On October 5, 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 an expansion of its expert-led Alliance Panel product offering (Press release, Twist Bioscience, OCT 5, 2021, View Source [SID1234590884]). Designed through collaboration with world-leading experts, Twist Alliance Panels combine validated content with Twist next-generation sequencing (NGS) workflow, target enrichment and DNA probes. In an extension of Twist’s OEM strategy, Twist will market products designed by key opinion leaders in a wide range of clinical applications and powered by Twist tools through the Alliance Panel program. In return, expert collaborators receive a royalty on the sale of products and will carry partner branding.

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"Data generated and validated by experts around the world bring incredible value to the research community," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "By working together, we are leveraging this extensive knowledge, providing the global community with better research tools, all powered by Twist products, and also ensuring the experts involved receive recognition and royalties for their hard work."

As the first Alliance Panel offering, Twist collaborated with the Regeneron Genetics Center LLC (RGC), a wholly-owned subsidiary of Regeneron, to develop the Twist Diversity SNP Panel, a custom NGS population genetics genotyping assay available to researchers globally for population genomics studies.

Today, Twist and AnchorDx launched the Twist Alliance Pan-cancer Methylation Panel based on The Cancer Genome Atlas (TCGA) database, including 31 cancer types and 47 TCGA database disease entities. The pan-cancer profile saves customers sequencing costs and reduces the complexity of analysis. Validation studies were conducted using tumor biopsy samples from breast cancer, colorectal cancer and non-small cell lung cancer. DNA methylation regions included in the panel have been found to clearly differentiate cancer tissues from the non-malignant tissue in these three cancer types, among the most common cancers.

About Twist Alliance Panels

In partnership with leading research institutions from around the world, Twist has curated a collection of high-quality target enrichment panels for applications ranging from carrier screening to cancer diagnostics and whole exome sequencing. The Twist Alliance Panels combine the strengths of precise, highly uniform oligonucleotide synthesis with the specialty expertise of leading scientific research partners.

Well designed, custom target enrichment panels enable increased sequencing depth on target genes while reducing overall sequencing. This allows for more sensitive detection of target sequences and higher confidence variant detection.

On October 5, 2021 AbbVie (NYSE: ABBV) reported that it will announce its third-quarter 2021 financial results on Friday, October 29, 2021, before the market opens (Press release, AbbVie, OCT 5, 2021, View Source [SID1234590808]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time. It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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On October 5, 2021 UroGen Pharma Ltd. (Nasdaq: URGN) reported that The Journal of Urology published results from the Phase 2b OPTIMA II trial, a Phase 2b, open-label, single-arm trial studying UGN-102 (mitomycin) for intravesical solution as primary non-surgical therapy for low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC)(Press release, UroGen Pharma, OCT 5, 2021, View Source [SID1234590828]). The study was published online and will be in the January print edition of The Journal of Urology.

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Approximately 50-60% of the 81,000 estimated new cases of non-muscle invasive bladder cancer (NMIBC) diagnosed in the U.S. in 2020 were low-grade. Patients with LG IR-NMIBC are chronically relapsing, and their only treatment option is repeated transurethral resection of bladder tumor (TURBT) with or without adjuvant chemotherapy. Some patients require multiple TURBT surgeries per year, which may lead to post-operative and long-term morbidity for this patient population.

The OPTIMA II Phase 2b results showed a significant treatment response with sustained durability in non-surgical chemoablation of LG IR-NMIBC. As previously reported, 65% (41/63) of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy, of whom 39 (95%), 30 (73%), and 25 (61%) remained disease-free at 6, 9, and 12 months after treatment initiation, respectively. The probability of durable response nine months after CR (12 months after treatment initiation) was estimated to be 72.5% by Kaplan-Meier analysis. Thirteen patients had documented recurrences. 57 of 63 (90%) patients completed all 6 instillations of UGN-102 according to study protocol.

