On December 2, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed the nine-months product stability testing that is required by the U.S. Food and Drug Administration (FDA) for its CypCaps final product, which will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (Press release, PharmaCyte Biotech, DEC 2, 2020, View Source [SID1234572092]).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed nine-month stability study, "The product stability studies of our CypCaps product initiated prior to submitting our Investigational New Drug application (IND) to the FDA are still proceeding smoothly while we are answering the questions raised by the FDA following our IND submission. We are also starting additional studies designed to provide information that the FDA has requested, which are mainly focused on the handling of the CypCaps product in the clinic, and on additional animal data to add to the data that we have already supplied in our IND package.

"The ongoing stability study is designed to determine the shelf life of the Cell-in-a-Box encapsulated cell product, CypCaps, frozen at -80°C, and I am pleased to report that the nine-month time point was recently reached and that CypCaps passed all of the necessary tests, including cell viability, enzyme activity and cell potency, pH, label check, capsule appearance and integrity. This nine-month data, as well as all future longer-term time points of the shelf life analyses, such as the next milestone, the 12-month time point, will be reported to the FDA as an update to our submitted IND."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On December 2, 2020 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR platform, reported that it has expanded its ADAPTIR bispecific platform technology to include a new multi-specific platform technology, ADAPTIR-FLEX (Press release, Aptevo Therapeutics, DEC 2, 2020, View Source [SID1234572091]). Aptevo also announced that it has developed a new bispecific candidate, APVO442, that uses ADAPTIR-FLEX platform technology. APVO442 is a unique T-cell engager designed to target PSMA (prostate specific membrane antigen) and CD3 with low affinity for the treatment of prostate cancer. Prostate cancer is one of the most common forms of cancer in men.

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ADAPTIR-FLEX expands Aptevo’s ability to create novel therapeutic multi-specific candidates with the potential of exhibiting a wide variety of mechanisms of action. The new ADAPTR-FLEX platform technology enables the design of candidates that have modified affinity and valency to a target, which has the potential to improve specificity, tumor targeting, and therapeutic benefit with application to multiple hematologic and solid tumors. ADAPTIR-FLEX utilizes the same IgG-backbone and linkers found in ADAPTIR, but in a heterodimeric format, while retaining good manufacturability attributes and extended half-life that may enable improved dosing regimens in clinical development.

Aptevo also announced that it has developed a new bispecific candidate, APVO442, that utilizes ADAPTIR-FLEX platform technology targeting PSMA and CD3 for the treatment of prostate cancer. There has been early clinical validation of the combination of PSMA x CD3 as a bispecific in clinical development. Aptevo designed the new bispecific candidate APVO442 to have two binding domains targeting PSMA, to potentially increase avidity (strength) of binding to the tumor antigen PSMA, with one binding domain to CD3 with reduced binding affinity to T cells demonstrated in vitro.

"We are very excited about the launch of our second platform technology, ADAPTIR-FLEX, which expands our capability to design candidates with multiple new mechanisms of action, with potential best-in-class attributes," said Mr. Marvin White, President and CEO of Aptevo. "Recently, we had two patients in cohort 6 of our phase 1 APVO436 clinical trial achieve complete remission, which strengthened our resolve around the capabilities of our ADAPTIR platform technology. Our new bispecific candidate APVO442, built on ADAPTIR-FLEX, is a unique T-cell engager targeting PSMA and CD3 for the treatment of prostate cancer, and we are optimistic about the potential outcomes for patients impacted by these tumors," concluded Mr. White.

"The low affinity to CD3 and increased binding strength to PSMA are designed to potentially achieve better biodistribution to PSMA-positive tumors. Reducing the affinity to CD3 may have improved therapeutic benefit for treatment of prostate cancer compared to other CD3-based bispecifics targeting PSMA. In addition, this approach, using ADAPTIR-FLEX, can be applied to additional solid tumor types," said Jane Gross Ph.D., Chief Scientific Officer of Aptevo.

