Teneobio Announces Achievement of Milestone Payment as Janssen Advances Phase I Study of Bispecific JNJ-75348780 for the Treatment of NHL and CLL

On April 5, 2021 Teneobio, Inc., a clinical stage biotech company focused on the discovery and development of novel multi-specific biotherapeutic antibodies, reported the Phase I clinical entry and the dosing of patients with the bispecific JNJ-75348780 in a Phase I study (View Source), which is sponsored by Janssen Research & Development, LLC (Janssen) (Press release, TeneoBio, APR 5, 2021, View Source;utm_medium=rss&utm_campaign=teneobio-announces-achievement-of-milestone-payment-as-janssen-advances-phase-i-study-of-bispecific-jnj-75348780-for-the-treatment-of-nhl-and-cll [SID1234577598]). The Phase I dose escalation study will evaluate patients with B-cell lymphoid malignancies, including non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Participants will receive JNJ-75348780 by intravenous (IV) or subcutaneous (SC) administration.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Teneobio entered a research collaboration and license agreement with Janssen in July of 2018. Janssen subsequently exercised a commercial license to Teneobio’s bispecific lead candidate in September of 2019. Teneobio will receive a payment for the Phase I clinical milestone and is eligible for future clinical development and commercial milestone payments per potential candidate. Teneobio would also receive royalties on world–wide net sales of each multi-specific product.

Omid Vafa, CBO at Teneobio added, "We are very pleased with the rapid advance of our licensed bispecific product to the clinic by the Janssen oncology development team. Teneobio’s collaborative spirit and productive teamwork with Janssen are a testament to our commitment to bring novel and innovative therapeutics to patients in need."

Invitae Announces $1.15 Billion Investment Supporting Ongoing Growth Initiatives

On April 5, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported that a small group of investors, led by SB Management, a subsidiary of Softbank Group Corp., will make an investment of $1.15 billion in convertible senior notes to support the Company’s future growth initiatives (Press release, Invitae, APR 5, 2021, View Source [SID1234577561]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"Invitae’s mission is to deliver genetic information to improve healthcare for billions of people at all stages of life. With the support of our long-term shareholders, we’re creating the platform to support the routine use of genetics in mainstream medicine to result in better healthcare for everyone," said Sean George, co-founder and chief executive officer of Invitae. "This investment will help us continue to fuel our growth, including expanding our platform, services and menu through both in-house development and the addition of complementary companies and technologies as we work to build a differentiated platform uniquely capable of driving the transition to personalized medicine."

"Invitae has a definitive head start in the rapidly expanding market for clinical genetic sequencing. Their comprehensive diagnostic products are well positioned to further grow the global understanding of how genomics predispose populations for certain diseases. These datasets will inform treatment and dramatically improve patient outcomes," said Akshay Naheta, chief executive officer of SB Management, a subsidiary of SoftBank Group Corp.

Under the terms of the investment, the participating investors, including SB Management, will purchase a total aggregate principal amount of $1.15 billion in Convertible Senior Notes due 2028 (the "Notes"). The Notes will have an initial conversion price of $43.18 per share of the Company’s common stock, subject to customary anti-dilution and other adjustments. The initial conversion price of $43.18 represents a 20% premium to the Company’s average 5-day trailing volume-weighted average price as of April 1, 2021. The Notes will mature on April 1, 2028, unless earlier converted, redeemed or repurchased. The Notes will bear 1.5% interest per year. Upon conversion, the Company will have the right to elect settlement in cash, shares, or any combination thereof in its sole discretion.

Additional information regarding this announcement may be found in a Current Report on Form 8-K that the Company intends to file today with the U.S. Securities and Exchange Commission.

J. Wood Capital Advisors LLC and Perella Weinberg Partners LP acted as financial advisors and J.P. Morgan acted as placement agent to Invitae on the transaction.

Invitae to acquire Genosity to accelerate access to personalized oncology testing worldwide

On April 5, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported it has entered into a definitive agreement to acquire Genosity Inc. ("Genosity"), a genomics company offering innovative software and laboratory solutions to enable development and deployment of complex sequencing based tests (Press release, Invitae, APR 5, 2021, View Source [SID1234577562]). The acquisition would bring Genosity’s specialized capabilities onto the Invitae platform to accelerate the time to market and decentralization of Invitae’s personalized oncology offerings, including somatic and germline offerings poised to help transform how cancer is diagnosed, treated and monitored.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"Each individual cancer is unique. The way we diagnose and treat it must be as well," said Robert Nussbaum, M.D., chief medical officer of Invitae. "Our goal is to move as quickly as we can toward the day where each cancer patient receives timely, comprehensive genetic information that is used to guide their care from diagnosis to monitoring for disease recurrence. Together with Genosity, we believe our combined novel capabilities and capacity will help us reach that day sooner for patients around the globe."

Genosity has built an industry-leading suite of highly specialized capabilities designed to support the use of next generation sequencing in oncology development and clinical care, ranging from basic research to clinical testing for regulated studies. The company currently works with Invitae on a number of projects and clinical trials. Becoming a part of Invitae is expected to provide important advantages for the development and launch of Invitae’s oncology products, which include three devices under development that have received breakthrough device designation from the U.S. Food and Drug Administration (FDA), including the capacity, speed, and efficiency required to serve mainstream medicine cost effectively both with central laboratory services and decentralized kitted products.

"Genosity, under the insightful leadership of Marc Grodman, MD, has been able to develop solutions which enable broader adoption of genomic testing. Our laboratory services, end-to-end software solutions and data management platform are an ideal fit as Invitae develops best-in-class options for MRD-based cancer monitoring," said Robert D. Daber, Ph.D., president and chief technology officer of Genosity. "In Invitae we have found a like-minded partner focused on making genomics more affordable and accessible worldwide."

