BiomX Announces Preclinical Results of Analysis of Patient Samples and Engineering of Phage for Therapeutic Applications in Colorectal Cancer

On December 9, 2020 BiomX Inc. (NYSE American: PHGE), a clinical stage company developing natural and engineered phage therapies targeting specific pathogenic bacteria, reported the results of an analysis of presence of target bacteria, Fusobacterium nucleatum, in tumor samples obtained from patients with colorectal cancer and reported on progress in engineering of genetic payloads for therapeutic applications (Press release, BiomX, DEC 9, 2020, View Source [SID1234572542]). The analysis confirmed the presence of Fusobacterium nucleatum in over 80 percent of tumor samples obtained from patients with colorectal cancer and identified Fusobacterium nucleatum animalis as the most prevalent subspecie.

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In addition, the Company reported successful engineering of a functional fluorescence gene payload into Fusobacterium nucleatum phage and disclosed three candidate payloads which are being evaluated for delivery to the tumor microenvironment via phage. Candidate payloads include gene-encoding immune-stimulating proteins GM-CSF and IL-15 as well as the pro-drug converting enzyme cytosine deaminase. The BiomX colorectal cancer program utilizes phage therapy in combination with checkpoint inhibitors in order to target bacteria that are naturally present within tumors, with the aim of converting ‘cold’ tumors to ‘hot’ by delivering a payload to the tumor.

The results are featured in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Virtual Congress 2020 and will be available at the Company’s website at View Source Presentation details are as follows:

Title: Novel Analysis of Fusobacterium Nucleatum Subspecies in Human Colorectal Cancer and Engineering of Therapeutic Bacteriophage
Lead Author: Lihi Ninio-Many, Ph.D., Project Leader, BiomX

Lineage Cell Therapeutics to Present at the 13th Annual LD Micro Main Event Conference on December 14, 2020

On December 9, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing three novel cell therapies for serious medical conditions, reported that Brian M. Culley, Chief Executive Officer, will be presenting at the 13th Annual LD Micro Main Event virtual conference on December 14, 2020 at 12:00 pm Eastern Time / 9:00am Pacific Time (Press release, Lineage Cell Therapeutics, DEC 9, 2020, View Source [SID1234572508]). Interested investors can register and access the live presentation on the 13th Annual LD Micro Main Event conference page as well as on the Events and Presentations section of Lineage’s website.

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The archived presentation will be available on the Events and Presentations section of Lineage’s website for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/.

Five Prime to Present Phase 2 FIGHT Trial Results of Bemarituzumab at American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Virtual Annual Symposium

On December 9, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported that detailed results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating bemarituzumab plus mFOLFOX6 chemotherapy in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive (non HER2+) advanced gastric and gastroesophageal junction (GEJ) cancer will be featured during an oral podium presentation on January 15, 2021, at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium being held virtually from January 15-17, 2021 (Press release, Five Prime Therapeutics, DEC 9, 2020, View Source [SID1234572524]).

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On November 10, 2020, Five Prime announced that the FIGHT trial met all three efficacy endpoints with bemarituzumab in combination with mFOLFOX6 chemotherapy providing statistically significant and clinically meaningful improvements in progression-free survival, overall survival, and objective response rate compared with mFOLFOX6 chemotherapy plus placebo in the front-line setting of patients with FGFR2b+, non HER2+ advanced gastric or GEJ cancer.

Bemarituzumab is the first and only investigational treatment targeting FGFR2b+ tumors. FGFR2b is overexpressed in approximately 30 percent of non HER2+ gastric and GEJ cancers. For these patients, no new front-line therapies have been approved in over a decade and systemic chemotherapy remains the standard of care. Five Prime and Roche Tissue Diagnostics (formerly Ventana Medical Systems) have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small cell lung cancer, triple negative breast cancer, ovarian cancer, pancreatic cancer and intrahepatic cholangiocarcinoma. This represents additional potential areas for development of bemarituzumab beyond gastric and GEJ cancer.

The Company will host a conference call and live audio webcast on Friday, January 15, 2021 at 4:30pm (EST) / 1:30pm (PST) to review highlights from the presentation and will feature members of the Five Prime management team and Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center, and a principal investigator of the trial.

Oral Presentation Details:

Title: Randomized Double-blind Placebo-Controlled Phase 2 Study of Bemarituzumab Combined with Modified FOLFOX6 (mFOLFOX6) in 1st Line (1L) Treatment of Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (FIGHT)
Abstract Number: 160
Oral Abstract Session: Esophageal and Gastric Cancer
Day and Time: Friday, January 15, 2021, 7:00am – 8:15am PST / 10:00am 11:15am EST
Author and Q&A Presenter: Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center
Conference Call Information

Five Prime will host a conference call and live audio webcast on Friday, January 15, 2021 at 4:30pm EST / 1:30pm PST to discuss the detailed Phase 2 FIGHT trial results presented at ASCO (Free ASCO Whitepaper) GI. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 2063209. To access the live webcast please visit View Source

An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

About the FIGHT Trial

The FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment (FIGHT) trial (NCT03694522) was designed to evaluate the efficacy and safety of bemarituzumab in combination with modified FOLFOX6 (mFOLFOX6; leucovorin calcium, fluorouracil, and oxaliplatin) vs. mFOLFOX6 plus placebo in the front-line setting of patients with newly diagnosed FGFR2b positive, locally advanced or metastatic gastric and GEJ cancer.

