On December 22, 2020 Helix BioPharma Corp. (TSX: HBP) ("Helix" or the "Company"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology based on its proprietary technological platform DOS47, reported that it has closed the transaction with CAIAC Fund Management AG ("CAIAC") for the Company’s remaining holdings in its Polish subsidiary, Helix Immuno-Oncology S.A. ("HIO"), for gross proceeds of PLN 6,700,000 (CAD2,308,000) (Press release, Helix BioPharma, DEC 22, 2020, View Source [SID1234573251]).

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As announced on November 9, 2020, the Company signed a definitive agreement with CAIAC to purchase Helix’s remaining holdings in HIO.

On August 28, 2020, CAIAC, as portfolio manager for Biotech Opportunity Fund ("Opportunity Fund"), announced that it acquired control and direction over, and Opportunity Fund had acquired beneficial ownership of, 26,363,172 common shares of the Company, representing approximately 19.83% of the Company’s issued and outstanding common shares on a non-diluted basis. Consequently, the disposition of the shares of HIO by Helix pursuant to the Transaction is considered a related party transaction within the meaning of Multilateral Instrument 61-101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company intends to rely on exemptions from the formal valuation and minority approval requirements in sections 5.5(a) and 5.7(1)(a) of MI 61-101 in respect of the Transaction on the basis that the directors of the Company, acting in good faith, have determined that, as of the date that the Transaction was agreed to, neither the fair market value of the subject matter of, nor the fair market value of the consideration for, the Transaction insofar as it involves "interested parties" (as such term is defined in MI 61-101) exceeds 25% of the Company’s market capitalization.

ACM Alpha Consulting Management Est. will be entitled to a 12.5% fee in connection with the closing of the Transaction

On December 22, 2020 Amgen (NASDAQ: AMGN) reported submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, an investigational KRASG12C inhibitor, for the treatment of adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Amgen, DEC 22, 2020, View Source [SID1234573242]).

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"Just over two years since the first patient was dosed, sotorasib is now on track to potentially be the first approved targeted therapy for patients with previously treated NSCLC harboring the KRAS G12C mutation," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "With this submission to EMA, Amgen is continuing to rapidly advance the KRASG12C inhibitor clinical program to bring this innovative potential therapy to patients globally as quickly as possible."

KRAS G12C is the most common KRAS mutation in NSCLC.1 Approximately 13% of patients with NSCLC harbor the KRAS G12C mutation and each year approximately 33,000 new patients in the EU-27 are diagnosed with KRAS G12C-mutated NSCLC.1,2 There is a high unmet need and poor outcomes in the second-line treatment of KRAS G12C-driven NSCLC and, currently, there are no KRAS G12C targeted therapies approved. 3,4,5

The submission is supported by positive Phase 2 results in patients with locally advanced or metastatic NSCLC with KRAS G12C mutation from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the Phase 1 study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile.6 These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium in January 2021.

About Sotorasib
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.7 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning four continents. In just over two years, the sotorasib clinical program CodeBreaK has established the deepest clinical data set with more than 600 patients studied across 13 tumor types.

Sotorasib has demonstrated a positive benefit-risk profile with fast, deep and durable anticancer activity in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation. Promising responses have also been observed in multiple other solid tumors.7

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 600 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutated solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 123 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has several Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.

On December 22, 2020 Genprex, Inc. (Nasdaq: GNPX) ("Genprex" or the "Company"), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported it has entered into a securities purchase agreement with a single healthcare-dedicated institutional investor for the purchase and sale of 3,116,884 shares of its common stock at a purchase price of $3.85 per share in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Genprex, DEC 22, 2020, View Source [SID1234573228]). No warrants will be issued in connection with the transaction. The closing of the offering is expected to occur on or about December 24, 2020, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-239134) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 22, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the publication in Molecular Cancer Research of preclinical results from studies of human and murine versions of DKN-01, a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein (Press release, Leap Therapeutics, DEC 22, 2020, View Source [SID1234573220]). The article, entitled "mDKN-01, a Novel Anti-DKK1 Monoclonal Antibody, Enhances Innate Immune Responses in the Tumor Microenvironment," is available online. The studies characterized a murine version of DKN-01 (mDKN-01) in order to better understand the mechanism of action (MOA) of DKK1 inhibition in two mouse cancer models.

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"In the current studies, we demonstrated that the inhibition of DKK1 with a monoclonal antibody in a syngeneic melanoma model led to tumor growth inhibition (TGI) requiring host NK1.1 cells, but not T or B cells, and provided enhanced efficacy when combined with a PD-1 inhibitor. In a second model, the antibody was a potent inhibitor of breast cancer metastases to lung," said Walter Newman, Ph.D., Senior Research Fellow of Leap. "These results show the innate immune system effects of mDKN-01 and support further exploration as to how DKN-01 results in the activation of NK cells and mitigation of metastatic spread."

DKK1, a secreted modulator of Wnt/Beta-catenin and CKAP4/PI3K/AKT signaling, is overexpressed in many cancers, is associated with worse clinical outcomes, and has been shown to have immunosuppressive effects. To better understand the DKN-01 MOA, Leap engineered a murine framework for the DKN-01 CDR domains and examined the efficacy of mDKN-01 in a mouse model of melanoma. These studies show that targeting DKK1 suppresses tumor growth, reduces intra-tumoral myeloid-derived suppressor cells (MDSC) in the tumor and spleen, activates NK cells, and up-regulates PD-L1 expression on MDSC. Tumor cell signaling analysis in these studies indicates that mDKN-01 is not acting as a Wnt/B-catenin pathway agonist, but is inducing a collection of favorable immune changes in the tumor microenvironment.

In the animal model studied, mDKN-01 and an anti-PD-1 antibody demonstrated additive TGI effects. A clinical trial of DKN-01 plus pembrolizumab, an anti-PD-1 antibody, has recently been completed in esophagogastric cancer patients with promising results in patients whose tumors express high levels of DKK1. Leap has recently initiated a trial of DKN-01 in combination with BeiGene’s tislelizumab, an anti-PD-1 antibody, in DKK1-high second line gastroesophageal junction and gastric cancer (GEJ/GC) patients and in combination with tislelizumab, capecitabine, and oxaliplatin in first-line GEJ/GC patients.

About DKN-01

DKN-01 is a humanized monoclonal antibody that binds to and specifically blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin and CKAP4/PI3K/AKT signaling pathways, frequently implicated in tumorigenesis. The U.S. Food and Drug Administration has granted Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy

On December 22, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported that Sarah Boyce, President and Chief Executive Officer, reported to present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14th, 2021 at 12:40pm PST (Press release, Avidity Biosciences, DEC 22, 2020, View Source [SID1234573219]). The conference is being held in a virtual format.

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A live webcast of the presentation will be available on the Company’s website at www.aviditybiosciences.com in the Investor Resources section. A replay of the presentation will be archived on the Company’s website for 30 days.