On June 25, 2018 Immune Design (Nasdaq:IMDZ), an immunotherapy company focused on novel therapies in oncology, reported preclinical and translational data that support the mechanism of action of G100 in patients with indolent non-Hodgkin Follicular lymphomas (FL) (Press release, Immune Design, JUN 25, 2018, View Source [SID1234527462]). These data were presented at the Inaugural AACR (Free AACR Whitepaper) International Meeting Advances in Malignant Lymphoma: Maximizing the Basic-Translational Interface for Clinical Application 2018 in Boston.

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The research presented was designed to understand why high TLR 4 expression in patient’s samples correlated with clinical responses to G100 treatment. By analyzing patient samples, cell lines and mouse lymphoma models the following was observed:

Murine and human B-lymphoma cell lines express TLR4 and respond in vitro to G100 stimulation with upregulation of MHC-II and co-stimulatory markers CD40 and CD80, typical of the activation of antigen-presenting function of B-cells;
In vivo murine tumors of lymphoma models respond to treatment with G100 in injected tumors as well as distal, untreated tumors showing local and abscopal tumor control, mediated by systemic T-cell response;
Approximately 70% of follicular lymphoma patients in a Phase 1/2 study express TLR4 in >50% of tumor cells in baseline biopsies. TLR4 expression ranging from 10%-100% of tumor cells was also detected in biopsies of patients with marginal zone lymphoma, small lymphocytic lymphoma, diffuse large B-cell lymphoma and cutaneous T-cell lymphoma; and
In an ongoing Phase 2 trial of G100 with low dose radiation and pembrolizumab, almost all patients with an objective tumor response (³50% tumor shrinkage) showed TLR4 expression in >50% of tumor cells.
"These data illustrate that in addition to the known activation by G100 of dendritic cells and macrophages in the tumor microenvironment, G100 can also act directly on malignant B cells expressing TLR4. G100 treated malignant B cells may become more visible to the anti-tumor immune response, which correlates with clinical responses following intratumoral therapy with G100." said Jan ter Meulen, MD, PhD, Chief Scientific Officer at Immune Design. "In FL patients, a strong correlation was observed between expression of TLR4 in more than 50% of tumor cells and objective responses following G100 therapy. This discovery potentially allows for a TLR4 biomarker-targeted G100 therapy of other tumor types, independent of histology."

The full poster presentation can be accessed from the publications page of the Immune Design website.

About G100

G100 is a product candidate from Immune Design’s internal discovery platforms and contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl Lipid A (GLA). G100 leverages the activation of both innate and adaptive immunity in the tumor microenvironment to create an immune response against the tumor’s preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate tumor-infiltrating lymphocytes, macrophages and dendritic cells, and promote antigen-presentation and the recruitment of T cells to the tumor. The ensuing induction of local and systemic immune responses has been shown to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control. G100 was evaluated in a Phase 1 study in Merkel cell carcinoma patients and produced a 50% overall response rate per protocol and a favorable safety profile. Currently, G100 is being evaluated as both a monotherapy (with local radiation) and in combination with Merck’s anti-PD-1 agent, pembrolizumab, pursuant to a clinical collaboration with Merck, in a randomized Phase 1/2 trial in patients with follicular non-Hodgkin lymphoma.

On June 25, 2018 Andarix Pharmaceuticals, a clinical stage company aimed at developing a targeted peptide therapies for hard to treat cancers, reported that it will present a poster at the Metals in Medicine Gordon Research Conference (Press release, Andarix Pharmaceuticals, JUN 25 2018, View Source [SID1234527792]) .The conference will take place June 25-29 in Andover, NH.

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The theme of the conference is: The Indispensable Role of Metals in Medical Diagnostics, Therapeutics and Beyond. Andarix will be presenting clinical findings pertaining to Tozaride, a Rhenium metal-based drug developed by the company. The conference is an opportunity for Andarix to present its innovative technology to world
leading scientists and international metal-science experts.

About Tozaride
Tozaride is a novel, best-in-class therapeutic for lung and other cancers, which is based on a radio-labeled somatostatin peptide. Early clinical studies demonstrated that Tozaride is well tolerated and that treatment can promote disease stabilization and improve overall survival in heavily pre-treated advanced lung cancer patients. Tozaride targeted radiotherapy represents a new treatment paradigm which is expected to yield
significant clinical benefits for both small cell lung cancer (SCLC), and non-small cell lung cancer (NSCLC) patients. This therapeutic stands to provide an additional treatment option for patients who are not eligible for, or who have not responded to current therapies.

On June 24, 2018 ERYTECH Pharma (Euronext:ERYP) (Nasdaq:ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it will focus its development efforts for its product candidate eryaspase on the potential treatment of selected solid tumor indications (Press release, ERYtech Pharma, JUN 24, 2018, View Source;p=RssLanding&cat=news&id=2355698 [SID1234527450]). The company also announced that it plans to cease its development program for eryaspase in acute lymphoblastic leukemia (ALL), including the withdrawal of its previously submitted MAA for eryaspase for the treatment of relapsed and refractory ALL.

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In 2017, ERYTECH announced positive results from a Phase 2b clinical trial of eryaspase combined with chemotherapy in patients suffering from second-line metastatic pancreatic cancer, as well as the intended launch of a pivotal Phase 3 clinical trial in this indication. Set-up activities are on track and the Phase 3 trial is expected to begin enrollment in the third quarter of 2018. ERYTECH now confirms that it intends to sponsor a Phase 2 proof-of-concept clinical trial of eryaspase later this year in first-line pancreatic cancer, with enrollment expected to commence in the first half of 2019.

