On January 28, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that its partner BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, positive interim results from the Phase I/IIa trial of the novel anti-FcγRIIB antibody BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL) (Press release, CASI Pharmaceuticals, JAN 28, 2021, View Source [SID1234574372]).

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"The responses observed in six out of nine patients are very encouraging and clearly suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. The complete responses we have seen in two patients are particularly impressive and indicate that BI-1206 has the potential to significantly improve the lives of NHL patients who have progressed after several lines of treatment. Based on these results, we will now move to identify the recommended Phase II dose for the Phase IIa part of the trial and look forward to further evaluating the exciting potential of BI-1206 to bring much needed innovation to lymphoma patients," said Martin Welschof, Ph.D, CEO of BioInvent.

Of the 9 patients who completed the induction cycle, 6 patients have shown either complete or partial responses several of which are still ongoing. Two patients (30 mg and 70 mg dose) achieved a complete response, which continues to be sustained 12 and 24 months later. Another patient who had a blastoid form of MCL achieved a partial response, and a complete depletion of peripheral tumor cells. Readout from two patients is still pending.

A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies.

To address dose limiting toxicities seen at higher doses earlier in the trial, a new safety protocol was implemented, enabling higher doses to be administered. No dose-limiting toxicities have been observed in the five patients who have been treated under the current protocol, despite receiving higher doses of BI-1206.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, said, "We continue to be excited about this anti-FcγRIIB antibody’s potential in restoring rituximab’s activity in NHL patients, and these results provided further encouraging evidence of its potential as a durable and safe treatment alternative. We remain encouraged by its potential application across multiple tumor types in many first line treatments and in refractory settings and are excited to be taking an important step closer to making BI-1206 available to patients and healthcare providers across Greater China."

BioInvent will hold a key opinion leader (KOL) call today, Thursday, January 28 at 5:30 p.m. CET (11:30 a.m. ET) to discuss the results and next steps in clinical development of BI-1206. Renowned lymphoma expert Mats Jerkeman, MD, Lund University, will give a presentation on the current treatment landscape, and unmet medical need for patients with relapsed or refractory NHL. The BioInvent management team will be available for Q&A and CASI will provide an update on the development plan and potential for BI-1206 in China.

About the BioInvent Phase I/IIa study of BI-1206 in NHL The Phase I/IIa study consists of two parts: i) Phase l, with dose escalation cohorts using a 3+3 dose-escalation design and selection of the recommended Phase IIa dose (RP2D); and ii) Phase IIa, an expansion cohort at the RP2D, enriched with patients with mantle cell lymphoma (MCL). Subjects in each phase receive 1 cycle (4 doses) of induction therapy with BI-1206 in combination with rituximab. Subjects who show clinical benefit at week 6 continue onto maintenance therapy and receive BI-1206 and rituximab once every 8 weeks for up to 6 maintenance cycles, or up to 1 year from first dose of BI-1206.

On January 28, 2021 CureVac N.V. (Nasdaq: CVAC) ("CureVac" or the "Company"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported the pricing of its follow-on public offering of 5,000,000 common shares at a public offering price of $90.00 per common share, for total gross proceeds of approximately $450 million (Press release, CureVac, JAN 28, 2021, View Source [SID1234574364]). In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 750,000 common shares at the public offering price, less underwriting discounts and commissions. All of the common shares are being offered by CureVac. The offering is expected to close on February 1, 2021, subject to satisfaction of customary closing conditions.

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BofA Securities, Jefferies and Evercore ISI are acting as joint book-running managers for the offering. UBS Investment Bank, Guggenheim Securities, Berenberg and Kempen & Co are acting as passive book running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission ("SEC") on January 27, 2021. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus, when available, may be obtained from BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, by telephone at (800) 299-1322 or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474 0200, 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 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 January 27, 2021 LegoChem Biosciences (141080KS, ‘LCB’) reported that it has entered into a worldwide license agreement with Pyxis Oncology (hereinafter ’Pyxis’) for the development and commercialization of LCB67, an innovative antibody-drug-conjugate (ADC) candidate (Press release, LegoChem Biosciences, JAN 27, 2021, View Source;sc_seq=413 [SID1234628152]).

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Under the terms of the agreement, Pyxis will make an upfront payment of $9.5 million plus the cost LCB has spent for clinical trial material production upon its completion next year. LCB is eligible to receive milestone payments of up to $284.5 million as well as royalties on commercial sales. In addition, LCB has a right to exercise an option for obtaining Pyxis’ equity and revenue sharing upon Pyxis’ sublicense agreement with third party companies. Payments from Pyxis though this agreement will be shared with Y-Biologics based on pre-agreed terms

The licensed ADC program (LCB67, a DLK1-targeting ADC) is an Investigational Drug Candidate that has been generated through combining LCB’s next-generation ADC platform with anti-DLK1 antibody, which was in-licensed from Y-Biologics. DLK-1 is a novel cancer target which is associated with various solid tumors including liver and small cell lung cancers. Pyxis plans to advance this program to clinical trials for progressive solid cancers with high medical unmet needs

Pyxis is a Boston-based biotechnology company developing first-in-class and best-in-class oncology therapeutics with a broad oncology biologics pipeline. Under the direction of its management team of experienced industry professionals and experts in the field, Pyxis is further strengthening its portfolio through this agreement with LCB

