On June 22, 2023 IGM Biosciences, Inc. (NASDAQ: IGMS) reported the pricing of its upsized underwritten public offering of 3,285,327 shares of its voting common stock and 7,312,500 shares of its non-voting common stock, in each case at a price to the public of $8.00 per share (Press release, IGM Biosciences, JUN 22, 2023, View Source [SID1234632848]). In addition, IGM has granted the underwriters a 30-day option to purchase up to an additional 1,589,673 shares of its voting common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the public offering will be sold by IGM. The public offering is expected to close on or about June 26, 2023, subject to satisfaction of customary closing conditions.

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Concurrent with the public offering, IGM intends to sell, subject to the consummation of the public offering and other customary conditions, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the Securities Act), 2,812,500 shares of non-voting common stock to certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC at a sale price equal to $8.00 per share. However, the consummation of the public offering is not contingent on the consummation of this concurrent private placement.

IGM expects to receive total gross proceeds of approximately $107.3 million from the public offering and the concurrent private placement, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM in connection with the public offering and the concurrent private placement.

BofA Securities, Jefferies, Stifel, and Guggenheim Securities are acting as joint book-running managers for the public offering.

The securities in the public offering will be offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on November 3, 2022 and declared effective on November 14, 2022. A final prospectus supplement and accompanying prospectus relating to the public offering will be filed with the SEC and may be accessed for free through the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained from: BofA Securities, Attention: Prospectus Department, NC1-0220-02-24, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, or via email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

The shares of non-voting common stock to be sold in the concurrent private placement have not been registered under the Securities Act or under any state securities laws and, unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

On June 22, 2023 Genmab A/S (Nasdaq: GMAB) reported that epcoritamab, a T-cell engaging bispecific antibody, has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for "B-cell Lymphomas" (Version 4.2023) for third-line and subsequent therapy for patients with diffuse large B-cell lymphoma (DLBCL), including patients with disease progression after transplant or chimeric antigen receptor (CAR) T-cell therapy and as a Category 2A, preferred regimen for patients with histologic transformation of indolent lymphomas to DLBCL and no intention to proceed to transplant, including patients with disease progression after transplant or CAR T-cell therapy (Press release, Genmab, JUN 22, 2023, View Source [SID1234632845]). This recommendation is based on uniform NCCN consensus that the intervention is appropriate.i Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV) as part of the companies’ oncology collaboration.

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Epcoritamab-bysp (EPKINLY) was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"The NCCN Guidelines are a resource for treating various types of cancer and providing healthcare providers with information for making informed treatment decisions," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We are pleased that the NCCN has updated its Guidelines to include epcoritamab in a speedy manner."

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of B-cell non-Hodgkin’s lymphoma (B-NHL) worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.ii,iii DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.iv,v

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T-cell mediated killing of CD20+ cells.vi

In October 2022, a Marketing Authorization Application was submitted for epcoritamab for the treatment of patients with R/R DLBCL after two or more lines of systemic therapy, which was validated by the European Medicines Agency. Additionally, in December 2022, a Japan new drug application was submitted to the Ministry of Health, Labor and Welfare of Japan for epcoritamab for the treatment of patients with R/R LBCL after two or more lines of systemic therapy. Epcoritamab is not approved in the European Union and Japan. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets excluding the U.S. and Japan throughout the year.

Genmab and AbbVie are continuing to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494), an ongoing phase 3, open-label, randomized trial evaluating epcoritamab in combination in adult participants with newly diagnosed DLBCL (NCT: 05578976), and a phase 3, open-label clinical trial evaluating epcoritamab in combination in patients with R/R follicular lymphoma (FL) (NCT: 05409066). Epcoritamab is not approved for the treatment of newly diagnosed DLBCL or R/R FL and the safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information.

U.S. IMPORTANT SAFETY INFORMATION
BOXED WARNINGS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY (epcoritamab-bysp). Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.

Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.
Cytokine Release Syndrome (CRS)

EPKINLY can cause CRS, including serious or life-threatening reactions. CRS occurred in 51 percent of patients at the recommended dose in the clinical trial (37 percent grade 1, 17 percent grade 2, and 2.5 percent grade 3). Recurrent CRS occurred in 16 percent of patients. Of all the CRS events, most (92 percent) occurred during cycle 1. In cycle 1, 9 percent of CRS events occurred after the 0.16 mg dose (cycle 1, day 1), 16 percent after the 0.8 mg dose (cycle 1, day 8), 61 percent after the 48 mg dose (cycle 1, day 15), and 6 percent after the 48 mg dose (cycle 1, day 22). The median time to onset of CRS from the most recently administered EPKINLY dose across all doses was 24 hours (range, 0-10 days). The median time to onset after the first full 48 mg dose was 21 hours (range, 0-7 days). CRS resolved in 98 percent of patients; the median duration of CRS events was 2 days (range, 1-27 days).
Signs and symptoms of CRS can include pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia. Concurrent neurological adverse reactions associated with CRS occurred in 2.5 percent of patients and included headache, confusional state, tremors, dizziness, and ataxia.
Initiate EPKINLY according to the step-up dosing schedule. Administer pretreatment medications to reduce the risk of CRS and monitor patients for potential CRS. Following administration of the first 48 mg dose, patients should be hospitalized for 24 hours. At the first signs or symptoms of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines, and administer supportive care as appropriate. Withhold or discontinue EPKINLY based on the severity of CRS.
Patients who experience CRS (or other adverse reactions that impair consciousness) should be evaluated and advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution.
Immune Effector Cell–Associated Neurotoxicity Syndrome (ICANS)

