On April 18, 2024 Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, reported the U.S. Food & Drug Administration (FDA) approved the company’s New Drug Application (NDA) for its LUMISIGHT (pegulicianine) optical imaging agent and its Premarket Approval (PMA) application for Lumicell Direct Visualization System (DVS), together referred to as LumiSystem (Press release, Lumicell Diagnostics, APR 18, 2024, View Source [SID1234642165]).

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With 84% diagnostic accuracy, LumiSystem enables surgeons to scan the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients from second surgeries.1-2 The LumiSystem combination is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

"We are immensely proud of the dual approval of LUMISIGHT and Lumicell DVS – we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA’s most stringent NDA and PMA review processes,"3 said Howard Hechler, President and Chief Operating Officer, Lumicell. "With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity."

"Breast cancer is all too common, and sadly, 1 in 8 women will develop it during their lifetime,"4 said Kelly Hunt, MD, Chair of the Department of Breast Surgical Oncology at MD Anderson Cancer Center and President of the Society of Surgical Oncology. "Our most common surgical procedure to treat these women is lumpectomy. Unfortunately, the intraoperative tools we have are limited and do not identify the extent of tumor accurately enough, making it challenging to achieve a complete tumor resection, leading to as many as 36% of patients needing a second surgery."5

"Up to 65% of the time, we do not find residual cancer in the second surgery and are left wondering if we performed an unnecessary surgery due to a false positive margin assessment or if the cancer was missed again in the second surgery,"6 said Irene Wapnir, MD, Breast Surgical Oncologist and Professor of Surgery, Stanford University School of Medicine.

"During lumpectomy surgery, surgeons still struggle to identify and remove all of the tumor during the first operation,"7 said Barbara Smith, MD, PhD, Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School. "With LumiSystem, we will now have a technology that is clinically proven to achieve a more complete cancer resection during lumpectomy that could help some patients avoid a second surgery."2

The safety of the system was established using data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers across the U.S. The most common side effects with LUMISIGHT are hypersensitivity and an abnormal color in urine. LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, used to support the efficacy of the system, were published in NEJM Evidence.

"We want to thank our clinical investigators and the hundreds of women who participated in our breast program for LUMISIGHT and Lumicell DVS," said Jorge Ferrer, Chief Scientific Officer, Lumicell. "Due to your important contributions, LUMISIGHT and Lumicell DVS are now approved and will be available in the United States shortly."

Please visit www.LumiSystem.com to learn more about LUMISIGHT and Lumicell DVS.

On April 18, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported that results from the Phase 3 SIERRA trial of Iomab-B were presented in an oral presentation at the 50th Annual European Bone Marrow Transplant Society Meeting (EBMT) held in Glasgow, Scotland on April 14-17 (Press release, Actinium Pharmaceuticals, APR 18, 2024, View Source [SID1234642164]). The results showed that an Iomab-B led bone marrow transplant (BMT) results in higher rates of remissions and durable Complete Remission (dCR), which is the primary endpoint of the SIERRA trial, as well as significant improvement in overall survival in TP53 positive patients. Iomab-B is a targeted radiotherapeutic comprised of an anti-CD45 monoclonal antibody with the Iodine-131 radioisotope payload. The Phase 3 SIERRA trial enrolled 153 patients age 55 and above with active relapsed or refractory acute myeloid leukemia (AML) and compared outcomes of patients receiving Iomab-B BMT to those of patients receiving physician’s choice of care in the control arm. In total, 24% (37/153) of the patients enrolled on SIERRA had a TP53 mutation, which is associated with limited treatment options and poor outcomes.

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Data highlighted in the ASH (Free ASH Whitepaper) oral presentation, which can be accessed on the investor relations page of Actinium’s website, included:

Response rates by TP53 Mutation Status:

Iomab-B & Crossover

Control Arm

TP53 Positive

N=27

N=10

CR

55.56% (15/27)

0 %

dCR

14.81% (4/27)

0 %

TP53 Wildtype

N=93

N=23

CR

58.06% (54/93)

17.39% (4/23)

dCR

16.13% (15/93)

0 %

Overall Survival in Patients with a TP53 Mutation:

Iomab-B & Crossover

Control Arm

Median OS

5.49 months

1.66 months

Number of Patients

27

10

Hazard Ratio

0.23

p-value

0.0002

Median OS was 6.37 months in TP53 negative patients receiving Iomab-B and 5.72 months for TP53 positive patients demonstrating Iomab-B’s ability to overcome TP53 gene mutations.

Dr. Hannah Choe, Assistant Professor of Medicine at Ohio State University and SIERRA trial investigator, commented, "TP53 mutations are associated with very poor outcomes due to resistance to anti-leukemic therapies with patients rarely offered access to potentially curative transplantation. The SIERRA trial showed that Iomab-B was well tolerated and can enable unprecedented access to transplant in this patient population and induce high complete remission rates despite active, relapsed/refractory disease and a TP53 mutation. These results were very well received at EBMT and demonstrate the novelty and safety of a CD45-directed antibody radiation conjugate. More importantly, we see that these response rates translated into improved overall survival, overcoming the increased risk associated with TP53 mutation while no other viable treatment options exist. We are excited for Iomab-B’s potential use and safety for disease control in patients with a TP53 mutation."

About the EBMT Annual Meeting

The Annual Meeting of the EBMT is attended by more than 5,500 participants, including physicians, nurses, data managers, statisticians, quality managers, cell therapists, paediatricians, pharmacists, psychologists, psychiatrists and psychoanalysts, transplant coordinators, lab scientists, trainees, and patients. This important congress ensures and encourages dialogues and information exchange, education and scientific productivity.

