On December 14, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that Lantern Pharma presented positive data on the effectiveness of LP-284 in hematologic cancers at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which was held in-person and virtually from December 11 – 14, 2021 (Press release, Lantern Pharma, DEC 14, 2021, View Source [SID1234597068]). This poster presentation can be viewed on Lantern Pharma’s website at: View Source

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LP-284 is a fully synthetic molecule belonging to the new generation of acylfulvenes, a family of naturally derived anti-cancer drug candidates. LP-284 is the stereoisomer (enantiomer) of LP-184 and has the potential for development as monotherapy and also as a synergistic agent in combination with other drugs. LP-284 is currently being evaluated for activity in a wide spectrum of hematological cancers. Earlier this year, Lantern filed multi-national patent applications directed to both the composition and manufacture of LP-284.

LP-284 demonstrated nanomolar potency in a variety of hematologic cell lines

The study demonstrated LP-284’s broad in vitro anti-tumor activity in lymphoma, multiple myeloma, and leukemia cells. Notably, the enantiomer pair, LP-184 and LP-284, exhibit distinct patterns of anti-tumor activities. As a result, the novel enantiomer LP-284 may provide a targeted therapy option for hematologic cancers with compromised DNA repair, supporting further targeted development plans for LP-284.

"Approximately every 3 minutes, one person in the U.S. is diagnosed with leukemia, lymphoma or myeloma and approximately every 9 minutes someone in the U.S. dies from a blood cancer1," commented Panna Sharma, CEO and President of Lantern Pharma Inc. "There is an urgent need to develop new, targeted therapies; however, the current industry approach is time consuming and expensive. This latest data provides further validation of Lantern’s RADR platform, which leverages A.I. and machine learning with the aim of dramatically shortening the timeline and reducing costs associated with drug discovery and development. Specifically, these findings support our hypothesis that LP-284 has the potential to become a targeted therapy option for hematologic cancers with compromised DNA repair. We plan to apply the insights obtained from this work to advance the development of LP-284 in rare blood cancer indications. This data is very encouraging, and we look forward to advancing LP-284 towards the clinic, while leveraging our RADR platform to develop new cutting-edge treatments for rare blood cancers and other indications."

Lantern’s proprietary RADR A.I. platform leverages over 10 billion data points, machine learning, genomics, and computational biology to accelerate the discovery of potential mechanisms of action, and biomarker signatures that correlate to drug response in rare blood cancers.

On December 14, 2021 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that it intends to offer and sell $300.0 million of American Depositary Shares ("ADSs"), each representing two ordinary shares, in an underwritten public offering. All ADSs to be sold in the proposed offering will be offered by Legend Biotech (Press release, Legend Biotech, DEC 14, 2021, View Source [SID1234597145]). Legend Biotech also intends to grant the underwriters a 30-day option to purchase up to an additional $45.0 million of ADSs sold in the public offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

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Morgan Stanley, J.P. Morgan, Jefferies, Piper Sandler & Co. and Barclays are serving as joint book-running managers for the offering. BTIG is serving as a co-manager for the offering.

The ADSs are being offered by Legend Biotech pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the preliminary prospectus supplement can be obtained, when available, from Morgan Stanley & Co. LLC, 180 Varick Street, New York, NY 10014, Attention: Prospectus Department, or by telephone at (866) 718-1649; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 866-803-9204 or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by email at [email protected] or by phone at (877) 821-7388; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by email at [email protected] or by telephone at 1-800-747-3924; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected] or by telephone at (888) 603-5847.

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.

On December 14, 2021 Targovax ASA’s (the "Company") reported that published on 30 November 2021 regarding the commencement of the subscription period in the rights issue of 101,744,186 new shares in the Company (the "Offer Shares") at a subscription price of NOK 1.72 per offer share (the "Rights Issue") (Press release, Targovax, DEC 14, 2021, View Source [SID1234597070]).

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The subscription period for the Rights Issue expired at 16:30 hours (CET) today, on 14 December 2021.

Preliminary counting indicates that the Company has received subscriptions for approximately 110 million Offer Shares in the Rights Issue.

The final allocation of the Offer Shares will take place on 15 December 2021 in accordance with the allocation criteria set out in the Company’s prospectus dated 29 November 2021, comprising a registration document and a securities note (jointly, the "Prospectus"). The final result of the Rights Issue will be published shortly thereafter, and letters regarding allocation of the Offer Shares and the corresponding subscription amount to be paid by each subscriber, are expected to be distributed on 15 December 2021.

The due date for payment of the Offer Shares is expected to be on or about 17 December 2021.

On December 14, 2021 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported a collaboration with Novartis in the form of a license agreement to develop, manufacture and commercialize DARPin-conjugated radioligand therapies (DARPin-RLTs) (Press release, Molecular Partners, DEC 14, 2021, View Source [SID1234597100]). The collaboration will combine Molecular Partners’ industry-leading ability to rapidly generate high-affinity DARPins and the RLT capabilities and expertise of Novartis.

