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.

Turning Point Therapeutics Announces New Preclinical Data for Three Drug Candidates

On April 9, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported new preclinical data supporting the ongoing development of three of its drug candidates, repotrectinib, TPX-0022 and TPX-0131 (Press release, Turning Point Therapeutics, APR 9, 2021, View Source [SID1234577798]). The findings will be presented this weekend at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, which is convening virtually through April 14.

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For lead drug candidate, repotrectinib, poster presentations will highlight new preclinical combination data with MEK and MEK/Raf inhibitors, as well as repotrectinib’s potency against wildtype and mutant TRKA/B/C as compared to approved TRK inhibitors. The preclinical studies found that repotrectinib combinations with approved MEK inhibitor, trametinib, or investigational MEK/Raf inhibitor, VS-6766, were more effective than single-agent treatment in patient-derived KRAS mutant G12D/V lung and G12D/V/R pancreatic cancer models. Based on the findings and additional preclinical support presented previously, Turning Point anticipates the first cohort of its planned Phase 1/2 TRIDENT-2 study will examine the safety, tolerability, pharmacokinetics, and any early signals of efficacy of repotrectinib in combination with trametinib in patients with KRAS mutant G12D advanced solid tumors.

"We are encouraged by the new preclinical data our research team has generated in support of our ongoing development of repotrectinib, TPX-0022 and TPX-0131," said Athena Countouriotis, M.D., president and CEO. "In particular, our preclinical models continue to suggest that the combination of repotrectinib with MEK inhibitors can suppress mutant KRAS signaling to achieve more potent and durable anti-tumor activity. We look forward to studying this further in the first cohort of our planned TRIDENT-2 combination study.

"In addition, preclinical studies show repotrectinib is highly potent against wild type TRK fusions and is less affected by NTRK resistance mutations than approved therapies, with strong potency in both in vitro and in vivo studies. We look forward to sharing additional clinical data from our TRIDENT-1 study of repotrectinib in the second half of the year."

TPX-0022, MET, SRC, CSF1R Inhibitor
For MET/SRC/CSF1R inhibitor TPX-0022, the company will present preclinical data demonstrating potential utility in combination with immune checkpoint inhibitors. In a syngeneic xenograft tumor model, TPX-0022 treatment downregulated immunosuppressive cytokines, increased anti-tumor M1 macrophages, and enriched levels of CD8+ cytotoxic T cells. TPX-0022 had single agent in vivo efficacy and enhanced the efficacy of an anti-PD-1 inhibitor. With the new data, Turning Point is evaluating a potential additional combination study of TPX-0022 and an anti-PD-1 checkpoint inhibitor. In the second half of 2021, the company plans to provide a clinical data update from the Phase 1 dose finding portion of its ongoing SHIELD-1 study and initiate its planned Phase 1b/2 SHIELD-2 clinical study of TPX-0022 in combination with an EGFR targeted therapy.

TPX-0131, ALK Inhibitor
For its ALK-inhibitor, TPX-0131, Turning Point will present preclinical data showing its potential to cross the blood-brain barrier and its potency against wild type ALK and a broad spectrum of acquired ALK resistance mutations, including the G1202R solvent front mutation, L1196M gatekeeper mutation, and the G1202R/L1196M and /L1198F compound mutations. Turning Point plans to initiate a Phase 1/2 study in patients with ALK-positive TKI-pretreated advanced non-small cell lung cancer in the second quarter of 2021.

AACR plans to make poster presentations available via its website on Saturday, April 10. The four posters to be presented are:

Title: Repotrectinib increases effectiveness of MEK inhibitors in KRAS mutant cancer models
Abstract Number: 1104

Title: Molecular characteristics of repotrectinib that enable potent inhibition of TRK fusion proteins and broad mutant selectivity
Abstract Number: 1119

Title: TPX-0022, a potent MET/SRC/CSF1R inhibitor that modulates the tumor immune microenvironment in preclinical models
Abstract Number: 1444

Title: TPX-0131, a potent inhibitor of wild type ALK and a broad spectrum of both single and compound ALK resistance mutations
Abstract Number: 1469

Oasmia Announces Conference Call to Present Cantrixil Final Phase I Data to be released at the 2021 AACR Annual Meeting

On April 9, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that it will host a conference call on April 12 at 14:00 CEST to present final Cantrixil Phase 1 data set to be released at the 2021 AACR (Free AACR Whitepaper) annual meeting (Press release, Oasmia, APR 9, 2021, View Source [SID1234577782]).

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The call will be hosted by CEO Francois Martelet and CSO Reinhard Koenig. The presentation will be in English.