On April 14, 2021 Samsung Biologics reported on the 17th that it has signed a consignment development (CDO) contract with Panolos Biosciences for ‘PB101’, a new anti-cancer drug candidate (Press release, Panolos Bioscience, APR 14, 2021, View Source [SID1234633685]).

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Through this contract, Samsung Biologics plans to provide services throughout the CDO process, from cell line development of Panolos ‘PB101’ to process development, clinical sample production and clinical trial plan (IND) submission support, and non-clinical and global clinical material production.

‘PB101′, Panolos’ next-generation anti-cancer drug candidate, targets all families (VEGF-A, VEGF-B, Placental Growth Factor) of VEGF (Vascular Endothelial Growth Factor) that is overexpressed around cancer cells. It acts to inhibit the growth of cancer cells. ‘PB101’ is a substance with high difficulty in research due to its complex protein structure.

Samsung Biologics established a customized development strategy for the success of ‘PB101’ and was once again recognized for its complex protein-based high-level development capability and differentiated expertise.

Lim Hye-seong, CEO of Panolos, said, "’PB101′ is expected to have excellent efficacy as an anticancer and VEGF-related disease treatment by itself, and moreover, the material itself has already proven its value as a platform technology." He continued, "In the future, in the development of multiple target candidates including ‘PB101’, we expect to be able to demonstrate high synergy through close mutual cooperation with Samsung Biologics, which has development capabilities."

Taehan Kim, CEO of Samsung Biologics, said, "We are very pleased to have entered into a partnership with Panolos, which has outstanding potential in the field of protein new drug development. We will do our best to accelerate the development of our client’s materials with the world’s best CDO service provided by our company"

On April 14, 2021 Celularity Inc. ("Celularity"), a clinical-stage biotechnology company, leading the next evolution in cellular medicine with the development of off-the-shelf allogeneic therapies derived from the postpartum human placenta, reported the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001, for the treatment of patients with malignant gliomas (Press release, Celularity, APR 14, 2021, View Source [SID1234578060]). CYNK-001 is currently being investigated in a phase 1 clinical trial (NCT04489420) for the treatment of patients with glioblastoma multiforme (GBM), an indication within the scope of this orphan designation.

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"We are very pleased the FDA has granted Orphan Designation in malignant gliomas to continue to develop off-the-shelf therapies for serious unmet clinical needs," said Robert J. Hariri, M.D., Ph.D., founder, Chairperson and Chief Executive Officer of Celularity. "Building on the FDA’s recent decision to grant Fast Track status to CYNK-001, we view the Orphan Drug Designation as yet another milestone on our journey to deliver patients a potentially novel treatment. To date, we have observed the potential of CYNK-001 in multiple preclinical models as well as early evidence of activity in the clinic and believe this approach may shift the paradigm in augmenting the body’s natural immune response to diseases such as glioblastoma, other cancer indications and infectious diseases. We are very excited to continue working with the FDA on the development of this exciting therapy."

About Orphan Drug Designation

The Orphan Drug Act (ODA) encourages biotechnology and pharmaceutical companies to develop drugs for conditions which affect fewer than 200,000 people in the United States by providing economic incentives. To qualify for orphan designation, both the drug and the condition must meet criteria specified in the ODA and FDA’s implementing regulations 21 CFR Part 316. Orphan designation qualifies the drug sponsor for development incentives including tax credits for qualified expenses, reduction in the FDA user fee, and seven years of exclusivity for a drug that obtains approval.

About Malignant Gliomas

Glioma is a type of tumor that occurs in the brain and spinal cord. Malignant gliomas consist of glioblastoma multiforme (GBM), anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, anaplastic ependymoma, and anaplastic ganglioglioma. Malignant gliomas are associated with high morbidity and mortality. GBM accounts for the majority of malignant gliomas. Currently there are no effective long-term treatments for the disease. Patients with GBM usually survive less than 15 months following diagnosis. In most patients, the rapidly growing malignant tumor tends to recur within 6-8 months following treatment. Patients with recurrent GBM have even poorer prognosis. Therefore, malignant gliomas, such as GBM, are serious diseases with high unmet medical needs.

About CYNK-001

Celularity’s lead therapeutic program based on its placental-derived unmodified NK cell type is CYNK-001, an allogeneic unmodified NK cell being developed as a treatment for hematologic malignancies, solid tumors, and infectious diseases.

On April 14, 2021 GeneLeap Bio., a subsidiary of Luye Life Sciences specializing in the development of nucleic acid therapeutics, reported that an ePoster entitled ‘Hydrogel encapsulated TLR9 agonists show sustained tumor growth inhibition and prolong survival of CT26 tumor-bearing mice’ at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting (Press release, GeneLeap Bio, APR 14, 2021, View Source [SID1234578058]). The preclinical study shows that compared with using TLR9 agonist on its own, a hydrogel encapsulated TLR9 agonist, independently developed by GeneLeap Biotech, can significantly improve antitumor performance, while demonstrating tumor growth inhibitory effects similar to that of TLR9 agonist without hydrogel encapsulation.