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By harnessing the power of radioactive atoms and applying it to cancers through targeted radioligand therapy, RLTs have the potential to deliver molecularly targeted radiation to tumor cells anywhere in the body. Under the terms of the agreement, Molecular Partners will collaborate with Novartis to discover DARPin-RLTs that target specific tumor associated antigens. DARPins have great potential to enable robust, tumor-specific delivery of radioligands owing to their small size, allowing for greater tumor penetration, and high specificity and affinity.

"We are very pleased to announce this new collaboration with Novartis. For several years, the team at NIBR has established themselves as the world leader in the RLT field and working with them on this program is an easy choice to make," said Patrick Amstutz, CEO of Molecular Partners. "While DARPins can be designed to perform any number of biological tasks, here we highlight some of their innate characteristics, including small size and high specificity and affinity, which may offer an advantage to RLT’s which often require a highly specific delivery vehicle."

"Radioligand therapy is a transformative platform for delivering radiation to target cells, and DARPins are a unique modality for specifically targeting tumors," said Jay Bradner, President of the Novartis Institutes for BioMedical Research. "The marriage of these two technologies is designed to enable us to target radioligands directly to tumor cells anywhere in the body with the goal of improving and extending patients’ lives."

Under the agreement, both parties will collaborate on the discovery and optimization of the therapeutic candidates. Novartis would be responsible for all clinical development and commercialization activities. Novartis will pay $20 million upfront to Molecular Partners, total potential development, regulatory and commercialization milestone payments of up to $560 million, and up to low double-digit percent of royalties.

On December 14, 2021 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported three poster presentations related to imetelstat, the Company’s first in class telomerase inhibitor, at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Geron, DEC 14, 2021, View Source [SID1234597146]). The posters are available at www.geron.com/r-d/publications.

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"The posters for this year’s ASH (Free ASH Whitepaper) Meeting highlight our ongoing Phase 3 development of imetelstat in lower risk MDS and refractory MF, as well as exploratory work in new indications to maximize the potential value of imetelstat," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "We believe the unique telomerase inhibition MOA of imetelstat has the potential to transform the standard of care in hematologic malignancies."

Clinical Posters

Lower Risk Myelodysplastic Syndromes (MDS)

Abstract Title: On-Target Activity of Imetelstat Correlates with Clinical Benefits, Including Overall Survival (OS), in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs) Abstract #2598

The poster reports new analyses to assess the correlation between imetelstat’s inhibition of telomerase with the efficacy and safety data from the IMerge Phase 2 clinical trial. These correlative analyses indicating that patients who achieved optimal pharmacodynamic (PD) effect achieved higher rates of red blood cell transfusion independence (RBC-TI), longer RBC-TI and a trend toward improved overall survival. Importantly, these patients did not have higher rates of Grade 3+ neutropenia, thrombocytopenia or liver function elevations compared to patients who did not achieve optimal PD effect.

These data provide further evidence for the on-target mechanism of action (MOA) of imetelstat through telomerase inhibition and links imetelstat’s on-target activity with clinical benefits.

To confirm these and other results from IMerge Phase 2, the Company is conducting a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of RBC-TI for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

IMerge Phase 3 is fully enrolled and patient enrollment has been closed. Based on current planning assumptions, the Company expects top-line results from IMerge Phase 3 in early January 2023.

Refractory Myelofibrosis (MF)

Abstract Title: A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy (BAT) in Patients with Intermediate-2 (Int-2) or High-risk Myelofibrosis (MF) Refractory to Janus Kinase Inhibitor (JAKi) Abstract #1503 Trials in Progress

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is planned to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

Pre-Clinical Poster – Pediatric Acute Myeloid Leukemia

Abstract Title: Imetelstat Significantly Reduces Leukemia Stem Cells in Patient-Derived Xenograft Models of Pediatric AML Abstract #3352

Acute myeloid leukemia (AML) is the deadliest malignancy in children. To improve survival in pediatric AML, novel targeted therapies and other alternative treatment methods are needed. Due to the significant unmet medical need in this disease, the use of imetelstat was evaluated to determine whether the drug 1) has anti-leukemia activity and 2) could be used as a therapeutic for pediatric AML.

The poster describes results from pre-clinical studies of imetelstat in pediatric AML cell lines (in vitro studies) and patient derived (PDX) mouse models (in vivo studies). The efficacy of imetelstat either as a single agent or in combination with chemotherapy or azacitidine was also evaluated. In cell line experiments, imetelstat treatment resulted in cell apoptosis/death of leukemia stem cells (LSCs) in a time- and dose-dependent manner and with minimal effect on normal bone marrow samples. In the in vivo studies, imetelstat treatment reduced LSC numbers and prolonged survival in mice. Observations of prolonged survival in mice were also seen when combining imetelstat with chemotherapy or azacitidine.

These data suggest imetelstat may represent an effective therapeutic strategy to target the LSC population in pediatric AML patients.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.