On April 3, 2024 Genmab A/S (Nasdaq: GMAB) and ProfoundBio, Inc. reported that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction (Press release, Genmab, APR 3, 2024, View Source [SID1234641710]). ProfoundBio is a privately-owned clinical-stage biotechnology company developing next-generation ADCs and ADC technologies for the treatment of certain cancers, including ovarian cancer and other FRα-expressing solid tumors. Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).

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!

The transaction will further broaden Genmab’s mid- to late-stage clinical pipeline and strengthen and complement Genmab’s already validated suite of proprietary technology platforms. The acquisition will give Genmab worldwide rights to ProfoundBio’s portfolio of next-generation ADCs, which consists of three clinical and multiple preclinical programs including Rina-S, a potential best-in-class, clinical-stage, FRα-targeted, Topo1 ADC, currently in Phase 2 of a Phase 1/2 clinical trial, for the treatment of ovarian cancer and other FRα-expressing solid tumors. In addition, the combination of ProfoundBio’s novel ADC technology platforms with Genmab’s proprietary antibody platforms will potentially create new opportunities to generate and develop new medicines with the potential to transform the treatment of cancer and improve the lives of patients.

The addition of Rina-S to Genmab’s portfolio will enable Genmab to deepen its presence in the gynecologic oncology space and establish a firm foundation in solid tumors. As a potential best-in-class ADC, Rina-S aims to address a broader patient population than first-generation FRα-targeted ADCs. Based on the data from the ongoing Phase 1/2 clinical trial Genmab intends to broaden the development plans for Rina-S within ovarian cancer and other FRα-expressing solid tumors. In January 2024, the U.S. Food and Drug Administration (U.S. FDA) granted Fast Track designation to Rina-S for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

"The proposed acquisition of ProfoundBio firmly aligns with our long-term strategy and our ambitious 2030 vision, to impact the lives of patients through innovative antibody medicines," said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. "We believe that ProfoundBio’s ADC candidates, proprietary technology platforms and talented team will be a great addition to Genmab and that, together, we will be able to accelerate the development of innovative, differentiated antibody therapies for cancer patients."

"Genmab shares our team’s mission of developing novel therapies to improve outcomes for cancer patients. Genmab’s deep expertise in antibody drug development and commercialization makes this a compelling union that will allow us to rapidly develop and realize the full potential of our ADC therapies to benefit patients," said Baiteng Zhao, Ph.D., ProfoundBio’s co-founder, Chief Executive Officer and Chairman of the Board.
Details of the Transaction
The proposed transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the first half of 2024. The closing of the proposed transaction is subject to the satisfaction of customary closing conditions.

Following today’s announcement, Genmab’s operating expenses before expenses incurred by it in connection with the proposed transaction are now anticipated to be at or moderately above the upper end of the previously disclosed guidance range of DKK 12.4 -13.4 billion. The anticipated increase reflects the incremental R&D investment to support the advancement of ProfoundBio’s clinical programs, primarily Rina-S. Genmab’s revenue guidance is unchanged and expected to be in the previously disclosed guidance range of DKK 18.7 – 20.5 billion. We expect to update our guidance no later than in connection with Genmab’s second quarter 2024 earnings.

Goldman Sachs International is acting as sole financial advisor to Genmab in this transaction and Shearman & Sterling LLP, Simmons & Simmons LLP and Kromann Reumert are its legal advisors.

BofA Securities, Inc. and Morgan Stanley & Co. LLC are acting as financial advisors to ProfoundBio in this transaction and Cooley LLP, Travers Thorp Alberga and Jun He Law Offices are its legal advisors.