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AACR Annual Meeting is one of the world’s biggest and most eminent conferences related to cancer research, covering the latest discoveries and drug developments across the spectrum of cancers and highlighting the work of the best minds in research and medicine from institutions all over the world. The meeting was held virtually this year, from April 10 to 15 and May 17 to 21.

TLR9 is one of the most promising targets in current cancer immunotherapies, whose agonist has emerged as a potential monotherapy or in combination with other anticancer therapies. As an innate immune stimulator, TLR9 agonist can be combined with checkpoint inhibitors to increase its anti-tumor effects. By activating the innate immune system, it provides increased immunological impetus against checkpoint inhibitor resistant and refractor tumors.

However, there are certain drawbacks in the clinical application of TLR9 agonist, such as increased toxicity seen with systemic administration. Local injection of the TLR9 agonist is well-tolerated but the drug can degrade in the local tissues or dissipate from the site of action rapidly, resulting in reduced efficacy. Thus, in such cases a weekly or biweekly dosing of TLR9 agonist is usually required to maintain the anti-tumor efficacy.

To address this medical need, GeneLeap Biotech has made a breakthrough by encapsulating TLR9 agonists in injectable hydrogels containing poloxamer for a slow and sustained release of TLR9 agonist over a period of time. GeneLeap’s researchers have conducted preclinical studies in a mouse tumor model to examine whether a single dose of Hydrogel encapsulated TLR9 agonist can be effective over a longer period in immune activation without toxicity.

The current preclinical study showed that a single administration of hydrogel encapsulated TLR9 agonist demonstrates tumor growth inhibition and non-toxicity similar to that of a multiple dose of TLR9 agonist without hydrogel encapsulation. This indicates that for those patients who are resistant or refractory to checkpoint inhibitors, hydrogel encapsulated TLR9 agonist could enhance the immune response to checkpoint inhibitors for a longer time. "Based on the positive preclinical data obtained in a mouse tumor model, we believe this novel formulation – hydrogel encapsulation – will ease frequency of dosing schedules of TLR9 agonists in clinic," said Dr. Jason Zhang, CSO of GeneLeap Biotech.

This preclinical study is also of pioneering significance in exploring further applications of hydrogel formulations. "To our knowledge, this is the first study using hydrogel encapsulation to improve the frequency of dosing of TLR9 agonists in cancer patients," said CEO of GeneLeap Biotech, Dr. Sean Fu. "It helps us enhance understanding of hydrogel formulations and has laid a good foundation for more in-depth clinical research in the area of therapeutic modalities including mRNA and oligonucleotides. As a pharmaceutical biotech focusing on frontier science, GeneLeap Biotech is committed to promoting pioneering science, developing nucleic-acid drugs for tumors and severe infectious diseases, and providing patients with innovative treatments to meet their health needs."

On April 14, 2021 Tango Therapeutics, a biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, and BCTG Acquisition Corp. (Nasdaq: BCTG), a special purpose acquisition company (SPAC) sponsored by Boxer Capital, reported they have entered into a definitive merger agreement. Upon closing of the transaction, the company will be named Tango Therapeutics, Inc. (Combined Company) and will be led by Barbara Weber, MD, President and Chief Executive Officer of Tango (Press release, Tango Therapeutics, APR 14, 2021, View Source [SID1234578057]). Tango Therapeutics, Inc. common stock is expected to be listed on Nasdaq under the ticker symbol "TNGX".

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In addition to the approximately $167 million held in BCTG Acquisition Corp.’s trust account (less any redemptions), a group of healthcare investors has committed to participate in the transaction through a common stock PIPE of approximately $186 million at $10.00 per share. Investors in the PIPE include lead investor and SPAC sponsor Boxer Capital, as well as Avoro Capital Advisors, Bain Capital Life Sciences, funds and accounts managed by Blackrock, EcoR1 Capital, Farallon Capital, Fidelity Management & Research Company LLC, Foresite Capital, Janus Henderson Investors, Logos Capital, RA Capital Management, Samsara BioCapital, Southpoint Capital, Surveyor Capital (a Citadel Company) and Woodline Partners LP, in addition to existing Tango Therapeutics shareholders including Casdin Capital, Cormorant Asset Management and Gilead Sciences.

"This morning’s announcement is a key milestone for Tango as it ensures we have access to the capital needed to advance our preclinical programs and initiate clinical studies of our three lead programs, as we continue our mission of bringing transformational therapies to patients," said Dr. Weber. "I would like to thank all those involved in making this transaction a success, including Boxer Capital, our existing and new investors, and the entire Tango team."

