missing some key pharmaceutical features that would make them good medicines.

"These mechanisms are a very powerful way to stimulate the immune system to attack tumors, but unfortunately, a number of cytokines can activate the immune system in an adverse way where it can attack normal tissues," Werewolf CEO Daniel Hicklin, Ph.D., said in January. Werewolf’s protein engineering technology is designed to limit its drugs’ effects on healthy tissues.

The biotech, which is preclinical but wants the cash to chase these drugs into the clinic, got off a $72 million raise in January just over a year after it nabbed $56 million series A back in November 2019. Now, according to its SEC-1 filing, it wants a $100 million IPO, though don’t be surprised if, like so many other biotechs over the past year, it ends up getting more than that.

Its two leading assets, WTX-124 and WTX-330, are seeking INDs with the FDA from next year, according to its filing, after which it plans to conduct phase 1/1b trials in patients with multiple tumor types both as standalone treatments and in combination with an immune checkpoint inhibitor.

It also has a third asset, WTX-613, which is much further back in the pipeline, with clinical trials not slated until 2023. This drug is designed to be a systemically delivered, conditionally activated interferon alpha, or IFN-a, molecule for the treatment of solid tumors and blood cancers.

Other players hoping to make better cytokines for cancer treatment include Synthekine, which launched in September with $82 million, and Bright Peak Therapeutics, which debuted in July with $35 million.

And Sanofi bet big on the approach in December 2019 when it inked a $2.5 billion deal to acquire Synthorx, with some early data dropping this weekend at the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

AstraZeneca accelerates early oncology pipeline across key strategic scientific platforms at AACR

On April 9, 2021 AstraZeneca reported that it will share updates from the Company’s innovative early oncology pipeline across multiple strategic platforms during the virtual American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, 10 to 15 April 2021 (Press release, AstraZeneca, APR 9, 2021, View Source [SID1234577781]).

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Five presentations will unveil the next-generation PARP1 selective inhibitor AZD5305, underscoring AstraZeneca’s commitment to advancing therapies that selectively kill cancer cells by targeting the system that cells rely on to repair damage to DNA. Additionally, research across multiple presentations will highlight novel technologies that enable early detection of disease recurrence to inform earlier interventions for patients who are more likely to benefit from treatment.

In total, data from more than 40 presentations will showcase progress with the next wave of anticancer medicines, novel insights in targeting resistance to therapy, and approaches that are advancing the personalised treatment of cancer.

Susan Galbraith, Senior Vice President and Head of Research and Early Development, Oncology R&D, said: "Our data at AACR (Free AACR Whitepaper) reflect a robust early-stage pipeline, poised to deliver life-changing medicines to patients living with cancer. Data for AZD5305 will demonstrate how the next wave of DNA damage response medicines can build on the success of PARP inhibitors, potentially allowing patients to stay on treatment longer. This innovative molecule is designed to optimise the therapeutic window of PARP inhibition, providing new opportunities for combination treatment with chemotherapy and targeted medicines."

The Company will share a Spotlight Theater Presentation: The Orchestrated Immune Response: Dynamic Forces Guiding Cancer Immunity, introducing a novel framework for understanding the role of the immune system in cancer, with the potential to reshape the way scientists develop medicines to counteract tumour growth.

AstraZeneca leaders will also participate in two educational symposia:

DNA Damage Response (DDR) Treatment: Evolving Diagnostic Approaches, Understanding of Replication Stress, and Resistance Mechanisms to DDR Targeting Therapies (Session #ADT04), with a discussion on targeting the replication stress response, which occurs when the genome is exposed to stresses that impede DNA replication.
Advances in Drug Delivery (Session #ADT08), with a discussion on the advances and innovations fueling the development of the next generation of antibody drug conjugates.
Key presentations will include:

Structural disclosure and key preclinical data for AZD5305, a next-generation PARP1 selective inhibitor
The introduction of AZD8853, a novel antibody targeting GDF15 for tumours refractory to immunotherapy treatment
Research from the HUDSON Phase II trial using deep learning algorithms on pathological images to identify features associated with progression on immunotherapy for patients with non-small cell lung cancer
A pooled analysis of interstitial lung disease data in patients treated with Enhertu across eight cancer trials
Two presentations from genome-wide CRISPR screenings that identify signalling in the Hippo pathway as an important driver of resistance in EGFR-mutated lung cancer and BRAF-mutated colon cancer
Data identifying a novel immunosuppressive myeloid gene signature for clinical biomarker development
Results from the ATRiUM Phase I trial, externally sponsored scientific research evaluating ceralasertib, an ATR inhibitor, and gemcitabine as combination therapy in biliary tract cancer
Key AstraZeneca presentations during AACR (Free AACR Whitepaper) 2021

Key AstraZeneca presentations during AACR (Free AACR Whitepaper) 2021
1Unless otherwise specified, all posters/presentations will be available starting 08:30 EDT on 10 April 2021.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.