Conference Call Details
Genmab will hold a conference call to discuss the transaction today, April 3 at 1:00 PM CEST / 12:00 PM BST / 7:00 AM EDT. To join the call please use the following registration link: https://register.vevent.com/register/BI9da0549848d848cdaa4b6cd96079bafd. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN. To listen to a live webcast of the call please use the following link: View Source An archive of the webcast and relevant slides will be available at View Source

On April 2, 2024 BioInvent International AB ("BioInvent"), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported a clinical trial collaboration and supply agreement with MSD International Business GmbH, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, for a Phase 1/2a study of its monoclonal antibody BI-1910 in combination with KEYTRUDA (pembrolizumab) (Press release, BioInvent, APR 2, 2024, https://www.bioinvent.com/en/press/bioinvent-announces-new-clinical-trial-collaboration-and-supply-agreement-msd-evaluate-bi [SID1234646696]).

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!

Under the terms of the supply agreement, MSD will provide its anti-PD-1 therapy KEYTRUDA to be used in combination with BI-1910. The Phase 1/2a trial will be conducted in the US and Europe and has an innovative, adaptive design to allow for ideal dose escalation.

BI-1910 is BioInvent’s second tumor necrosis factor receptor 2 (TNFR2) program to enter clinical development, after BI-1808 currently in Phase 2a. BI-1910 displays a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent’s first-in-class anti-TNFR2 antibody. Both monoclonal antibodies were chosen as potential best-in-class, from a large family of binders generated through BioInvent’s proprietary F.I.R.S.T technology platform. The single agent arm of the Phase 1/2a BI-1910 study was initiated in December 2023 and first data is expected by YE 2024.

"We are delighted to enter into another clinical trial collaboration and supply agreement with MSD to investigate the unique features of BI-1910 in combination with KEYTRUDA. This trial will build on our deep understanding of the TNFR2 biology as we move two differentiated monoclonal antibodies through clinical development. This is our fifth product in ongoing clinical trials, demonstrating the capacity of BioInvent’s technology to identify novel, first-in-class therapeutic cancer targets," said Martin Welschof, CEO of BioInvent.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On April 2, 2024 KiraGen Bio, a pioneering biotech company in the field of innovative cellular therapies for solid tumors, is pleased to announce today a strategic partnership with Flash BioSolutions, a leading CDMO providing state-of-the-art lentiviral particles (Press release, KiraGen Bio, APR 2, 2024, View Source [SID1234644884]). This collaboration aims to fully harness the potential of CAR-T (Chimeric Antigen Receptor T-cell) therapies in cancer treatment.

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!

Through this alliance, KiraGen Bio will leverage the advanced expertise of Flash BioSolutions and its flagship technology, LentiCare. This cutting-edge lentiviral platform will be seamlessly integrated into the development of KiraGen Bio’s groundbreaking CAR-T therapies, playing a crucial role in the Proof of Concept stage and beyond.

The revolutionary aspect of this partnership lies in the synergistic combination of KiraGen Bio’s proprietary AI-driven platform, KiraLOGIC, and Flash BioSolutions’ state-of-the-art LentiCare technology. KiraLOGIC employs advanced machine learning algorithms to rationally design CAR-T cells equipped with a combination of highly multiplexed gene edits, rendering them resistant to the immunosuppressive tumor microenvironment. By integrating these AI-powered gene editing capabilities with the high-quality lentiviral vectors provided by Flash BioSolutions, KiraGen Bio is poised to unlock the full potential of CAR-T therapies for solid tumors, addressing a critical unmet need in cancer treatment.

"Our KiraLOGIC platform leverages AI to rationally design CAR-T cells resistant to immunosuppression, unlocking the potential of cell therapies for solid tumors. Partnering with Flash BioSolutions, a leader in lentiviral vector manufacturing, is pivotal in advancing our multiplex gene-edited CAR-T therapies. Their LentiCare technology ensures high-quality lentiviral vectors, essential for generating robust preclinical data and propelling our therapies towards clinical development. Together, we are poised to accelerate scientific progress and deliver transformative treatments to patients in need," stated Ryan Murray, PhD, CSO & Co-Founder of KiraGen Bio.