"We were particularly interested in partnering BCTG with a company with a novel approach to treating cancer, a deep pipeline and an exceptional management team, and Tango perfectly embodies the platform and company we had in mind with its focus on synthetic lethality," said Aaron Davis, co-founder and Chief Executive Officer of Boxer Capital, LLC and Chairman and Chief Executive Officer of BCTG Acquisition Corp. "Tango’s lead program, targeting PRMT5, leverages a unique mechanism of action with the potential to address a significant patient population across multiple cancer types, and we are excited about this transaction and supporting Tango on their path into the clinic and beyond."

Proceeds from the transaction are expected to provide Tango with the capital needed to further develop its pipeline, including the following activities:

IND filing for Tango’s lead program, TNG908, an MTA-cooperative PRMT5 inhibitor, expected in the fourth quarter of 2021 and advance it into the clinic with a comprehensive development plan exploring multiple cancer types;
IND filing for Tango’s USP1 inhibitor expected in 2022 and advance it into the clinic for treatment of BRCA1-mutant breast, ovarian and prostate cancer;
IND filing for an undisclosed target expected in 2023 and advance it into the clinic for treatment of STK11-mutant lung cancer; and
Progressing multiple preclinical programs into development with the goal of filing one new IND every 12 to 18 months.
Summary of Transaction

Current Tango shareholders are converting 100% of their existing equity interests into common stock of the Combined Company. In addition to the approximately $167 million held in the BCTG trust account (less any redemptions), an additional group of premier healthcare investors has committed to participate in the transaction through a common stock PIPE of approximately $186 million at $10.00 per share.

The Combined Company is expected to receive gross proceeds of approximately $353 million at the closing of the transaction (assuming no redemptions from BCTG’s trust account), which is expected in the third quarter of 2021. The close of this transaction is subject to approval of BCTG shareholders and the satisfaction or waiver of certain other customary closing conditions.

Goldman Sachs & Co. LLC and SVB Leerink acted as financial advisors for BCTG Acquisition Corp. Goldman Sachs & Co. LLC, SVB Leerink, and Guggenheim Securities, LLC acted as private placement agents for BCTG Acquisition Corp. Barclays acted as capital market and financial advisor to Tango. Wedbush PacGrow also acted as an advisor to Tango. Goodwin Procter LLP acted as legal counsel to Tango. Loeb & Loeb LLP acted as legal counsel to BCTG Acquisition Corp. Cooley LLP acted as legal counsel to the private placement agents.

The description of the business combination contained herein is only a high-level summary. Additional information about the transaction will be provided in a Current Report on Form 8-K that will contain an investor presentation to be filed by BCTG Acquisition Corp. with the Securities and Exchange Commission ("SEC") and will be available at www.sec.gov. In addition, BCTG Acquisition Corp. intends to file a registration statement on Form S-4 with the SEC, which will include a proxy statement/prospectus, and will file other documents regarding the proposed transaction with the SEC.

Conference Call Information

Tango and BCTG Acquisition Corp. will host a conference call today, Wednesday, April 14, 2021, at 10:00 a.m. Eastern Time, to discuss the proposed transaction. To access the conference call, please dial 1 (888) 317-6003 (local) or 1 (412) 317-6061 (international) at least 10 minutes prior to the start time and reference conference ID: 9522795.

On April 14, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported a partnership with Pure Biologics to accelerate the discovery of immuno-oncology antibody-based drugs (Press release, Twist Bioscience, APR 14, 2021, View Source [SID1234578056]).

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"Twist’s unique technological approaches and abilities allow for the rapid generation of diverse synthetic libraries with novel and recent data-based randomization schemes. Combined with our immuno-oncology pipeline and scientific background in the field of therapeutic bispecific antibodies and antibodies bearing protein fusions, we expect this partnership to accelerate our discovery pipeline and build a base for research expansion in the future," said Filip Jelen, Ph.D., CEO of Pure Biologics SA.

Under the terms of the agreement, Twist Biopharma, a division of Twist Bioscience, will grant Pure Biologics’ access to select synthetic antibody phage display libraries derived only from sequences that exist in the human body and further optimized by leveraging state-of-the-art approaches, including artificial intelligence and big data analytics. Certain libraries among the portfolio are deliberately tailored to match chosen classes of biological targets as well as to enhance bispecific antibody forming capabilities. Together, the companies will work to discover, validate and optimize new antibody candidates against targets useful for immuno-oncology applications. Pure Biologics will pay Twist annual technology access fees in addition to future payments for preclinical, clinical and commercial achievement for any antibodies resulting from the collaboration.

"We look forward to augmenting Pure Biologics’ immuno-oncology pipeline with first-in-class bispecific antibodies identified and designed using our robust discovery and optimization engine," commented Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Highly selective, potent bispecific antibodies that bind to multiple targets have the potential to change the way cancer is treated in the future."