On July 22, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported the closing of an underwritten public offering of 13,225,000 shares of common stock at a public offering price of $20.00 per share, before underwriting discounts and commissions (Press release, Revolution Medicines, JUL 22, 2022, View Source [SID1234616889]). The shares of common stock issued and sold in the offering include 1,725,000 shares issued upon exercise in full by the underwriters of their option to purchase additional shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Revolution Medicines, were $264.5 million. All shares in the offering were offered by Revolution Medicines.

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J.P. Morgan, Cowen and Guggenheim Securities acted as the joint book-running managers for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission on March 2, 2021, and automatically became effective upon filing. This offering was made solely by means of a prospectus. A copy of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting: 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]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected]; or Guggenheim Securities, LLC, Attn: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

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

On July 22, 2022 Immune Therapeutics, Inc. (OTC Pink: IMUN) ("Immune" or "IMUN"), a specialty pharmaceutical company involved in the acquisition, development and commercialization of pharmaceutical and biotechnology products that have a short and well-defined path to market, reported the appointment of Dr. Stephen "Steve" Wilson as Immune’s Chief Executive Officer (CEO), President, and interim Chief Financial Officer (CFO) effective July 19, 2022; he will continue to serve as a member of the Company’s Board of Directors (Press release, Immune Therapeutics, JUL 22, 2022, View Source [SID1234616888]).

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Dr. Wilson brings over 20 years of experience in biomedical research, executive management, and corporate governance. He is a trained immunologist. In addition, he is, among other things, an Associate Clinical Professor at the University of California, San Diego, and he previously served as the Chief Operating Officer at the La Jolla Institute for Immunology as it grew to become an international powerhouse.

Immune also announced that Kevin Phelps has stepped down from his positions as the company’s CFO, President, and CEO, but he will remain a member of Immune’s Board of Directors.

The appointment of Dr. Wilson as Immune’s CEO, President, and interim CFO is expected to further strengthen IMUN’s global executive leadership team to drive its next phase of growth and operational success within a new operational model, initially focused on regulatory approval and commercialization of existing assets that treat patients with inflammatory disease.

Dr. Wilson stated, "Our strategy is to lever the global need for affordable and effective therapeutics and modern financial tools; this hinges on acquisition, development and commercialization of pharmaceutical and biotechnology products that have a short and well-defined path to market. We have assets that fit this profile, and our business objectives fit immediate patient needs. Going forward, we will take a measured portfolio approach to investment, development and commercialization that will mandate each additional program be hyper focused, capital efficient and small-scale with clear paths to regulatory approval. Financing these programs through modern investment vehicles and partnerships, we plan to deploy in markets that include, but are not dependent upon, US commercialization."

On July 22, 2022 GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, reported that China’s National Medical Products Administration (NMPA) has approved the Clinical Trial Applications (CTAs) for GFH018 in two clinical studies for combination therapies (Press release, GenFleet Therapeutics, JUL 22, 2022, View Source;r1-inhibitor-gfh018-with-pd-1-inhibitor-301591532.html [SID1234616885]).

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One study is a phase Ib/II trial of GFH018 with PD-1 inhibitor treating patients with advanced solid tumors; the other study is a phase II trial of GFH018, PD-1 inhibitor with concurrent chemoradiotherapy treating patients with locally advanced & unresectable NSCLC. GenFleet has completed a phase I trial of GFH018 monotherapy treating solid tumors in early 2022, and the data will soon be published in relevant international medical conference.

"Pre-clinical in-vivo data have demonstrated desirable anti-tumor effects of GFH018 in combination with PD-1 inhibitors; the combo study（GFH018X0201）being conducted in Australia and China’s Taiwan has completed the dose escalation phase (phase Ib), with the dose expansion phase (phase II) currently ongoing. From this multi-regional, multi-center clinical trial, we expect to collect additional evidence to further confirm the efficacy of combination therapies with GFH018 in cancer patients. In the study of GFH018, PD-1 inhibitor with concurrent chemoradiotherapy（GFH018X1202）, we will investigate the combination’s potential in improving the immunosuppressive microenvironment and reducing the side effects from concurrent chemoradiotherapy." said Yu Wang, M.D./Ph.D., Chief Medical Officer of GenFleet.