Aptevo believes that ADAPTIR-FLEX CD3-based candidates have the potential to demonstrate reduced production of cytokines consistent with other ADAPTIR-based T-cell engagers like observations made for APVO436 in preclinical studies. The reduced cytokine profile has been demonstrated for APVO442 in both in vitro and in vivo preclinical studies when T cells are challenged in the presence of drug and antigen-expressing tumors. This may reduce toxicities compared to those observed by other CD3-based T cell engagers with potential to achieve better efficacy and an increased therapeutic index in clinical development.

The therapeutic candidates APVO436, ALG.APV-527 and APVO603 based on the bivalent, bispecific ADAPTIR platform technology are advancing in clinical and preclinical development, respectively. Both the ADAPTIR platform technology and the ADAPTIR-FLEX platform technology will be used to develop therapeutic candidates based on desired mechanisms of action, to populate our portfolio with new bispecific and multi-specific protein therapeutics to potentially address unmet medical needs.

On December 2, 2020 Exelixis, Inc. (Nasdaq: EXEL), Iconic Therapeutics, Inc. (Iconic) and Zymeworks Inc. (NYSE:ZYME) reported that Exelixis has exercised its exclusive option for Iconic’s lead oncology antibody-drug conjugate (ADC) program under the companies’ May 2019 agreement (Press release, Exelixis, DEC 2, 2020, View Source [SID1234572090]). As a result, Exelixis now has responsibility for the future clinical development, commercialization, and manufacturing of the Tissue Factor (TF)-targeting ADC now known as XB002 (formerly ICON-2). A rationally designed next-generation ADC, XB002 comprises a Tissue Factor-targeting antibody with Zymeworks’ proprietary ZymeLink linker-payload, creating the potential for an improved therapeutic index and favorable safety profile as compared to earlier-generation, TF-targeting ADCs. Exelixis plans to file an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for XB002 in the near-term and, pending the FDA’s acceptance of the IND, initiate a phase 1 clinical trial of XB002 in early 2021.

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"XB002 is an important addition to the Exelixis pipeline given its potential differentiation from other Tissue Factor-targeting antibody-drug conjugates and its status as the first program in our growing biologics portfolio to reach IND filing stage," said Peter Lamb, Ph.D., Executive Vice President and Chief Scientific Officer of Exelixis. "Iconic designed a highly promising molecule and advanced it through a rigorous preclinical evaluation, setting the stage for Exelixis to complete our planned IND filing in the coming weeks. We are grateful for Iconic’s partnership over the past 18 months and look forward to fully evaluating the potential of XB002 to help patients with cancer."

Under the terms of the May 2019 agreement between Exelixis and Iconic, Exelixis gained an exclusive option to license XB002 (then ICON-2) in exchange for an upfront payment to Iconic of $7.5 million and a commitment of preclinical development funding. In exercising its exclusive option, Exelixis has made an additional option exercise payment of $20 million to Iconic. Iconic is now also eligible for future development, regulatory and commercialization milestone payments, as well as royalties on potential sales. The ZymeLink ADC technology in XB002 was originally licensed to Iconic from Zymeworks. Under the terms of their 2019 agreement, Zymeworks will receive a share of the $20 million option fee and is eligible to receive a share of all future revenue received by Iconic, as well as tiered royalties on worldwide sales.

"Exelixis’ decision to in-license our lead oncology program provides important validation of Iconic’s discovery and development capabilities, our platform of proprietary anti-Tissue Factor molecules designed to efficiently but safely bind Tissue Factor, and the potential of Tissue Factor as an oncology antibody-drug conjugate target," said William L. Greene, M.D., Chief Executive Officer of Iconic Therapeutics. "Preclinical data presented earlier this year demonstrate that XB002 binds Tissue Factor without affecting the coagulation cascade, which has hindered prior development of Tissue Factor-targeting molecules, has activity in multiple solid tumor cancer models and has improved tolerability compared to other Tissue Factor-targeting ADCs. We are excited to see XB002 make further progress as part of Exelixis’ highly-regarded clinical development organization."