"The data from the OPTIMA II trial represent a significant advancement in the development of UGN-102 for the treatment of LG IR-NMIBC and further support the contention that non-surgical therapy for this disease is both technically feasible and clinically meaningful," said Dr. Mark Schoenberg, Chief Medical Officer at UroGen. "With UGN-102, our goal is to change the treatment paradigm in LG IR-NMIBC by enabling non-surgical chemoablation. These results provide an important validation of our approach to treating low-grade disease, and our rationale for the continued evaluation of UGN-102 in the ongoing Phase 3 ATLAS study."

Treatment with UGN-102 was generally well tolerated and the safety profile was consistent with previously reported results. The most common adverse events (≥ 10%) were generally reported as mild to moderate and included dysuria, urinary frequency, hematuria, micturition urgency, urinary tract infection, and fatigue.

"The significant treatment response and sustained durability observed in this trial indicate that UGN-102 has the potential to become a non-surgical alternative for these chronically relapsing patients, who typically undergo repetitive surgeries," said William C. Huang, M.D., FACS, Professor of Urology and Radiology and Vice Chair of Urology at NYU Langone Health and Principal Investigator of the OPTIMA II trial. "Even more encouraging is that 12 months after treatment was initiated, approximately 73% achieved durable response."

Final top-line data were announced in November 2020 and additional details were presented at the American Urological Association (AUA) 2021 Annual Meeting in September 2021 [21-8601-Podium Presentation].

About the Phase 2b OPTIMA II Trial

OPTIMA II (OPTimized Instillation of Mitomycin for Bladder Cancer Treatment) is an open-label, single-arm, multi-center Phase 2b clinical trial of investigational agent UGN-102 (mitomycin) for intravesical solution to evaluate its safety and efficacy in patients with low-grade non-muscle invasive bladder cancer (LG NMIBC) at intermediate risk of recurrence. Intermediate risk is defined as one or two of the following: multiple tumors, a low-grade solitary tumor >3 cm, or recurrence of LG NMIBC within one year of the current diagnosis. Patients were to receive six weekly intravesical instillations of 75 mg UGN‑102 in an office setting. The chemoablative effect of UGN-102 was assessed three months after initiation of study treatment with complete response (CR) defined as a negative endoscopic examination, negative cytology, and when indicated, a negative for-cause biopsy. Patients achieving CR were followed quarterly to 12 months after initiation of study treatment to evaluate safety, efficacy, and durability.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer. Utilizing the RTGel Technology Platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter. The Company reported final results from the Phase 2b OPTIMA II trial in November 2020 and initiated a Phase 3 study to further investigate UGN-102 in the treatment of this condition in December 2020. Additional details of the OPTIMA II Phase 2b study have been published in The Journal of Urology.

On October 5, 2021 Exscientia plc (Nasdaq: EXAI), an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner, reported the closing of its previously-announced upsized initial public offering in the United States of 15,927,500 American Depositary Shares ("ADSs") representing 15,927,500 ordinary shares, including 2,077,500 ADSs sold pursuant to the full exercise of the underwriters’ previously granted option to purchase additional ADSs (Press release, Exscientia, OCT 5, 2021, View Source [SID1234590851]). All ADSs sold in the offering were offered by Exscientia at a public offering price of $22.00 per ADS. The total gross proceeds to Exscientia from the offering were approximately $350.4 million, prior to deducting underwriting discounts and commissions and estimated offering expenses payable by Exscientia. The offering was upsized from the number of shares offered at launch and priced at the top of the price range indicated at launch.

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The Company also closed the concurrent sale of an additional 7,272,727 ADSs at a price of $22.00 per ADS, for gross proceeds of $160.0 million, prior to deducting underwriting discounts and commissions payable by Exscientia, in concurrent private placements to SVF II Excel (DE) LLC, or Softbank, and the Bill & Melinda Gates Foundation.

Goldman Sachs & Co. LLC, Morgan Stanley & Co. LLC, BofA Securities and Barclays Capital Inc. acted as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on September 30, 2021. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from any of the joint book-running managers for the offering: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected]; Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at 866-718-1649 or by email at [email protected]; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or email: [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 1-888-603-5847 or by email at [email protected]. For the avoidance of doubt, such prospectus will not constitute a "prospectus" for the purposes of the Regulation (EU) 2017/1129 and has not been reviewed by any competent authority in any member state in the European Economic Area or the United Kingdom.

