On August 5, 2024 Tubulis reported that Fierce Biotech has named the company as one of 2024’s "Fierce 15" biotechnology companies (Press release, Tubulis, AUG 5, 2024, View Source [SID1234645356]). The annual special report features the most innovative and promising biotechnology companies in the industry.

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"Being selected for this prestigious industry award is an important recognition of our leadership position in the ADC space as well as the potential of our unique approach to ADC development. It also is a great reward for all the hard work our team has been putting into driving innovation and realizing our mission of improving the outcomes for cancer patients. I specifically would like to thank every team member and our Board for their contributions," said Dominik Schumacher, CEO at Tubulis. "2024 is a pivotal year for us and we are committed to further building on this momentum to push the boundaries of ADCs and unlock their full therapeutic potential."

Tubulis was established with the goal of maximizing the overall performance of ADCs by addressing the main bottlenecks in the field through innovation in all aspects of ADC development. The company has created a unique suite of technologies that combine a diverse range of targeting molecules, innovative payloads, and proprietary conjugation technologies to deliver revolutionary ADCs with superior biophysical properties and durable anti-tumor effects. Based on differentiated preclinical results recently presented at AACR (Free AACR Whitepaper) and backed by an upsized €128 million Series B2 financing in March, the company is now translating the durable efficacy of its lead candidates, TUB-030 and TUB-040, into the clinic. In June, the first patient was dosed with TUB-040 in a Phase I/IIa study (NAPISTAR 1-01, NCT06303505) to investigate its safety, pharmacokinetics and efficacy in patients with platinum-resistant high-grade ovarian cancer (PROC) and relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC), who have exhausted other available treatment options. Shortly afterwards, the candidate was granted Fast Track designation by the U.S. Food and Drug Administration ("FDA") for the treatment of patients with PROC.

"For the past 22 years, we have evaluated hundreds of companies for inclusion in the ‘Fierce 15’ special report. Our selection process considers various factors, including technological robustness, strategic partnerships, venture support and market positioning," said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare. "This report highlights innovation and creativity amid intense competition."

On August 5, 2024 Genmab A/S (Nasdaq: GMAB) reported that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab (Press release, Genmab, AUG 5, 2024, View Source [SID1234645338]). BioNTech SE (BioNTech) has opted not to participate in the further development of the acasunlimab program under the parties’ existing collaboration agreement. The program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech. Genmab plans to initiate the Phase 3 study in the second half of this year. While the emerging clinical profile of acasunlimab is encouraging, BioNTech informed the company that it has taken this decision for reasons relating to its portfolio strategy. The companies’ long-standing collaboration in antibody science remains in place, and both parties will continue with the existing programs under development under their existing agreements, which were expanded in 2022.

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"Genmab’s partnership with BioNTech is a highly successful one. Together, we have demonstrated acasunlimab’s potential to impact patients with metastatic non-small cell lung cancer, as evidenced by the promising initial results presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Genmab is exceptionally well-positioned to maximize the potential of acasunlimab, and we are confident about the prospect of taking acasunlimab into late-stage development as our second wholly owned Genmab asset in addition to Rina-S. We look forward to our continued partnership with BioNTech on other pipeline programs."

The decision by BioNTech to not participate in the further development of the acasunlimab program is not expected to impact Genmab’s 2024 financial guidance.

About Acasunlimab (GEN1046)
Acasunlimab (GEN1046) is an investigational PD-L1x4-1BB bispecific antibody fusing Genmab’s proprietary DuoBody technology platform and BioNTech’s proprietary immunomodulatory antibodies. Acasunlimab is designed to elicit an antitumor response via conditional activation of 4-1BB on T cells and natural killer (NK) cells, which is strictly dependent on simultaneous binding of the PD-L1 arm.
The candidate is currently being investigated in three clinical trials: (1) a Phase 1/2 safety and PK trial in patients with multiple solid tumors, (2) a Phase 1 dose escalation trial in patients with advanced solid tumors in Japan, and (3) a randomized Phase 2 safety and efficacy trial with acasunlimab as a monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC) who have failed previous standard of care treatments with immune checkpoint inhibitors. Please visit www.clinicaltrials.gov for more information.

On August 5, 2024 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported the completion of its acquisition of select assets of Invitae (OTC:NVTAQ), a leading medical genetics company (Press release, Invitae, AUG 5, 2024, View Source [SID1234645339]). Together, Labcorp and Invitae will support patients, clinicians and pharmaceutical partners across the continuum of care, including therapy development, patient diagnosis and personalized care.

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"Labcorp and Invitae are on a shared mission to harness the power of genetic insights to transform medicine, deliver personalized care and improve health outcomes," said Mark Schroeder, Executive Vice President and President of Diagnostics Laboratories and Chief Operations Officer of Labcorp. "By adding Invitae’s cutting edge science and industry-leading experience, we will extend our leadership in genetic testing solutions with the most comprehensive offerings in areas such as oncology and select rare diseases. We are excited to welcome Invitae’s talented team to Labcorp and look forward to bringing genetic testing solutions to patients and physicians to improve health and improve lives."

The acquisition expands Labcorp’s specialty testing capabilities and the company’s ability to utilize genetic data to improve clinical trials and treatment regimens in oncology and select rare diseases. By integrating Invitae’s genetic testing technology with Labcorp’s specialty testing capabilities, the company will offer a more complete set of insights for each patient – from testing to diagnosis to treatment.

For more information visit Labcorp.com/invitae.

Invitae is advised by Kirkland & Ellis LLP as legal counsel, Moelis & Company LLC as investment banker and FTI Consulting, Inc. as financial and communications advisor. Citi is serving as Labcorp’s financial advisor and Hogan Lovells and Kilpatrick Townsend are serving as Labcorp’s legal counsel.

On August 5, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it will host a corporate update webcast presentation on Tuesday, August 6, 2024 at 8:30 AM ET to discuss its recently announced plans to advance Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") to a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (Press release, Moleculin, AUG 5, 2024, View Source [SID1234645341]). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US.

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For the webcast presentation, Walter Klemp, Chairman and Chief Executive Officer, and Dr. Paul Waymack, Senior Chief Medical Officer of Moleculin will be joined by Michael Andreeff, MD, PhD, Professor of Medicine, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

Interested participants and investors may access the webcast presentation via conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call or by clicking here. The live audio webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.

On August 5, 2024 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported that an abstract presenting updated data from the VERSATILE-002 trial evaluating first-line treatment with Versamune HPV (formerly PDS0101) in combination with KEYTRUDA (pembrolizumab) in patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) has been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 being held September 13-17, 2024, in Barcelona, Spain (Press release, PDS Biotechnology, AUG 5, 2024, View Source [SID1234645342]).

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Details of the poster presentation are as follows:

Poster number: 879P
Poster title: VERSATILE-002: Survival with First-Line Treatment with PDS0101 Therapeutic Vaccine and Pembrolizumab in HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Presenting author: Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at University of North Carolina, and Principal Investigator of the VERSATILE-002 clinical trial