"We are excited to see this promising molecule take an important step towards clinical trials backed by the experienced clinical team at Exelixis," said Tony Polverino, Ph.D., Executive Vice President, Early Development and Chief Scientific Officer of Zymeworks. "This would mark the second ZymeLink-based therapeutic to enter the clinic in addition to our bispecific HER2 antibody-drug conjugate, ZW49, further highlighting the differentiative potential of our novel antibody-drug conjugate platform."

Pending the completion of Exelixis’ planned IND and the FDA’s acceptance of the filing, Exelixis intends to initiate a phase 1 dose escalation and expansion study of XB002 in subjects with inoperable locally advanced or metastatic solid tumors early in 2021.

On December 2, 2020 FibroGen, Inc. (Nasdaq: FGEN) and its partner, AstraZeneca (LSE/STO/Nasdaq: AZN), reported that it will present additional analyses of roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (MDS) and results from multiple roxadustat phase 3 studies. Roxadustat is a first-in-class oral small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in development for the treatment of patients with anemia of CKD and anemia secondary to lower-risk MDS (Press release, FibroGen, DEC 2, 2020, View Source [SID1234572089]). FibroGen and its partner will present eight abstracts at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually December 5-8, 2020.

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"We are pleased to share additional 52-week data from the open-label portion of our Phase 3 anemia of MDS trial with the medical community at ASH (Free ASH Whitepaper)," said Enrique Conterno, Chief Executive Officer, FibroGen. "In addition, we are presenting Phase 3 cardiovascular safety and efficacy results of roxadustat, which highlight its potential in a broad range of CKD patients."

MDS is a group of blood disorders characterized by poorly formed or dysfunctional blood cells, resulting in chronic anemia.1 Exploratory analyses to be presented at ASH (Free ASH Whitepaper) show the efficacy of roxadustat in transfusion-dependent lower-risk MDS patients regardless of ring sideroblast and baseline erythropoietin status – characteristics used to predict response to treatment.2 Patients with ring sideroblasts (RS+), without ring sideroblasts (RS-), baseline erythropoietin (BL EPO) ≤ 200 mIU/ml, and BL EPO > 200 mIU/ml achieved the primary endpoint of transfusion independence for ≥ 8 weeks during the first 28 treatment weeks (23% of MDS-RS+, 55% of MDS-RS-, 39% of BL EPO ≤ 200 mIU/ml, and 33% of BL EPO > 200 mIU/ml patients). Detailed results will be presented at the meeting.

Enrollment in the double-blind placebo-controlled portion of the Phase 3 roxadustat study of patients with anemia secondary to lower-risk MDS is ongoing (NCT03263091).

Roxadustat presentations during the 62nd ASH (Free ASH Whitepaper) Annual Meeting and Exposition:

Presenter Presentation title Presentation details
David Henry, MD Oral Roxadustat Demonstrates Efficacy in Anemia Secondary to Lower-Risk Myelodysplastic Syndrome Irrespective of Ring Sideroblasts and Baseline Erythropoietin Levels ePoster #1277
Session 637: Myelodysplastic Syndromes—Clinical Studies (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Steven Fishbane, MD Roxadustat Lowers Risk of RBC Transfusion in Patients with Anemia of CKD

