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Boehringer Ingelheim Advances First Pan-KRAS Inhibitor BI 1701963 into Clinical Testing

On October 29, 2019 Boehringer Ingelheim reported promising preclinical data from its pan-KRAS program including the novel, oral inhibitor BI 1701963 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, USA1 (Press release, Boehringer Ingelheim, OCT 29, 2019, View Source [SID1234549990]). Based on these results the compound has been advanced to Phase I clinical testing alone and in combination with trametinib in patients with different types of advanced solid tumors with KRAS mutations.

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KRAS mutations occur in one in seven of all human metastatic cancers making it the most frequently mutated cancer-causing oncogene, with mutation rates of more than 90 percent in pancreatic cancers, more than 40 percent in colorectal cancers and more than 30 percent in lung adenocarcinomas. It has evaded attempts to develop inhibitors for almost 40 years. Only recently have promising compounds targeting the specific KRAS mutation G12C entered the clinic. There are however many KRAS gene mutations beyond G12C that drive tumor growth and have previously been ‘undrugged,’ such as KRAS-G12D and KRAS-G12V, which make up half of all KRAS driven cancers.

"Our pan-KRAS inhibitor has been designed to target a broad range of oncogenic KRAS variants, including all major G12 and G13 oncoproteins. Effective targeting of the most prevalent KRAS mutant alleles that have so far proved elusive could enable us to develop much needed new therapy regimens for patients with gastrointestinal and lung cancers who have limited treatment options available," said Norbert Kraut, Ph.D., Head of Global Cancer Research at Boehringer Ingelheim.

"We have a comprehensive KRAS R&D program beyond BI 1701963 and aim to develop therapies for all patients with mutant KRAS driven cancer," said Clive R. Wood, Ph.D., Corporate Senior Vice President and global head of Discovery Research at Boehringer Ingelheim. "This program is part of our strategy to defeat cancer with optimal combinations of cancer cell-directed and immune cell-directed therapies," added Wood.

BI 1701963 inhibits KRAS by binding to SOS1, which plays an essential role in activating KRAS through the exchange of RAS-bound GDP for GTP. The selective inhibition of SOS1 is a therapeutic concept that could allow KRAS blockade irrespective of KRAS mutation type. Preclinical data have shown that the pan-KRAS inhibitor blocks tumor growth for many tested G12 and G13 KRAS gene mutations, the most frequently affected residues of the protein. Further, the compound is selective for cancer cell lines with mutations in the KRAS gene.

In non-clinical studies, the combination of BI 1701963 with a MEK inhibitor demonstrated a strong impact on KRAS signaling and resulted in increased anti-tumor activity based on dual pathway blockade and complementary mechanism of action in keeping KRAS-driven cancers in check. BI 1701963 will be further developed in combination with LNP3794 a MEK inhibitor compound in-licensed from Lupin.

Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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CEL-SCI Corporation to Present at Dawson James Securities 5th Annual Small Cap Growth Conference

On October 29, 2019 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that Geert Kersten, Chief Executive Officer, will be presenting at the Dawson James Securities Small Cap Growth Conference on Tuesday, October 29th at 10:55 a.m. ET.

To access the live webcast and subsequent archived recordings for the presentation, please visit the Investor Relations section of the Company’s website at View Source The webcast will be archived for 90 days following the presentation.

About Dawson James Securities

Dawson James Securities, Inc., a member of FINRA/SIPC, is a full-service investment bank headquartered in Boca Raton, FL. View Source

Propanc Biopharma Provides Shareholder Update and Forecast for 2020

On October 29, 2019 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported an update on the progress of the Company, its R&D activities and forecast for 2020, as the Company plans to prepare for initiating a First-In-Human (FIH) study for its lead product, PRP, a novel formulation consisting of two proenzymes for the treatment and prevention of metastatic cancer from solid tumors in advanced cancer patients, which management hopes to commence in the second half of next year (Press release, Propanc, OCT 29, 2019, View Source [SID1234549988]). According to a new market intelligence report by BIS Research, titled "Global Metastatic Cancer Treatment Market – Analysis and Forecast, 2018-2025", the global metastatic cancer treatment market was estimated at $54.11 billion in 2017, and is anticipated to reach $98.24 billion by 2025.

The Company will continue to expend its efforts to complete the following activities in 2020:

Completion of remaining process development activities, subsequent engineering run and full scale GMP manufacture of PRP in preparation for a FIH study in advanced cancer patients;
Completion of the validation of the bioanalytical method for the FIH study.
Once the manufacturing is completed, preparation of the Investigational Medicinal Product Dossier (IMPD), as part of a clinical trial application (CTA) for the FIH study, most likely to be submitted at the Peter Mac Center, in Melbourne, Australia; and
Advancement of the joint POP1 research program at the Universities of Jaén and Granada by investigating the production of synthetic compounds that mimics the action of the proenzymes, whilst minimizing the variation between different lots and without the use of animals as the primary source of materials. They are currently optimizing conditions to extract high titers of the active materials before further analysis determining whether they are producing the right quality compounds.
The Company is making concerted efforts to raise sufficient capital to complete the planned R&D activities in 2019/2020. Management are exploring several strategic options to enable the Company’s lead asset, PRP, enter the next important stage of pre-commercialization by undertaking clinical trials.

