On September 12, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that preliminary results from the company’s Phase 1 clinical trial evaluating zanidatamab zovodotin (ZW49) for the treatment of HER2-positive tumors (Press release, Zymeworks, SEP 12, 2022, View Source [SID1234619440]). The presentation, entitled "Preliminary Results From a Phase 1 Study Using the Bispecific, Human Epidermal Growth Factor 2 (HER2)-targeting Antibody-drug Conjugate (ADC) zanidatamab zovodotin (ZW49) in Solid Cancers", was presented by Komal Jhaveri, MD, FACP, medical oncologist, Memorial Sloan Kettering Cancer Center in NYC, in a mini-oral presentation today during the European Society for Medical Oncology Annual Congress at the Paris Expo Porte de Versailles in Paris, France.

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A total of 77 patients were enrolled in this first-in-human trial, which was designed to determine the maximum tolerated dose of zanidatamab zovodotin, characterize its safety and tolerability, and evaluate anti-tumor activity in HER2-expressing cancers as monotherapy. The patients represented a variety of HER2-expressing cancers including breast, gastroesophageal, ovarian, endometrial, bladder, biliary tract, anal, colorectal, pancreatic and lung. At the time of the analysis, the maximum tolerated dose had not yet been reached.

Commenting on the data, Dr. Jhaveri noted, "The preliminary results of this trial are very encouraging. Zanidatamab zovodotin dosed on an every three week (Q3W) schedule is active and has a manageable safety profile. I am excited to see further clinical development of zanidatmab zovodotin across a variety of HER2-expressing cancers."

In the trial, zanidatamab zovodotin was shown to have a manageable safety profile with the majority of adverse events being Grade 1 or 2 in severity. In patients with HER2-positive cancers treated with zanidatamab zovodotin at 2.5 mg/kg Q3W (dose escalation + dose expansion), the confirmed objective response rate was 31% and the disease control rate was 72%. The Phase 1 clinical trial is ongoing and continues to enroll patients to study safety, tolerability and activity for an alternate qW dosing regimen. The Company expects to present results of this dosing regimen at a medical meeting in 2023.

"We are grateful to the patients who participated in this trial and appreciate the collaborative efforts and dedication of the outstanding group of clinical investigators who are participating in this Phase 1 study," said Neil Josephson, MD, Chief Medical Officer of Zymeworks. "These promising results provide significant momentum for the further clinical development of zanidatamab zovodotin, as a monotherapy, and in combination with standard of care agents, for the treatment of cancers expressing HER2 or harboring HER2 gene alterations."

Conference Call

Dr. Jhaveri’s complete presentation at the ESMO (Free ESMO Whitepaper) 2022 Congress is available for review on Zymeworks’ website. Zymeworks will hold a conference call to discuss Dr. Jhaveri’s presentation and future clinical development plans for zanidatamab zovodotin on Monday, September 12th at 4:30 pm EST. Interested parties can access the live webcast via Zymeworks’ website at View Source A recorded replay will be accessible after the event through the Zymeworks website.

Disclosure: Dr. Jhaveri has a consulting relationship with Zymeworks.

On September 12, 2022 Volastra Therapeutics, an oncology company focused on exploiting chromosomal instability to treat cancer, reported it has been named as one of Fierce Biotech’s 2022 "Fierce 15," designating it as one of the most promising early-stage biotechnology companies in the industry (Press release, Volastra Therapeutics, SEP 12, 2022, View Source;utm_medium=rss&utm_campaign=volastra-therapeutics-named-one-of-fierce-biotechs-fierce-15-companies-of-2022 [SID1234619438]).

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"It is an honor and tremendous validation of our team and progress to be among the Fierce 15," said Charles Hugh-Jones, M.D., FRCP, Chief Executive Officer at Volastra. "Our unique understanding of chromosomal instability combined with our proprietary CINtech platform allows us to develop potentially life-saving therapies for patients. I am extremely proud of what we have accomplished in just the last three years, and the promise of what lies ahead."

Michael Su, Ph.D., the company’s Chief Scientific Officer, added, "We are particularly excited about our lead program, a KIF18A inhibitor that is on track to begin a Phase 1 trial in the second half of 2023. We recently announced compelling preclinical data supporting the potential of Volastra’s KIF18A inhibitor to induce tumor regression."

Now in its 20th Fierce 15 selection, Fierce Biotech evaluates hundreds of early-stage companies from around the world for its annual list, which celebrates the spirit of being "fierce"— championing innovation and creativity in the face of strong competition. Winners are selected based on a variety of factors, such as the strength of their scientific approach, leadership, technology, partnerships, venture backers, and scale of unmet needs they are solving for.