"GFH018 is GenFleet’s first product that has moved into clinical development stage. The progress of GFH018’s multi-regional studies clearly demonstrates GenFleet’s capability in global regulatory registration, patient enrollment and market positioning, and will substantially accelerate GFH018’s global clinical development. TGF-β signaling pathway has been studied as a critical target in multiple solid tumors; however, no drugs have been approved to date for this pathway. GFH018 is a small molecule drug designed to specifically target and inhibit TGF-β R1, and the discovery and development of GFH018 truly reflects GenFleet’s strategy of novel mechanism-focused innovation in drug development. GenFleet expects the development of the GFH018 to bring a novel therapy with great clinical benefit to cancer patients. "said Jiong Lan, Ph.D., Chief Executive Officer of GenFleet.

Both studies are multi-center, single-arm, and open-label trials designed to evaluate the safety/tolerability and efficacy of the GFH018 in combination therapies. Shanghai Oriental Hospital and Sun Yat-Sen University Cancer Center will lead the phase Ib/II study evaluating the combination of GFH018 and anti-PD-1 monoclonal antibody conducted in over 20 domestic hospitals. The safety/tolerability and efficacy of combination of GFH018, anti-PD-1 monoclonal antibody, concurrent chemoradiotherapy will be evaluated in the phase II study, which will be conducted at over 10 hospitals including West China Hospital of Sichuan University, Peking Union Medical College Hospital.

About GFH018 and TGF-β R1

Developed by GenFleet Therapeutics, GFH018 is an orally administered TGF-β R1 inhibitor and entered into phase I clinical trial in 2019. Preclinical data showed evidence of GFH018’s good anti-tumor properties against cancer cells in vivo and in vitro. Besides, translational and mechanistic studies confirmed it effectively acts on TGF-β signaling pathway and synergizes with checkpoint inhibitors.

In the microenvironment of advanced solid tumors, TGF-β signaling pathway can promote epithelial mesenchymal transition (EMT) & metastasis, induce the formation of cancer stem cells and their functional maintenance, inhibit anti-tumor immunity, enhance vasculature and fibrosis, and ultimately result in tumor progression. Among patients of hepatocellular carcinoma, glioma, colorectal cancer, lung cancer, pancreatic cancer, urothelial cancer and other solid tumors, high expression of genes related to TGF-β signaling pathway is frequently discovered in their blood and tumor tissues. The expression level is positively correlated to the malignancy & poor differentiation of tumor and unfavorable prognosis in patients.

On July 22, 2022 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that the first patient in China has been treated with TJ-CD4B (also known as ABL111), a novel Claudin 18.2 x 4-1BB bispecific antibody, in a Phase 1 international multi-center clinical trial (IMCT) for patients with solid tumors, including gastric cancer, gastroesophageal junction carcinoma, esophageal adenocarcinoma, and pancreatic ductal carcinoma (NCT04900818) (Press release, I-Mab Biopharma, JUL 22, 2022, View Source [SID1234616884]).

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TJ-CD4B is the first clinical-stage bispecific antibody of its drug class. It binds to Claudin 18.2-expressing cancer cells and co-stimulatory molecule 4-1BB on T cells to exert a tumor-killing effect. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TJ-CD4B for the treatment of gastric cancer including cancer of gastroesophageal junction.

"Patients with gastric, esophageal and pancreatic cancers carry a poor prognosis with limited treatment options. TJ-CD4B has demonstrated its potential to become an effective treatment option in preclinical studies. In particular, TJ-CD4B is superior to other therapies targeting Claudin 18.2 and has a broader anti-tumor effect covering cancers expressing low levels of Claudin 18.2," said Professor Lin Shen, Vice President of Clinical Oncology at the Beijing Cancer Hospital of Peking University, and leading principal investigator of the study. "The ongoing clinical testing of TJ-CD4B in cancer patients will help determine its treatment potential for a wide range of malignancies that currently lack effective therapies."

"TJ-CD4B, powered by 4-1BB-activation platform, is a promising asset of the Company’s highly innovative bispecific antibody pipeline and represents the new generation of I-Mab’s continued innovation. This asset has the potential to treat highly challenging cancers, such as gastric cancer, one of the most prevalent cancer types in China and an illness that often suffers from poor prognosis," said Dr. Andrew Zhu, President of I-Mab. "TJ-CD4B is being developed both in the U.S. and China. This is another important milestone in global clinical development of TJ-CD4B. We look forward to rapidly advancing the study to evaluate the key drug properties of TJ-CD4B for further development."