ePoster #748
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Steven Fishbane, MD Pooled Efficacy and Cardiovascular Safety Results of Roxadustat Compared with Epoetin Alfa in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis ePoster #749
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Carol Pollock, MD Roxadustat Increases Hemoglobin in Anemic Non-Dialysis-Dependent (NDD) Chronic Kidney Disease (CKD) Patients Independent of Inflammation ePoster #757
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Roberto Pecoits-Filho, MD Roxadustat Treatment Results in Consistent Improvements in Hemoglobin (Hb) Versus Placebo: An Analysis of 3 Multinational RCTs in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) ePoster #758
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Anjay Rastogi, MD Roxadustat Treatment Corrects Anemia to Hemoglobin (Hb) Values ≥10 g/dL in the Majority of Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) ePoster #761
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Steven Fishbane, MD Hemoglobin (Hb) Correction with Roxadustat is Associated with Improved Iron Homeostasis in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) ePoster #766
Session 102: Regulation of Iron Metabolism (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Robert Provenzano, MD Pooled Efficacy and Cardiovascular Analysis of Roxadustat Compared with Placebo in Anemia Correction in Chronic Kidney Disease Patients Not on Dialysis ePoster #1671
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster II)
Sun., Dec. 6: 7:00 AM–3:30 PM PT
About Anemia of CKD
Chronic kidney disease (CKD) is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant. CKD is estimated to occur in approximately 10-12% of adults worldwide and is predicted to become the fifth most common cause of premature death globally by 2040.

Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is a common early complication of CKD, affecting approximately 20% of CKD patients. Anemia of CKD is associated with an increased risk of hospitalization, cardiovascular complications, and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life. Blood transfusions are used for treating severe anemia, however, they may reduce a patient’s opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.

About MDS
MDS develops because the bone marrow cells do not develop into mature blood cells. Instead, these blood cells stay within the bone marrow in an immature state. There are many subtypes of MDS. Some cases are mild, while others are more severe, and carry a high risk of becoming acute myelogenous leukemia (AML). It is estimated that more than 10,000 patients are diagnosed with MDS each year in the U.S.,3 and overall prevalence is estimated to be between 60,000 – 170,000 in the country.4

About Roxadustat
Roxadustat is a first-in-class orally administered inhibitor of HIF-PH, which increases hemoglobin levels through a mechanism of action that is different from that of traditional erythropoiesis-stimulating agents. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. Roxadustat promotes red blood cell production through increased endogenous production of erythropoietin; improved iron absorption, transport, and mobilization; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production.

Roxadustat is approved and launched for the treatment of anemia of CKD in Japan and China in adult patients on dialysis (DD) and not on dialysis (NDD). A New Drug Application for the treatment of anemia of CKD in patients both DD and NDD is under review by the U.S. Food and Drug Administration with a decision expected in December 2020. The marketing authorization application for roxadustat for the treatment of anemia of CKD in patients both DD and NDD was accepted by the European Medicines Agency for review on May 21, 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, which are currently in review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

On December 2, 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 financial results for the second quarter and first six months of fiscal 2021, ended October 31, 2020 (Press release, Avid Bioservices, DEC 2, 2020, View Source [SID1234572083]).

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Highlights Since July 31, 2020

"During the second quarter, we recorded strong revenues, expanded our customer base and project pipeline, and advanced the company’s expansion plans," stated Nicholas Green, president and chief executive officer of Avid Bioservices. "Driven by growth in customer demand, the company achieved higher-than-expected revenues and margins, and generated operating cash flow and income from operations during the period. In consideration of these results combined with our substantial backlog and our visibility into customer demand, we are raising revenue guidance for fiscal 2021 from between $76 and $81 million to between $84 and $88 million.

"On the business development front, our team continues to execute, signing new business orders and project expansion orders with existing customers for $28 million during the quarter and increasing backlog to $67 million, our highest level since becoming a pure-play CDMO.

"With respect to operations, we have completed a comprehensive review of our options and have initiated a phased approach plan for expansion. Phase 1, which is currently underway, is focused on the streamlining of existing facilities. We are confident that this work will allow us to optimize capacity, increase revenue, minimize near-term expense, and best align our expansion with growth in customer demand.

"And finally, it is important to note that we continue to execute our business and achieve growth without interruption to our operations as a result of the COVID-19 pandemic. This resilience is due largely to the diligence and dedication of our employees. Despite these challenging times, Avid’s incredible workforce remains committed to excellence to ensure the highest quality product for our clients."

Financial Highlights and Guidance

The company is increasing revenue guidance for the full fiscal year 2021 from between $76 million and $81 million to between $84 million and $88 million.