Patients’ tumors were identified to be FGFR2b+ by immunohistochemistry and by FGFR2 gene amplification using a blood-based circulating tumor DNA assay. Testing was performed at a central laboratory.

The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States.

About FGFR2b

The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells. FGFR2b is a form of FGFR found in epithelial cells, such as those in the stomach and skin. Data from the FIGHT trial suggests that approximately 30% of patients with non HER2+ gastroesophageal cancers overexpress FGFR2b.1 Five Prime and Roche Tissue Diagnostics have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small cell lung cancer (NSCLC), triple negative breast (TNBC), ovarian, pancreatic and intrahepatic cholangiocarcinoma.

About Bemarituzumab

Bemarituzumab (anti-FGFR2b, FPA144) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pathways. Blocking FGFR2b activation is thought to slow cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b.

Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.

About Gastric Cancer and GEJ Cancer

Gastric cancer, also known as stomach cancer, is the third most common cause of cancer death worldwide and, excluding non-melanoma skin cancer, the fifth most common cancer worldwide, with over 1,000,000 new cases diagnosed each year.2 For HER2- patients, front-line therapy available today is the same systemic chemotherapy available since the 1990s.3,4

Puma Biotechnology Presents Updated Results from the Phase II SUMMIT Trial of Neratinib for HER2-Mutant, HR-Positive Metastatic Breast Cancer at SABCS 2020

On December 9, 2020 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that updated results from the ongoing Phase II SUMMIT trial of neratinib at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place (Press release, Puma Biotechnology, DEC 9, 2020, View Source [SID1234572543]). The presentation entitled, "Latest findings from the breast cancer cohort in SUMMIT – a phase 2 ‘basket’ trial of neratinib + trastuzumab + fulvestrant for HER2-mutant, hormone receptor-positive, metastatic breast cancer," is being presented at a Spotlight Poster Discussion Session by Komal Jhaveri, M.D., FACP, Memorial Sloan Kettering Cancer Center, an investigator of the trial. A copy of this poster presentation is available on the Puma website.

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The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating HER2 (ERBB2) or lung cancers with EGFR exon 18 mutations (NCT01953926). In the HER2-mutant, hormone receptor (HR)-positive breast cancer cohort, 51 patients received 240 mg of neratinib daily in combination with trastuzumab and fulvestrant. In this cohort, patients had received a median of 4 prior lines of therapy in the metastatic setting (range 1-10 prior regimens) before entering the trial. 36 patients (70.6%) had received prior fulvestrant, 35 patients (68.6%) had received prior aromatase inhibitor and 4 patients (7.8%) had received prior tamoxifen. Further, 30 patients (58.8%) received prior cyclin-dependent kinase 4/6-inhibitor (CDK4/6i) therapy. Thirty-five patients (68.6%) had received prior chemotherapy.

The interim efficacy summary of the breast cohort that received neratinib in combination with trastuzumab and fulvestrant showed that for the 37 RECIST efficacy evaluable patients, 17 patients (45.9%) experienced a confirmed objective response, including one complete response (2.7%) and 16 (43.2%) partial responses, and 20 patients (54.1%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 24 weeks). The median duration of response was 10.9 months and the median progression-free survival was 8.3 months.

The safety profile observed in patients treated with the combination of neratinib plus trastuzumab plus fulvestrant in the SUMMIT study was consistent with that observed previously in metastatic patients with HER2 amplified tumors. All patients received anti-diarrheal prophylaxis with loperamide alone. The interim safety results of the study showed that the most frequently observed adverse event was diarrhea. For the 51 safety evaluable patients enrolled in this cohort, 20 patients (39.2%) reported grade 3 diarrhea. The median duration of grade 3 diarrhea for those patients was 6 days. No patient permanently discontinued neratinib due to diarrhea.

Komal Jhaveri, M.D., FACP, Memorial Sloan Kettering Cancer Center, Clinical Director of the Early Drug Development Service and Assistant Professor of Medicine, Weill Cornell Medical College, said, "HER2 mutations appear to be oncogenic drivers in a subset of metastatic breast cancers and are clinically actionable. The combination of neratinib + trastuzumab + fulvestrant therapy demonstrates encouraging clinical activity with durable responses in this molecular-defined patient population with clinical benefit observed in patients who have previously been treated after standard of care CDK4/6i and endocrine therapies."

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are pleased to see that the combination of neratinib + fulvestrant + trastuzumab continues to demonstrate encouraging clinical activity in this heavily pre-treated cohort. We are continuing to enroll the randomized cohorts in the SUMMIT trial of neratinib in hormone receptor positive breast cancer patients with HER2 mutations and we anticipate the completion of this enrollment in the first half of 2021."

Oncternal Therapeutics Announces $40.0 Million Bought Deal Offering

On December 9, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 8,888,889 shares of common stock of the Company, at a price to the public of $4.50 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, DEC 9, 2020, View Source [SID1234572613]). The closing of the offering is expected to occur on or about December 14, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 1,333,333 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $40.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

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