EPKINLY can cause life-threatening and fatal ICANS. ICANS occurred in 6 percent (10/157) of patients in the clinical trial (4.5 percent grade 1, 1.3 percent grade 2, 0.6 percent fatal: 1 event). Of the 10 ICANS events, 9 occurred in cycle 1 of treatment. The median time to onset was 16.5 days (range, 8-141 days) from the start of treatment. Relative to the most recent administration, the median time to onset was 3 days (range, 1-13 days). The median duration of ICANS was 4 days (range, 0-8 days), with ICANS resolving in 90 percent of patients with supportive care.
Signs and symptoms of ICANS can include confusional state, lethargy, tremors, dysgraphia, aphasia, and nonconvulsive status epilepticus. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.
Monitor for potential ICANS. At the first signs or symptoms of ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or discontinue EPKINLY per recommendations and consider further management per current practice guidelines.
Patients who experience signs or symptoms of ICANS or any other adverse reactions that impair cognition or consciousness should be evaluated, including potential neurology evaluation, and patients at increased risk should be advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution.
Infections

EPKINLY can cause serious and fatal infections. In the clinical trial, serious infections, including opportunistic infections, were reported in 15 percent of patients treated with EPKINLY at the recommended dose (14 percent grade 3 or 4, 1.3 percent fatal). The most common grade 3 or greater infections were sepsis, COVID-19, urinary tract infection, pneumonia, and upper respiratory tract infection.
Monitor patients for signs and symptoms of infection prior to and during treatment with EPKINLY and treat appropriately. Avoid administration of EPKINLY in patients with active infections.
Prior to starting EPKINLY, provide Pneumocystis jirovecii pneumonia (PJP) prophylaxis and consider prophylaxis against herpes virus.
Withhold or consider permanent discontinuation of EPKINLY based on severity.
Cytopenias

EPKINLY can cause serious or severe cytopenias, including neutropenia, anemia, and thrombocytopenia. Among patients who received the recommended dose in the clinical trial, grade 3 or 4 events occurred in 32 percent (decreased neutrophils), 12 percent (decreased hemoglobin), and 12 percent (decreased platelets). Febrile neutropenia occurred in 2.5 percent.
Monitor complete blood counts throughout treatment. Based on severity of cytopenias, temporarily withhold or permanently discontinue EPKINLY. Consider prophylactic granulocyte colony-stimulating factor administration as applicable.
Embryo-Fetal Toxicity

EPKINLY may cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating EPKINLY. Advise females of reproductive potential to use effective contraception during treatment with EPKINLY and for 4 months after the last dose.
Adverse Reactions

The most common (≥20 percent) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. The most common grade 3 to 4 laboratory abnormalities (≥10 percent) were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets.
Lactation

Advise women not to breastfeed during treatment and for 4 months after the last dose of EPKINLY.
Please see the full Prescribing Information and Medication Guide, including Boxed Warnings.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

On June 22, 2023 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the first patient has been dosed in the triple immunotherapy combination proof-of-concept study evaluating COM701, Compugen’s potential first-in-class anti-PVRIG antibody, with COM902, Compugen’s potential best-in-class anti-TIGIT antibody and pembrolizumab in patients with platinum resistant ovarian cancer (Press release, Compugen, JUN 22, 2023, View Source [SID1234632843]).

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"We are very excited that the first patient with platinum resistant ovarian cancer has been dosed with the triple immunotherapy combination of COM701, COM902 and pembrolizumab in our proof-of-concept study. This milestone keeps us on track to report initial findings by the end of this year," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "The goal of the study is to build on the encouraging data previously reported by us at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2022, with the dual and triple blockade of PVRIG and PD-1 with or without TIGIT. We expect that this study will help us to better understand the contribution of the components and contribute to our ongoing biomarker work to try and identify the patients most likely to respond, with the purpose of building a path to registration."