Revenues for the second quarter of fiscal 2021 were $21.1 million, a 15% increase compared to revenues of $18.3 million recorded during the second quarter of fiscal 2020. The year-over-year increase in revenue was primarily attributable to the growth in the number and scope of in-process and/or completed manufacturing runs during the quarter. In addition, the increase in manufacturing revenues included the recognition of $1.7 million from changes in estimated variable revenue consideration as a result of completing performance obligations for certain projects during the quarter, therefore increasing revenue recognized for those projects during the period. For the first six months of fiscal 2021, revenues were $46.5 million, a 38% increase as compared to revenues of $33.6 million in the prior year period. The increase in revenues can be attributed to a $13.6 million increase in manufacturing revenues primarily due to an increase in the number and scope of in-process and/or completed manufacturing runs during the first six months of fiscal 2021, partially offset by a $0.7 million decrease in process development revenues.

As of October 31, 2020, revenue backlog was $67 million, an increase of 12% compared to $60 million at the end of the first quarter of fiscal 2021, and an increase of 3% compare to $65 million at the end of last fiscal year. The company expects to recognize the majority of this backlog over the next twelve months.

Gross margin for the second quarter of fiscal 2021 was 30%, a significant increase compared to a gross margin of 18% for the second quarter of fiscal 2020. The increase in gross margin for the 2021 quarter was primarily attributable to the growth in manufacturing revenues, including the $1.7 million in additional manufacturing revenue recognized, as previously discussed. Excluding the $1.7 million in additional variable revenue consideration, gross margin for the second quarter was approximately 24%. Gross margin for the first six months of fiscal 2021 was 32%, a significant increase compared to 13% in the prior year period. This increase was also primarily due to the growth in manufacturing revenues.

Selling, general and administrative expenses ("SG&A") for the second quarter of fiscal 2021 were $4.2 million, an increase compared to $3.5 million recorded for the second quarter of fiscal 2020. The increase during the 2021 quarter was due primarily to increases in payroll related costs, including stock-based compensation. For the first six months of fiscal 2021, SG&A expenses were $8 million, consistent with $8 million for the prior year period.

For the second quarter of fiscal 2021, the company recorded a consolidated net income attributable to common stockholders of $0.8 million or $0.01 per basic and diluted share, as compared to a consolidated net loss attributable to common stockholders of $1.9 million or $0.03 per basic and diluted share, for the second quarter of fiscal 2020. For the first six months of fiscal 2021, the company recorded a consolidated net income attributable to common stockholders of $4.5 million or $0.08 per basic and diluted share, compared to a consolidated net loss attributable to common stockholders of $6.1 million or $0.11 per basic and diluted share, for fiscal 2020.

Avid reported $35.7 million in cash and cash equivalents as of October 31, 2020, an increase of $7.5 million compared to cash of $28.2 million at the end of the first quarter of fiscal 2021, and consistent with $36.3 million in cash as of the prior fiscal year ended April 30, 2020. The company also generated cash flows from operating activities of $8.1 million during the six months ended October 31. 2020.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

Signed orders for $28 million during the quarter with new and existing customers, driving Avid’s backlog to its highest level since transitioning to a dedicated CDMO.
Developed plans for a two-phased expansion of our Myford facility. The first phase, which has commenced, expands the production capacity of our existing Myford North facility by adding a second downstream processing suite. The second phase, the timing of which will be dictated by revenue growth and projected customer demand, will further expand capacity through the build out of a second manufacturing train, including both upstream and downstream processing suites within Myford South.

The company estimates the first phase will take approximately 12 to 15 months to complete at an estimated cost of approximately $15 million and may increase the company’s annual revenue generating capacity by up to $50 million, bringing the combined annual revenue generating capacity of our Franklin and Myford North facilities to up to $170 million.
Conference Call

Avid will host a conference call and webcast this afternoon, December 2, 2020, at 4:30 PM EST (1:30 PM PST).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source