"During this recent period, we have undertaken a significant amount of work to advance our lead product PRP towards clinical stage," said James Nathanielsz, Propanc’s Chief Executive Officer. "The extensive IP portfolio, the scientific research and preclinical studies, and regulatory agency meetings, as well as achieving Orphan Drug Designation status from the US Food and Drug Administration for treatment of pancreatic cancer, have us well positioned to realize significant value for the Company in the coming years. Our immediate objective is to explore all possible avenues to ensure a timely commencement of our FIH study in cancer patients."

In 2019, the Company initiated and completed a number of activities, including:

Established a cooperation agreement between the University of Jaén and Propanc to commence the POP1 joint drug discovery program to be co-funded by both parties. The program involves advancing new compounds through a drug screening process, followed by preclinical and early stage clinical development. As the drug candidate progresses along the development pathway, the collaboration will also involve the Universities of Granada and Jaén, as well as Granada and Almeria Hospitals, which are members of FIBAO, a Public Health Foundation, based in Granada, Spain, committed to assisting commercial partners with the development and commercialization of innovative technologies designed to benefit humankind.
Oversaw rapid growth of the company’s intellectual property ("IP") portfolio, with sixty-five patents currently either in force or pending in most major countries and regions around the world. The IP covers Propanc’s underlying anti-cancer technology in development. In the past year, three additional patent families entered national phase, where a patent application is filed in individual countries and regions to achieve grant status. Additionally, the Company received a granted US patent from the United States Patent and Trademark Office (USPTO) covering composition of matter claims. The claims are a continuation from the original foundation patent in the U.S., and as a result, method of treatment and composition claims now protect the Company’s lead product candidate, PRP.
Appointed Mr. Carlo Campiciano as its Chief Financial Officer, commencing July 1, 2019. Mr. Campiciano brings significant experience to the Company across a broad range of financial disciplines in the healthcare sector, including taxation, finance, operations, planning and financial strategy.
Developed a method to quantify the active ingredients of Propanc’s lead product candidate, PRP, in preparation for the company’s First-In-Human ("FIH") study, planned for early 2020. The bioanalytical method development and validation plays a significant role in evaluation and interpretation of the systemic absorption of PRP in humans including its distribution, and clinical effects throughout the body.
Evaluated sites to conduct the FIH study in advanced cancer patients, such as the Peter Mac Center, Australia’s largest cancer hospital, which has significant experience in early stage clinical development. Propanc is evaluating Australia as a potential destination where it may commence the Phase Ib clinical trial because of its research and development tax incentives, as well as simplified regulatory environment. As part of such incentives, eligible companies conducting clinical trials in Australia may receive up to a 43.5% "cash-back" benefit in the form of a refund of their qualified research and development costs and expenses.
The company’s scientific researchers, together with its joint research partners, Universities of Jaén and Granada, published key data in a peer reviewed journal, Scientific Reports, confirming the mechanism of action of proenzymes and its anti-cancer effects against cancer stem cells.

Blueprint Medicines to Host R&D Day and Announce Third Quarter 2019 Financial Results on November 5, 2019

On October 29, 2019 Blueprint Medicines Corporation (NASDAQ:BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that it will host a Research and Development (R&D) Day for analysts and investors on Tuesday, November 5, 2019 beginning at 8:30 a.m. ET in New York City (Press release, Blueprint Medicines, OCT 29, 2019, View Source [SID1234549987]). In addition, the company will report its third quarter 2019 financial results on Tuesday, November 5, 2019.

The R&D Day will feature presentations by Blueprint Medicines’ management team, which will review the company’s precision therapy research vision and portfolio, as well as a presentation from Dr. Cem Akin, M.D., Ph.D., Professor of Medicine, University of Michigan, who is an expert in the field of allergy and immunology, and whose work focuses on the treatment of mastocytosis.

A live webcast of the event will be available under "Events and Presentations" in the Investors & Media section of Blueprint Medicines’ website at View Source A replay of the webcast will be archived on Blueprint Medicines’ website for 90 days following the event.

BioLineRx to Deliver Oral Presentation at ESMO Immuno-Oncology Congress 2019

On October 29, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported that it will deliver a proffered paper (oral) presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2019, which is being held December 11-14 at the Palexpo in Geneva, Switzerland (Press release, BioLineRx, OCT 29, 2019, View Source [SID1234549986]).

Presentation details:

Abstract title: A Multi-Center Phase 2a Trial to Assess the Safety and Efficacy of BL-8040 (a CXCR4 inhibitor) in Combination with Pembrolizumab and Chemotherapy in Patients with Metastatic Pancreatic Adenocarcinoma (PDAC)

Date: Friday, December 13, 2019

Presentation No.: 91O

Lecture time: 11:15-11:30am CET

Location: Room C

About BL-8040

BL-8040 is a short synthetic peptide that functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor over-expressed in many human cancers, where it has been shown to be correlated with poor prognosis, and plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance. CXCR4 is also directly involved in the homing and retention of hematopoietic stem cells (HSCs) and various hematological malignant cells in the bone marrow.

In a number of clinical and pre-clinical studies, BL-8040 has shown a critical role in immune cell trafficking, tumor infiltration by immune effector T cells and reduction in immunosuppressive cells within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" tumors (i.e., sensitizing them to immune check point inhibitors). BL-8040-mediated inhibition of the CXCR4-CXCL12 (SDF-1) axis has also shown robust mobilization of HSCs for transplantation in hematological malignancies.

BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.