On December 2, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that it will be presenting at the Annual LD Micro Main Event to be held virtually from December 14-15, 2020 (Press release, Greenwich LifeSciences, DEC 2, 2020, View Source [SID1234572094]).

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Snehal Patel, CEO of Greenwich LifeSciences, will present and then participate in a live Q&A session by a panel of investors. The presentation will be held at 1:20 pm EST on December 15, 2020, and will highlight the Company’s recently published GP2 data and its plans to commence a Phase III clinical trial. The corporate presentation is currently available on the investor section of the Company’s website at: View Source

About LD Micro

LD Micro is the host of the most influential conferences in the small-cap world. LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. What started out as a newsletter highlighting unique companies has transformed into several influential events annually (Invitational, Summit, and Main Event). With the recent SRAX acquisition, LD has access to the largest active base of micro-cap investors in the world at over 2 million and counting. For more information, please visit the conference website at: View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On December 2, 2020 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported that it will host a webcast on Monday, December 7 at 6:00PM EST to discuss presentations at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held virtually December 5-8, 2020 (Press release, Rocket Pharmaceuticals, DEC 2, 2020, View Source [SID1234572093]). The ASH (Free ASH Whitepaper) presentations will highlight data from the Fanconi Anemia, Leukocyte Adhesion Deficiency-I and the Pyruvate Kinase Deficiency programs.

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Following the discussion, Rocket management and key opinion leaders will be available for a brief Q&A session.

To access the live webcast and presentation, please click here. The webcast replay will be available on the Rocket website following the completion of the call.

Investors may listen to the call by dialing (866) 866-1333 from locations in the United States or +1 (404) 260-1421 from outside the United States. Please refer to conference ID number 50038102.

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.