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.

On December 9, 2020 Biochain reported that There have been tremendous advances in cancer treatment since President Richard Nixon declared war on malignancies in 1971 (Press release, Biochain, DEC 9, 2020, View Source [SID1234572520]). Despite having treatments such as targeted radiation, estrogen blockers, and CAR-T cell immunotherapies, early detection of cancer remains one of the most important factors. For instance, the five-year relative survival rate for non-small cell lung cancer is 61% when cancer has not yet spread outside the lung. The survival rate drops to 35% once the cancer invades nearby structures, and to 6% once it metastasizes to other organ systems.

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However, early detection of cancer has proven easier said than done, and not without risks. When screening for cancer certain number of patients experience anxiety and undergo unnecessary invasive procedures based on false positives. While some cancers make for relatively easy screening such as cervical cancer via the Pap test, many cancers are inaccessible, and tissue biopsy too invasive for population-level screenings.

The oncologist’s objective is to come up with a less invasive way of screening the healthy population for specific and accurate indications of early-stage cancer. This motivated scientists to develop "liquid biopsy," where doctors hope to detect tumor-specific protein biomarkers or cancer-associated genetic mutations in circulating free DNA (cfDNA) blood samples.

In an article published in the journal Science, Johns Hopkins researchers Bert Vogelstein and Nickolas Papadopoulos and their colleagues appear to have done exactly that.

A leap in early cancer detection

A breakthrough was achieved using a liquid biopsy test called "DETECT-A" ̶̶ Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing ̶ which involved more than 9,911 women who had no history of cancer. The study used a multi-cancer blood test, to identify 26 undiagnosed cancers in 10 different organ systems: appendix, breast, colorectal, kidney, lung, lymphomas, ovary, thyroid, uterine and unknown primary site. The tumors were then localized using techniques such as PET-CT, a combination that was 99.6% specific.

Importantly, 17 of the cancers detected by the blood test were diagnosed at an early stage. Twelve of the 26 patients were in remission and eight were still in treatment or had stable disease nine months post-diagnosis.

This was a landmark result for the liquid biopsy field and the industry took note. A more advanced version of the multi-cancer blood test known as CancerSEEK had been licensed by Johns Hopkins to Thrive Earlier Detection Corp for development. On Oct. 27, Exact Sciences announced it would acquire Thrive for $2.15 billion.

Foundational technology

Although much of the liquid biopsy breakthrough has come from next-generation sequencing (NGS) and machine learning, the fundamentals of the field are still focused on an accurate and successful sampling process. If there is no adequate sample in the first place, no algorithm can support it. The DETECT-A study made use of the cfPure extraction kit from BioChain, a magnetic bead-based technology that demonstrated high yields in extracting cfDNA from blood plasma. "In order to get that cfDNA, you need to have the right tools," says BioChain’s Production and R&D Manager Dr. Franklin Chin, "and we have them. Our extraction kit is the first step in any research that involves cfDNA biomarker discovery"

The cfPure kits are available from BioChain in three different sizes for the extraction of a maximum of 250 ml of cfDNA from human plasma samples. The kit has two different versions: the original cfPure kit which maximizes yield, and the "V2," which minimizes carryover of genomic DNA into the final elution.

Dr. Bert Vogelstein and his colleagues used the original version of cfPure kits, and the fact that such pioneering researchers used BioChain’s technology in a groundbreaking study to process tens of thousands of samples is a source of pride for BioChain. "Dr. Vogelstein is one of the pioneers of liquid biopsy research," Chin says, "that he is using our kit is pretty big for us."

Detection of early-stage cancer using the DETECT-A test is just the first of many breakthroughs BioChain hopes their technology will enable. Beyond early diagnosis, for instance, there are efforts at precision tumor treatment and companion diagnostics, according to Chin. Many cancers are drug-resistant, and that resistance is based on their mutational profile. Pairing the cfPure kit with NGS using specific biomarker panels can help identify the mutational landscape for a patient, indicating the therapies best suited to treating their specific cancer.

Chin also hopes to see BioChain’s technology used in the creation of biomarker panels to help identify mutations with a strong correlation to oncogenesis. "You need to have a solid foundation," he says. "You need to collect as many samples as possible, analyze them, and come up with a panel of biomarkers." That will expand the reach and accuracy of liquid biopsy, and, ultimately, the success of cancer treatments. That’s something Chin and BioChain are excited to be a part of.

A menu of research solutions

Whatever your research needs, BioChain offers a cfPure cell-free DNA extraction kit providing market-leading yields for the best possible input for NGS or other processing.

BioChain also offers blood plasma and tissue samples for researchers who need inputs to develop and test their technologies and offers the cfPure cell-free DNA extraction process as a service for those who cannot perform the extractions themselves.