On July 1, 2021 Hansa Biopharma AB (Nasdaq Stockholm: HNSA) reported that it will publish its interim report for January-June 2021 at 8:00 CET on July 15, 2021 (Press release, Hansa Biopharma, JUL 1, 2021, https://www.prnewswire.com/news-releases/hansa-biopharma-to-host-conference-call-to-provide-interim-results-for-first-half-2021-and-business-update-301324007.html [SID1234584560]). All interested parties are invited to participate in a telephone conference, which will include a presentation of the interim results and a business update, on the same date at 14:00 CET/8:00am EST. The event will be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota, and the presentation will be held in English.

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!

Slides used in the presentation will be live on the company website during the call under "Events & Webcast," and will also be made available online after the call. Link to presentation

On July 1, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported multiple advancements in its 4-1BB bispecific antibody portfolio (Press release, I-Mab Biopharma, JUL 1, 2021, View Source [SID1234584559]). Stimulation of 4-1BB is a promising therapeutic strategy for improving the current immunotherapy for cancers. I-Mab’s lead bi-specific antibody assets TJ-CD4B/ABL111 and TJ-L14B/ABL503, both jointly developed with ABL Bio, Inc. (Kosdaq: 298380), are undergoing clinical development in the United States.

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!

TJ-CD4B/ABL111 is the only clinical-stage bispecific antibody that binds to Claudin 18.2 (CLDN18.2)-expressing cancer cells and co-stimulatory molecule 4-1BB on immune cells to elicit a localized and combined immune response against solid tumors. Preclinical studies have demonstrated superior CLDN18.2-dependent immune activation with TJ-CD4B/ABL111 compared to 4-1BB monoclonal antibodies. The anti-tumor activity is achieved locally at the tumor site with no hepatotoxicity or systemic side effects that are commonly seen with 4-1BB monoclonal antibodies when used alone. Studies have also demonstrated a memory response that can resist tumor rechallenge for a long-lasting treatment effect.

A U.S. phase 1 clinical trial of TJ-CD4B/ABL111 in advanced or metastatic solid tumors (NCT04900818) has been initiated with the first patient being dosed on June 29, 2021. The phase 1 clinical study is a multi-center dose escalation and dose expansion study. To accelerate TJ-CD4B/ABL111 development, China sites will join the dose expansion part of the study. Patients with gastric cancer, esophageal adenocarcinoma and pancreatic cancer in China will be enrolled later this year.

TJ-L14B/ABL503 is another novel bispecific antibody uniquely designed to activate 4-1BB signalling in the presence of PD-L1, while simultaneously blocking PD-1/PD-L1 signalling. Preclinical studies have demonstrated superior anti-tumor activity for TJ-L14B/ABL503 compared to equimolar doses of 4-1BB and PD-L1 monoclonal antibodies single agents alone or in combination. The data suggest that TJ-L14B/ABL503 induced anti-tumor response was protective against tumor rechallenge in animal studies. These results have now been accepted for publication by the Journal for ImmunoTherapy of Cancer (JITC), titled "Novel anti-4-1BB X PD-L1 bispecific antibody augments anti-tumor immunity through tumor-directed T-cell activation and checkpoint blockade." A phase 1 clinical trial for TJ-L14B/ABL503 was initiated in the U.S. earlier in April 2021 in patients with locally advanced or metastatic solid tumors (NCT04762641).

"As the next-wave of innovation in immuno-oncology, bispecific antibodies could be a promising solution to cancers that are resistant to the existing standard of care," said Dr. Joan Shen, CEO of I-Mab. "With the rapid development of our bispecific antibody portfolio, we are excited to progress one of the world’s first echelon of 4-1BB bispecific antibodies in the clinic."

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 whilst silent elsewhere. TJ-CD4B 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 it avoids or minimizes liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. TJ-CD4B is being developed under collaboration between I-Mab and ABL.

About TJ-L14B/ABL503

Being developed jointly with ABL, TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL’s ‘Grabody-T’ bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination.

On July 1, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported a business update (Press release, CNS Pharmaceuticals, JUL 1, 2021, View Source [SID1234584558]).

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!

