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

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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.

On April 5, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its Executive Vice President and Chief Operating Officer, Michael Redman, will present at the annual Cell & Gene Meeting on the Mediterranean, which will take place virtually April 6-9, 2021 (Press release, Genprex, APR 5, 2021, View Source [SID1234577560]).

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Event: 2021 Virtual Cell & Gene Meeting on the Mediterranean

Date: The conference will take place virtually Tuesday, April 6 – Friday, April 9

Time: Company presentations will be available to view on-demand throughout the entirety of the conference

Registration Link: https://bit.ly/3wdVAd1

Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mediterranean is a four-day virtual conference featuring more than 80 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies. The meeting also includes more than 50 panelists and featured speakers taking part in 13 in-depth sessions covering all aspects of cell and gene therapy commercialization.

Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Laura Stringham at [email protected] and interested media should contact Kaitlyn Dupont at [email protected].

On April 5, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the successful completion of the safety run-in of the Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients (Press release, Bio-Path Holdings, APR 5, 2021, View Source [SID1234577578]). The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.

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"We are particularly pleased with the clean side effect profile and lack of toxicity shown in this segment of the study, as our Phase 2 efficacy segment will include de novo fragile AML patients for whom drug side effect profiles are particularly important. We are also very encouraged by the efficacy signals shown in this dataset, with five of six evaluable relapsed, refractory and newly diagnosed AML patients demonstrating clinical activity. These positive signals give us further confidence in the potential for this program in these late-stage and compromised patients," stated Peter H. Nielsen, Chief Executive Officer of Bio-Path Holdings.

"We look forward to advancing this Phase 2 study, as we believe its unique design provides us with several definable registration pathways. We believe that prexigebersen, with its promising efficacy and safety profile, has the potential to be an ideal combination candidate with frontline therapies," concluded Mr. Nielsen.

In the safety run-in, six evaluable patients were treated with the combination of prexigebersen, decitabine and venetoclax. These patients included four relapsed/refractory AML patients, and two newly diagnosed AML patients. In the preliminary safety data review, five of the patients (83%) responded to treatment, including four (67%) achieving complete response (CR) and one (17%) complete response with incomplete hematologic recovery (CRi). CR rates to combination treatment with decitabine and venetoclax for relapsed/refractory AML patients is 42-52%1,2 and 0-39%1,2 for relapsed/refractory secondary AML patients. Response rates to frontline treatment decitabine and venetoclax for newly diagnosed AML patients is 62-71%3,4. These preliminary data showed the treatment was well-tolerated and there were no dose limiting toxicities attributed to prexigebersen. Three patients remained on treatment for more than one cycle.

Stage 2 of the Phase 2 clinical trial has three treatment cohorts, which the Company believes provides for several potential regulatory pathways. The first two cohorts will treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes newly diagnosed AML patients and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort treats relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine.

The Phase 2 clinical trial continues with 21 patients currently enrolled across all three cohorts. Enrollment of 19 patients in each cohort should enable a data review to determine if there is a comparative increase in efficacy versus the decitabine and venetoclax combination therapy sufficient to support petitioning the FDA for approval to switch to breakthrough therapy for accelerated approval. The Phase 2 trial will be conducted at up to ten clinical sites in the U.S. For more information on the Phase 2 study, visit www.clinicaltrials.gov.

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.

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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."

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]).

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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.