"At KiraGen, our unwavering commitment is to bring our revolutionary TME-Guard technology to patients as quickly and broadly as possible. Collaborating with Flash BioSolutions is a significant milestone in realizing this vision. Their deep expertise in lentiviral manufacturing will be instrumental as we rapidly advance our innovative cell therapies through preclinical development and into the clinic. This strategic partnership is key to accelerating our lead programs, forging powerful industry and academic alliances, and building a robust and sustainable pipeline. By joining forces with Flash BioSolutions, we are creating a powerful model that can drive transformative impact for patients while generating value for our investors, as we work to establish KiraGen as a pioneer in solid tumor cell therapy," added Aaron Edwards, CEO & Co-Founder of KiraGen Bio.

"Flash BioSolutions is thrilled to collaborate with KiraGen Bio in reshaping the paradigm of CAR-T therapies for solid tumors," stated Jérôme Bédier, CEO of Flash BioSolutions. "Through the potent fusion of our expertise and state-of-the-art technologies, we are steadfast in our commitment to propelling scientific innovation and introducing revolutionary treatment options for patients confronting this formidable disease."

This partnership between Flash BioSolutions and KiraGen Bio embodies the commitment of both companies to push the boundaries of research to improve the lives of cancer patients. Together, they aspire to open new perspectives in the treatment of solid tumors and bring renewed hope to those battling this disease.

On April 2, 2024 EpicentRx, Inc, a clinical-stage biotechnology drug and device company with two therapeutic platforms that address cancer and inflammatory diseases of unmet clinical need, reported that an abstract on its lead therapy, AdAPT-001, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held in San Diego, CA from April 5-10, 2024 (Press release, EpicentRx, APR 2, 2024, View Source [SID1234641777]).

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!

AdAPT-001 constitutes a novel strategy to deliver a transforming growth factor-beta (TGF-β) trap to tumors. Importantly, data from a Phase 1/2 clinical trial demonstrate that administration of AdAPT-001 successfully converted immunologically cold tumors, such as sarcomas and triple negative breast cancer, into immunologically hot tumors. Furthermore, AdAPT-001 administration also demonstrates reversion of established resistance to checkpoint inhibitors.

"We’re excited to share groundbreaking clinical data with our lead therapy, AdAPT-001, against several treatment- and checkpoint inhibitor resistant solid tumors," said Tony R. Reid, MD, PhD, CEO of EpicentRx. "We’re also thrilled to be working with top-notch investigators like Dr. Anthony P. Conley from the MD Anderson Cancer Center and Dr. Lucy B. Kennedy from the Cleveland Clinic."

"Immune checkpoint inhibitors are largely ineffective against sarcomas. TGF-β is a soluble protein that suppresses immune responses," said treating study investigator and sarcoma oncologist, Dr. Conley from the MD Anderson Cancer Center. "Based on the several unprecedented responses that I have seen with AdAPT-001, which expresses a TGF-β trap, this TGF-β blockade from AdAPT-001 synergizes with PD-1/PD-L1 inhibition in checkpoint-resistant sarcoma."

Poster Presentation:
Title: Improved clinical outcomes in patients that received treatment beyond tumor progression with AdAPT-001 +/- a checkpoint inhibitor
Presenters: Dr. Anthony P. Conley of MD Anderson Cancer Center and Drs Tony Reid (CEO) and Chris Larson (VP) of EpicentRx.
Date and Time: Tuesday, April 9, 2024, 1:30 PM – 5:00 PM PDT
Location: Poster Section 48
Poster Number: 23

About AdAPT-001
AdAPT-001 is an investigational immunotherapy with a TGF-β receptor-immunoglobulin Fc fusion trap, designed to neutralize isoforms 1 and 3 of the profibrotic, proangiogenic, prohypoxic, and immunosuppressive cytokine, TGF-β, and to sensitize resistant tumors to checkpoint blockade.

In the ongoing Phase 1/2 BETA PRIME trial, AdAPT-001 was administered as single-agent and in combination with checkpoint inhibitors to patients with treatment-refractory tumors.

Importantly, AdAPT-001 plus checkpoint inhibitors improved toxicity and AE profile over what is typically observed with checkpoint inhibitors. No dose limiting toxicities, AdAPT-001 related serious adverse events, or dose reductions have been observed to date.