"Despite recent advances in the treatment of patients with platinum resistant ovarian cancer, there remains a significant unmet need for new treatment options for these patients," said Dr. Manish Sharma, Associate Director of Clinical Research at START Midwest in Grand Rapids, Michigan. "I am very excited to participate in this proof-of-concept study with the novel triple immunotherapy combination of COM701, COM902 and pembrolizumab. Our initial observation is that this combination is well tolerated by patients as observed in our microsatellite stable colorectal cancer proof-of-concept study initiated recently. I hope this differentiated approach of blocking three pathways in the DNAM-1 axis, PVRIG, TIGIT and PD-1 will result in additional treatment options for patients with platinum resistant ovarian cancer."

Details on the study:
This proof-of-concept study (NCT04354246) is an open label study evaluating the combination of COM701 with COM902 and pembrolizumab in up to 40 patients with high grade platinum resistant epithelial ovarian cancer including patients with fallopian tube cancer and primary peritoneal cancer who have received up to 3 lines of prior therapy for platinum resistant ovarian cancer. The study includes patients with all histologies. The initiation of the study is based on Phase 1 cohort expansion data reported at ESMO (Free ESMO Whitepaper)-IO 2022, showing a favorable safety and tolerability profile and durable anti-tumor activity with the combination of COM701 and nivolumab ± BMS-986207 in platinum resistant ovarian cancer patients.

On June 22, 2023 Circio Holding ASA (OSE: CRNA), reported that the first multiple myeloma (MM) patient has been dosed with mutant RAS cancer vaccine TG01 at Oslo University Hospital (OUS) (Press release, Circio, JUN 22, 2023, View Source [SID1234632842]). The study is led by multiple myeloma expert Dr. Fredrik Schjesvold in a clinical collaboration between OUS and Circio. OUS is the study sponsor, with Dr. Schjesvold as the principal investigator, in collaboration with project lead Dr Hanne Norseth and Research medical student Hedda Monsen. Circio will provide TG01 drug supply, scientific support and a financial contribution.

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Mutations in the RAS genes are commonly found in pancreatic cancer, colon cancer myeloma and lung cancer but outside of lung cancer there are no RAS-targeted therapies available for these patients. TG01 is a mutant RAS therapeutic cancer vaccine adjuvanted by QS-21 STIMULON, which targets the seven most commonly found RAS mutations. TG01 has previously demonstrated robust immune responses and survival benefit in resected pancreatic cancer combined with standard of care chemotherapy.

In this study, TG01 vaccination will be tested as a monotherapy in 20 KRAS or NRAS mutated myeloma patients who have either high risk smoldering myeloma or have evidence of disease after completion of standard of care (SoC) therapy. The treatment period is 12 months. In the first 3 months TG01 is given every other week, and thereafter it is given once every second month for 9 months. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can delay the disease progression and enhance the clinical response.

Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group, said: "There are no targeted therapy options available for RAS-mutated multiple myeloma patients which continue to have a clear need for better and more tolerable treatments. I believe the TG01 vaccine has the potential to eliminate residual disease and delay recurrence following standard of care treatment, and we look forward to work with Circio to test this therapeutic concept at our center."

Margrethe Sørgaard, VP and Head of Clinical Development of Circio Holding ASA, added: "Having the first patient dosed in Dr. Schjesvold´s study in multiple myeloma is an important milestone for the TG program. It is the first time the TG01 cancer vaccine will be tested in this indication, and the first time the new and enhanced vaccine format of sub-cutaneous single-injection TG01 adjuvanted by QS-21 STIMULON has been administered to a patient in Europe. We firmly believe that TG01 can bring targeted clinical benefit, with a favorable safety profile, to this underserved area of RAS-mutated multiple myeloma."

About TG01 mutant RAS vaccine

Oncogenic mutations in the RAS family of genes drive up to 30% of all cancers and remain a major unmet medical need with few good treatment alternatives. Circio was recently awarded two prestigious research grants from Innovation Norway and the Norwegian Research Council, totaling NOK 18m, to advance its TG mutant RAS cancer vaccine program.

About Agenus, QS-21 STIMULON
Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer and infections. In March 2022, Circio announced a collaboration with Agenus to utilize the proprietary adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 STIMULON has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and as a component of the commercial Shingrix*, Mosquirix* and Arexvy* vaccines. QS-21 STIMULON is expected to further potentiate the TG vaccines by driving stronger anti-RAS T-cell responses.

On June 22, 2023 Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, and Cimeio Therapeutics, a biotechnology company that is reinventing cell therapy through its leadership in the emerging field of epitope shielding, reported a research collaboration to combine their respective technologies, including Prime Medicine’s Prime Editing platform and Cimeio’s Shielded Cell and Immunotherapy Pairs (SCIP) platform (Press release, Cimeio Therapeutics, JUN 22, 2023, View Source [SID1234632841]).