In any member state of the European Economic Area (the "EEA") this announcement and any offering are only addressed to and directed at persons who are "qualified investors" ("Qualified Investors") within the meaning of the Prospectus Regulation (Regulation (EU) 2017/1129). In the United Kingdom, this announcement and any offering are only addressed to and directed at persons who are "qualified investors" within the meaning of the UK Prospectus Regulation (Regulation (EU) 2017/1129 as if forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), (ii) high net worth entities who fall within Article 49(2)(a) to (d) of the Order, or (iii) to whom it may otherwise lawfully be communicated (all such persons being referred to as "relevant persons").

This announcement must not be acted on or relied on (i) in the United Kingdom, by persons who are not relevant persons, and (ii) in any member state of the EEA, by persons who are not Qualified Investors. Any investment or investment activity to which this announcement relates is available only to and will only be engaged with (i) in the United Kingdom, relevant persons

On October 5, 2021 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, will present clinical and translational data from the Phase 2 SPEARHEAD-1 trial at the Connective Tissue Oncology Society (CTOS) meeting(Press release, Adaptimmune, OCT 5, 2021, View Source [SID1234590810]). The Company will also present translational data based on the patients for whom safety and efficacy were recently reported at ESMO (Free ESMO Whitepaper) from the Phase 1 SURPASS trial, as well as a data update from the four patients treated in the Radiation sub-study of the Phase 1 trial with afami-cel, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting. Abstracts are available online on the meetings’ web sites.

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"At CTOS, we will present clinical and translational data updates from our SPEARHEAD-1 trial. Data from this trial will form the basis of our first BLA submission next year for afami-cel in synovial sarcoma and MRCLS," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "During SITC (Free SITC Whitepaper), we will present translational data from the SURPASS trial with our next-gen therapy ADP-A2M4CD8, as well as clinical data from a sub-study combining low-dose radiation with afami-cel. These two trials represent investigational approaches to improving the potency of our SPEAR T-cells. Understanding how we can continually enhance our T-cell therapies, so as to ultimately improve clinical outcomes for patients, is a key focus of our translational and early phase clinical research."

CTOS Meeting

Abstract Title: SPEARHEAD-1: A Phase 2 trial of afamitresgene autoleucel (formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma (Abstract #1080870)
Oral presentation: November 12, 2021, in the Immunotherapy & Immune Microenvironment Session starting at 10:00 a.m. EST. Presenter: Dr. Brian Van Tine, Associate Professor of Medicine at Washington University School of Medicine in St. Louis

Abstract Title: SPEARHEAD-1 preliminary translational insights from a Phase 2 trial of afamitresgene autoleucel (formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma (Abstract #1080366)

Poster Presentation: November 12, 2021, 2:30 p.m. – 3:15 p.m. EST during the Immunology & Immunotherapy Session. Presenter: Dr. Sandra D’Angelo, Medical Oncologist at Memorial Sloan Kettering Cancer Center
At CTOS, Adaptimmune will host its first virtual medical symposium on Thursday, November 11, 4:30-6:30 p.m. EST.

SITC meeting

Abstract Title: Enhancement of TCR-engineered T-cells targeting MAGE-A4 antigen by co-expression of CD8α and inhibition of AKT signaling during ex vivo T-cell expansion (Abstract #373)
Poster presentation: November 12-14, 2021, 7:00 a.m – 5:00 p.m. EST. Presenter: Alex Tipping, Adaptimmune
Abstract Title: Radiation sub-study to characterize safety and tolerability of low-dose radiation in combinations with afami-cel in patients with advanced cancers (Abstract #376)

Poster Presentation: November 12-14, 2021, 7:00 a.m. – 5:00 p.m. EST. Presenter: Dr. James W. Welsh, Professor, Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center