VBL Therapeutics to Present at H.C. Wainwright BioConnect Virtual Conference

On January 6, 2022 VBL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune-inflammatory indications, reported that Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics, will present a corporate overview at the H.C. Wainwright BioConnect Virtual Conference being held on January 10 – 13, 2022 (Press release, VBL Therapeutics, JAN 6, 2022, View Source [SID1234598323]).

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H.C. Wainwright BioConnect Virtual Conference
Date: Monday, January 10th, 2022
Time: 7:00 a.m. ET
Format: Corporate Presentation
Webcast: View Source

A link to this webcast will be available on the Events and Presentations page of the Investors section on the Company’s website at www.vblrx.com.

Exelixis and Iconic Therapeutics Amend Option and License Agreement for XB002, an Antibody-Drug Conjugate Targeting Tissue Factor

On January 6, 2022 Exelixis, Inc. (Nasdaq: EXEL) and Iconic Therapeutics, Inc. (Iconic) reported that the companies have amended the terms of their May 2019 exclusive option and license agreement for XB002 (formerly ICON-2), a next-generation tissue factor (TF)-targeting antibody-drug conjugate (ADC) (Press release, Exelixis, JAN 6, 2022, View Source [SID1234598322]). Under the amended agreement announced today, Exelixis has acquired broad rights to use the anti-TF antibody incorporated into XB002, for any application, including conjugated to other payloads, as well as rights within oncology to a number of other anti-TF antibodies developed by Iconic, including for use in ADCs and multi-specific biologics. In exchange, Exelixis will make a one-time payment of $55 million to Iconic and will not owe any further payments to the company. Exelixis will continue to be responsible for milestone payments and royalties owed to Adimab, LLC and royalties owed to Zymeworks Inc. pursuant to prior agreements between Iconic and those companies.

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"We are excited by the early data from the XB002 clinical program and its potential for patients. Tissue factor is a validated target for cancer therapy and may have utility in treating a broad number of cancer types," said Michael Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "Amending our agreement with Iconic provides Exelixis with an opportunity to build the foundation of a promising franchise in this area and will facilitate the discovery and development of additional TF-targeted biologics potentially addressing a wide range of oncology indications that complement and expand on those targeted by XB002. This could include development of new antibody-drug conjugates with alternative toxin payloads, multi-specific antibodies, and other biologics. We look forward to sharing initial data from the ongoing XB002 phase 1 clinical trial this year."

In December 2020 Exelixis exercised its option to in-license XB002 and is currently conducting a phase 1 trial in patients with advanced solid tumors. XB002 is the first of Exelixis’ biologics candidates to enter clinical development, and the company expects to report initial data from the phase 1 study in 2022.

Under the terms of the original May 2019 agreement, Iconic granted Exelixis rights to XB002 and limited rights to the specific anti-TF antibody as incorporated into XB002. The original agreement stipulated that Iconic would be eligible for future development, regulatory and commercialization milestone payments, as well as royalties on potential sales.

Aprea Therapeutics to Present at the 40th Annual J.P. Morgan Healthcare Conference on Thursday, January 13, 2022

On January 6, 2022 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported that Christian S. Schade, Chairman and Chief Executive Officer, will present a corporate update at the 40th Annual J.P. Morgan Healthcare Conference on Thursday, January 13, 2022 at 11:15 a.m. ET (Press release, Aprea, JAN 6, 2022, View Source [SID1234598321]).

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A live webcast of the presentation can be accessed under the "Events Calendar" in the Investors section of the Aprea website at Link.

Lilly and Entos Pharmaceuticals Enter into Research and Collaboration Agreement to Support the Development of Innovative Therapies in Multiple Neurologic Indications

On January 6, 2022 Eli Lilly and Company (NYSE: LLY) reported that has acquired exclusive rights to Entos Pharmaceuticals’ Fusogenix nucleic acid delivery technology to research, develop and commercialize nucleic acid products targeting the central and peripheral nervous system (Press release, Eli Lilly, JAN 6, 2022, View Source [SID1234598320]). This technology provides an opportunity for Lilly to access a novel delivery platform technology with the potential to solve a key delivery challenge for many nucleic acid therapeutic modalities.

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Under the terms of the research and collaboration agreement, Lilly and Entos have agreed to multiple programs focused on the development of proteo-lipid vehicles (PLV) for delivery of therapeutic cargo supplied by Lilly to targets in the central and peripheral nervous systems. Entos will be responsible for the generation, development and optimization of PLVs using its proprietary Fusogenix platform technology. Lilly will be responsible for selecting PLVs for clinical development and commercialization. Entos will receive an initial payment of $50 million, which includes an equity investment by Lilly in Entos. For each of the programs under the collaboration, Entos is also eligible to receive up to $400million in potential developmental and commercial milestone payments, as well as royalties upon the successful development and commercialization of products.