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The goal of the research is to improve the safety and effectiveness of hematopoietic stem cell (HSC) transplants to treat genetic diseases, acute myeloid leukemia (AML), and myelodysplastic syndrome (MDS), as well as enable the in vivo selection of edited HSCs to potentially remove the need for transplantation entirely.

HSC transplant offers a potentially curative approach for many debilitating and life-threatening diseases, including malignancies such as AML and rare genetic diseases like Gaucher’s and Hurler’s, though its clinical utility is limited by the current need for myeloablative conditioning regimens and the risk of post-transplant progression of malignant disease. Cimeio’s SCIP platform combined with Prime Editing may significantly improve the accessibility, eligibility and outcomes for patients who could benefit from HSC transplant. These combined technologies may also enable selection of in vivo edited HSCs, which could allow for the treatment of genetic diseases without a transplant.

Under the terms of the agreement, Prime Medicine will develop a Prime Editor for Cimeio’s CD117 shielding variant that will then be evaluated by both companies. CD117 is a receptor tyrosine kinase expressed on normal HSCs and on leukemia cells, and therefore is an attractive target for an antibody-based conditioning therapy for patients needing a stem cell transplant, or for patients with AML or MDS needing new treatment options.

If the research collaboration is successful, the companies will grant exclusive license options to each other for their technology. Prime Medicine will receive an exclusive option to license Cimeio’s cell shielding technology for CD117-shielded HSC transplant, as well as in vivo editing of CD117-shielded HSCs, for genetic diseases, not including Sickle cell disease. Cimeio will receive an exclusive option to license Prime Medicine’s Prime Editing technology for its CD117-shielded allogeneic HSC product for use in AML and MDS, and, potentially, a second shielding protein for use in AML and MDS. If the companies exercise their exclusive license options, they will each be eligible to receive economics on net sales of licensed products. Specific financial terms were not disclosed.

Cimeio’s proprietary investigational immunotherapies are designed to selectively deplete diseased HSCs, while its novel CD117 protein variant, which can be introduced into HSCs using Prime Editing, has the potential to protect the healthy transplanted HSCs from depletion, allowing them to engraft while maintaining the normal function of the CD117 receptor. Because the edited HSCs are shielded, the diseased HSCs can be more gradually depleted, which could reduce toxicity and increase safety. The immunotherapies can also be administered post-transplant with the potential to boost engraftment or treat minimal residual disease.

Prime Editing is uniquely suited to introduce these novel protein variants into HSCs by virtue of its versatility, precision and efficiency, without causing double strand breaks and with minimal off target editing. Because Prime Editing can be multiplexed (i.e., multiple Prime Edits can be made with a single administration), rare genetic diseases such as beta thalassemia, immunodeficiencies and bone marrow failure syndromes may be corrected by Prime Editing at the same time as cell shielding, offering the possibility of autologous transplant for these patients without toxic conditioning.

"We believe Prime Editing is an incredibly powerful technology that could impact the care and treatment of a wide range of diseases. To fully exploit the potential of our technology, we are committed to collaborating with partners who can meaningfully expand our reach, accelerating our efforts to deliver important new medicines to patients worldwide," said Keith Gottesdiener, M.D., Chief Executive Officer of Prime Medicine. "Through this partnership, we are gaining access to a promising platform technology, which, when combined with Prime Editing, may allow many more patients to benefit from the potentially curative power of HSC transplant and, for the first time, make feasible in vivo treatment of many genetic diseases. We are delighted to collaborate with the Cimeio team, which includes experts in the fields of cell therapy, gene editing and HSC transplant, and look forward to working closely together to evaluate the synergistic potential of our technologies."

At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022, Cimeio presented results from a preclinical study demonstrating proof-of-concept for its CD117-shielded cells. The data showed that its shielded cells expressing a genetically engineered variant of CD117 were fully functional in vitro and contributed to engraftment in vivo, similar to unmodified HSCs expressing the wild-type receptor. Mice transplanted with a mix of human HSCs expressing either wild-type CD117 or the Cimeio shielded CD117 variant showed a selective depletion of wild-type CD117 cells following treatment with Cimeio’s antibody directed against wild-type CD117, while those cells expressing the shielded CD117 variant were spared.

"Our recently disclosed data continues to show that our unique shielding technology and paired immunotherapies have the potential to deliver transformative therapies for patients with many types of diseases," said Thomas Fuchs, Chief Executive Officer of Cimeio Therapeutics. "Through this collaboration, we are bringing together industry leading protein engineering and genome editing, with the potential to deliver safer, curative therapies for patients. Our aim is to eliminate the need for toxic chemotherapies and radiation, and enable new therapeutic approaches post-transplant. Our goal is to reinvent HSC transplant as a more effective and practical option for many more patients facing debilitating and fatal diseases. We look forward to partnering with the extremely talented team at Prime Medicine to advance our novel CD117 program."