The full annual meeting program is available online at:

View Source

On April 18, 2024 GV20 Therapeutics, a clinical stage biotechnology company integrating AI, genomics, and disease biology to create next-generation antibody therapeutics, reported that it has entered into a clinical collaboration and supply agreement with Merck (known as MSD outside the US and Canada) (Press release, GV20 Therapeutics, APR 18, 2024, View Source [SID1234642163]). Under the terms of the agreement, GV20 will evaluate its lead investigational program GV20-0251, a first-in-class antibody targeting the novel immune checkpoint IGSF8, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA(pembrolizumab), in patients with advanced solid tumors in an ongoing Phase I study (NCT05669430).

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"We are excited to advance the development of GV20-0251 and explore its potential in combination with KEYTRUDA," said Dr. Shirley Liu, Co-Founder and CEO of GV20 Therapeutics. "IGSF8 is a novel immune checkpoint target that inhibits the function of natural killer cells and dendritic cells. By releasing this inhibition, the antagonistic antibody GV20-0251 has the potential to become another pillar in cancer immunotherapy and bring significant benefits to cancer patients."

GV20 is currently enrolling an open-label, multi-center, dose-escalation and dose-expansion Phase I clinical trial testing GV20-0251 in patients with advanced solid tumors who are not eligible for standard of care therapies (NCT05669430). The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of GV20-0251 as a single agent and in combination with KEYTRUDA(pembrolizumab). GV20 has generated preclinical data demonstrating that antibody blockade of IGSF8 results in compelling anti-tumor activity as monotherapy as well as in combination with anti-PD-1 across multiple tumor models. Recently, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, GV20 delivered an oral presentation titled "IGSF8 is a novel innate immune checkpoint and cancer immunotherapy target" during the immunology mini-symposium session.

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

On April 18, 2024 Biohaven Ltd. (NYSE: BHVN), a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology, reported the pricing of its underwritten public offering of 5,609,757 of its common shares at a price to the public of $41.00 per share (Press release, Biohaven Pharmaceutical, APR 18, 2024, View Source [SID1234642161]). In addition, Biohaven has granted the underwriters a 30-day option to purchase up to an additional 841,463 common shares at the public offering price, less underwriting discounts, and commissions. The gross proceeds from the offering are expected to be approximately $230 million before deducting underwriting discounts and commissions and offering expenses payable by Biohaven. The offering is expected to close on April 22, 2024, subject to satisfaction of customary closing conditions. Biohaven intends to use the net proceeds received from the offering for general corporate purposes.

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J.P. Morgan, Morgan Stanley, TD Cowen, and Piper Sandler & Co. are acting as the joint lead book-running managers of the offering. Cantor is acting as a book-runner of the offering. Baird is also acting as a book-runner of the offering.

The offering is being made only by means of a prospectus supplement and the accompanying prospectus, copies of which, when available, may be obtained from the offices of the following: 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], Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected], and Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected].

The shares will be issued pursuant to an effective shelf registration statement on Form S-3. Copies of the registration statement can be accessed through the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.

On April 18, 2024 D2M Biotherapeutics, Inc. (D2M), a clinical stage biotech company focused on developing innovative therapies in treating Immunological-Inflammatory diseases and cancers, reported that the first patient had been dosed in a phase 1, open-label, dose escalation and expansion study of DM919, a novel monoclonal antibody targeting MICA/B to restore and promote anti-tumor response by T and natural killer (NK) cells for the treatment of advanced solid tumors (Press release, D2M Biotherapeutics, APR 18, 2024, View Source [SID1234642160]).

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This phase 1, first-in-human, multicenter, dose-escalation and expansion trial (NCT06328673) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of DM919 alone and in combination with anti-PD1 therapy in patients with advanced or metastatic solid tumors.

"The initiation of this clinical study represents a major milestone for D2M," said Nan Bing, MD., Ph.D., co-founder and CEO of D2M. "The MICA/B targeted therapy is a novel modality in cancer treatment through its unique mode-of-action by addressing MICA/B mediated immune escape presented in many types of tumors. It also has potential to bring effective treatment against certain tumors with MHC-I low expression, which are typically resistant to the current immune check inhibitor agents. We are thrilled to work with our Principal Investigator, Dr. Shiraj Sen at Next Oncology to assess DM919’s safety and clinical activities in this Ph1 study."

Dr. Sen commented "DM919 has unique biological properties to potentially restore a patient’s innate and adaptive immunity against cancers. We are eager to investigate DM919 as a monotherapy agent and in combination with anti-PD1 therapy".

About DM919

DM919 is a humanized MICA/B-specific IgG1 monoclonal antibody designed to block the shedding of MICA and MICB proteins from cancer cells. Highly expressed in cancer cells, MICA/B are stress-induced ligands recognized by both innate and adaptive immune cells via NKG2D receptors. Through shedding MICA/B, tumor cells develop immune escape. DM919 restores and enhances NKG2D-dependent activation of T and NK cells in the tumor micro-environment, and therefore promotes anti-tumor activity in cancer patients.

D2M Biotherapeutics have shown that DM919 prevents MICA/B shedding, stabilizes surface MICA/B and presents shed MICA/B to activate NKG2D on NK or T cells and mediates antibody-dependent cytotoxicity (ADCC) of tumor cells. In preclinical studies, DM919 has demonstrated significant antitumor activity as a single agent in a variety of tumor models. Furthermore, substantial synergistic anti-tumor effects have been demonstrated when DM919 is combined with anti-PD1 agent.