About TJ-CD4B/ABL111

TJ-CD4B, also known as ABL111, is a Claudin 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to be activated only upon tumor engagement while silent elsewhere. TJ-CD4B/ABL111 effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin 18.2 antibody and 4-1BB antibody while avoiding or minimizing liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. Being developed under collaboration between I-Mab and ABL Bio, a clinical-stage biotechnology company in South Korea, TJ-CD4B/ABL111 is currently being investigated in a phase 1 clinical study in the U.S. and China. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TJ-CD4B/ABL111 for the treatment of gastric cancer, including cancer of gastroesophageal junction.

On July 22, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation (CMA) for TECVAYLI (teclistamab) as monotherapy for adult patients with relapsed and refractory multiple myeloma (RRMM), who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy (Press release, Johnson & Johnson, JUL 22, 2022, View Source [SID1234616883]). Teclistamab is an off-the-shelf, T-cell redirecting bispecific antibody. It targets both B-cell maturation antigen (BCMA), a marker found on multiple myeloma cells, and CD3, on T-cells.1

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CMA is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future.2 While newer treatment options have nearly doubled survival outcomes for patients living with multiple myeloma over the past few decades, it remains an incurable disease.3 Nearly all patients will relapse and require subsequent therapy.4 Generally, efficacy outcomes decrease with each line of therapy, and patients face poor prognoses.5

In December 2021, the EMA granted accelerated assessment for teclistamab. Accelerated assessment reduces the timeframe for the CHMP to review a marketing authorisation application (MAA) and is granted when a medicinal product is of major interest for public health and therapeutic innovation.6

"We endeavour to deliver our robust multiple myeloma pipeline of diverse mechanisms and targets with the aim of improving outcomes for patients," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "Teclistamab is testament to this approach. If adopted by the European Commission, the approval could be the first worldwide for teclistamab, as the first T-cell redirecting bispecific antibody for the treatment of patients with relapsed and refractory multiple myeloma."

This CHMP recommendation is based on positive results from the multicohort, open-label, Phase 1/2 MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM.7,8

The latest findings from the study were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting and published in The New England Journal of Medicine.1 Teclistamab resulted in deep and durable responses in patients with triple-class exposed multiple myeloma (n=165). With a median follow-up of approximately 14 months (14.1), the overall response rate was 63 percent (95 percent confidence interval [CI]: 55.2–70.4), with 39.4 percent having a complete response (CR) or better.1 Almost half (46 percent) of patients who achieved a CR or better were minimal residual disease (MRD) negative (10-5).1

Adverse events (AEs) were consistent with this patient population and toxicities consistent with T-cell redirection were mostly Grade 1/2.1 The most common AEs were cytokine release syndrome (72.1 percent; 0.6 percent Grade 3, no Grade 4) and neutropenia (70.9 percent; 64.2 percent Grade 3 or 4).1 Infections were frequent (76.4 percent; 44.8 percent Grade 3 or 4).1 The overall incidence of neurotoxic events was low (24 patients; 14.5 percent) and five patients (three percent) had immune effector cell-associated neurotoxicity syndrome.1 There were five treatment-related deaths, and dose reductions and discontinuations due to AEs were infrequent.1

"Our ambition to eliminate multiple myeloma is stronger today than ever before. We aim to reach this goal by investing in cutting-edge innovations that address individual patient needs and offer healthcare professionals options they have not had before," said Edmond Chan MBChB M.D. (Res), Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. "Today’s recommendation from the CHMP marks exciting progress in this journey, and we look forward to working with health authorities to make teclistamab available to patients across the region, as soon as possible."

About Teclistamab
Teclistamab is an investigational, fully humanised, T-cell redirecting, IgG4 bispecific antibody targeting both BCMA and CD3, on T-cells.1 BCMA is expressed at high levels on multiple myeloma cells.9,10,11 Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumour cells.12

Teclistamab is currently being evaluated in several monotherapy and combination studies.13,14,15,16,17 In January 2021 and June 2021, teclistamab received a PRIority MEdicines (PRIME) designation by the EMA and Breakthrough Therapy Designation (BTD) by the U.S. FDA, respectively. PRIME offers enhanced interaction and early dialogue to optimise drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.18 The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition based on preliminary clinical evidence that demonstrates the drug may have substantial improvement in at least one clinically significant endpoint over available therapy.19

In December 2021, Janssen Research & Development, LLC submitted a Biologics License Application (BLA) to the FDA seeking approval of teclistamab for the treatment of patients with RRMM; the MAA was submitted to the EMA for teclistamab approval in January 2022.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.20 In multiple myeloma, cancerous plasma cells change and grow out of control.20 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,500 patients died.21 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels or kidney failure.22