On September 12, 2022 Upsher-Smith Laboratories, LLC (Upsher-Smith) reported that it has expanded its ongoing partnership with Appco Pharma LLC (Appco) with the addition of a near-term generic product opportunity to its portfolio (Press release, Upsher-Smith Laboratories, SEP 12, 2022, View Source [SID1234619437]). This collaboration is part of Upsher-Smith’s company-wide effort to grow the Company’s portfolio of products through strategic partnerships and product acquisitions.

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"This agreement further expands an already solid working relationship between Upsher-Smith and Appco," said Rich Fisher, President and COO, Upsher-Smith. "Appco has extensive skills and experience in the development of diverse dosage forms that span a wide range of therapeutic areas. Our long-standing partnership has yielded a number of commercial-stage products. We are pleased to add their development strengths to our core competencies and expand Upsher-Smith’s product portfolio to accelerate growth in the U.S."

"We are pleased to add one more product to our partnership with Upsher-Smith," said Srini Paruchuri, COO, Appco. "Appco highly values Upsher-Smith’s strength in sales and marketing which complements Appco’s development and manufacturing capabilities. We look forward to expanding and growing this partnership.’’

Upsher-Smith will open its world-class manufacturing facility in Maple Grove, MN later this year. The new, 270,000 square foot facility will have fully up-to-date serialization and packaging capabilities and has capacity and capabilities that can support contract manufacturing for third parties. To learn more, visit www.upsher-smith.com.

On September 12, 2022 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported that it has entered into a debt financing facility for up to $60 million with K2 HealthVentures (K2HV), a healthcare-focused specialty finance company (Press release, TScan Therapeutics, SEP 12, 2022, View Source [SID1234619436]).

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"Access to the first $30 million tranche of this substantive additional capital, along with the current cash on hand, will provide TScan with a cash runway well into the second quarter of 2024. This will allow us to achieve additional value-creating milestones across both our solid tumor and hematologic malignancy clinical programs," said David P. Southwell, President and Chief Executive Officer. "We anticipate building out our ImmunoBank with the filing of IND applications in our solid tumor program for two TCRs in 2022 as planned, to be followed by IND filings for two additional TCRs in the first half of 2023 that will enable us to launch multiplexing clinical trials for solid tumors."

TScan drew $30 million from K2HV upon closing of the loan agreement. The Company has the option to draw the remaining tranches subject to certain conditions and by mutual agreement of TScan and K2HV to further support development of additional programs and/or business development. The borrowings under the loan agreement have an interest rate equal to the greater of 8.75%, or the Prime Rate plus 4.75%, subject to a cap of 9.90%. The first tranche of the loan is convertible at the option of K2HV into common shares of TScan at a conversion price of approximately $4.785 per share. Future tranches will be convertible as specified in the agreement. In addition, TScan has the ability to repay the loan at any time either in cash or in shares, subject to applicable premiums as specified in the loan agreement. Further information with respect to the loan agreement is set forth in a Form 8-K filed by TScan with the Securities and Exchange Commission on September 12, 2022.

Parag Shah, Founding Managing Director and CEO of K2 HealthVentures, said, "We are pleased to partner with TScan on this financing and will work closely with them as they progress their clinical pipeline in both solid tumors and hematologic malignancies. TScan’s deep understanding of tumor biology along with their proprietary technologies will enable them to advance their ImmunoBank and bring multiplexed therapies to the clinic."

On September 12, 2022 Triumvira Immunologics ("Triumvira"), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported positive initial clinical data from its ongoing TACTIC‑2 Phase 1/2 trial of TAC01-HER2 in patients with human epidermal growth factor receptor 2 (HER2) positive solid tumors (Press release, Triumvira Immunologics, SEP 12, 2022, View Source [SID1234619435]). Initial clinical data demonstrate TAC01-HER2 was well-tolerated in both dosing cohorts and early signals of clinical activity were observed in the higher of the two dosing cohorts, demonstrating a 75% disease control rate, including one partial response. These initial results were presented in a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2022 Congress.

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"Every milestone achievement bolsters our confidence as we leverage our novel, versatile TAC platform to develop a T cell therapy that is less toxic than existing T cell therapies yet effective in killing target-bearing solid tumors"

The first two dosing cohorts of the trial enrolled eight patients with advanced, metastatic, unresectable HER2-positive solid tumors who had experienced up to two prior lines of therapy including HER2 targeted therapies. Early signals of clinical activity were observed in the second dosing cohort (6-8 x 105 cells/kg) with a disease control rate of 75%. A partial response was observed in a patient with stage IVb metastatic gastric cancer who was heavily pre-treated and defined as 3+ HER2 by immunohistochemistry (IHC). CT scans taken 29-days after dosing showed a 36.5% reduction in tumor size in target lesions compared to baseline and the size of numerous metabolically active lymph nodes associated with the mass decreased. Two patients with significant disease burden within the second cohort, one with colorectal cancer and one with gall bladder cancer, have been observed with stable disease with no change in tumor measurements compared to baseline.