On April 02, 2024 Onconova Therapeutics, Inc., and Trawsfynydd Therapeutics, Inc. ("Trawsfynydd"), a privately-held biotechnology company developing next-generation, best-in-class antivirals for influenza, COVID and other infectious diseases, reported that the companies have entered into a definitive merger agreement to combine in an all-stock transaction (the "Merger") (Press release, Onconova, APR 2, 2024, View Source [SID1234641769]). Under the terms of the agreement, Onconova acquired 100% of Trawsfynydd’s outstanding equity interests. In connection with the transaction and concurrent with the Merger, the combined company which has been renamed "Traws Pharma, Inc." ("Traws") will trade on NASDAQ under the new ticker symbol "TRAW", commencing prior to the opening of trading Wednesday, April 3, 2024.

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!

In connection with the Merger, Traws announced that it will raise $14 million in a committed private placement financing by OrbiMed and Torrey Pines, expected to close on April 3, 2024. Upon closing of the private placement, Traws expects to have in excess of $28 million of cash and cash equivalents from the proceeds of the private placement and cash from both companies. These proceeds will be used to advance the Traws’ programs through multiple clinical data catalysts and complete the dose ranging study for narazaciclib.

"I am pleased to announce the combination of Onconova and Trawsfynydd at this important time, as Trawsfynydd readies to initiate Phase 2 studies in H2 2024 for its lead antiviral programs for influenza and COVID19, supported by advisors with unparalleled expertise in viral disease, and Onconova is preparing to finalize the recommended Phase 2 dose (RP2D) for narazaciclib," said Dr. Cautreels incoming Chief Executive Officer of the combined company.

Commented Steven Fruchtman, M.D., President and Chief Executive Officer of Onconova and President and CSO, Oncology of the combined company, "Trawsfynydd has a differentiated pipeline and an accomplished leadership team poised to advance their lead programs. With a shared focus on developing best-in-class medicines for patients with unmet needs, we look forward to Traws’ continued progress with its anti-viral programs and narazaciclib."

Traws Proprietary Portfolio:

TRX100 (viroksavir): a cap-dependent endonuclease inhibitor for influenza: Phase 1

Targets the cap-dependent endonuclease of influenza and is a potent inhibitor of influenza virus replication including A and B strains
Preclinical data showed that TRX100 inhibits viral replication of pandemic-potential influenza viruses circulating in nature during 2022, and importantly, also in oseltamivir and baloxavir-resistant viruses
Completed a first Phase 1 study that demonstrated safety and tolerability in healthy volunteers. The study also provided pharmacokinetics and pharmacodynamics (PK/PD) data to support the potential use of a single oral dose administration for either treatment or prophylaxis
Next milestones: H2 2024

Phase 1 dose extension will evaluate two additional, higher doses prior to the initiation of Phase 2 studies in H2 2024. Topline data from the Phase 2 study are expected in H1 2025
TRX01 (travaltrevir): Mpro protease inhibitor for COVID19: Phase 1

Potent oral inhibitor of SARS-CoV-2 Mpro (3CL protease), effective against the original, delta, and omicron variants of SARS-CoV-2, with potentially superior properties to nirmatrelvir (Pfizer’s Mpro inhibitor, PAXLOVID)
Does not require co-administration with a human cytochrome P450 (CYP) inhibitor such as ritonavir, avoiding potential significant drug:drug interactions, with the opportunity to expand the number of eligible patients
Safe in GLP toxicology studies with no adverse events (AEs) in the expected human dose range. The drug candidate’s pharmacokinetic (PK) profile may enable a once-daily 10 day treatment regimen, to reduce the likelihood of viral rebound
Next milestones:

Phase 1 first-in-human single ascending dose/multiple ascending dose (SAD/MAD) study in normal volunteers initiated screening in Q1 2024. Topline data are expected H2 2024
Phase 2 study planned to be initiated in H2 2024. The study will enroll people with moderate to severe COVID19. Topline data are expected H1 2025
Narazaciclib: CDK 4/6 inhibitor for LGEEC: Phase 1/2