In 2018, following the positive results in second-line metastatic pancreatic cancer, ERYTECH also evaluated other potential solid tumor indications and selected metastatic triple-negative breast cancer (TNBC) as the next indication for which to pursue clinical development of eryaspase. ERYTECH is preparing for a Phase 2 proof-of-concept clinical trial in this indication, with the first patient expected to be enrolled in the fourth quarter of 2018. ERYTECH is also evaluating development options in other pancreatic cancer settings and in additional solid tumor indications with high unmet medical need.

In order to ensure adequate supply of eryaspase for its planned clinical trials, as well as the potential commercialization of eryaspase, if approved, the Company is constructing a large-scale manufacturing facility in the United States (Princeton, New Jersey) and is also expanding its manufacturing capacity in Lyon, France. ERYTECH expects both facilities to be operational for clinical production at the expanded capacity in the first quarter of 2019.

Despite having observed favorable efficacy results and safety profile in multiple clinical trials of eryaspase in patients with ALL, ERYTECH now believes, based on recent feedback from the regulatory agencies in Europe and the United States, that significant additional investment would be required in order to seek regulatory approval of eryaspase for the treatment of ALL. In the context of the rapidly changing and increasingly competitive landscape with newly-approved treatment options for ALL, the regulatory requirements and what ERYTECH observes to be a limited market opportunity for eryaspase in ALL, ERYTECH has elected to cease further clinical development efforts in ALL and to withdraw its European MAA. The resources that will become available as a result of this strategic decision will be allocated to what ERYTECH estimates is a significantly larger unmet medical needs and market opportunity for the potential treatment of solid tumors.

ERYTECH’s preclinical development efforts are not affected by this strategic decision. The next product candidate, erymethionase, methionine-g-lyase encapsulated in red blood cells, and the ERYMMUNE (immuno-therapy) research program are also targeting solid tumor indications. ERYTECH intends to initiate a Phase 1 clinical trial of erymethionase later this year, with enrollment expected to commence in the first half of 2019.

Conference Call Details

ERYTECH management will hold a conference call on Monday, June 25, 2018 at 02:30pm CET / 08:30am EDT. Gil Beyen, Chairman and CEO, Eric Soyer, CFO and COO and Iman El-Hariry, CMO will be available for a Q&A session.

On June 23, 2018 Array BioPharma Inc. (NASDAQ: ARRY) reported updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAFV600E-mutant metastatic colorectal cancer (CRC) (Press release, Array BioPharma, JUN 23, 2018, View Source [SID1234527439]). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO (Free ESMO Whitepaper) 20thWorld Congress on Gastrointestinal Cancer in Barcelona, Spain.

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The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines of therapy. The confirmed overall response rate (ORR) was 48% and among the 17 patients who received only one prior line of therapy the ORR was 62%.

"The results of the BEACON CRC safety lead-in demonstrate substantial improvements in efficacy outcomes when compared to current approved standard of care benchmarks in patients with BRAF-mutant metastatic CRC. The median progression-free survival of 8 months is a meaningful improvement compared to the benchmark of about 2 months, and the overall survival of 62% at 12 months is very promising given that with current approved standards of care, half of patients will succumb to their disease within 4 to 6 months," said Axel Grothey, M.D., Division of Hematology/Oncology, Mayo Clinic. "These data underscore the potential of this triplet combination to benefit patients with BRAFV600E-mutant metastatic CRC, who, despite their poor prognosis, currently have limited effective treatment options."

The triple combination was generally well-tolerated with no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue (13%), anemia (10%), increased blood creatine kinase (10%) and increased aspartate aminotransferase (10%).

The presentation also referenced updated, mature Phase 2 results for the doublet of encorafenib and cetuximab that showed a mOS of 9.3 months, mPFS of 4.2 months and an ORR of 24%. The data cutoff for that analysis was January 2018 with the last patient enrolled in April of 2015; a detailed presentation of these data will occur at a future medical congress.

Enrollment in the randomized portion of the BEACON CRC trial is ongoing. Patients interested in participating in this trial may talk to their doctor to have their tumor tested for the BRAF mutation for eligibility to enroll in this new and important trial. Further details on the trial are available at clinicaltrials.gov (NCT02928224).

A PDF of the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer presentation will be available on Array’s website.

Array will host an encore webcast presentation of the BEACON CRC safety lead-in data.

Encore Investor Webcast:

Presenter:

Axel Grothey, M.D., Division of Hematology/Oncology, Mayo Clinic

Date:

Saturday, June 23

Time:

4:30 pm CET (10:30 am ET)

Toll-Free:

(844) 464-3927

Toll:

(765) 507-2598

Pass Code:

8588348

On June 22, 2018 Eidos Therapeutics, Inc. (Nasdaq: EIDX), a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR), reported the closing of its initial public offering of 7,187,500 shares of common stock, including the exercise in full of the underwriters’ option to purchase 937,500 additional shares of common stock, at a public offering price of $17.00 per share (Press release, Eidos Therapeutics, JUN 22, 2018, View Source [SID1234576276]). The aggregate gross proceeds to Eidos from the offering were approximately

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$122.2 million, before deducting underwriting discounts and other offering expenses. All of the shares in the offering were offered by Eidos. Eidos’ common stock is listed on The NASDAQ Global Select Market under the ticker symbol "EIDX."

J.P. Morgan Securities LLC and BofA Merrill Lynch acted as joint book-running managers for the offering. Barclays Capital Inc. also participated as a joint book-running manager.

The shares were offered by Eidos pursuant to a registration statement that was declared effective by the Securities and Exchange Commission ("SEC") on June 19, 2018. A prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov.

This offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering can be obtained from (1) J.P. Morgan Securities LLC, Attention: c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected]; (2) BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by emailing [email protected]; and (3) Barclays Capital Inc., c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (888) 603-5847, or by emailing [email protected].

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.