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."

On April 14, 2021 Hansa Biopharma AB (Nasdaq Stockholm: HNSA) will publish its interim report for January-March 2021 at 8:00 CET on April 22, 2021. All interested parties are invited to participate in a telephone conference, which will include a presentation of the interim results and a business update, on the same date at 14:00 CET/8:00am EST (Press release, Hansa Biopharma, APR 14, 2021, https://www.prnewswire.com/news-releases/hansa-biopharma-to-host-conference-call-to-provide-interim-results-from-q1-2021-and-business-update-301268463.html [SID1234578055]). The event will be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota, and the presentation will be held in English.

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Slides used in the presentation will be live on the company website during the call under "Events & Webcast," and will also be made available online after the call. Link to presentation

On April 14, 2021 Adlai Nortye, a global biopharmaceutical company focused on developing innovative oncology drugs, reported that the first patient has been dosed in the global phase III clinical trial (BURAN) at Shanghai Eastern Hospital Medical Center in China (Press release, Adlai Nortye Biopharma, APR 14, 2021, View Source [SID1234578053]). This clinical study evaluates Buparlisib (AN2025), an oral pan-PI3K inhibitor, in combination with paclitaxel for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This represents the first global multicenter phase III trial for HNSCC in the class of PI3K inhibitors.

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This trial is a randomized, open-label, multicenter phase III study to evaluate the efficacy and safety of Buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC. The primary endpoint of this study is overall survival (OS) for the entire population of patients. This study plans to recruit approximately 500 HNSCC patients from around 150 clinical centers across 15 major countries and regions in North America, Europe and Asia-Pacific. Enrollment includes patients who have disease progressed after prior anti–PD–1/anti–PD–L1 monotherapy, prior anti–PD–1/anti–PD–L1 therapy in combination with platinum-based therapy, or after sequential treatment of anti–PD–1/anti–PD–L1 therapy, either prior to or post, platinum-based therapy.

"Results from a previously completed phase II trial have demonstrated that Buparlisib (AN2025) is well tolerated and shows clear clinical benefits," said Professor Denis Soulières, the Primary Investigator of BURAN study." The objective with BURAN is to be able to offer patients with progression after platinum-based and immunotherapy a better option than taxol."

"Although progress has been made in the treatment of patients with HNSCC in recent years, for those with recurrent or metastatic HNSCC, there is still a high unmet medical need. This BURAN study is expected to change the paradigm of second-line treatment for HNSCC, which offers a new treatment option for patients in China and the rest of the world," said Professor Guo Ye, Director of Phase I Clinical Trail Center of Shanghai East Hospital Affiliated to Tongji University and Member of the Head and Neck Cancer Committee of the Chinese Society of Clinical Oncology (CSCO). "As a physician, I am pleased and welcome more and more clinical trials to be carried out in China. This trial will provide us firsthand data in terms of safety and efficacy in Chinese patients with HNSCC and we are looking forward to bringing the best treatment option for them."

"Cooperating with world-class researchers to conduct high-quality clinical trials is an essential part of Adlai Nortye’s global strategy," said Dr. Lars Birgerson, Chief Medical Officer of Adlai Nortye. "We hope to provide safer and more effective treatments to patients in a timely manner to ultimately save lives. With an impressive median overall survival of 10.4 months and the FDA granted Fast-Track designation, Buparlisib (AN2025) has the potential to become the first PI3K inhibitor on the market for patients with HNSCC."

About BURAN study

The BURAN study is a randomized, open-label, multicenter phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti–PD–1/anti–PD–L1 monotherapy; prior anti–PD–1/anti–PD–L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti–PD–1/anti–PD–L1 therapy, either prior to or post, platinum-based therapy.

About Buparlisib (AN2025)

Buparlisib (AN2025) is an oral pan-PI3K inhibitor that targets all class I PI3K isoforms and is active in both hematologic malignancies and solid tumors. In the global phase II clinical trial for the treatment of head and neck squamous cell carcinoma (HNSCC), the median overall survival was as high as 10.4 months. It has received Fast-Track designation and an approval for initiating the phase III clinical study from FDA. The BURAN study investigating Buparlisib is also the first global phase III clinical trial conducted by Adlai Nortye.