"Nucleic acid-based therapies hold great promise in addressing the biologic cause of many serious diseases that have significant unmet medical need," said Andrew Adams, vice president, Lilly Genetic Medicine. "Overcoming barriers to the safe and effective delivery of such therapies to specific target cells is essential to realizing their potential. We look forward to working with Entos as part of our efforts to overcome this challenge and develop potential new therapies that may improve patient outcomes."
"For more than 145 years, Lilly has demonstrated its ability to incorporate cutting-edge scientific advances into drug development strategies," said John Lewis, Ph.D., founder and CEO of Entos. "We are excited for the opportunity to play a part in Lilly’s ongoing quest to develop high-quality medicines and believe our collaboration with Lilly is an important validation of the potential value of our expertise and technology platform."
This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2021 or 2022 non-GAAP earnings per share guidance as a result of this transaction.

ONK Therapeutics Announces $21.5M Series A Financing to Advance Pipeline of Next-Generation Optimally Engineered Off-the-Shelf NK Cell Therapies

On January 6 2022 ONK Therapeutics, an innovative NK cell therapy platform company, reported the closing of its $21.5 million Series A financing, led by current investors Acorn Bioventures and ALSHC, who were joined by Cormorant Asset Management (Press release, ONK Therapeutics, JAN 6, 2022, View Source [SID1234598318]).

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The financing will enable ONK to maintain its strong momentum as it advances pre-clinical programs through comprehensive IND-enabling studies, including in-vivo proof-of-concept models across multiple programs. ONK will also continue progress towards a GMP manufacturing capability, as it optimizes both its proprietary cell engineering platform and process development.

ONK’s pipeline currently has three programs in pre-clinical development across both hematological malignancies and solid tumors. The Company is pioneering optimally engineered natural killer (NK) cell therapies, utilising a suite of engineering strategies to optimize cytotoxic potential, metabolic health and persistence of NK cells, while reducing the potential for their exhaustion in the tumor microenvironment. This is made possible through the Company’s ability to achieve unique proprietary gene edits.

ONK’s comprehensive owned and exclusively licensed patent estate covers CISH knockout (KO) in the field of human NK cells for the treatment of cancer, irrespective of the NK cell source; the expression of high affinity, membrane bound,TNF-related apoptosis-inducing ligand variants (TRAILv); and the deletion of checkpoint receptors in NK cells, including extracellular proteins CD96, TIGIT, Siglec-7 and PD-1.

These different strategies are being employed across the ONK pre-clinical product portfolio, including:

ONKT102, the Company’s lead program, an optimized affinity CD38 CAR (chimeric antigen receptor) NK cell therapy being developed for the treatment of patients with relapsed refractory multiple myeloma
ONKT104, a CLL-1 CAR-NK program targeting AML stem cells, which is advancing through later stages of its pre-clinical evaluation
ONKT103, which is being optimized to treat solid tumors such as Ovarian, Breast and Non-Small Cell Lung Cancer (NSCLC) and is based on tumor associated MUC-1 targeting CAR NK cells
In addition, these programs will explore incorporating further novel gene edits, such as CISH KO and TRAIL variants targeting DR5 or DR4.

ONK has also recently started two programs focused on the potential of highly functional CISH KO NK cells, namely:

ONKT105, exploring CISH KO cord blood derived NK cells
ONKT106, exploring CISH KO iPSC derived NK cells
The Company also continues to make significant progress on the manufacturing front, optimizing its process development, gene editing capability, efficient expansion techniques and its cryopreservation capability. In combination, these will support manufacturing as part of ONK’s progress towards GMP manufacturing of large numbers of NK cell therapy batches from a single cord.

Chris Nowers, ONK Therapeutics’ CEO said, "We thank our existing investors for their continued support and are pleased to welcome Cormorant Asset Management as a new investor and Andy Phillips to our Board, as we continue against our goal to optimally engineer, off-the-shelf, NK cell therapies to potentially cure patients with cancer. This financing will allow us to continue to deliver against our focused strategy, funding significant program progression, organizational development, and company growth. Within the next 18 months, we have the potential for multiple IND approvals to enable our evolution into a clinical-stage company."

Commenting on the investment, Isaac Manke, Ph.D., Partner at Acorn Bioventures said, "Over the 12 months of our investment, ONK Therapeutics has made excellent progress in advancing both its innovative next-generation NK cell therapy platform and across its exciting portfolio of pre-clinical assets. We are pleased to continue our support and to have introduced Cormorant Asset Management as a new investor to join with ourselves and founding investor ALSHC."

Andy Phillips, Ph.D., Managing Director at Cormorant Asset Management said, "We are impressed by the Company’s potential to make a highly innovative contribution to the quickly evolving field of NK cell therapies, which we believe have the opportunity to improve the lives of patients in need of new treatments for their disease. We are pleased to join the current investor groups in financing ONK as it looks forward to important proof of principle in vivo data and additional value catalyzing milestones."