On April 14, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported a license agreement for use of a proprietary Bio-Techne antibody by Xencor, Inc., a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, for its therapeutic development pipeline (Press release, Bio-Techne, APR 14, 2021, View Source [SID1234578017]).

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Bio-Techne is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne is a preferred partner for many pharma and biotech companies who are developing antibody-based therapeutics for a variety of pathologies. Having access to a robust portfolio of antibodies for these coveted targets, as well as an extensive collection of unreleased monoclonal antibody libraries available for screening in novel applications, makes these valuable partnerships possible. This is Bio-Techne’s third licensing agreement with Xencor, a leader in protein engineering in the immuno-oncology field. Under the terms of this agreement, Bio-Techne grants Xencor access to a proprietary Bio-Techne antibody for use with their proprietary XmAb protein engineering technology, which is revolutionizing the development of new cancer therapeutics such as bispecific antibodies and engineered cytokines.

"We are extremely excited about this agreement with Xencor. Our goal for antibody development is to create highly specific antibodies against important therapeutic targets. This additional licensing agreement with Xencor is a perfect example of the value our vast antibody portfolio brings to the biopharma industry," stated Dave Eansor, President of Bio-Techne’s Protein Sciences Segment. "We are proud of our long history of being the partner of choice for therapeutic antibody discovery and our innovative antibody discovery platform that is harnessed by our pharma customers to fast-track their therapeutic programs. With this license agreement, Bio-Techne will increase its presence as a key player in the development of the next generation of immunotherapies."

On April 14, 2021 TriSalus Life Sciences, an emerging immuno-oncology company committed to transforming outcomes for patients with liver and pancreatic tumors, reported data presented at the American Association of Cancer Research showing that regional delivery of oligodeoxynucleotide 2395 (ODN2395) activated the toll-like receptor 9 (TLR9), resulting in reduced tumor burden of liver metastases in mice (Press release, TriSalus Life Sciences, APR 14, 2021, View Source [SID1234578037]).1

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ODNs bind and activate TLR9 to initiate an immune response against certain cancer cells.2 TLR9 agonists (TLR9A) activate both the innate and adaptive immune systems, and play an important role in antiviral and anti-tumor immunity.3 TLR agonists have been administered via different routes based on the therapeutic purpose, however, delivery of TLR agonists into liver tumors by direct needle injection has been clinically challenging, particulary in the setting of a large tumor burden.

The pre-clinical study presented at AACR (Free AACR Whitepaper), conducted by Chandra C. Ghosh and fellow researchers at Roger Williams Medical Center, examined the impact of metastatic liver disease in 12 mice, which were randomized to receive either 1, 3, 10 or 30 micrograms of the TLR9A, ODN2395, through the portal vein (PV) or 30 micrograms administered intravenously (IV). The study showed regional delivery of the TLR9A through the PV at the 30 micrograms dose level was superior to systemic IV administration with respect to control of liver metastases and reduction of liver myeloid-derived suppressor cells (MDSC), which play a crucial role in solid tumor immunosuppression, in addition to favorable effects on liver macrophage subsets.

"Understanding the impact of delivery route on the ability of TLR9 agonists to control liver metastases and favorably modulate the immune microenvironment may help unleash the potential to use the immune system to fight cancer," said Steven Katz, M.D., Chief Medical Officer, TriSalus Life Sciences. "This foundational work will help us tap into the potential of integrating novel therapeutics with drug delivery technology to better penetrate solid tumors."

Solid tumors continue to represent one of the single biggest hurdles to successful cancer treatment.4 High levels of pressure inside solid tumors prevent the delivery of oncology therapeutics, with less than 1% of therapy penetrating solid tumors in some circumstances.5,6 TriSalus developed PEDD to deliver immuno-oncology therapeutics directly into the vasculature of solid tumors with the potential for minimizing systemic toxicity.

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.