On December 9, 2020 Pacira BioSciences, Inc. (Nasdaq: PCRX), the leading provider of innovative non-opioid pain management options, reported preliminary unaudited net product sales of EXPAREL (bupivacaine liposome injectable suspension) and iovera° of $38.1 million and $0.8 million, respectively, for the month of November 2020 (Press release, Pacira Pharmaceuticals, DEC 9, 2020, View Source [SID1234572526]).

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"We are pleased to report our sixth consecutive month of year-over-year growth for EXPAREL in the face of ongoing challenges from the COVID-19 pandemic. Sales for the final two days of November were meaningfully below the daily average for the month, which we believe to be attributable to the Thanksgiving holiday. Such anomalies aside, market indicators remain favorable as EXPAREL growth rates are significantly exceeding those of the elective surgery market versus pre-COVID baseline levels. This outperformance reflects the increasing use of EXPAREL within 23-hour sites of care and within non-elective procedures, such as cesarean section, oncology, and cardiovascular surgeries. We expect these favorable market dynamics to continue as we drive stronger growth in a post-pandemic world. EXPAREL not only helps enable the shifting of complex, painful procedures to outpatient settings but is well entrenched as the forerunner in opioid-sparing postsurgical pain management," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

The company’s 2020 product sales have been negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the fourth quarter or full year 2020.

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

On December 9, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that it has commenced an underwritten public offering of its common stock (Press release, Avid Bioservices, DEC 9, 2020, View Source [SID1234572523]). Avid Bioservices, Inc. also intends to grant the underwriters a 30-day option to purchase from it up to an additional 15% of the shares of common stock offered in the public offering. Avid Bioservices, Inc. intends to use the net proceeds from the offering primarily for the expansion of its manufacturing capabilities and any remainder for general corporate purposes.

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RBC Capital Markets is acting as sole book-running manager for the proposed offering. Craig-Hallum Capital Group and Stephens Inc. are acting as co-managers for the proposed offering.

The shares described above are being offered by Avid Bioservices, Inc. pursuant to a shelf registration statement on Form S-3 previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the offering has also been filed with the SEC and is available on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying base prospectus relating to this offering may be obtained from RBC Capital Markets, LLC, Attn: Equity Capital Markets, 200 Vesey Street, New York, NY 10281, by telephone at 877-822-4089 or by email at [email protected], Craig-Hallum Capital Group LLC, Attn: Equity Capital Markets, 222 South Ninth Street, Suite 350, Minneapolis, MN 55402, by telephone at (612) 334-6300 or by e-mail at [email protected] or from Stephens Inc., Attn: Equity Syndicate, 111 Center Street Little Rock, AR 72201, by telephone at (501) 377-2000 or by email at [email protected].

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

On December 9, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that a clinical update on DANYELZA (naxitamab-gqgk) for the treatment of Refractory/Relapsed High-Risk Neuroblastoma was given at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Virtual Congress 2020, which is being held December 9 through December 12, 2020 (Press release, Y-mAbs Therapeutics, DEC 9, 2020, View Source [SID1234572522]). The DANYELZA data was presented by Dr. Jaume Mora from SJD Barcelona Children’s Hospital, Spain and Dr. Daniel A. Morgenstern from The Hospital for Sick Children, Toronto, Canada.

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In the Company’s Study 201, a total of 95% of the infusions were administered in an outpatient setting. The median infusion time was 37 minutes, and all infusions were completed in less than 2 hours. The adherence rate was deemed very satisfactory, as 98% of the infusions were completed as planned, and the treatments appeared to be generally well tolerated. By independent review, the overall response rate ("ORR") in Study 201 was 68% with 59% complete responses ("CR"). In refractory patients, the ORR was 71% with 64% CR, and in relapsed patients the ORR was 63% with 50% CR.

DANYELZA 40mg/10ml was recently approved by the U.S. FDA. DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. DANYELZA is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. During the Company’s Study 201, DANYELZA was primarily administered to patients in an outpatient setting three times in a week and the treatment was repeated every four weeks.

"I am very pleased to see that 98% of the infusions were completed as planned and 95% of the infusions were outpatient. Furthermore, the response rates achieved in these patients, who were either refractory to frontline treatment or had relapsed are notable, as this is a difficult to treat patient population, and the responses are based on antibody treatment alone, and not combination treatment with chemotherapy," said Thomas Gad, founder, Chairman and President.

"We are pleased that Study 201 showed that when DANYELZA is given in an outpatient setting with a high degree of treatment adherence, it addressed a significant unmet medical need in an efficient way. In addition, in Study 201 we saw that the median infusion time was just over half an hour, and when compared to the duration of the first infusion, the subsequent infusion times were generally lower, which we believe is great news for children living with refractory/relapsed high-risk neuroblastoma," said Dr. Claus Moller, Chief Executive Officer.

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compound and Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest, anaphylaxis, hypotension, bronchospasm and stridor and neurotoxicity, such as severe neuropathic pain, transverse myelitis and reversible posterior leukoencephalopathy syndrome. See full Prescribing Information for complete Boxed Warning and other important safety information.

On December 9, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases, reported that the pivotal phase 2 HORIZON study evaluating intravenous melflufen (INN melphalan flufenamide) in combination with dexamethasone in relapsed refractory multiple myeloma, has been published in the peer-reviewed Journal of Clinical Oncology (Press release, Oncopeptides, DEC 9, 2020, View Source [SID1234572521]).

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The phase 2 HORIZON data are the basis for the ongoing priority review of the New Drug Application to the US Food and Drug Administration FDA, for accelerated approval of melflufen in combination with dexamethasone in triple-class refractory multiple myeloma patients, who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody.

"The results from the HORIZON study demonstrate that melflufen in combination with dexamethasone, has a potential to provide a therapeutic option for patients who are difficult to treat and have a poor prognosis, including patients with triple class refractory myeloma and patients with extramedullary disease", says Klaas Bakker, MD, PhD, Chief Medical Officer, Oncopeptides AB. "These patients have limited, or no treatment options left. The introduction of a new treatment class may represent a potentially important alternative".

The phase 2 HORIZON study is a pivotal, single-arm, multicenter, phase 2 study evaluating the safety and efficacy of melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma. The study included 157 heavily pretreated patients, who had received >2 earlier lines of therapy with immunomodulatory drugs and proteasome inhibitors and were refractory to pomalidomide and/or daratumumab. The HORIZON study population includes subgroups of patients who were triple?class refractory and/or had extramedullary disease and/or had cytogenetic high?risk features.

Summary of results:

30 Intention to Treat (n=157) Triple Class Refractory (n=119) Extra Medullary Disease (n=55)
Overall Response Rate (ORR) 29% 26% 24%
Median Progression Free Survival (PFS)) 4.2 months 3.9 months 2.9 months
Median Overall Survival (OS) 11.6 months 11.2 months 6.5 months
Responding patients n=45 n=31 n=13
Median Duration of Response (DOR) 5.5 months 4.4 months 5.5 months
Median Progression Free Survival (PFS) 8.5 months 8.5 months 17.3 months
The publication is available on; View Source

The information in this press release was submitted for publication on December 9, 2020 at 22:00 (CET).

About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.