Maximum flexibility to accelerate the future of cancer care worldwide

Invitae is currently developing its Personalized Cancer MonitoringTM (PCM) platform as an in vitro diagnostic (IVD) intended for regulatory submission. PCM analyzes a patient’s unique genetic profile of their specific cancer and uses it to monitor their blood to detect cancer recurrence early when it is most curable. Invitae’s PCM test, if approved for use, will be augmented by Genosity technology and capabilities to distribute PCM globally, increasing accessibility and reducing turnaround time. With this capability, we believe Invitae will be uniquely able to meet the needs of cancer patients worldwide, whether their clinicians send out to a central testing service or rely on tests that are completed locally by in-house laboratories.

In January 2020, Invitae received Breakthrough Device Designation from the FDA for PCM.

Transaction Terms

Under the terms of the agreement, Invitae will acquire Genosity for approximately $200 million, consisting of (i) approximately $120 million in cash and (ii) approximately $80 million in shares of Invitae common stock (based upon a trailing average closing price prior to the date of closing but subject to certain potential adjustments), with such stock and cash consideration subject to reduction based upon certain debt and transaction expenses of Genosity determined at closing.

The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter, subject to customary closing conditions including the expiration or early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

In connection with the transaction, Invitae will grant restricted stock units ("RSUs") having a value of up to $15 million to certain continuing employees of Genosity. These RSUs will be granted under Invitae’s 2015 Stock Incentive Plan (the "2015 Plan"), which is being amended to create an additional pool of shares of Invitae common stock to be used exclusively for the grant of inducement awards in compliance with New York Stock Exchange Rule 303A.08 ("Rule 303A.08"). These RSUs were approved by the Invitae Board of Directors and will be granted as an inducement material for continued employment following the acquisition of Genosity in reliance on the employment inducement exemption under Rule 303A.08. These RSUs will vest annually over three years and, in certain instances, the number of RSUs that vest on each vesting date will be calculated based upon a trailing average closing price prior to the date of closing of the Genosity acquisition.

Advisors

Cowen served as exclusive financial advisor to Genosity in connection with the acquisition.

Other Inducement Grants for Previous Transaction

Unrelated to the Genosity transaction, Invitae reported inducement grants in connection with the addition of certain assets and key personnel from a small organization called IntelliGene Health Informatics, LLC. which was focused on specialized software capabilities and technologies and will augment Invitae’s oncology offerings.

In connection with Invitae’s acquisition of assets from IntelliGene Health Informatics, LLC ("IntelliGene") for approximately $2.7 million, Invitae granted RSUs having a value of up to $6.225 million to certain employees and consultants of IntelliGene who continue as employees of Invitae. These RSUs were granted under the 2015 Plan, which was amended to provide for an additional pool of shares of Invitae’s common stock to be used exclusively for the grant of inducement awards in compliance with Rule 303A.08. These RSUs were approved by the Invitae Board of Directors and were granted as a material inducement for continued employment following the acquisition of assets from IntelliGene in reliance on the employment inducement exemption under NYSE Rule 303A.08. These RSUs vest in two installments at 12 months and 24 months following the acquisition of IntelliGene assets. The number of RSUs that vest on each vesting date will be calculated based on the volume-weighted average trading price of the company’s common stock on the NYSE for a trailing 20 trading day period prior to the grant date or, in certain situations, the vesting date.

Spectrum Pharmaceuticals Presentations at the Upcoming AACR Virtual Meeting 2021 to Include Updated Poziotinib Twice Daily Dosing Data

On April 5, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported a poster presentation on safety and tolerability of twice daily administered poziotinib in patients with EGFR or HER2 exon 20 mutations (Press release, Spectrum Pharmaceuticals, APR 5, 2021, View Source [SID1234577580]). The company will also present a poster on the evaluation of same-day dosing of ROLONTIS (eflapegrastim) in neutropenic rats and patients with early-stage breast cancer. These poster presentations will be available at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, taking place from April 10-15, 2021. Details of the presentations are as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Title: Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2 exon 20 mutations
Speaker: Xiuning Le, M.D., Ph.D.
Session: PO.CT02 – Phase 2 Clinical Trials
Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET
Presentation Number: CT169

Title: Same-day administration of Eflapegrastim with chemotherapy enhances neutropenic recovery in neutropenic rats and in early-stage breast cancer patients
Speaker: John A. Barrett
Session: PO.CT01 – Phase 1 Clinical Trials
Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET
Presentation Number: CT116

The poster presentations will be available for viewing by registered participants during the conference via the AACR (Free AACR Whitepaper) website on April 10, 2021.

Outpace Bio raises $30 Million to design next generation cell therapies

On April 5, 2021 Outpace Bio, a spinout from Lyell Immunopharma, reported that the company has landed $30 million in Series A funding to design new proteins that solve problems in cell therapies (Press release, Outpace Bio, APR 5, 2021, View Source [SID1234637777]). Lyell’s focus is developing new T cell therapies to fight cancer. To get started, Outpace is collaborating with Lyell to develop molecular controls for T cells that could refine and strengthen targeted cell therapies. Beyond that, the company plans to establish a series of partnerships to develop a variety of next-generation cell therapies

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Outpace co-founders Marc Lajoie and Scott Boyken both trained in the Baker lab at the Institute for Protein Design at the University of Washington, which specializes in "de novo protein design." Rather than finding proteins that already exist and then trying to customize them, de novo protein design means building completely original proteins from basic building blocks, using advanced computer algorithms to predict the created protein’s final 3D shape.