On October 2, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that four abstracts highlighting its TIL therapy will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting from November 6-10, 2019 in National Harbor, Maryland (Press release, Iovance Biotherapeutics, OCT 2, 2019, View Source [SID1234540022]). One of the abstracts is a late-breaking submission and presentation details will be made available to the public on November 1, 2019. Details on the three posters that will be presented as part of the regular submissions are below.

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Title: Expanding Iovance’s tumor infiltrating lymphocytes (TIL) from core biopsies for adoptive T cell therapy using a 22-day manufacturing process
Author: Abelson et al.
Poster #: P145
Presentation date/time: November 8, 2019, 7:00 am – 8:00 pm

Title: Silencing PD-1 using self-delivering RNAi PH-762 to improve Iovance TIL effector function using Gen 2 manufacturing method
Author: Azoulay-Alfaguter et al.
Poster #: P149
Presentation date/time: November 8, 2019, 7:00 am – 8:00 pm

Title: Iovance Gen2 TIL manufacturing process produces drug products that exhibit favorable quality attributes for adoptive cell transfer across 5 solid tumor indications
Author: Wardell et al.
Poster #: P226
Presentation date/time: November 9, 2019, 7:00 am – 8:30 pm

The SITC (Free SITC Whitepaper) abstract titles are listed on the conference website under Abstracts at View Source

On October 2, 2019 Viela Bio, Inc., a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, reported the pricing of its initial public offering of 7,900,000 shares of its common stock at a price to the public of $19.00 per share (Press release, Viela Bio, OCT 2, 2019, View Source [SID1234540021]). The gross proceeds to Viela Bio from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be approximately $150 million. The shares are expected to begin trading on the Nasdaq Global Select Market on October 3, 2019 under the symbol "VIE." The offering is expected to close on October 7, 2019, subject to customary closing conditions. In addition, Viela Bio has granted the underwriters a 30-day option to purchase up to an additional 1,185,000 shares of common stock at the initial price to the public less underwriting discounts.
Goldman Sachs & Co. LLC, Morgan Stanley & Co. LLC, and Cowen and Company, LLC are acting as the joint book-running managers for this offering. Guggenheim Securities, LLC is acting as lead manager for this offering.

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The offering will be made only by means of a prospectus. Copies of the final prospectus related to the offering, when available, may be obtained from:

Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, email: [email protected], telephone: 1-866-471-2526, fax: 1-212-902-9316;
Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, NY 10014; or
Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, email: [email protected], telephone: 1-833-297-2926.
Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 2, 2019. This press release shall not constitute an offer to sell or a 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 October 2, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI) reported that the U.S. Food and Drug Administration (FDA) has approved a labeling supplement for NERLYNX (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer (Press release, Puma Biotechnology, OCT 2, 2019, View Source [SID1234540020]). With the approval of the labeling supplement, the label now includes safety information based on interim results from Puma’s Phase II CONTROL Trial, a study evaluating antidiarrheal prophylaxis or dose escalation in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 or higher diarrhea. Interim data from the trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.

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In the ongoing CONTROL Trial, patients with HER2-positive early stage breast cancer who have completed trastuzumab-based adjuvant therapy receive neratinib daily for a period of one year. The trial initially tested high dose loperamide prophylaxis given for the first 2 cycles (56 days) of treatment (12 mg on days 1-14, 8 mg on days 15-56 and as needed thereafter). The CONTROL Trial (NCT02400476) was then expanded to include four additional cohorts. One cohort received the combination of loperamide and budesonide. For the 64 patients who received the combination of loperamide plus budesonide, the incidence of grade 3 diarrhea was 28% compared to 32% in patients treated with loperamide alone. Diarrhea leading to treatment discontinuation declined to 11% in the loperamide plus budesonide cohort, compared to 18% in the loperamide alone cohort.

"We are pleased to be able to update the label for NERLYNX to include the data on the use of prophylactic loperamide plus budesonide," said Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology. "We believe FDA approval of the labeling supplement will help us to ensure that physicians and patients are better informed in selecting prophylactic therapy that may improve the tolerability of the drug."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

On October 2, 2019 IGM Biosciences, Inc. (Nasdaq: IGMS), a biotechnology company focused on creating and developing engineered IgM antibodies for the treatment of cancer patients, reported that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-2323, the Company’s CD20 x CD3 bispecific IgM antibody, in patients with relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL) (Press release, IGM Biosciences, OCT 2, 2019, View Source [SID1234540019]).

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This Phase 1 clinical trial represents the first in-human application of IGM Biosciences’ engineered IgM antibody technology. The Phase 1 multi-center, open label trial is intended to assess the safety, pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with relapsed/refractory B cell NHL. IGM-2323 will initially be administered at a planned fixed-dose, as part of a dose escalation protocol.

On October 2, 2019 Elicio Therapeutics, a next generation immuno-oncology company, reported that it has closed its $33 million Series B financing (Press release, Elicio Therapeutics, OCT 2, 2019, View Source [SID1234540018]).

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Proceeds from the financing will be used to advance Elicio’s pipeline of novel lymph node targeted immuno-therapies, including ELI-002, an Amphiphile mKRAS vaccine (AMP KRAS). ELI-002 targets all seven KRAS mutations that drive 99% of all mKRAS-driven cancers, estimated to be 25% of all human solid tumors.

"We believe ELI-002 can become a universal mKRAS vaccine with the potential to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal and lung cancer," said Robert Connelly, CEO of Elicio. "This new funding is a strong endorsement of this program, the Amphiphile platform, and our progress."

Elicio has established an international investor base, including Clal Biotechnology Industries, Livzon Pharmaceutical Group and Efung Capital. "We are gratified to be able to expand our investor base and strengthen our balance sheet as we advance multiple Amphiphile immuno-therapies towards initial patient studies," Connelly said.

Elicio’s AMP KRAS vaccine ELI-002 has completed preclinical validation, IND-enabling GLP toxicology studies, GMP manufacturing, and a pre-IND meeting with the FDA and Elicio intends to begin an initial patient study in pancreatic cancer patients in the first half of 2020. These trials will be multi-site, randomized, controlled studies. Initial ELI-002 pancreatic cancer patient data is expected in the second half of 2020.

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.