Recent Highlights

Secured an additional $4.7 million in gross proceeds from ATM at average price of $2.32; extending the Company’s cash runway to Q2 2022;
Granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) for lead investigational drug candidate, Berubicin, for the treatment of patients with recurrent GBM; and
Commenced enrollment in potentially pivotal study evaluating the efficacy and safety of Berubicin in the treatment of recurrent GBM.
"In the last 60 days alone we have achieved fundamental clinical, regulatory and corporate milestones that together demonstrate CNS’ operational, strategic and financial strengths. We are continuously de-risking our Berubicin clinical program by driving development of this truly novel treatment forward as expeditiously as possible. In a mere 18 months from our IPO our laser focus on this program created a potentially pivotal study now open for enrollment with patient dosing expected to commence at any time. With the addition of our recent Fast Track Designation for GBM, we believe we are poised to execute on our milestones ahead and bring a meaningful treatment to patients who suffer from this devasting and heretofore incurable disease," commented John Climaco, CEO of CNS Pharmaceuticals. "Additionally, the $4.7 million of ATM transactions significantly bolsters our cash runway and provides funding to advance our important clinical programs for several quarters to come. We are passionate about driving Berubicin’s development forward, creating value in the near- and long-term, and most importantly making a positive impact on patients lives."

Clinical Programs Update

Berubicin – Novel anthracycline

CNS’ lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications. The Company recently announced the commencement of its potentially pivotal study evaluating the efficacy of Berubicin in the treatment of adult GBM, one of the most aggressive types of brain cancer. Patient dosing is expected to commence in the third quarter of 2021.

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

On July 1, 2021 Orion Biotech Opportunities Corp. (Nasdaq: ORIAU) (the "Company" or "us") reported that, commencing July 2, 2021, holders of the units sold in the Company’s initial public offering of 20,000,000 units, completed on May 17, 2021, may elect to separately trade the Class A ordinary shares and warrants included in the units (Press release, Orion Biotechnology, JUL 1, 2021, View Source [SID1234584557]). Those units that are not separated at the election of the holder will continue to trade on the Nasdaq Stock Market LLC ("Nasdaq") under the symbol "ORIAU," and the Class A ordinary shares and warrants that are separated will trade on the Nasdaq under the symbols "ORIA" and "ORIAW," respectively. Holders of the units will need to have their brokers contact Continental Stock Transfer & Trust Company, the Company’s transfer agent, in order to separate the units into Class A ordinary shares and warrants.

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 units were initially offered by the Company in an underwritten offering. Cantor Fitzgerald & Co. acted as the book running manager for the offering. A registration statement relating to the units and the underlying securities was declared effective by the Securities and Exchange Commission (the "SEC") on May 12, 2021.

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

On July 1, 2021 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for ALUNBRIG (brigatinib), which is currently FDA-approved for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test (Press release, Foundation Medicine, JUL 1, 2021, View Source [SID1234584555]). FoundationOne CDx, the only FDA-approved tissue-based comprehensive genomic profiling (CGP) test, is now able to detect ALK+ mNSCLC and identify patients who may be appropriate for treatment with ALUNBRIG which is approved as a first-line or later-line therapy.

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!

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for 85 percent of the estimated 1.8 million new cases of lung cancer diagnosed globally each year. 1 2 Approximately three to five percent of patients with NSCLC have a rearrangement in the ALK gene.3

"This approval reinforces the importance of comprehensive genomic profiling in patient care and confirms its value in guiding treatment decisions at diagnosis of metastatic non-small cell lung cancer," said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. "We’re proud to partner with Takeda to ensure patients with this serious condition have access to this important treatment option."

FoundationOne CDx, which now has 28 companion diagnostic claims, is the first and only FDA-approved tissue-based broad companion diagnostic that is clinically and analytically validated for solid tumors. This latest approval reinforces FoundationOne CDx’s ability to detect ALK rearrangements, which can be missed with alternate testing methods.

"It’s exciting to see continued advancement in personalizing medicine," said Gina Hollenbeck, President of ALK Positive. "As a non-small cell lung cancer patient myself who has experienced brain metastases, I know how important it can be to find the right treatment at the right time, especially in the first line."

Foundation Medicine and Takeda entered into an agreement to develop companion diagnostics for therapies in its late-stage lung portfolio in September 2020.

"We are excited by the approval of FoundationOne CDx as a companion diagnostic for ALUNBRIG, an important milestone in the diagnosis and treatment of people living with ALK+ non-small cell lung cancer," said Dion Warren, head, U.S. Oncology Business Unit, Takeda. "The approval of FoundationOne CDx to inform treatment with ALUNBRIG is the first of three companion diagnostics in development as part of our ongoing partnership between Foundation Medicine and Takeda aimed at addressing the urgent need for broad access to genomic tests, and expanding treatment options for people with lung cancer."

ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) that was designed to target ALK molecular alterations. ALUNBRIG is approved in the U.S., European Union (EU) and Japan as a first-line treatment for patients with ALK+ mNSCLC previously not treated with an ALK inhibitor. ALUNBRIG is also approved in more than 40 countries, including the U.S., Canada and the EU, for the treatment of people living with ALK+ mNSCLC who have taken the medicine crizotinib, but their NSCLC has worsened or they cannot tolerate taking crizotinib.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source