About HNSCC

HNSCC is the 8th leading cancer by incidence worldwide and constitutes 90% of all head and neck cancers. The overall annual incidence of HNSCC patients globally reached approximately 0.84 million in 2020, and is expected to increase to approximately 1 million in 2030. Most patients are suffering from locally advanced HNSCC present with a high risk of recurrence; approximately 50-60% of HNSCC patients are diagnosed with metastatic disease. Although immune checkpoint inhibitors have significantly benefited patients with HNSCC, the overall response rates are relatively low in general. Treatment option for patients that do not respond to immune checkpoint inhibitors is increasingly becoming a significant unmet medical need.

On April 14, 2021 StemSynergy Therapeutics reported that A major scientific breakthrough in the development of novel cancer therapeutics targeting the Notch pathway has been published online ahead of print in the journal Cancer Research (Press release, StemSynergy, APR 14, 2021, View Source [SID1234578051]). In this report scientists describe a small-molecule inhibitor of the Notch pathway that is selective against Notch1, which contributes to many stages of cancer including in the maintenance of cancer stem cells, a main cause of resistance to chemotherapy and metastatic disease. StemSynergy Therapeutics, Inc., who collaborated on this study holds worldwide exclusivity to develop these molecules for the clinic.

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"The Notch pathway is an extremely attractive target for cancer therapeutics, as it is a critical driver of many human cancers. However, several approaches have failed to inhibit Notch safely in clinical trials and progress has nearly stagnated over the last few decades," said Anthony J. Capobianco, Ph.D., corresponding author of the study. "To date, there are no inhibitors that directly target the intracellular Notch pathway with any significant specificity, which is central to safety in humans. Pharma has been trying to target this pathway for more than 20 years and this is the first example of a targeted therapeutic specific for Notch1 that has robust efficacy and minimal toxicity in human-derived malignant tumors models."

In this study, the team of scientists refined their previous proof-of-concept inhibitor using computer modeling and experimental validation to identify chemical compounds that are selective for the Notch1 transcriptional complex. The lead compound, NADI-351, potently disrupts the formation of the Notch1 transcriptional complex which prevents transcription of oncogenic target genes and inhibits the growth of Notch1-dependent cancer cells and tumors.

Further validation confirmed NADI-351 is selective against Notch1 and against cancer stem cells, which require Notch1 activity. This mechanism was observed in multiple in vitro cancer models and replicated in NADI-351-treated human tumors in mice. "Our analysis confirms NADI-351 selectively disrupts Notch1-dependent transcription and that this mechanism has powerful downstream effects on cancer," said Annamil Alvarez-Trotta, Ph.D., first author on the study. "Specifically, NADI-351 clears cancer stem cells by starving them of Notch signaling and causes cell death in tumors, including esophageal and triple-negative breast cancer. "

Most importantly, NADI-351 does not induce the gastrointestinal toxicity which has long hampered development of Notch pathway inhibitors. The key to this therapeutic window is in the selective inhibition of the Notch1 transcriptional complex, while sparing those of other Notch proteins. "It’s likely that this selectivity, along with the short ‘pulse’ of inhibition that small molecules achieve, allows us to preferentially inhibit tumors addicted to Notch1 signaling without causing toxicity in tissues dependent on Notch signaling more generally," noted William Guerrant, Ph.D., Senior Scientist at StemSynergy Therapeutics.

"We feel this new class of Notch1 inhibitors could be a game-changer for patients with Notch-dependent tumors and those that are highly resistant due to cancer stem cell activity," said Capobianco, who is also a co-founder and President of StemSynergy Therapeutics. At the same time this breakthrough science is being published, StemSynergy Therapeutics is developing this class of compound for clinical evaluation. "We plan on aggressively pushing this through preclinical development and into cancer patients as a high priority and hope to be in clinical trials in the near term."