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 TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapeutics, reported a clinical trial collaboration agreement with MSD, a premier research-intensive biopharmaceutical company, to evaluate TILT’s adenoviral cancer immunotherapy TILT-123, a dual cytokine armed oncolytic adenovirus, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in a Phase I dose escalation trial in platinum resistant or refractory ovarian cancer (Press release, TILT Biotherapeutics, APR 14, 2021, View Source [SID1234577994]).

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The trial will include 15 to 30 patients and will be led by Dr. Matt Block at Mayo Clinic (Minnesota, USA). During the first month of the trial, patients will receive TILT-123 monotherapy, and thereafter consecutive treatments of TILT-123 in conjunction with pembrolizumab. The trial’s objective is to evaluate the safety and efficacy of TILT-123 in combination with pembrolizumab and is designed to also deliver insights about the mechanism of action of TILT-123 in humans.

A Phase I trial with TILT-123 conducted in Europe showed no serious adverse events when used as a monotherapy or in combination with tumour infiltrating lymphocytes (TILs) at the first dose level (1) and has now progressed to the second dose level.

TILT Biotherapeutics’ CEO, Akseli Hemminki, a biotech entrepreneur and cancer clinician who has personally treated almost 300 patients with ten different oncolytic viruses, said, "There is a pressing need for a therapy to address platinum refractory ovarian cancer. The heart of our approach revolves around the use of oncolytic adenoviruses armed with cytokines to boost the patient’s immune response towards the tumor, enabling it to find and destroy cancer cells. We are delighted to be working with MSD to progress our lead candidate, TILT-123, towards the clinic in combination with its breakthrough immunotherapy KEYTRUDA."

(1) View Source

On April 14, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPD) to its p-STAT3 inhibitor, WP1066, for the treatment of ependymoma (Press release, Moleculin, APR 14, 2021, View Source [SID1234578018]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

Ependymoma is a rare type of tumor that can form in the brain or spinal cord. Ependymoma begins in the ependymal cells in the brain and spinal cord that line the passageways where the fluid (cerebrospinal fluid) that nourishes your brain flows. Ependymoma can occur at any age, but most often occurs in young children.

"The FDA’s recognition of the high prevalence and unmet needs in the treatment landscape for ependymoma, especially in pediatric patients is a significant milestone as we continue to advance and expand the WP1066 development program. We currently have Orphan Drug Designation for WP1066 for the treatment of brain tumors, as well as RPD designation for three other pediatric indications, and believe that ependymoma represents another important rare indication. We continue to be encouraged by the data WP1066 has demonstrated to date and believe it has the potential to be an effective therapy for pediatric patients with ependymoma," commented Walter Klemp, Chairman and CEO of Moleculin.

The Rare Pediatric Disease Priority Review Voucher program, which was created as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, is intended to incentivize the development of new therapies for rare pediatric diseases. Under the FDA’s rare pediatric disease designation program, the FDA may grant a priority review voucher to a sponsor who receives a product approval for a "rare pediatric disease," which is defined as a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years and affects fewer than 200,000 people in the U.S. Subject to FDA approval of WP1066 for the treatment of ependymoma, Moleculin would be eligible to receive a voucher that may be redeemed to receive priority review for a subsequent marketing application for a different product candidate or which could be sold or transferred.

About WP1066

WP1066 is an immune/transcription modulator capable of directly inhibiting certain key oncogenic transcription factors, including the activated form of a protein known as STAT3. The activated form of STAT3 referred to as p-STAT3, is considered a master regulator of tumor activity. In addition to inhibiting p-STAT3 and several other signaling proteins linked to tumor development, WP1066 has also been shown in animal models to stimulate a natural immune response and immune memory to fight tumor progression.

On April 14, 2021 Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported business highlights and financial results for the first quarter ended February 28, 2021 (Q1 Fiscal 2021) (Press release, Theratechnologies, APR 14, 2021, View Source [SID1234578039]).

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"Theratechnologies is at a unique point in its evolution, and we have a tremendous opportunity ahead of us," said Paul Levesque, President and Chief Executive Officer at Theratechnologies. "We are particularly pleased with the swift advancement of our Phase 1 oncology program, which has dosed its first patient, and the continued progress we have made toward advancing our Phase 3 trial in NASH.

"We believe we are well-positioned for growth when we begin to emerge from the COVID-19 pandemic. In line with these efforts is our continued focus on strengthening our business with the addition of key talent and resources. While first-quarter revenues were relatively flat year-over-year, we believe that we have aligned our organization to provide an optimal landscape to further validate and drive value for our commercial and R&D opportunities," concluded Mr. Levesque.

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."