The members of Pyxis are industry-leading US experts who have successfully led the development of innovative new drugs, and we have a strong confidence that Pyxis will enter LCB67 into clinical trials in the most efficient manner." said Dr. Yong-Zu Kim, CEO and President of LCB

Dr. Lara Sullivan, CEO of Pyxis, added, "LCB67 has significant potential to be an effective treatment for a range of indications. LegoChem’s unique ADC platform drastically improves upon existing technology to provide a highly stable therapeutic with unparalleled manufacturing consistency. Our partnership with LegoChem is crucial to advance this next generation ADC to the clinic and ultimately bring a new potential treatment option to patients

This agreement is the second case of LCB’s ADCs generated through successful collaboration between Korean biotech companies, first being LCB71, an anti-ROR1 ADC which was co-developed by LCB and ABL BIO and licensed to CStone Pharmaceuticals last month. This is the 4th global licensing agreement of LCB’s ADCs this year only

On January 27, 2021 LegoChem Biosciences reported that it has entered into a worldwide license agreement with Pyxis Oncology for the development and commercialization of LCB67, an innovative antibody-drug-conjugate (ADC) candidate (Press release, LegoChem Biosciences, JAN 27, 2021, View Source;sc_seq=413 [SID1234628151]).

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Under the terms of the agreement, Pyxis will make an upfront payment of $9.5 million plus the cost LCB has spent for clinical trial material production upon its completion next year. LCB is eligible to receive milestone payments of up to $284.5 million as well as royalties on commercial sales. In addition, LCB has a right to exercise an option for obtaining Pyxis’ equity and revenue sharing upon Pyxis’ sublicense agreement with third party companies. Payments from Pyxis though this agreement will be shared with Y-Biologics based on pre-agreed terms.

The licensed ADC program (LCB67, a DLK1-targeting ADC) is an Investigational Drug Candidate that has been generated through combining LCB’s next-generation ADC platform with anti-DLK1 antibody, which was in-licensed from Y-Biologics. DLK-1 is a novel cancer target which is associated with various solid tumors including liver and small cell lung cancers. Pyxis plans to advance this program to clinical trials for progressive solid cancers with high medical unmet needs.

"The members of Pyxis are industry-leading US experts who have successfully led the development of innovative new drugs, and we have a strong confidence that Pyxis will enter LCB67 into clinical trials in the most efficient manner." said Dr. Yong-Zu Kim, CEO and President of LCB.

Dr. Lara Sullivan, CEO of Pyxis, added, "LCB67 has significant potential to be an effective treatment for a range of indications. LegoChem’s unique ADC platform drastically improves upon existing technology to provide a highly stable therapeutic with unparalleled manufacturing consistency. Our partnership with LegoChem is crucial to advance this next generation ADC to the clinic and ultimately bring a new potential treatment option to patients."

This agreement is the second case of LCB’s ADCs generated through successful collaboration between Korean biotech companies, first being LCB71, an anti-ROR1 ADC which was co-developed by LCB and ABL BIO and licensed to CStone Pharmaceuticals last month. This is the 4th global licensing agreement of LCB’s ADCs this year only.

On January 27, 2021 FORUS Therapeutics reported that launches bringing a new pharmaceutical company onto the Canadian landscape (Press release, FORUS Therapeutics, JAN 27, 2021, View Source [SID1234578027]). With a highly-experienced and proven team, an FDA-approved product already in its pipeline, and significant financial investment secured, the Toronto-based company looks to bring innovative cancer therapies to Canadian patients, new treatment tools for caregivers and physicians, and in the future, be a preferred partner for emerging Canadian-based research companies.

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To support its launch, FORUS has raised approximately $20 million from investors that include adMare BioInnovations, Canada’s global life sciences venture, and sophisticated international and institutional investors.

FORUS has also secured an exclusive Canadian distribution agreement with Karyopharm Therapeutics Inc. (Nasdaq: KPTI) for the commercialization of XPOVIO (selinexor), an FDA-approved cancer medicine for adults with multiple myeloma and lymphoma. "We are thrilled to launch on the heels of our first licensing agreement to deliver a novel cancer treatment for Canadians," said Kevin Leshuk, Founder and President of FORUS.

Multiple myeloma is the second most common blood cancer. Every year, 3,400 Canadians are diagnosed with multiple myeloma, and sadly 1,600 die from the disease. FORUS will submit XPOVIO to Health Canada for approval in the coming months.

"We are investing in and supporting the launch of FORUS to address a major gap in the Canadian life sciences ecosystem," said Gordon C. McCauley, President and CEO of adMare BioInnovations. "We have an abundance of world-leading health research, a growing industry to translate that research into new therapeutics, but we have limited home-grown companies to bring these innovations directly to Canadian patients. FORUS begins to fill this gap by connecting medical innovations with the healthcare and patient communities across the country."

"We’re turning the traditional start-up model upside down," said Leshuk. Biopharmaceutical start-ups typically begin with early research, then undergo an arduous process of translating the research into a product, which can take at least a decade and have high associated failure rates. In this case, FORUS is starting on strong footing with an FDA-approved product already in place, considerable investment, and an experienced team. The company will move quickly to identify and secure development partnerships with Canadian research companies and globally-sourced innovations.

Leshuk brings over 25 years of experience in the pharmaceutical industry. He and the FORUS founding team have delivered significant financial returns; and since 2009, secured 12 Health Canada approvals, including five in multiple myeloma. The FORUS goal is to continue this track record of success and bring important new medicines to Canadians to actively contribute to the Canadian life sciences innovation ecosystem.