Narazaciclib’s mechanism of action in LGEEC has been validated by Phase 2 studies with other approved CDK4/6 inhibitors: palbociclib (Pfizer), ribociclib (Novartis), and abemaciclib (Lilly). Available preclinical and clinical data suggest that narazaciclib has the potential to provide a better efficacy/safety ratio compared to approved products with respect to reduced gastrointestinal (GI) and hematological toxicities. These characteristics may permit daily administration with no need for the drug holidays employed by other approved agents to manage severe bone marrow suppression.
In pre-clinical studies, narazaciclib demonstrated reduced neutropenia compared to palbociclib and inhibited the growth of cancer cell lines resistant to palbociclib
Currently in Phase 1/2a study to define the RP2D
Next milestone:

Define the RP2D and development strategy for LGEEC/other indications
Management and Organization

Traws will be led by incoming Chief Executive Officer, Werner Cautreels, Ph.D.; President and Chief Scientific Officer, Oncology, Steven Fruchtman M.D., (Onconova); Chief Financial Officer, Mark Guerin (Onconova), Chief Medical Officer, Robert Redfield, M.D., (Trawsfynydd), Chief Scientific Officer, Virology, C. David Pauza, Ph.D., (Trawsfynydd) and Chief Operating Officer, Nikolay Savchuk, Ph.D., (Trawsfynydd/Torrey Pines), as well as several other members of the Onconova and Trawsfynydd teams.

Traws’ Board of Directors will be comprised of Trawsfynydd’s Chairman Iain Dukes, DPhil (Venture Partner at OrbiMed), Executive Chairman, Werner Cautreels, Nikolay Savchuk, Ph.D. (General Partner of Torrey Pines) as well as existing Onconova Directors Trafford Clarke, Ph.D, James Marino, J.D. and M. Theresa Shoemaker and Jack E. Stover.

About the Merger and Private Financing

Onconova issued the following in the transactions: in connection with the merger, the stockholders of Traswfynydd received an aggregate of 3,549,538 shares of common stock and 10,359.0916 shares of newly issued Series C non-voting convertible preferred stock (with a conversion ratio of preferred to common at 1:10,000) (the "Series C preferred stock"), and in connection with the private financing, OrbiMed and Torrey Pines received an aggregate of 496,935 shares of common stock and 1,578.2120 shares of Series C preferred stock. This represents, on a fully diluted basis, 75.7% for Trawsfynydd, 13.7% for Onconova and 10.6% for new investors with a combined fully diluted equity value of $132 million (excluding transaction fees). In connection with the transactions, a non-transferrable contingent value right (a "CVR") will be distributed to Onconova stockholders of record as of the close of business on April 15, 2024. Holders of the CVR will be entitled to receive certain proceeds received by Onconova, if any, related to the disposition, net sales or monetization of narazaciclib and rigosertib.

The shares of common stock issuable upon conversion of the Series C preferred stock issued in the Merger and the private financing shall be subject to stockholder approval in compliance with the rules of the NASDAQ Stock Market.

Tungsten Advisors served as the exclusive financial advisor and placement agent to Onconova. Orrick, Herrington & Sutcliffe, LLP and Morgan, Lewis & Bockius LLP are serving as legal counsel to Onconova. Snell & Wilmer L.L.P. is serving as legal counsel to Trawsfynydd.

Webcast Presentation

The companies will host a webcast presentation to discuss the proposed transaction tomorrow, April 2 at 8:30 a.m. ET.

Dial-in details are:

Investors Dial-in: 1-877-407-0784
International Investors Dial-in: 1-201-689-8560
Conference ID: 13745512
Call me: Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me link for instant telephone access to the event.

View Source;passcode=13745512&h=true&info=company-email&r=true&B=6
Call me link will be made active 15 minutes prior to scheduled start time.
Webcast: View Source;tp_key=8103bfd962:

A replay of the webcast will also be available via Onconova’s investor website approximately two hours after the call’s conclusion.